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| Stem definition | Drug id | CAS RN |
|---|---|---|
| sodium glucose co-transporter inhibitors, phlorizin derivatives | 4830 | 864070-44-0 |
| Dose | Unit | Route |
|---|---|---|
| 17.50 | mg | O |
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Hosey CM, Chan R, Benet LZ |
| S (Water solubility) | 0.11 mg/mL | Bocci G, Oprea TI, Benet LZ |
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 1.566 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 25.823 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 3.673 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 2.312 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 14.830 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 25.090 | % | High | 1 |
| herg | hERG pIC50 | 4.436 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.528 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.451 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 15.100 | % | High | 1 |
| kinase-safety-class | ACVR2B,BRAF,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAPK10,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK,ZAP70 | 17 | |||
| kinase-selectivity-class | MAP2K6 | 1 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 17.539 | High | 1 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 8.531 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 10.375 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 10.950 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 20.277 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 19.350 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.017 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 5.248 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 76.310 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 7.740 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 881.049 | uM | High | 1 |
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 1, 2014 | FDA | BOEHRINGER INGELHEIM | |
| March 20, 2014 | EMA | ||
| Dec. 26, 2014 | PMDA | Nippon Boehringer Ingelheim Co., Ltd |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Diabetic ketoacidosis | 5267.34 | 12.30 | 1355 | 37553 | 23052 | 90566487 |
| Euglycaemic diabetic ketoacidosis | 3547.26 | 12.30 | 760 | 38148 | 5441 | 90584098 |
| Ketoacidosis | 2428.43 | 12.30 | 547 | 38361 | 5048 | 90584491 |
| Fungal infection | 1326.12 | 12.30 | 545 | 38363 | 42116 | 90547423 |
| Lactic acidosis | 495.35 | 12.30 | 294 | 38614 | 50169 | 90539370 |
| Metabolic acidosis | 349.72 | 12.30 | 245 | 38663 | 55431 | 90534108 |
| Acute kidney injury | 312.31 | 12.30 | 521 | 38387 | 319866 | 90269673 |
| Glycosylated haemoglobin increased | 286.77 | 12.30 | 138 | 38770 | 15424 | 90574115 |
| Urinary tract infection | 272.72 | 12.30 | 478 | 38430 | 305154 | 90284385 |
| Blood ketone body increased | 268.14 | 12.30 | 55 | 38853 | 306 | 90589233 |
| Blood glucose increased | 258.75 | 12.30 | 258 | 38650 | 94988 | 90494551 |
| Hypoglycaemia | 200.43 | 12.30 | 195 | 38713 | 69653 | 90519886 |
| Ketosis | 179.14 | 12.30 | 46 | 38862 | 763 | 90588776 |
| Dehydration | 174.31 | 12.30 | 305 | 38603 | 194142 | 90395397 |
| Glomerular filtration rate decreased | 166.91 | 12.30 | 99 | 38809 | 16833 | 90572706 |
| Necrotising fasciitis | 163.96 | 12.30 | 62 | 38846 | 3818 | 90585721 |
| Malignant mediastinal neoplasm | 145.28 | 12.30 | 44 | 38864 | 1364 | 90588175 |
| Cardiac failure | 135.46 | 12.30 | 199 | 38709 | 109297 | 90480242 |
| Urosepsis | 132.21 | 12.30 | 93 | 38815 | 21139 | 90568400 |
| Urine ketone body present | 130.79 | 12.30 | 47 | 38861 | 2505 | 90587034 |
| Vulvovaginal pruritus | 130.61 | 12.30 | 53 | 38855 | 3940 | 90585599 |
| Emphysematous pyelonephritis | 128.39 | 12.30 | 30 | 38878 | 328 | 90589211 |
| Vomiting | 121.29 | 12.30 | 661 | 38247 | 787632 | 89801907 |
| Infusion related reaction | 117.65 | 12.30 | 19 | 38889 | 416761 | 90172778 |
| Glossodynia | 116.78 | 12.30 | 5 | 38903 | 321774 | 90267765 |
| Pemphigus | 115.65 | 12.30 | 6 | 38902 | 326858 | 90262681 |
| Hyperglycaemia | 109.65 | 12.30 | 122 | 38786 | 50848 | 90538691 |
| Blood glucose abnormal | 105.48 | 12.30 | 60 | 38848 | 9432 | 90580107 |
| Ketonuria | 105.17 | 12.30 | 30 | 38878 | 751 | 90588788 |
| Treatment failure | 103.20 | 12.30 | 7 | 38901 | 303921 | 90285618 |
| Genital infection fungal | 103.18 | 12.30 | 23 | 38885 | 200 | 90589339 |
| Pericarditis | 98.67 | 12.30 | 4 | 38904 | 270147 | 90319392 |
| Systemic lupus erythematosus | 94.60 | 12.30 | 20 | 38888 | 361876 | 90227663 |
| Blood immunoglobulin E increased | 93.06 | 12.30 | 43 | 38865 | 4382 | 90585157 |
| Hypovolaemia | 92.99 | 12.30 | 61 | 38847 | 12370 | 90577169 |
| Polyuria | 91.95 | 12.30 | 56 | 38852 | 9984 | 90579555 |
| Vulvovaginal mycotic infection | 89.82 | 12.30 | 47 | 38861 | 6267 | 90583272 |
| Hyperkalaemia | 89.02 | 12.30 | 124 | 38784 | 64840 | 90524699 |
| Acetonaemia | 89.01 | 12.30 | 22 | 38886 | 310 | 90589229 |
| Synovitis | 88.73 | 12.30 | 17 | 38891 | 329735 | 90259804 |
| Arthropathy | 88.35 | 12.30 | 24 | 38884 | 366218 | 90223321 |
| Eosinophilic myocarditis | 86.37 | 12.30 | 25 | 38883 | 660 | 90588879 |
| Wound | 85.04 | 12.30 | 14 | 38894 | 302966 | 90286573 |
| Sepsis | 84.73 | 12.30 | 217 | 38691 | 179597 | 90409942 |
| Contraindicated product administered | 83.03 | 12.30 | 18 | 38890 | 320121 | 90269418 |
| Pancreatitis | 82.15 | 12.30 | 124 | 38784 | 69702 | 90519837 |
| Helicobacter infection | 80.73 | 12.30 | 4 | 38904 | 226846 | 90362693 |
| Swelling | 80.02 | 12.30 | 40 | 38868 | 419018 | 90170521 |
| COVID-19 | 79.79 | 12.30 | 204 | 38704 | 168639 | 90420900 |
| Therapeutic product effect decreased | 79.77 | 12.30 | 12 | 38896 | 277559 | 90311980 |
| Drug intolerance | 77.84 | 12.30 | 48 | 38860 | 447543 | 90141996 |
| Impaired healing | 77.75 | 12.30 | 6 | 38902 | 234193 | 90355346 |
| Maternal exposure during pregnancy | 77.25 | 12.30 | 29 | 38879 | 360034 | 90229505 |
| Exposure during pregnancy | 76.69 | 12.30 | 7 | 38901 | 238403 | 90351136 |
| Prerenal failure | 75.85 | 12.30 | 30 | 38878 | 2085 | 90587454 |
| Folliculitis | 74.70 | 12.30 | 3 | 38905 | 204350 | 90385189 |
| Pollakiuria | 72.70 | 12.30 | 80 | 38828 | 32925 | 90556614 |
| Pyelonephritis fungal | 71.69 | 12.30 | 17 | 38891 | 199 | 90589340 |
| Acidosis | 70.62 | 12.30 | 52 | 38856 | 12684 | 90576855 |
| Perinephric abscess | 70.24 | 12.30 | 18 | 38890 | 296 | 90589243 |
| Irritable bowel syndrome | 69.75 | 12.30 | 5 | 38903 | 207443 | 90382096 |
| Hyperglycaemic hyperosmolar nonketotic syndrome | 69.35 | 12.30 | 25 | 38883 | 1344 | 90588195 |
| Stomatitis | 66.23 | 12.30 | 18 | 38890 | 274680 | 90314859 |
| Drug hypersensitivity | 66.14 | 12.30 | 61 | 38847 | 463548 | 90125991 |
| Pyelonephritis | 65.81 | 12.30 | 62 | 38846 | 21254 | 90568285 |
| Hypersensitivity | 64.65 | 12.30 | 60 | 38848 | 454617 | 90134922 |
| Glucose urine present | 62.75 | 12.30 | 21 | 38887 | 903 | 90588636 |
| Rheumatoid factor positive | 61.15 | 12.30 | 3 | 38905 | 171647 | 90417892 |
| Rheumatoid arthritis | 60.14 | 12.30 | 41 | 38867 | 362573 | 90226966 |
| Diabetic ketosis | 59.90 | 12.30 | 18 | 38890 | 543 | 90588996 |
| Musculoskeletal stiffness | 57.03 | 12.30 | 28 | 38880 | 296504 | 90293035 |
| Pruritus genital | 56.61 | 12.30 | 31 | 38877 | 4527 | 90585012 |
| Nausea | 56.50 | 12.30 | 725 | 38183 | 1109591 | 89479948 |
| Ischaemic contracture of the left ventricle | 56.24 | 12.30 | 13 | 38895 | 135 | 90589404 |
| Hypophagia | 55.93 | 12.30 | 73 | 38835 | 35864 | 90553675 |
| Hepatic enzyme increased | 55.66 | 12.30 | 44 | 38864 | 360692 | 90228847 |
| Injury | 55.62 | 12.30 | 9 | 38899 | 197340 | 90392199 |
| Urinary tract candidiasis | 54.70 | 12.30 | 18 | 38890 | 734 | 90588805 |
| Bronchiectasis | 54.23 | 12.30 | 57 | 38851 | 22273 | 90567266 |
| Genitourinary tract infection | 54.03 | 12.30 | 14 | 38894 | 241 | 90589298 |
| C3 glomerulopathy | 53.93 | 12.30 | 13 | 38895 | 164 | 90589375 |
| Glycosylated haemoglobin abnormal | 53.18 | 12.30 | 14 | 38894 | 257 | 90589282 |
| Genital infection | 52.74 | 12.30 | 13 | 38895 | 181 | 90589358 |
| Perineal infection | 52.67 | 12.30 | 13 | 38895 | 182 | 90589357 |
| Musculoskeletal pain | 52.54 | 12.30 | 6 | 38902 | 171245 | 90418294 |
| Vesicoureteric reflux | 51.41 | 12.30 | 14 | 38894 | 294 | 90589245 |
| Candida sepsis | 50.85 | 12.30 | 21 | 38887 | 1632 | 90587907 |
| Joint swelling | 50.14 | 12.30 | 87 | 38821 | 503213 | 90086326 |
| Glycosuria | 50.13 | 12.30 | 20 | 38888 | 1422 | 90588117 |
| Vulvovaginal candidiasis | 49.75 | 12.30 | 27 | 38881 | 3873 | 90585666 |
| Alopecia | 48.94 | 12.30 | 86 | 38822 | 494985 | 90094554 |
| Pain | 48.93 | 12.30 | 241 | 38667 | 996100 | 89593439 |
| Fibromyalgia | 48.80 | 12.30 | 14 | 38894 | 206255 | 90383284 |
| Mobility decreased | 47.72 | 12.30 | 24 | 38884 | 250710 | 90338829 |
| Candida infection | 46.63 | 12.30 | 65 | 38843 | 33992 | 90555547 |
| Urine ketone body | 46.60 | 12.30 | 11 | 38897 | 126 | 90589413 |
| Blood ketone body | 46.53 | 12.30 | 10 | 38898 | 72 | 90589467 |
| Toe amputation | 46.32 | 12.30 | 21 | 38887 | 2048 | 90587491 |
| Weight decreased | 46.17 | 12.30 | 300 | 38608 | 379610 | 90209929 |
| Diabetes mellitus inadequate control | 45.92 | 12.30 | 48 | 38860 | 18636 | 90570903 |
| Sinusitis | 45.60 | 12.30 | 48 | 38860 | 343040 | 90246499 |
| Discomfort | 45.49 | 12.30 | 31 | 38877 | 274304 | 90315235 |
| Ill-defined disorder | 44.76 | 12.30 | 12 | 38896 | 184879 | 90404660 |
| Diabetic metabolic decompensation | 44.24 | 12.30 | 20 | 38888 | 1937 | 90587602 |
| Systemic candida | 43.72 | 12.30 | 27 | 38881 | 4932 | 90584607 |
| Blister | 43.38 | 12.30 | 28 | 38880 | 254970 | 90334569 |
| Coagulation test abnormal | 42.78 | 12.30 | 16 | 38892 | 955 | 90588584 |
| Blood cholesterol increased | 42.54 | 12.30 | 18 | 38890 | 207994 | 90381545 |
| Urine protein/creatinine ratio increased | 42.14 | 12.30 | 16 | 38892 | 996 | 90588543 |
| Vulval abscess | 42.14 | 12.30 | 16 | 38892 | 996 | 90588543 |
| Bursitis | 41.96 | 12.30 | 4 | 38904 | 131650 | 90457889 |
| Altered state of consciousness | 41.42 | 12.30 | 59 | 38849 | 31473 | 90558066 |
| Glycosylated haemoglobin decreased | 41.12 | 12.30 | 14 | 38894 | 635 | 90588904 |
| Cardiac failure chronic | 40.51 | 12.30 | 27 | 38881 | 5619 | 90583920 |
| Hypernatraemia | 40.43 | 12.30 | 33 | 38875 | 9354 | 90580185 |
| Anion gap increased | 38.41 | 12.30 | 19 | 38889 | 2251 | 90587288 |
| Renal impairment | 37.56 | 12.30 | 115 | 38793 | 105306 | 90484233 |
| Nasopharyngitis | 37.31 | 12.30 | 74 | 38834 | 407030 | 90182509 |
| Pyelonephritis acute | 36.64 | 12.30 | 25 | 38883 | 5407 | 90584132 |
| Rhabdomyolysis | 36.58 | 12.30 | 73 | 38835 | 51183 | 90538356 |
| Starvation ketoacidosis | 36.50 | 12.30 | 10 | 38898 | 215 | 90589324 |
| Vulvovaginal discomfort | 35.32 | 12.30 | 19 | 38889 | 2678 | 90586861 |
| Necrotising soft tissue infection | 35.26 | 12.30 | 10 | 38898 | 245 | 90589294 |
| Diarrhoea | 35.23 | 12.30 | 582 | 38326 | 938608 | 89650931 |
| Oliguria | 34.91 | 12.30 | 32 | 38876 | 10592 | 90578947 |
| Vulvovaginitis | 34.88 | 12.30 | 11 | 38897 | 391 | 90589148 |
| Psoriatic arthropathy | 33.77 | 12.30 | 29 | 38879 | 228306 | 90361233 |
| Renal abscess | 33.67 | 12.30 | 14 | 38894 | 1107 | 90588432 |
| Crush syndrome | 33.36 | 12.30 | 10 | 38898 | 299 | 90589240 |
| Hypertension | 33.28 | 12.30 | 94 | 38814 | 457438 | 90132101 |
| Product use issue | 32.85 | 12.30 | 57 | 38851 | 329862 | 90259677 |
| Neutropenia | 32.73 | 12.30 | 29 | 38879 | 224875 | 90364664 |
| Polycythaemia | 32.49 | 12.30 | 14 | 38894 | 1209 | 90588330 |
| Joint range of motion decreased | 32.46 | 12.30 | 9 | 38899 | 135634 | 90453905 |
| Pulmonary fibrosis | 32.39 | 12.30 | 4 | 38904 | 107499 | 90482040 |
| Pancreatitis acute | 32.17 | 12.30 | 53 | 38855 | 32062 | 90557477 |
| Blood glucose decreased | 31.01 | 12.30 | 44 | 38864 | 23385 | 90566154 |
| Diabetic ketoacidotic hyperglycaemic coma | 30.89 | 12.30 | 7 | 38901 | 66 | 90589473 |
| pH body fluid abnormal | 30.08 | 12.30 | 7 | 38901 | 75 | 90589464 |
| Blood ketone body present | 30.00 | 12.30 | 7 | 38901 | 76 | 90589463 |
| Thirst | 29.98 | 12.30 | 36 | 38872 | 16259 | 90573280 |
| Hypercholesterolaemia | 29.81 | 12.30 | 4 | 38904 | 100888 | 90488651 |
| Leukopenia | 29.73 | 12.30 | 4 | 38904 | 100706 | 90488833 |
| Gait inability | 29.42 | 12.30 | 13 | 38895 | 146443 | 90443096 |
| Vascular stent stenosis | 29.28 | 12.30 | 11 | 38897 | 665 | 90588874 |
| Failure to suspend medication | 29.21 | 12.30 | 7 | 38901 | 86 | 90589453 |
| Liver disorder | 29.10 | 12.30 | 8 | 38900 | 121261 | 90468278 |
| Lung disorder | 29.03 | 12.30 | 14 | 38894 | 149869 | 90439670 |
| Genital erythema | 28.72 | 12.30 | 6 | 38902 | 37 | 90589502 |
| Catarrh | 28.61 | 12.30 | 14 | 38894 | 1620 | 90587919 |
| Genital abscess | 28.61 | 12.30 | 9 | 38899 | 317 | 90589222 |
| Prescribed overdose | 28.53 | 12.30 | 4 | 38904 | 97621 | 90491918 |
| Septic shock | 28.31 | 12.30 | 90 | 38818 | 84070 | 90505469 |
| Diabetic coma | 28.28 | 12.30 | 11 | 38897 | 731 | 90588808 |
| Sleep disorder | 28.26 | 12.30 | 26 | 38882 | 198004 | 90391535 |
| Sensorimotor disorder | 28.10 | 12.30 | 11 | 38897 | 744 | 90588795 |
| Blood lactic acid increased | 27.99 | 12.30 | 26 | 38882 | 8752 | 90580787 |
| Allergic sinusitis | 27.99 | 12.30 | 15 | 38893 | 2098 | 90587441 |
| Dysuria | 27.97 | 12.30 | 56 | 38852 | 39345 | 90550194 |
| Pemphigoid | 27.37 | 12.30 | 26 | 38882 | 9000 | 90580539 |
| Liver injury | 27.31 | 12.30 | 20 | 38888 | 170547 | 90418992 |
| Perineal pain | 27.13 | 12.30 | 10 | 38898 | 573 | 90588966 |
| Impaired quality of life | 27.06 | 12.30 | 41 | 38867 | 23103 | 90566436 |
| Steroid dependence | 26.99 | 12.30 | 15 | 38893 | 2254 | 90587285 |
| Cerebral infarction | 26.79 | 12.30 | 44 | 38864 | 26552 | 90562987 |
| BRASH syndrome | 26.76 | 12.30 | 14 | 38894 | 1865 | 90587674 |
| Night sweats | 26.55 | 12.30 | 11 | 38897 | 128755 | 90460784 |
| Glucose urine | 26.15 | 12.30 | 5 | 38903 | 18 | 90589521 |
| Burns second degree | 26.07 | 12.30 | 14 | 38894 | 1966 | 90587573 |
| Blood pH abnormal | 25.73 | 12.30 | 5 | 38903 | 20 | 90589519 |
| Embolic cerebellar infarction | 25.73 | 12.30 | 5 | 38903 | 20 | 90589519 |
| Genital swelling | 25.53 | 12.30 | 7 | 38901 | 151 | 90589388 |
| Drug ineffective | 25.50 | 12.30 | 430 | 38478 | 1383868 | 89205671 |
| Contusion | 25.36 | 12.30 | 43 | 38865 | 251173 | 90338366 |
| Stoma site ulcer | 25.32 | 12.30 | 8 | 38900 | 286 | 90589253 |
| Urticaria | 25.21 | 12.30 | 61 | 38847 | 312673 | 90276866 |
| Pancreatic carcinoma | 25.16 | 12.30 | 24 | 38884 | 8353 | 90581186 |
| Creatinine renal clearance | 24.99 | 12.30 | 5 | 38903 | 24 | 90589515 |
| Cardiac amyloidosis | 24.74 | 12.30 | 11 | 38897 | 1025 | 90588514 |
| Overdose | 24.59 | 12.30 | 19 | 38889 | 157690 | 90431849 |
| Completed suicide | 24.56 | 12.30 | 16 | 38892 | 145042 | 90444497 |
| Emphysematous cystitis | 24.48 | 12.30 | 8 | 38900 | 319 | 90589220 |
| Infection | 24.44 | 12.30 | 77 | 38831 | 362017 | 90227522 |
| Renal cell carcinoma | 24.27 | 12.30 | 17 | 38891 | 3834 | 90585705 |
| Genital discomfort | 23.99 | 12.30 | 6 | 38902 | 89 | 90589450 |
| Hypotension | 23.98 | 12.30 | 229 | 38679 | 325168 | 90264371 |
| Oxygen saturation increased | 23.77 | 12.30 | 8 | 38900 | 350 | 90589189 |
| Microalbuminuria | 23.77 | 12.30 | 9 | 38899 | 556 | 90588983 |
| Wound infection | 23.76 | 12.30 | 8 | 38900 | 106394 | 90483145 |
| Pancreatitis necrotising | 23.66 | 12.30 | 14 | 38894 | 2367 | 90587172 |
| Vitamin B12 decreased | 23.57 | 12.30 | 19 | 38889 | 5291 | 90584248 |
| Genital candidiasis | 23.49 | 12.30 | 7 | 38901 | 205 | 90589334 |
| Cardiac failure acute | 23.01 | 12.30 | 27 | 38881 | 11902 | 90577637 |
| Limb amputation | 22.80 | 12.30 | 5 | 38903 | 40 | 90589499 |
| Red blood cell sedimentation rate increased | 22.74 | 12.30 | 4 | 38904 | 82591 | 90506948 |
| Female reproductive tract disorder | 22.73 | 12.30 | 9 | 38899 | 627 | 90588912 |
| Chest wall haematoma | 22.66 | 12.30 | 7 | 38901 | 232 | 90589307 |
| Synovial disorder | 22.59 | 12.30 | 15 | 38893 | 3103 | 90586436 |
| Lower respiratory tract infection | 22.57 | 12.30 | 46 | 38862 | 250613 | 90338926 |
| Neoplasm skin | 22.48 | 12.30 | 15 | 38893 | 3127 | 90586412 |
| Angina pectoris | 22.42 | 12.30 | 51 | 38857 | 39109 | 90550430 |
| Type 2 diabetes mellitus | 22.21 | 12.30 | 33 | 38875 | 203211 | 90386328 |
| Skin sensitisation | 21.77 | 12.30 | 10 | 38898 | 1005 | 90588534 |
| Myalgia | 21.66 | 12.30 | 139 | 38769 | 174986 | 90414553 |
| Paraesthesia | 21.64 | 12.30 | 47 | 38861 | 250279 | 90339260 |
| Full blood count abnormal | 21.33 | 12.30 | 48 | 38860 | 36549 | 90552990 |
| Blood glucose normal | 21.23 | 12.30 | 4 | 38904 | 13 | 90589526 |
| Blood creatinine increased | 21.17 | 12.30 | 93 | 38815 | 101293 | 90488246 |
| Peripheral venous disease | 21.17 | 12.30 | 5 | 38903 | 83916 | 90505623 |
| Body mass index increased | 20.88 | 12.30 | 11 | 38897 | 1486 | 90588053 |
| Hypocapnia | 20.84 | 12.30 | 8 | 38900 | 513 | 90589026 |
| Urinary tract infection enterococcal | 20.63 | 12.30 | 14 | 38894 | 3002 | 90586537 |
| Morganella infection | 20.57 | 12.30 | 9 | 38899 | 807 | 90588732 |
| Autoimmune disorder | 20.52 | 12.30 | 4 | 38904 | 76740 | 90512799 |
| Injection site reaction | 20.43 | 12.30 | 7 | 38901 | 92073 | 90497466 |
| Respiratory sinus arrhythmia magnitude | 20.39 | 12.30 | 5 | 38903 | 68 | 90589471 |
| Prostatic specific antigen abnormal | 20.39 | 12.30 | 5 | 38903 | 68 | 90589471 |
| Urine alcohol test positive | 20.26 | 12.30 | 3 | 38905 | 0 | 90589539 |
| Drug dispensed to wrong patient | 19.87 | 12.30 | 7 | 38901 | 352 | 90589187 |
| Therapeutic product effect incomplete | 19.74 | 12.30 | 33 | 38875 | 193863 | 90395676 |
| Insomnia | 19.74 | 12.30 | 75 | 38833 | 333399 | 90256140 |
| Hyperventilation | 19.68 | 12.30 | 19 | 38889 | 6709 | 90582830 |
| Headache | 19.63 | 12.30 | 257 | 38651 | 862489 | 89727050 |
| Blood insulin decreased | 19.54 | 12.30 | 4 | 38904 | 22 | 90589517 |
| Acute myocardial infarction | 19.49 | 12.30 | 45 | 38863 | 34845 | 90554694 |
| Haematuria | 19.45 | 12.30 | 45 | 38863 | 34892 | 90554647 |
| Eyelid haematoma | 19.25 | 12.30 | 5 | 38903 | 87 | 90589452 |
| Urine output increased | 19.21 | 12.30 | 11 | 38897 | 1751 | 90587788 |
| Febrile neutropenia | 19.02 | 12.30 | 24 | 38884 | 158325 | 90431214 |
| Peripheral swelling | 19.00 | 12.30 | 102 | 38806 | 413004 | 90176535 |
| Toxicity to various agents | 18.86 | 12.30 | 62 | 38846 | 287784 | 90301755 |
| Leg amputation | 18.78 | 12.30 | 12 | 38896 | 2325 | 90587214 |
| N-terminal prohormone brain natriuretic peptide increased | 18.49 | 12.30 | 13 | 38895 | 2949 | 90586590 |
| Polydipsia | 18.49 | 12.30 | 15 | 38893 | 4216 | 90585323 |
| Atrial fibrillation | 18.37 | 12.30 | 109 | 38799 | 133502 | 90456037 |
| Hip arthroplasty | 18.34 | 12.30 | 5 | 38903 | 76203 | 90513336 |
| Bladder cancer | 18.15 | 12.30 | 17 | 38891 | 5784 | 90583755 |
| Prescribed underdose | 17.90 | 12.30 | 5 | 38903 | 75014 | 90514525 |
| Vaginal infection | 17.79 | 12.30 | 20 | 38888 | 8420 | 90581119 |
| Hypoaesthesia | 17.74 | 12.30 | 72 | 38836 | 314138 | 90275401 |
| Abdominal discomfort | 17.72 | 12.30 | 126 | 38782 | 477202 | 90112337 |
| Vulvovaginal swelling | 17.57 | 12.30 | 8 | 38900 | 788 | 90588751 |
| Coma acidotic | 17.53 | 12.30 | 5 | 38903 | 125 | 90589414 |
| Haemorrhoidal haemorrhage | 17.43 | 12.30 | 16 | 38892 | 5307 | 90584232 |
| Adverse event | 17.24 | 12.30 | 15 | 38893 | 117403 | 90472136 |
| Diabetes mellitus | 17.12 | 12.30 | 64 | 38844 | 64811 | 90524728 |
| Haematochezia | 17.11 | 12.30 | 68 | 38840 | 70845 | 90518694 |
| Fungal cystitis | 16.97 | 12.30 | 3 | 38905 | 6 | 90589533 |
| Condition aggravated | 16.81 | 12.30 | 169 | 38739 | 595376 | 89994163 |
| Vasoconstriction | 16.76 | 12.30 | 8 | 38900 | 877 | 90588662 |
| Fatigue | 16.75 | 12.30 | 373 | 38535 | 1153650 | 89435889 |
| Blood bicarbonate abnormal | 16.70 | 12.30 | 4 | 38904 | 49 | 90589490 |
| Gastroenteritis | 16.66 | 12.30 | 38 | 38870 | 29191 | 90560348 |
| Disease progression | 16.56 | 12.30 | 26 | 38882 | 156589 | 90432950 |
| White blood cell count decreased | 16.50 | 12.30 | 29 | 38879 | 167080 | 90422459 |
| Anal abscess | 16.47 | 12.30 | 16 | 38892 | 5692 | 90583847 |
| Hyperparathyroidism secondary | 16.37 | 12.30 | 10 | 38898 | 1791 | 90587748 |
| Glomerular filtration rate abnormal | 16.30 | 12.30 | 9 | 38899 | 1336 | 90588203 |
| Migraine | 16.25 | 12.30 | 36 | 38872 | 190356 | 90399183 |
| Weight increased | 16.16 | 12.30 | 109 | 38799 | 417818 | 90171721 |
| Therapy non-responder | 16.13 | 12.30 | 21 | 38887 | 136683 | 90452856 |
| Papilloma | 15.98 | 12.30 | 6 | 38902 | 362 | 90589177 |
| Eyelid injury | 15.95 | 12.30 | 5 | 38903 | 174 | 90589365 |
| Hypopnoea | 15.85 | 12.30 | 14 | 38894 | 4417 | 90585122 |
| Haematocrit increased | 15.80 | 12.30 | 12 | 38896 | 3066 | 90586473 |
| Pancytopenia | 15.76 | 12.30 | 17 | 38891 | 120246 | 90469293 |
| Blood pH increased | 15.66 | 12.30 | 7 | 38901 | 660 | 90588879 |
| Gastrointestinal disorder | 15.66 | 12.30 | 57 | 38851 | 256630 | 90332909 |
| Blood bicarbonate decreased | 15.66 | 12.30 | 12 | 38896 | 3107 | 90586432 |
| Anxiety | 15.66 | 12.30 | 74 | 38834 | 309698 | 90279841 |
| Renal failure | 15.59 | 12.30 | 103 | 38805 | 130904 | 90458635 |
| Inappropriate schedule of product administration | 15.56 | 12.30 | 114 | 38794 | 149819 | 90439720 |
| Incorrect product formulation administered | 15.56 | 12.30 | 5 | 38903 | 189 | 90589350 |
| Blood triglycerides increased | 15.56 | 12.30 | 24 | 38884 | 13737 | 90575802 |
| Road traffic accident | 15.50 | 12.30 | 14 | 38894 | 107612 | 90481927 |
| Mucosal inflammation | 15.42 | 12.30 | 3 | 38905 | 57622 | 90531917 |
| Hypovolaemic shock | 15.28 | 12.30 | 17 | 38891 | 7077 | 90582462 |
| Polycythaemia vera | 15.26 | 12.30 | 5 | 38903 | 201 | 90589338 |
| Language disorder | 15.09 | 12.30 | 11 | 38897 | 2641 | 90586898 |
| Glycosylated haemoglobin | 15.02 | 12.30 | 4 | 38904 | 77 | 90589462 |
| Lower limb fracture | 14.91 | 12.30 | 9 | 38899 | 85004 | 90504535 |
| Pyrexia | 14.90 | 12.30 | 197 | 38711 | 660288 | 89929251 |
| Shock | 14.86 | 12.30 | 36 | 38872 | 28742 | 90560797 |
| Urinary tract infection fungal | 14.86 | 12.30 | 7 | 38901 | 745 | 90588794 |
| Right atrial enlargement | 14.79 | 12.30 | 5 | 38903 | 222 | 90589317 |
| Diabetic foot | 14.68 | 12.30 | 9 | 38899 | 1622 | 90587917 |
| Blood iron decreased | 14.55 | 12.30 | 27 | 38881 | 17932 | 90571607 |
| Haemoglobin increased | 14.54 | 12.30 | 17 | 38891 | 7464 | 90582075 |
| Genital tract inflammation | 14.43 | 12.30 | 4 | 38904 | 90 | 90589449 |
| Periorbital haematoma | 14.36 | 12.30 | 7 | 38901 | 804 | 90588735 |
| Arthralgia | 14.20 | 12.30 | 242 | 38666 | 778280 | 89811259 |
| Blood uric acid increased | 14.14 | 12.30 | 17 | 38891 | 7687 | 90581852 |
| Abnormal loss of weight | 14.10 | 12.30 | 16 | 38892 | 6807 | 90582732 |
| Vasculitic ulcer | 14.03 | 12.30 | 5 | 38903 | 260 | 90589279 |
| Coronary artery bypass | 13.95 | 12.30 | 10 | 38898 | 2339 | 90587200 |
| Dizziness | 13.89 | 12.30 | 341 | 38567 | 588943 | 90000596 |
| Ventricular asystole | 13.77 | 12.30 | 4 | 38904 | 107 | 90589432 |
| Meralgia paraesthetica | 13.68 | 12.30 | 6 | 38902 | 541 | 90588998 |
| Electrolyte imbalance | 13.68 | 12.30 | 31 | 38877 | 23714 | 90565825 |
| Kussmaul respiration | 13.61 | 12.30 | 5 | 38903 | 284 | 90589255 |
| Urethral disorder | 13.51 | 12.30 | 5 | 38903 | 290 | 90589249 |
| Genital herpes zoster | 13.47 | 12.30 | 3 | 38905 | 26 | 90589513 |
| Nephrolithiasis | 13.43 | 12.30 | 49 | 38859 | 49036 | 90540503 |
| Illness | 13.35 | 12.30 | 70 | 38838 | 81899 | 90507640 |
| Laryngitis | 12.85 | 12.30 | 3 | 38905 | 50750 | 90538789 |
| Cardiac arrest | 12.79 | 12.30 | 83 | 38825 | 104852 | 90484687 |
| Cough | 12.78 | 12.30 | 226 | 38682 | 368736 | 90220803 |
| Dyspepsia | 12.76 | 12.30 | 43 | 38865 | 198117 | 90391422 |
| Blepharospasm | 12.67 | 12.30 | 4 | 38904 | 55441 | 90534098 |
| Sciatica | 12.56 | 12.30 | 15 | 38893 | 101367 | 90488172 |
| Pyuria | 12.54 | 12.30 | 9 | 38899 | 2110 | 90587429 |
| Parkinsonism | 12.49 | 12.30 | 22 | 38886 | 14043 | 90575496 |
| Amnesia | 12.46 | 12.30 | 17 | 38891 | 108488 | 90481051 |
| Perineal abscess | 12.42 | 12.30 | 5 | 38903 | 364 | 90589175 |
| Genital burning sensation | 12.39 | 12.30 | 5 | 38903 | 366 | 90589173 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Diabetic ketoacidosis | 4973.59 | 12.51 | 1606 | 50929 | 20761 | 42548039 |
| Euglycaemic diabetic ketoacidosis | 3783.08 | 12.51 | 960 | 51575 | 4700 | 42564100 |
| Ketoacidosis | 2057.52 | 12.51 | 587 | 51948 | 4765 | 42564035 |
| Urinary tract infection | 432.80 | 12.51 | 571 | 51964 | 98713 | 42470087 |
| Fungal infection | 376.25 | 12.51 | 258 | 52277 | 19464 | 42549336 |
| Metabolic acidosis | 332.22 | 12.51 | 363 | 52172 | 51495 | 42517305 |
| Glycosylated haemoglobin increased | 289.77 | 12.51 | 187 | 52348 | 12737 | 42556063 |
| Pollakiuria | 280.40 | 12.51 | 228 | 52307 | 22277 | 42546523 |
| Lactic acidosis | 247.64 | 12.51 | 292 | 52243 | 44969 | 42523831 |
| Ketonuria | 237.84 | 12.51 | 69 | 52466 | 595 | 42568205 |
| Balanoposthitis | 220.94 | 12.51 | 81 | 52454 | 1540 | 42567260 |
| Blood ketone body increased | 220.05 | 12.51 | 62 | 52473 | 476 | 42568324 |
| Toe amputation | 216.08 | 12.51 | 94 | 52441 | 2835 | 42565965 |
| Ketosis | 212.65 | 12.51 | 68 | 52467 | 837 | 42567963 |
| Urine ketone body present | 187.57 | 12.51 | 69 | 52466 | 1325 | 42567475 |
| Necrotising fasciitis | 171.13 | 12.51 | 92 | 52443 | 4454 | 42564346 |
| Hyperglycaemia | 169.70 | 12.51 | 244 | 52291 | 45615 | 42523185 |
| Acidosis | 166.99 | 12.51 | 131 | 52404 | 12148 | 42556652 |
| Urosepsis | 151.86 | 12.51 | 135 | 52400 | 14885 | 42553915 |
| Hypovolaemia | 150.74 | 12.51 | 120 | 52415 | 11365 | 42557435 |
| Dehydration | 133.48 | 12.51 | 431 | 52104 | 141336 | 42427464 |
| Acute kidney injury | 131.47 | 12.51 | 837 | 51698 | 366500 | 42202300 |
| Glomerular filtration rate decreased | 130.74 | 12.51 | 129 | 52406 | 16222 | 42552578 |
| Weight decreased | 124.77 | 12.51 | 547 | 51988 | 207401 | 42361399 |
| Blood glucose increased | 123 | 12.51 | 277 | 52258 | 73422 | 42495378 |
| Polyuria | 115.41 | 12.51 | 97 | 52438 | 9914 | 42558886 |
| Genital infection fungal | 114.69 | 12.51 | 31 | 52504 | 200 | 42568600 |
| Pancreatitis | 111.33 | 12.51 | 195 | 52340 | 43073 | 42525727 |
| Blood glucose abnormal | 110.76 | 12.51 | 82 | 52453 | 6971 | 42561829 |
| Glycosylated haemoglobin abnormal | 101.48 | 12.51 | 30 | 52505 | 278 | 42568522 |
| Polycythaemia | 99.19 | 12.51 | 55 | 52480 | 2831 | 42565969 |
| Diabetes mellitus inadequate control | 98.89 | 12.51 | 108 | 52427 | 15282 | 42553518 |
| Urine ketone body | 97.36 | 12.51 | 21 | 52514 | 40 | 42568760 |
| Blood ketone body | 96.57 | 12.51 | 24 | 52511 | 105 | 42568695 |
| Burns second degree | 96.01 | 12.51 | 71 | 52464 | 6025 | 42562775 |
| Catarrh | 94.91 | 12.51 | 70 | 52465 | 5916 | 42562884 |
| Febrile neutropenia | 94.34 | 12.51 | 56 | 52479 | 185647 | 42383153 |
| Drug ineffective | 94.25 | 12.51 | 429 | 52106 | 629768 | 41939032 |
| Gangrene | 90.54 | 12.51 | 64 | 52471 | 5062 | 42563738 |
| Steroid dependence | 87.70 | 12.51 | 70 | 52465 | 6652 | 42562148 |
| Product monitoring error | 84.62 | 12.51 | 58 | 52477 | 4365 | 42564435 |
| Neutropenia | 84.47 | 12.51 | 73 | 52462 | 199358 | 42369442 |
| Parosmia | 83.50 | 12.51 | 72 | 52463 | 7619 | 42561181 |
| Toxicity to various agents | 83.17 | 12.51 | 96 | 52439 | 229040 | 42339760 |
| Cardiac failure | 82.27 | 12.51 | 304 | 52231 | 106552 | 42462248 |
| Gingival pain | 81.22 | 12.51 | 74 | 52461 | 8420 | 42560380 |
| Hypopnoea | 79.97 | 12.51 | 71 | 52464 | 7811 | 42560989 |
| Hypoglycaemia | 79.47 | 12.51 | 206 | 52329 | 59648 | 42509152 |
| Disease progression | 77.74 | 12.51 | 40 | 52495 | 143616 | 42425184 |
| Anaemia | 77.62 | 12.51 | 142 | 52393 | 280136 | 42288664 |
| Haemoglobin increased | 76.13 | 12.51 | 58 | 52477 | 5148 | 42563652 |
| Vomiting | 75.95 | 12.51 | 613 | 51922 | 289110 | 42279690 |
| Phimosis | 74.87 | 12.51 | 34 | 52501 | 1137 | 42567663 |
| Glycosuria | 72.80 | 12.51 | 35 | 52500 | 1335 | 42567465 |
| Systemic lupus erythematosus | 71.64 | 12.51 | 72 | 52463 | 9252 | 42559548 |
| Drug abuse | 70.11 | 12.51 | 21 | 52514 | 104750 | 42464050 |
| Haematocrit increased | 69.78 | 12.51 | 42 | 52493 | 2525 | 42566275 |
| Cardiac failure chronic | 68.08 | 12.51 | 71 | 52464 | 9530 | 42559270 |
| Thrombocytopenia | 64.50 | 12.51 | 84 | 52451 | 190195 | 42378605 |
| Anion gap increased | 64.11 | 12.51 | 37 | 52498 | 2057 | 42566743 |
| Thirst | 63.95 | 12.51 | 67 | 52468 | 9041 | 42559759 |
| Glucose urine present | 63.73 | 12.51 | 32 | 52503 | 1343 | 42567457 |
| Hyperkalaemia | 63.66 | 12.51 | 231 | 52304 | 80227 | 42488573 |
| Pancytopenia | 63.37 | 12.51 | 33 | 52502 | 117710 | 42451090 |
| Swollen tongue | 62.98 | 12.51 | 102 | 52433 | 21129 | 42547671 |
| Death | 62.59 | 12.51 | 334 | 52201 | 470851 | 42097949 |
| Acquired phimosis | 62.16 | 12.51 | 18 | 52517 | 154 | 42568646 |
| Genital infection | 62.02 | 12.51 | 14 | 52521 | 36 | 42568764 |
| Dysuria | 61.16 | 12.51 | 125 | 52410 | 30971 | 42537829 |
| Platelet count decreased | 59.53 | 12.51 | 50 | 52485 | 138531 | 42430269 |
| Hyperthyroidism | 58.50 | 12.51 | 80 | 52455 | 14261 | 42554539 |
| Rhinitis | 58.47 | 12.51 | 73 | 52462 | 11904 | 42556896 |
| Dizziness | 58.16 | 12.51 | 514 | 52021 | 248740 | 42320060 |
| Alcohol poisoning | 57.30 | 12.51 | 58 | 52477 | 7516 | 42561284 |
| Cardiac murmur | 56.29 | 12.51 | 74 | 52461 | 12701 | 42556099 |
| Leriche syndrome | 55.33 | 12.51 | 15 | 52520 | 98 | 42568702 |
| Prostatitis | 55.03 | 12.51 | 52 | 52483 | 6196 | 42562604 |
| Medication error | 54.57 | 12.51 | 124 | 52411 | 33030 | 42535770 |
| Orchitis | 53.98 | 12.51 | 34 | 52501 | 2217 | 42566583 |
| Pruritus genital | 53.81 | 12.51 | 36 | 52499 | 2603 | 42566197 |
| Perineal abscess | 53.60 | 12.51 | 20 | 52515 | 400 | 42568400 |
| Diabetic foot | 53.42 | 12.51 | 38 | 52497 | 3035 | 42565765 |
| Drug interaction | 53.26 | 12.51 | 161 | 52374 | 266838 | 42301962 |
| Impaired work ability | 53.22 | 12.51 | 70 | 52465 | 12021 | 42556779 |
| Genital rash | 52.70 | 12.51 | 24 | 52511 | 808 | 42567992 |
| Glomerular filtration rate abnormal | 52.48 | 12.51 | 27 | 52508 | 1193 | 42567607 |
| Balanitis candida | 51.91 | 12.51 | 16 | 52519 | 173 | 42568627 |
| Starvation ketoacidosis | 50.93 | 12.51 | 15 | 52520 | 137 | 42568663 |
| Blood ketone body present | 50.89 | 12.51 | 13 | 52522 | 65 | 42568735 |
| pH body fluid abnormal | 49.59 | 12.51 | 10 | 52525 | 11 | 42568789 |
| Scrotal abscess | 49.46 | 12.51 | 22 | 52513 | 700 | 42568100 |
| Frequent bowel movements | 48.09 | 12.51 | 91 | 52444 | 21316 | 42547484 |
| Malignant neoplasm progression | 47.92 | 12.51 | 38 | 52497 | 108362 | 42460438 |
| Completed suicide | 47.67 | 12.51 | 30 | 52505 | 96435 | 42472365 |
| Impaired quality of life | 47.45 | 12.51 | 72 | 52463 | 14105 | 42554695 |
| BRASH syndrome | 47.40 | 12.51 | 29 | 52506 | 1796 | 42567004 |
| N-terminal prohormone brain natriuretic peptide increased | 47.28 | 12.51 | 37 | 52498 | 3416 | 42565384 |
| Diabetic ketosis | 46.48 | 12.51 | 16 | 52519 | 251 | 42568549 |
| Seizure | 46.46 | 12.51 | 48 | 52487 | 120513 | 42448287 |
| Leukopenia | 46.46 | 12.51 | 17 | 52518 | 74729 | 42494071 |
| Hypotension | 45.77 | 12.51 | 502 | 52033 | 257129 | 42311671 |
| Leg amputation | 44.59 | 12.51 | 32 | 52503 | 2591 | 42566209 |
| Testicular abscess | 43.43 | 12.51 | 12 | 52523 | 85 | 42568715 |
| Penile discomfort | 43.43 | 12.51 | 10 | 52525 | 29 | 42568771 |
| Therapeutic drug monitoring analysis incorrectly performed | 43.40 | 12.51 | 16 | 52519 | 309 | 42568491 |
| Cystitis | 42.87 | 12.51 | 62 | 52473 | 11636 | 42557164 |
| Left atrial dilatation | 42.44 | 12.51 | 30 | 52505 | 2372 | 42566428 |
| Kussmaul respiration | 42.37 | 12.51 | 12 | 52523 | 94 | 42568706 |
| Insulin C-peptide decreased | 42.23 | 12.51 | 10 | 52525 | 34 | 42568766 |
| Haemoglobin decreased | 41.34 | 12.51 | 62 | 52473 | 132409 | 42436391 |
| Peripheral artery bypass | 41.24 | 12.51 | 11 | 52524 | 67 | 42568733 |
| Cellulitis of male external genital organ | 40.69 | 12.51 | 11 | 52524 | 71 | 42568729 |
| Amputation | 40.53 | 12.51 | 20 | 52515 | 808 | 42567992 |
| White blood cell count decreased | 40.26 | 12.51 | 46 | 52489 | 110350 | 42458450 |
| Scrotal cellulitis | 39.68 | 12.51 | 11 | 52524 | 79 | 42568721 |
| International normalised ratio increased | 39.65 | 12.51 | 6 | 52529 | 48162 | 42520638 |
| Pneumonia | 39.50 | 12.51 | 332 | 52203 | 421817 | 42146983 |
| COVID-19 | 39.24 | 12.51 | 261 | 52274 | 115687 | 42453113 |
| Acetonaemia | 39.15 | 12.51 | 14 | 52521 | 247 | 42568553 |
| Renal impairment | 39.05 | 12.51 | 251 | 52284 | 109977 | 42458823 |
| Therapy cessation | 38.79 | 12.51 | 81 | 52454 | 20369 | 42548431 |
| Palpitations | 38.61 | 12.51 | 144 | 52391 | 50653 | 42518147 |
| Bronchiectasis | 38.51 | 12.51 | 75 | 52460 | 17944 | 42550856 |
| Vertigo | 38.37 | 12.51 | 111 | 52424 | 34236 | 42534564 |
| Pancreatitis acute | 38.01 | 12.51 | 109 | 52426 | 33455 | 42535345 |
| Emphysematous cystitis | 37.99 | 12.51 | 14 | 52521 | 270 | 42568530 |
| Spleen ischaemia | 37.61 | 12.51 | 10 | 52525 | 60 | 42568740 |
| Abdominal discomfort | 36.95 | 12.51 | 187 | 52348 | 75068 | 42493732 |
| Urinary tract candidiasis | 36.27 | 12.51 | 16 | 52519 | 499 | 42568301 |
| Myelosuppression | 35.80 | 12.51 | 4 | 52531 | 40457 | 42528343 |
| Anxiety | 35.55 | 12.51 | 57 | 52478 | 118503 | 42450297 |
| Anion gap abnormal | 35.44 | 12.51 | 15 | 52520 | 422 | 42568378 |
| Alanine aminotransferase increased | 35.42 | 12.51 | 34 | 52501 | 88372 | 42480428 |
| Foetal exposure during pregnancy | 34.45 | 12.51 | 8 | 52527 | 47303 | 42521497 |
| Ischaemic nephropathy | 34.28 | 12.51 | 10 | 52525 | 88 | 42568712 |
| Diabetic metabolic decompensation | 34.27 | 12.51 | 25 | 52510 | 2077 | 42566723 |
| Genital discolouration | 34.20 | 12.51 | 6 | 52529 | 0 | 42568800 |
| Diabetic coma | 34.19 | 12.51 | 19 | 52516 | 982 | 42567818 |
| Foot amputation | 34.10 | 12.51 | 18 | 52517 | 839 | 42567961 |
| Genital discomfort | 33.71 | 12.51 | 9 | 52526 | 55 | 42568745 |
| Pyelonephritis | 33.57 | 12.51 | 45 | 52490 | 7869 | 42560931 |
| Neutrophil count decreased | 32.33 | 12.51 | 19 | 52516 | 63396 | 42505404 |
| Ulnar nerve injury | 32.20 | 12.51 | 10 | 52525 | 111 | 42568689 |
| Mucosal dryness | 32.09 | 12.51 | 22 | 52513 | 1656 | 42567144 |
| Penile rash | 31.90 | 12.51 | 7 | 52528 | 15 | 42568785 |
| Anion gap | 31.75 | 12.51 | 17 | 52518 | 816 | 42567984 |
| Treatment failure | 31.59 | 12.51 | 19 | 52516 | 62605 | 42506195 |
| Thrombosis | 31.57 | 12.51 | 23 | 52512 | 68488 | 42500312 |
| Haematuria | 31.50 | 12.51 | 148 | 52387 | 57651 | 42511149 |
| Circumcision | 30.53 | 12.51 | 8 | 52527 | 45 | 42568755 |
| Neuropathy peripheral | 30.50 | 12.51 | 49 | 52486 | 101804 | 42466996 |
| Abnormal loss of weight | 30.31 | 12.51 | 34 | 52501 | 4953 | 42563847 |
| Limb amputation | 30.29 | 12.51 | 9 | 52526 | 85 | 42568715 |
| Migraine | 30.21 | 12.51 | 84 | 52451 | 25330 | 42543470 |
| Genital candidiasis | 29.83 | 12.51 | 9 | 52526 | 90 | 42568710 |
| Colitis ulcerative | 29.63 | 12.51 | 85 | 52450 | 26090 | 42542710 |
| Suicide attempt | 29.47 | 12.51 | 10 | 52525 | 46090 | 42522710 |
| Mucosal inflammation | 29.40 | 12.51 | 12 | 52523 | 49362 | 42519438 |
| Aspartate aminotransferase increased | 29.40 | 12.51 | 31 | 52504 | 77132 | 42491668 |
| Penile erythema | 29.34 | 12.51 | 11 | 52524 | 223 | 42568577 |
| Accidental overdose | 29.22 | 12.51 | 89 | 52446 | 28241 | 42540559 |
| Ascites | 28.86 | 12.51 | 17 | 52518 | 56661 | 42512139 |
| Drug resistance | 28.80 | 12.51 | 4 | 52531 | 34244 | 42534556 |
| Infusion related reaction | 28.56 | 12.51 | 20 | 52515 | 60786 | 42508014 |
| Cerebrovascular accident | 28.34 | 12.51 | 211 | 52324 | 96949 | 42471851 |
| Urinary tract infection fungal | 28.34 | 12.51 | 14 | 52521 | 567 | 42568233 |
| Genital infection male | 28.28 | 12.51 | 7 | 52528 | 30 | 42568770 |
| Hyperglycaemic hyperosmolar nonketotic syndrome | 28.11 | 12.51 | 20 | 52515 | 1598 | 42567202 |
| Cardio-respiratory arrest | 27.92 | 12.51 | 19 | 52516 | 58617 | 42510183 |
| Overdose | 27.60 | 12.51 | 55 | 52480 | 105209 | 42463591 |
| Penile discharge | 27.17 | 12.51 | 8 | 52527 | 73 | 42568727 |
| Cerebral infarction | 26.78 | 12.51 | 92 | 52443 | 31077 | 42537723 |
| Troponin increased | 26.72 | 12.51 | 67 | 52468 | 18995 | 42549805 |
| Hypoxia | 26.62 | 12.51 | 28 | 52507 | 69758 | 42499042 |
| Low density lipoprotein abnormal | 26.49 | 12.51 | 12 | 52523 | 399 | 42568401 |
| Mitral valve incompetence | 26.38 | 12.51 | 61 | 52474 | 16428 | 42552372 |
| Polydipsia | 26.26 | 12.51 | 30 | 52505 | 4458 | 42564342 |
| Ejection fraction decreased | 26.25 | 12.51 | 73 | 52462 | 22014 | 42546786 |
| Diabetic neuropathy | 26.18 | 12.51 | 30 | 52505 | 4472 | 42564328 |
| Peripheral arterial occlusive disease | 26.17 | 12.51 | 37 | 52498 | 6801 | 42561999 |
| Stomatitis | 25.76 | 12.51 | 15 | 52520 | 50314 | 42518486 |
| Necrotising soft tissue infection | 25.53 | 12.51 | 9 | 52526 | 152 | 42568648 |
| Tinnitus | 25.38 | 12.51 | 86 | 52449 | 28852 | 42539948 |
| Bone marrow failure | 25.31 | 12.51 | 5 | 52530 | 33088 | 42535712 |
| Diabetic foot infection | 25.04 | 12.51 | 14 | 52521 | 732 | 42568068 |
| Glycosylated haemoglobin | 24.98 | 12.51 | 6 | 52529 | 22 | 42568778 |
| Pancreatic carcinoma | 24.63 | 12.51 | 43 | 52492 | 9463 | 42559337 |
| Cytomegalovirus infection | 24.46 | 12.51 | 5 | 52530 | 32301 | 42536499 |
| Pleural effusion | 24.43 | 12.51 | 52 | 52483 | 97114 | 42471686 |
| Dysgeusia | 24.39 | 12.51 | 95 | 52440 | 34094 | 42534706 |
| Epididymitis | 24.36 | 12.51 | 24 | 52511 | 3010 | 42565790 |
| Skin ulcer | 24.16 | 12.51 | 78 | 52457 | 25523 | 42543277 |
| Skin pressure mark | 23.86 | 12.51 | 7 | 52528 | 63 | 42568737 |
| Eczema | 23.74 | 12.51 | 94 | 52441 | 33992 | 42534808 |
| Respiratory distress | 23.57 | 12.51 | 11 | 52524 | 41809 | 42526991 |
| Acute myocardial infarction | 23.45 | 12.51 | 137 | 52398 | 58028 | 42510772 |
| Nightmare | 23.42 | 12.51 | 76 | 52459 | 24936 | 42543864 |
| Plasma cell myeloma | 23.21 | 12.51 | 15 | 52520 | 47563 | 42521237 |
| Inappropriate schedule of product administration | 22.92 | 12.51 | 199 | 52336 | 95703 | 42473097 |
| Intentional overdose | 22.77 | 12.51 | 18 | 52517 | 51438 | 42517362 |
| Multiple organ dysfunction syndrome | 22.71 | 12.51 | 54 | 52481 | 96981 | 42471819 |
| Spondylolysis | 22.05 | 12.51 | 7 | 52528 | 84 | 42568716 |
| Atrial fibrillation | 22.03 | 12.51 | 266 | 52269 | 139327 | 42429473 |
| Lumbosacral radiculoplexus neuropathy | 21.97 | 12.51 | 7 | 52528 | 85 | 42568715 |
| Creatinine renal clearance increased | 21.96 | 12.51 | 11 | 52524 | 459 | 42568341 |
| Perineal cellulitis | 21.84 | 12.51 | 5 | 52530 | 14 | 42568786 |
| Hypophagia | 21.81 | 12.51 | 78 | 52457 | 26878 | 42541922 |
| Lymphocyte count decreased | 21.69 | 12.51 | 4 | 52531 | 27805 | 42540995 |
| Varicella zoster pneumonia | 21.27 | 12.51 | 9 | 52526 | 253 | 42568547 |
| Gastroenteritis | 21.18 | 12.51 | 56 | 52479 | 16393 | 42552407 |
| Tinea cruris | 20.89 | 12.51 | 11 | 52524 | 510 | 42568290 |
| Blood glucose fluctuation | 20.87 | 12.51 | 27 | 52508 | 4560 | 42564240 |
| Urinary hesitation | 20.72 | 12.51 | 22 | 52513 | 3013 | 42565787 |
| Pancreatitis necrotising | 20.69 | 12.51 | 24 | 52511 | 3625 | 42565175 |
| Diabetic ketoacidotic hyperglycaemic coma | 20.57 | 12.51 | 8 | 52527 | 180 | 42568620 |
| Albumin urine present | 20.50 | 12.51 | 10 | 52525 | 394 | 42568406 |
| Henoch-Schonlein purpura nephritis | 20.48 | 12.51 | 5 | 52530 | 20 | 42568780 |
| Urinary incontinence | 20.43 | 12.51 | 66 | 52469 | 21602 | 42547198 |
| Product use issue | 20.20 | 12.51 | 40 | 52495 | 76711 | 42492089 |
| Pemphigoid | 20.11 | 12.51 | 44 | 52491 | 11423 | 42557377 |
| Urinary tract operation | 20.03 | 12.51 | 4 | 52531 | 4 | 42568796 |
| Adrenal insufficiency | 20.03 | 12.51 | 60 | 52475 | 18864 | 42549936 |
| Pyrexia | 19.90 | 12.51 | 354 | 52181 | 393688 | 42175112 |
| Prostatic abscess | 19.78 | 12.51 | 12 | 52523 | 732 | 42568068 |
| Blood lactic acid decreased | 19.62 | 12.51 | 6 | 52529 | 63 | 42568737 |
| Measles | 19.57 | 12.51 | 9 | 52526 | 310 | 42568490 |
| Transaminases increased | 19.56 | 12.51 | 8 | 52527 | 32877 | 42535923 |
| Glycosylated haemoglobin decreased | 19.54 | 12.51 | 10 | 52525 | 437 | 42568363 |
| Rash maculo-papular | 19.45 | 12.51 | 11 | 52524 | 37492 | 42531308 |
| Decreased ventricular preload | 19.41 | 12.51 | 5 | 52530 | 26 | 42568774 |
| Hepatocellular injury | 19.37 | 12.51 | 3 | 52532 | 23675 | 42545125 |
| Blood creatinine increased | 19.31 | 12.51 | 214 | 52321 | 109789 | 42459011 |
| Interstitial lung disease | 18.89 | 12.51 | 43 | 52492 | 78419 | 42490381 |
| Penile swelling | 18.82 | 12.51 | 13 | 52522 | 990 | 42567810 |
| Urine output increased | 18.47 | 12.51 | 15 | 52520 | 1461 | 42567339 |
| Myelodysplastic syndrome | 18.34 | 12.51 | 3 | 52532 | 22742 | 42546058 |
| Agitation | 18.27 | 12.51 | 32 | 52503 | 64282 | 42504518 |
| Altered state of consciousness | 18.25 | 12.51 | 78 | 52457 | 29181 | 42539619 |
| Abnormal behaviour | 18.24 | 12.51 | 5 | 52530 | 26446 | 42542354 |
| N-terminal prohormone brain natriuretic peptide decreased | 18.10 | 12.51 | 4 | 52531 | 9 | 42568791 |
| Tubulointerstitial nephritis | 18.08 | 12.51 | 82 | 52453 | 31466 | 42537334 |
| Respiratory failure | 17.94 | 12.51 | 89 | 52446 | 128043 | 42440757 |
| Blood lactate dehydrogenase increased | 17.85 | 12.51 | 5 | 52530 | 26076 | 42542724 |
| Hallucination | 17.84 | 12.51 | 27 | 52508 | 57480 | 42511320 |
| Urinary tract infection bacterial | 17.65 | 12.51 | 18 | 52517 | 2352 | 42566448 |
| Oxygen saturation decreased | 17.64 | 12.51 | 33 | 52502 | 64654 | 42504146 |
| Serotonin syndrome | 17.60 | 12.51 | 5 | 52530 | 25840 | 42542960 |
| Lower respiratory tract infection | 17.51 | 12.51 | 15 | 52520 | 41191 | 42527609 |
| Pericardial fibrosis | 17.42 | 12.51 | 7 | 52528 | 172 | 42568628 |
| Rheumatoid arthritis | 17.37 | 12.51 | 16 | 52519 | 42424 | 42526376 |
| Fasting | 17.35 | 12.51 | 5 | 52530 | 42 | 42568758 |
| Glucose urine | 17.27 | 12.51 | 4 | 52531 | 12 | 42568788 |
| Alcoholic ketoacidosis | 17.24 | 12.51 | 5 | 52530 | 43 | 42568757 |
| Sepsis | 17.22 | 12.51 | 343 | 52192 | 198991 | 42369809 |
| Genital infection bacterial | 17.10 | 12.51 | 3 | 52532 | 0 | 42568800 |
| Drug reaction with eosinophilia and systemic symptoms | 17.06 | 12.51 | 16 | 52519 | 42059 | 42526741 |
| Hypernatraemia | 17.03 | 12.51 | 38 | 52497 | 9994 | 42558806 |
| Candida infection | 17.03 | 12.51 | 62 | 52473 | 21548 | 42547252 |
| Coma acidotic | 17.03 | 12.51 | 4 | 52531 | 13 | 42568787 |
| Scrotal pain | 16.95 | 12.51 | 12 | 52523 | 951 | 42567849 |
| Genital tract inflammation | 16.94 | 12.51 | 5 | 52530 | 46 | 42568754 |
| Pneumocystis jirovecii pneumonia | 16.92 | 12.51 | 5 | 52530 | 25176 | 42543624 |
| Debridement | 16.83 | 12.51 | 12 | 52523 | 962 | 42567838 |
| Immune-mediated myositis | 16.75 | 12.51 | 22 | 52513 | 3771 | 42565029 |
| Insomnia | 16.63 | 12.51 | 82 | 52453 | 118171 | 42450629 |
| Application site haematoma | 16.57 | 12.51 | 5 | 52530 | 50 | 42568750 |
| Disseminated intravascular coagulation | 16.52 | 12.51 | 5 | 52530 | 24789 | 42544011 |
| Stress | 16.46 | 12.51 | 102 | 52433 | 44110 | 42524690 |
| Encephalopathy | 16.43 | 12.51 | 16 | 52519 | 41317 | 42527483 |
| Leukocyturia | 16.42 | 12.51 | 11 | 52524 | 797 | 42568003 |
| Blood creatine increased | 16.38 | 12.51 | 27 | 52508 | 5673 | 42563127 |
| Off label use | 16.35 | 12.51 | 633 | 51902 | 637702 | 41931098 |
| Glomerular filtration rate increased | 16.35 | 12.51 | 11 | 52524 | 803 | 42567997 |
| Drug hypersensitivity | 16.34 | 12.51 | 65 | 52470 | 99324 | 42469476 |
| Angina pectoris | 16.31 | 12.51 | 82 | 52453 | 32814 | 42535986 |
| Substance use | 16.24 | 12.51 | 15 | 52520 | 1736 | 42567064 |
| Non-compaction cardiomyopathy | 16.14 | 12.51 | 5 | 52530 | 55 | 42568745 |
| Cardiac failure acute | 16.14 | 12.51 | 45 | 52490 | 13588 | 42555212 |
| Lacunar infarction | 16.12 | 12.51 | 20 | 52515 | 3240 | 42565560 |
| Skin wrinkling | 16.06 | 12.51 | 9 | 52526 | 473 | 42568327 |
| Gastrointestinal haemorrhage | 16.01 | 12.51 | 64 | 52471 | 97662 | 42471138 |
| Drug ineffective for unapproved indication | 16.00 | 12.51 | 20 | 52515 | 46143 | 42522657 |
| Orchidectomy | 15.83 | 12.51 | 5 | 52530 | 59 | 42568741 |
| Therapeutic product effect decreased | 15.74 | 12.51 | 15 | 52520 | 39135 | 42529665 |
| Lipase increased | 15.72 | 12.51 | 38 | 52497 | 10528 | 42558272 |
| Tumour lysis syndrome | 15.71 | 12.51 | 4 | 52531 | 22227 | 42546573 |
| Staphylococcal infection | 15.63 | 12.51 | 14 | 52521 | 37629 | 42531171 |
| Herpes zoster | 15.51 | 12.51 | 15 | 52520 | 38862 | 42529938 |
| Pterygium | 15.42 | 12.51 | 6 | 52529 | 135 | 42568665 |
| Haematochezia | 15.41 | 12.51 | 124 | 52411 | 58312 | 42510488 |
| Urine odour abnormal | 15.35 | 12.51 | 14 | 52521 | 1594 | 42567206 |
| Colitis | 15.30 | 12.51 | 21 | 52514 | 46551 | 42522249 |
| Respiratory arrest | 15.23 | 12.51 | 8 | 52527 | 28416 | 42540384 |
| Illness | 15.20 | 12.51 | 66 | 52469 | 24864 | 42543936 |
| Chronic kidney disease | 15.16 | 12.51 | 105 | 52430 | 47136 | 42521664 |
| Scrotal dermatitis | 15.02 | 12.51 | 3 | 52532 | 3 | 42568797 |
| Haemoptysis | 14.98 | 12.51 | 21 | 52514 | 46146 | 42522654 |
| Hospitalisation | 14.65 | 12.51 | 45 | 52490 | 74285 | 42494515 |
| Electrocardiogram abnormal | 14.58 | 12.51 | 36 | 52499 | 10109 | 42558691 |
| Loss of personal independence in daily activities | 14.41 | 12.51 | 108 | 52427 | 49708 | 42519092 |
| Electrocardiogram QT prolonged | 14.41 | 12.51 | 23 | 52512 | 47922 | 42520878 |
| Diabetic nephropathy | 14.29 | 12.51 | 16 | 52519 | 2325 | 42566475 |
| Intentional product misuse | 14.04 | 12.51 | 35 | 52500 | 61865 | 42506935 |
| Full blood count decreased | 13.96 | 12.51 | 4 | 52531 | 20556 | 42548244 |
| Chronic coronary syndrome | 13.93 | 12.51 | 7 | 52528 | 294 | 42568506 |
| Unresponsive to stimuli | 13.88 | 12.51 | 11 | 52524 | 31392 | 42537408 |
| Peritonitis | 13.86 | 12.51 | 3 | 52532 | 18630 | 42550170 |
| Stevens-Johnson syndrome | 13.85 | 12.51 | 5 | 52530 | 22173 | 42546627 |
| Peripheral artery occlusion | 13.84 | 12.51 | 14 | 52521 | 1812 | 42566988 |
| Fungal cystitis | 13.81 | 12.51 | 3 | 52532 | 6 | 42568794 |
| Gait disturbance | 13.75 | 12.51 | 68 | 52467 | 97932 | 42470868 |
| Tremor | 13.75 | 12.51 | 67 | 52468 | 96862 | 42471938 |
| Tachypnoea | 13.70 | 12.51 | 58 | 52477 | 21604 | 42547196 |
| Blood potassium increased | 13.62 | 12.51 | 52 | 52483 | 18484 | 42550316 |
| Liver function test abnormal | 13.51 | 12.51 | 12 | 52523 | 32379 | 42536421 |
| Muscle atrophy | 13.45 | 12.51 | 31 | 52504 | 8330 | 42560470 |
| Genitourinary symptom | 13.44 | 12.51 | 4 | 52531 | 38 | 42568762 |
| Perineal necrosis | 13.35 | 12.51 | 4 | 52531 | 39 | 42568761 |
| Haematocrit decreased | 13.32 | 12.51 | 14 | 52521 | 34894 | 42533906 |
| Wheezing | 13.20 | 12.51 | 30 | 52505 | 54751 | 42514049 |
| Neutrophil count increased | 13.18 | 12.51 | 4 | 52531 | 19800 | 42549000 |
| Urine abnormality | 13.16 | 12.51 | 15 | 52520 | 2224 | 42566576 |
| Drug dependence | 13.10 | 12.51 | 10 | 52525 | 29084 | 42539716 |
| Limb injury | 12.97 | 12.51 | 43 | 52492 | 14262 | 42554538 |
| Penile infection | 12.96 | 12.51 | 5 | 52530 | 110 | 42568690 |
| Clostridium difficile colitis | 12.92 | 12.51 | 5 | 52530 | 21247 | 42547553 |
| Rhabdomyolysis | 12.84 | 12.51 | 51 | 52484 | 77968 | 42490832 |
| Incorrect route of product administration | 12.79 | 12.51 | 7 | 52528 | 24298 | 42544502 |
| Penis disorder | 12.76 | 12.51 | 12 | 52523 | 1421 | 42567379 |
| Genitourinary tract infection | 12.75 | 12.51 | 5 | 52530 | 115 | 42568685 |
| Spermatic cord inflammation | 12.71 | 12.51 | 3 | 52532 | 10 | 42568790 |
| Arthritis | 12.62 | 12.51 | 92 | 52443 | 41973 | 42526827 |
| Anal abscess | 12.51 | 12.51 | 29 | 52506 | 7821 | 42560979 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Diabetic ketoacidosis | 7619.31 | 11.59 | 2281 | 78050 | 39777 | 110469191 |
| Euglycaemic diabetic ketoacidosis | 6810.16 | 11.59 | 1599 | 78732 | 10024 | 110498944 |
| Ketoacidosis | 3553.24 | 11.59 | 923 | 79408 | 9164 | 110499804 |
| Metabolic acidosis | 713.06 | 11.59 | 586 | 79745 | 99158 | 110409810 |
| Lactic acidosis | 641.96 | 11.59 | 535 | 79796 | 92276 | 110416692 |
| Urinary tract infection | 503.48 | 11.59 | 872 | 79459 | 325410 | 110183558 |
| Acute kidney injury | 474.97 | 11.59 | 1264 | 79067 | 634166 | 109874802 |
| Fungal infection | 461.40 | 11.59 | 344 | 79987 | 50462 | 110458506 |
| Glycosylated haemoglobin increased | 413.29 | 11.59 | 241 | 80090 | 23378 | 110485590 |
| Blood ketone body increased | 395.00 | 11.59 | 98 | 80233 | 790 | 110508178 |
| Ketosis | 346.38 | 11.59 | 102 | 80229 | 1652 | 110507316 |
| Dehydration | 312.96 | 11.59 | 652 | 79679 | 278859 | 110230109 |
| Hyperglycaemia | 308.82 | 11.59 | 344 | 79987 | 84746 | 110424222 |
| Pollakiuria | 307.93 | 11.59 | 256 | 80075 | 43939 | 110465029 |
| Ketonuria | 290.18 | 11.59 | 85 | 80246 | 1350 | 110507618 |
| Blood glucose increased | 285.43 | 11.59 | 413 | 79918 | 132083 | 110376885 |
| Urine ketone body present | 267.81 | 11.59 | 102 | 80229 | 3744 | 110505224 |
| Urosepsis | 265.79 | 11.59 | 202 | 80129 | 30473 | 110478495 |
| Glomerular filtration rate decreased | 253.80 | 11.59 | 192 | 80139 | 28764 | 110480204 |
| Hypoglycaemia | 251.65 | 11.59 | 363 | 79968 | 115741 | 110393227 |
| Acidosis | 244.41 | 11.59 | 170 | 80161 | 22361 | 110486607 |
| Necrotising fasciitis | 239.92 | 11.59 | 115 | 80216 | 7476 | 110501492 |
| Toe amputation | 231.79 | 11.59 | 95 | 80236 | 4243 | 110504725 |
| Hypovolaemia | 231.52 | 11.59 | 162 | 80169 | 21512 | 110487456 |
| Cardiac failure | 216.08 | 11.59 | 443 | 79888 | 187183 | 110321785 |
| Polyuria | 204.59 | 11.59 | 139 | 80192 | 17599 | 110491369 |
| Balanoposthitis | 194.94 | 11.59 | 62 | 80269 | 1314 | 110507654 |
| Hyperkalaemia | 182.23 | 11.59 | 342 | 79989 | 135454 | 110373514 |
| Blood glucose abnormal | 177.66 | 11.59 | 113 | 80218 | 12803 | 110496165 |
| Infusion related reaction | 163.76 | 11.59 | 38 | 80293 | 381124 | 110127844 |
| Catarrh | 147.53 | 11.59 | 82 | 80249 | 7253 | 110501715 |
| Burns second degree | 146.17 | 11.59 | 83 | 80248 | 7650 | 110501318 |
| Diabetes mellitus inadequate control | 145.06 | 11.59 | 141 | 80190 | 29634 | 110479334 |
| Weight decreased | 141.26 | 11.59 | 693 | 79638 | 467364 | 110041604 |
| Steroid dependence | 139.16 | 11.59 | 83 | 80248 | 8386 | 110500582 |
| Vomiting | 137.95 | 11.59 | 1130 | 79201 | 909545 | 109599423 |
| Cardiac failure chronic | 137.72 | 11.59 | 99 | 80232 | 13712 | 110495256 |
| Glossodynia | 132.45 | 11.59 | 7 | 80324 | 221997 | 110286971 |
| Pancreatitis | 129.74 | 11.59 | 239 | 80092 | 93294 | 110415674 |
| Glycosuria | 128.38 | 11.59 | 54 | 80277 | 2576 | 110506392 |
| Blood ketone body | 125.63 | 11.59 | 29 | 80302 | 165 | 110508803 |
| Therapeutic product effect decreased | 123.13 | 11.59 | 16 | 80315 | 244300 | 110264668 |
| Synovitis | 122.41 | 11.59 | 25 | 80306 | 274067 | 110234901 |
| Genital infection fungal | 121.33 | 11.59 | 30 | 80301 | 238 | 110508730 |
| Emphysematous pyelonephritis | 120.24 | 11.59 | 35 | 80296 | 543 | 110508425 |
| Malignant mediastinal neoplasm | 119.70 | 11.59 | 43 | 80288 | 1335 | 110507633 |
| Stomatitis | 117.92 | 11.59 | 26 | 80305 | 270216 | 110238752 |
| Hypopnoea | 116.75 | 11.59 | 83 | 80248 | 11297 | 110497671 |
| Acetonaemia | 116.59 | 11.59 | 34 | 80297 | 531 | 110508437 |
| Treatment failure | 112.55 | 11.59 | 31 | 80300 | 277203 | 110231765 |
| Maternal exposure during pregnancy | 112.27 | 11.59 | 24 | 80307 | 254859 | 110254109 |
| Glucose urine present | 111.74 | 11.59 | 47 | 80284 | 2242 | 110506726 |
| COVID-19 | 111.26 | 11.59 | 411 | 79920 | 244649 | 110264319 |
| Anion gap increased | 111.13 | 11.59 | 57 | 80274 | 4287 | 110504681 |
| Polycythaemia | 110.79 | 11.59 | 52 | 80279 | 3223 | 110505745 |
| Drug intolerance | 108.51 | 11.59 | 82 | 80249 | 406430 | 110102538 |
| Parosmia | 108.04 | 11.59 | 84 | 80247 | 13096 | 110495872 |
| Arthropathy | 108.00 | 11.59 | 37 | 80294 | 287485 | 110221483 |
| Folliculitis | 107.76 | 11.59 | 3 | 80328 | 167650 | 110341318 |
| Helicobacter infection | 107.66 | 11.59 | 6 | 80325 | 181871 | 110327097 |
| Rheumatoid arthritis | 106.73 | 11.59 | 42 | 80289 | 299571 | 110209397 |
| Pemphigus | 105.87 | 11.59 | 15 | 80316 | 214555 | 110294413 |
| Irritable bowel syndrome | 105.32 | 11.59 | 3 | 80328 | 164212 | 110344756 |
| Swelling | 104.14 | 11.59 | 63 | 80268 | 350978 | 110157990 |
| Drug hypersensitivity | 102.70 | 11.59 | 107 | 80224 | 453983 | 110054985 |
| Bronchiectasis | 101.70 | 11.59 | 129 | 80202 | 36364 | 110472604 |
| Renal impairment | 101.06 | 11.59 | 334 | 79997 | 188111 | 110320857 |
| Exposure during pregnancy | 100.74 | 11.59 | 5 | 80326 | 167419 | 110341549 |
| Pericarditis | 99.90 | 11.59 | 19 | 80312 | 219095 | 110289873 |
| Glycosylated haemoglobin abnormal | 99.32 | 11.59 | 29 | 80302 | 455 | 110508513 |
| Gingival pain | 99.02 | 11.59 | 86 | 80245 | 15650 | 110493318 |
| Sepsis | 96.02 | 11.59 | 481 | 79850 | 326865 | 110182103 |
| Urine ketone body | 93.86 | 11.59 | 23 | 80308 | 175 | 110508793 |
| Diabetic ketosis | 91.94 | 11.59 | 32 | 80299 | 904 | 110508064 |
| Dysuria | 87.43 | 11.59 | 157 | 80174 | 60074 | 110448894 |
| Pruritus genital | 87.07 | 11.59 | 56 | 80275 | 6466 | 110502502 |
| Toxicity to various agents | 87.06 | 11.59 | 134 | 80197 | 480421 | 110028547 |
| Drug ineffective | 86.29 | 11.59 | 700 | 79631 | 1519840 | 108989128 |
| Thirst | 86.08 | 11.59 | 92 | 80239 | 21615 | 110487353 |
| Impaired quality of life | 85.06 | 11.59 | 107 | 80224 | 29910 | 110479058 |
| Urinary tract candidiasis | 84.20 | 11.59 | 32 | 80299 | 1167 | 110507801 |
| Hypotension | 83.92 | 11.59 | 659 | 79672 | 523190 | 109985778 |
| Phimosis | 83.63 | 11.59 | 29 | 80302 | 810 | 110508158 |
| Sinusitis | 82.86 | 11.59 | 57 | 80274 | 296631 | 110212337 |
| Alcohol poisoning | 81.67 | 11.59 | 61 | 80270 | 8959 | 110500009 |
| Starvation ketoacidosis | 81.67 | 11.59 | 23 | 80308 | 315 | 110508653 |
| Joint swelling | 81.65 | 11.59 | 122 | 80209 | 442723 | 110066245 |
| Alopecia | 81.26 | 11.59 | 87 | 80244 | 364666 | 110144302 |
| Product monitoring error | 80.00 | 11.59 | 60 | 80271 | 8867 | 110500101 |
| Pancreatitis acute | 79.80 | 11.59 | 151 | 80180 | 60123 | 110448845 |
| Hypersensitivity | 79.74 | 11.59 | 106 | 80225 | 403892 | 110105076 |
| BRASH syndrome | 78.67 | 11.59 | 43 | 80288 | 3680 | 110505288 |
| Hyperglycaemic hyperosmolar nonketotic syndrome | 78.47 | 11.59 | 40 | 80291 | 2969 | 110505999 |
| Vulvovaginal pruritus | 77.46 | 11.59 | 41 | 80290 | 3290 | 110505678 |
| Rhinitis | 76.38 | 11.59 | 88 | 80243 | 22457 | 110486511 |
| Neutropenia | 76.29 | 11.59 | 96 | 80235 | 374524 | 110134444 |
| Genital infection | 75.28 | 11.59 | 20 | 80311 | 217 | 110508751 |
| Hypophagia | 73.62 | 11.59 | 135 | 80196 | 52491 | 110456477 |
| Fibromyalgia | 73.42 | 11.59 | 17 | 80314 | 170892 | 110338076 |
| Rheumatoid factor positive | 73.06 | 11.59 | 6 | 80325 | 131634 | 110377334 |
| Cerebral infarction | 72.54 | 11.59 | 133 | 80198 | 51705 | 110457263 |
| Haematocrit increased | 72.24 | 11.59 | 45 | 80286 | 4914 | 110504054 |
| Diabetic foot | 72.18 | 11.59 | 42 | 80289 | 4053 | 110504915 |
| Cardiac murmur | 71.71 | 11.59 | 89 | 80242 | 24539 | 110484429 |
| Febrile neutropenia | 71.17 | 11.59 | 75 | 80256 | 316692 | 110192276 |
| Hyperthyroidism | 70.04 | 11.59 | 96 | 80235 | 29165 | 110479803 |
| Drug abuse | 69.84 | 11.59 | 21 | 80310 | 177390 | 110331578 |
| Musculoskeletal pain | 69.67 | 11.59 | 23 | 80308 | 183000 | 110325968 |
| Completed suicide | 68.43 | 11.59 | 46 | 80285 | 242335 | 110266633 |
| N-terminal prohormone brain natriuretic peptide increased | 68.29 | 11.59 | 47 | 80284 | 6074 | 110502894 |
| Atrial fibrillation | 67.69 | 11.59 | 338 | 79993 | 229304 | 110279664 |
| Nasopharyngitis | 67.61 | 11.59 | 114 | 80217 | 394247 | 110114721 |
| Pyelonephritis | 66.81 | 11.59 | 87 | 80244 | 25163 | 110483805 |
| Injury | 66.22 | 11.59 | 23 | 80308 | 177242 | 110331726 |
| Glomerular filtration rate abnormal | 66.02 | 11.59 | 33 | 80298 | 2350 | 110506618 |
| Acquired phimosis | 65.62 | 11.59 | 16 | 80315 | 119 | 110508849 |
| Contraindicated product administered | 65.03 | 11.59 | 51 | 80280 | 248216 | 110260752 |
| Pyelonephritis fungal | 64.55 | 11.59 | 19 | 80312 | 307 | 110508661 |
| Orchitis | 64.33 | 11.59 | 30 | 80301 | 1832 | 110507136 |
| Wound | 64.18 | 11.59 | 46 | 80285 | 234391 | 110274577 |
| Haemoglobin increased | 63.71 | 11.59 | 53 | 80278 | 9094 | 110499874 |
| Perinephric abscess | 63.64 | 11.59 | 20 | 80311 | 407 | 110508561 |
| Prostatitis | 63.54 | 11.59 | 41 | 80290 | 4760 | 110504208 |
| Emphysematous cystitis | 62.89 | 11.59 | 22 | 80309 | 631 | 110508337 |
| Product use issue | 62.28 | 11.59 | 81 | 80250 | 311614 | 110197354 |
| Musculoskeletal stiffness | 62.02 | 11.59 | 67 | 80264 | 279755 | 110229213 |
| Bursitis | 61.97 | 11.59 | 10 | 80321 | 129908 | 110379060 |
| Acute myocardial infarction | 60.50 | 11.59 | 165 | 80166 | 83612 | 110425356 |
| Balanitis candida | 60.36 | 11.59 | 16 | 80315 | 172 | 110508796 |
| Diabetic coma | 59.87 | 11.59 | 26 | 80305 | 1342 | 110507626 |
| Scrotal abscess | 59.81 | 11.59 | 21 | 80310 | 609 | 110508359 |
| Necrotising soft tissue infection | 59.65 | 11.59 | 20 | 80311 | 503 | 110508465 |
| Perineal abscess | 58.29 | 11.59 | 22 | 80309 | 787 | 110508181 |
| Leriche syndrome | 58.21 | 11.59 | 15 | 80316 | 143 | 110508825 |
| Leukopenia | 57.87 | 11.59 | 18 | 80313 | 148773 | 110360195 |
| Hepatic enzyme increased | 57.57 | 11.59 | 90 | 80241 | 320802 | 110188166 |
| Altered state of consciousness | 56.97 | 11.59 | 128 | 80203 | 57498 | 110451470 |
| Disease progression | 56.83 | 11.59 | 56 | 80275 | 243978 | 110264990 |
| Blister | 56.71 | 11.59 | 49 | 80282 | 227327 | 110281641 |
| Genitourinary tract infection | 56.63 | 11.59 | 17 | 80314 | 295 | 110508673 |
| Blood cholesterol increased | 56.41 | 11.59 | 32 | 80299 | 184753 | 110324215 |
| Impaired work ability | 56.30 | 11.59 | 82 | 80249 | 26337 | 110482631 |
| Pancytopenia | 56.24 | 11.59 | 42 | 80289 | 209571 | 110299397 |
| Psoriatic arthropathy | 55.99 | 11.59 | 37 | 80294 | 196724 | 110312244 |
| Diabetic metabolic decompensation | 55.92 | 11.59 | 35 | 80296 | 3854 | 110505114 |
| Blood creatinine increased | 55.88 | 11.59 | 272 | 80059 | 182617 | 110326351 |
| Mobility decreased | 55.84 | 11.59 | 54 | 80277 | 237368 | 110271600 |
| Anxiety | 55.31 | 11.59 | 104 | 80227 | 344974 | 110163994 |
| Impaired healing | 54.63 | 11.59 | 38 | 80293 | 196679 | 110312289 |
| Ill-defined disorder | 54.19 | 11.59 | 23 | 80308 | 156830 | 110352138 |
| Prerenal failure | 53.94 | 11.59 | 36 | 80295 | 4423 | 110504545 |
| Blood ketone body present | 53.73 | 11.59 | 14 | 80317 | 140 | 110508828 |
| Candida infection | 53.59 | 11.59 | 112 | 80219 | 47897 | 110461071 |
| Penile discomfort | 53.13 | 11.59 | 10 | 80321 | 15 | 110508953 |
| White blood cell count decreased | 53.00 | 11.59 | 53 | 80278 | 229337 | 110279631 |
| Lower respiratory tract infection | 53.00 | 11.59 | 59 | 80272 | 243047 | 110265921 |
| Polydipsia | 52.42 | 11.59 | 44 | 80287 | 7644 | 110501324 |
| Vulvovaginal mycotic infection | 52.37 | 11.59 | 38 | 80293 | 5339 | 110503629 |
| Blood immunoglobulin E increased | 51.38 | 11.59 | 43 | 80288 | 7439 | 110501529 |
| Pain | 51.07 | 11.59 | 446 | 79885 | 954509 | 109554459 |
| Genital rash | 50.80 | 11.59 | 23 | 80308 | 1312 | 110507656 |
| Kussmaul respiration | 49.99 | 11.59 | 17 | 80314 | 447 | 110508521 |
| Diabetic ketoacidotic hyperglycaemic coma | 49.77 | 11.59 | 15 | 80316 | 264 | 110508704 |
| Vesicoureteric reflux | 49.36 | 11.59 | 14 | 80317 | 197 | 110508771 |
| Therapy cessation | 49.32 | 11.59 | 104 | 80227 | 44753 | 110464215 |
| Haematuria | 48.89 | 11.59 | 152 | 80179 | 82853 | 110426115 |
| Swollen tongue | 48.80 | 11.59 | 124 | 80207 | 60238 | 110448730 |
| Ischaemic contracture of the left ventricle | 48.77 | 11.59 | 13 | 80318 | 143 | 110508825 |
| Leg amputation | 48.50 | 11.59 | 33 | 80298 | 4185 | 110504783 |
| Hypernatraemia | 48.05 | 11.59 | 62 | 80269 | 17771 | 110491197 |
| Genital candidiasis | 47.58 | 11.59 | 14 | 80317 | 226 | 110508742 |
| Anion gap abnormal | 47.03 | 11.59 | 19 | 80312 | 817 | 110508151 |
| Eosinophilic myocarditis | 46.61 | 11.59 | 25 | 80306 | 2060 | 110506908 |
| Left atrial dilatation | 46.12 | 11.59 | 30 | 80301 | 3530 | 110505438 |
| Haematochezia | 46.03 | 11.59 | 186 | 80145 | 115338 | 110393630 |
| Testicular abscess | 45.94 | 11.59 | 11 | 80320 | 75 | 110508893 |
| Cellulitis of male external genital organ | 45.83 | 11.59 | 10 | 80321 | 42 | 110508926 |
| Gait inability | 45.52 | 11.59 | 21 | 80310 | 136355 | 110372613 |
| Scrotal cellulitis | 45.45 | 11.59 | 11 | 80320 | 79 | 110508889 |
| Pemphigoid | 44.69 | 11.59 | 63 | 80268 | 19644 | 110489324 |
| Paraesthesia | 44.60 | 11.59 | 83 | 80248 | 276438 | 110232530 |
| Systemic candida | 44.44 | 11.59 | 45 | 80286 | 9929 | 110499039 |
| Insulin C-peptide decreased | 44.30 | 11.59 | 11 | 80320 | 89 | 110508879 |
| Contusion | 44.23 | 11.59 | 63 | 80268 | 233298 | 110275670 |
| Inappropriate schedule of product administration | 44.17 | 11.59 | 276 | 80055 | 203361 | 110305607 |
| Nightmare | 43.77 | 11.59 | 91 | 80240 | 38772 | 110470196 |
| Troponin increased | 43.72 | 11.59 | 78 | 80253 | 29688 | 110479280 |
| Angina pectoris | 43.30 | 11.59 | 121 | 80210 | 62174 | 110446794 |
| Ischaemic nephropathy | 43.25 | 11.59 | 11 | 80320 | 99 | 110508869 |
| Insomnia | 43.11 | 11.59 | 127 | 80204 | 360463 | 110148505 |
| Spleen ischaemia | 42.87 | 11.59 | 10 | 80321 | 60 | 110508908 |
| Discomfort | 42.67 | 11.59 | 56 | 80275 | 214651 | 110294317 |
| Peripheral artery bypass | 42.21 | 11.59 | 11 | 80320 | 110 | 110508858 |
| Foot amputation | 41.55 | 11.59 | 19 | 80312 | 1109 | 110507859 |
| Diabetic neuropathy | 41.53 | 11.59 | 37 | 80294 | 6962 | 110502006 |
| Amputation | 41.41 | 11.59 | 18 | 80313 | 931 | 110508037 |
| Gangrene | 41.21 | 11.59 | 55 | 80276 | 16286 | 110492682 |
| Peripheral venous disease | 41.20 | 11.59 | 6 | 80325 | 84111 | 110424857 |
| Candida sepsis | 40.95 | 11.59 | 26 | 80305 | 2935 | 110506033 |
| Pyelonephritis acute | 40.57 | 11.59 | 37 | 80294 | 7176 | 110501792 |
| Liver injury | 40.52 | 11.59 | 30 | 80301 | 150383 | 110358585 |
| Accidental overdose | 40.37 | 11.59 | 105 | 80226 | 51729 | 110457239 |
| Thrombocytopenia | 40.19 | 11.59 | 125 | 80206 | 348760 | 110160208 |
| Glucose urine | 40.13 | 11.59 | 9 | 80322 | 44 | 110508924 |
| Dizziness | 39.75 | 11.59 | 720 | 79611 | 697473 | 109811495 |
| Therapeutic drug monitoring analysis incorrectly performed | 39.43 | 11.59 | 16 | 80315 | 696 | 110508272 |
| Tubulointerstitial nephritis | 39.27 | 11.59 | 107 | 80224 | 54177 | 110454791 |
| Platelet count decreased | 39.11 | 11.59 | 67 | 80264 | 230376 | 110278592 |
| Liver disorder | 38.80 | 11.59 | 28 | 80303 | 142215 | 110366753 |
| Joint range of motion decreased | 38.78 | 11.59 | 20 | 80311 | 121812 | 110387156 |
| Seizure | 38.75 | 11.59 | 63 | 80268 | 221122 | 110287846 |
| Vulvovaginal candidiasis | 38.49 | 11.59 | 26 | 80305 | 3259 | 110505709 |
| Hypertension | 38.11 | 11.59 | 216 | 80115 | 509868 | 109999100 |
| Mitral valve incompetence | 37.48 | 11.59 | 78 | 80253 | 33251 | 110475717 |
| Myelosuppression | 37.43 | 11.59 | 11 | 80320 | 94329 | 110414639 |
| Pancreatic carcinoma | 37.42 | 11.59 | 50 | 80281 | 14822 | 110494146 |
| Red blood cell sedimentation rate increased | 37.40 | 11.59 | 6 | 80325 | 78296 | 110430672 |
| Genital discolouration | 37.37 | 11.59 | 6 | 80325 | 0 | 110508968 |
| Haemoglobin decreased | 37.22 | 11.59 | 78 | 80253 | 248649 | 110260319 |
| Blood glucose fluctuation | 36.64 | 11.59 | 36 | 80295 | 7662 | 110501306 |
| Blood pH abnormal | 36.58 | 11.59 | 8 | 80323 | 34 | 110508934 |
| Pancreatitis necrotising | 36.51 | 11.59 | 31 | 80300 | 5470 | 110503498 |
| Overdose | 36.10 | 11.59 | 72 | 80259 | 233722 | 110275246 |
| Injection site reaction | 36.05 | 11.59 | 10 | 80321 | 89060 | 110419908 |
| Nausea | 36.04 | 11.59 | 1162 | 79169 | 1234528 | 109274440 |
| Eczema | 35.95 | 11.59 | 125 | 80206 | 72168 | 110436800 |
| Cerebrovascular accident | 35.81 | 11.59 | 240 | 80091 | 181044 | 110327924 |
| Dysgeusia | 35.67 | 11.59 | 122 | 80209 | 69863 | 110439105 |
| Blood glucose decreased | 35.52 | 11.59 | 71 | 80260 | 29417 | 110479551 |
| Medication error | 35.31 | 11.59 | 161 | 80170 | 105205 | 110403763 |
| Cardiac failure acute | 35.24 | 11.59 | 63 | 80268 | 24015 | 110484953 |
| Wound infection | 35.19 | 11.59 | 13 | 80318 | 96452 | 110412516 |
| Blood lactic acid increased | 35.02 | 11.59 | 50 | 80281 | 15771 | 110493197 |
| Mucosal inflammation | 35 | 11.59 | 13 | 80318 | 96128 | 110412840 |
| Mucosal dryness | 34.57 | 11.59 | 27 | 80304 | 4236 | 110504732 |
| Peripheral arterial occlusive disease | 34.46 | 11.59 | 38 | 80293 | 9242 | 110499726 |
| Arthralgia | 34.12 | 11.59 | 382 | 79949 | 779250 | 109729718 |
| Vertigo | 33.91 | 11.59 | 139 | 80192 | 86731 | 110422237 |
| Lung disorder | 33.72 | 11.59 | 49 | 80282 | 179998 | 110328970 |
| Memory impairment | 33.65 | 11.59 | 57 | 80274 | 196887 | 110312081 |
| Pulmonary fibrosis | 33.61 | 11.59 | 16 | 80315 | 102026 | 110406942 |
| Hypercholesterolaemia | 33.55 | 11.59 | 12 | 80319 | 90825 | 110418143 |
| Prescribed overdose | 33.33 | 11.59 | 11 | 80320 | 87570 | 110421398 |
| Perineal infection | 33.19 | 11.59 | 15 | 80316 | 852 | 110508116 |
| Urinary tract infection fungal | 33.15 | 11.59 | 17 | 80314 | 1278 | 110507690 |
| Glycosylated haemoglobin decreased | 33.11 | 11.59 | 15 | 80316 | 857 | 110508111 |
| Headache | 33.09 | 11.59 | 447 | 79884 | 881930 | 109627038 |
| Urticaria | 32.78 | 11.59 | 120 | 80211 | 318737 | 110190231 |
| Gastroenteritis | 32.71 | 11.59 | 81 | 80250 | 38719 | 110470249 |
| Vulval abscess | 32.51 | 11.59 | 15 | 80316 | 894 | 110508074 |
| Palpitations | 32.18 | 11.59 | 212 | 80119 | 159000 | 110349968 |
| Gastrointestinal disorder | 32.06 | 11.59 | 81 | 80250 | 241871 | 110267097 |
| pH body fluid abnormal | 31.71 | 11.59 | 9 | 80322 | 127 | 110508841 |
| Systemic lupus erythematosus | 31.54 | 11.59 | 88 | 80243 | 254250 | 110254718 |
| Neutrophil count decreased | 31.46 | 11.59 | 25 | 80306 | 120916 | 110388052 |
| Genital infection male | 31.13 | 11.59 | 6 | 80325 | 11 | 110508957 |
| Ejection fraction decreased | 31.00 | 11.59 | 82 | 80249 | 40798 | 110468170 |
| Genital erythema | 30.70 | 11.59 | 11 | 80320 | 339 | 110508629 |
| Wheezing | 30.41 | 11.59 | 90 | 80241 | 255140 | 110253828 |
| Therapy non-responder | 30.26 | 11.59 | 42 | 80289 | 157265 | 110351703 |
| Urine output increased | 30.16 | 11.59 | 21 | 80310 | 2765 | 110506203 |
| Vulvovaginitis | 30.01 | 11.59 | 11 | 80320 | 362 | 110508606 |
| Coagulation test abnormal | 29.91 | 11.59 | 17 | 80314 | 1569 | 110507399 |
| Penile rash | 29.86 | 11.59 | 6 | 80325 | 15 | 110508953 |
| Tachypnoea | 29.86 | 11.59 | 79 | 80252 | 39316 | 110469652 |
| Diabetic foot infection | 29.79 | 11.59 | 14 | 80317 | 870 | 110508098 |
| Abnormal loss of weight | 29.75 | 11.59 | 37 | 80294 | 10220 | 110498748 |
| Chronic kidney disease | 29.72 | 11.59 | 122 | 80209 | 76169 | 110432799 |
| Sciatica | 29.66 | 11.59 | 15 | 80316 | 92384 | 110416584 |
| International normalised ratio increased | 29.52 | 11.59 | 13 | 80318 | 86759 | 110422209 |
| Peripheral artery occlusion | 29.37 | 11.59 | 21 | 80310 | 2884 | 110506084 |
| Tinnitus | 28.66 | 11.59 | 103 | 80228 | 60437 | 110448531 |
| Night sweats | 28.66 | 11.59 | 33 | 80298 | 133950 | 110375018 |
| Ulnar nerve injury | 28.61 | 11.59 | 10 | 80321 | 286 | 110508682 |
| Penile discharge | 28.60 | 11.59 | 7 | 80324 | 53 | 110508915 |
| Fungal cystitis | 28.59 | 11.59 | 6 | 80325 | 20 | 110508948 |
| Genital swelling | 28.37 | 11.59 | 11 | 80320 | 424 | 110508544 |
| Therapeutic product effect incomplete | 28.07 | 11.59 | 77 | 80254 | 223728 | 110285240 |
| Diabetic nephropathy | 27.98 | 11.59 | 22 | 80309 | 3486 | 110505482 |
| Left ventricular dysfunction | 27.62 | 11.59 | 56 | 80275 | 23437 | 110485531 |
| Aspartate aminotransferase increased | 27.59 | 11.59 | 46 | 80285 | 159890 | 110349078 |
| Anal abscess | 27.57 | 11.59 | 38 | 80293 | 11600 | 110497368 |
| Obesity | 27.56 | 11.59 | 25 | 80306 | 113326 | 110395642 |
| Epididymitis | 27.54 | 11.59 | 19 | 80312 | 2465 | 110506503 |
| Renal abscess | 27.53 | 11.59 | 16 | 80315 | 1540 | 110507428 |
| Cardiac amyloidosis | 27.52 | 11.59 | 20 | 80311 | 2817 | 110506151 |
| Blood bicarbonate decreased | 27.39 | 11.59 | 27 | 80304 | 5770 | 110503198 |
| Debridement | 27.21 | 11.59 | 17 | 80314 | 1866 | 110507102 |
| Failure to suspend medication | 27.18 | 11.59 | 11 | 80320 | 475 | 110508493 |
| Inflammation | 26.93 | 11.59 | 63 | 80268 | 193175 | 110315793 |
| Blepharospasm | 26.66 | 11.59 | 4 | 80327 | 54847 | 110454121 |
| Product prescribing error | 26.61 | 11.59 | 90 | 80241 | 51241 | 110457727 |
| Blood urea increased | 26.44 | 11.59 | 94 | 80237 | 54863 | 110454105 |
| Cytomegalovirus infection | 26.39 | 11.59 | 4 | 80327 | 54440 | 110454528 |
| Anion gap | 26.39 | 11.59 | 17 | 80314 | 1968 | 110507000 |
| Coma acidotic | 26.32 | 11.59 | 8 | 80323 | 145 | 110508823 |
| Language disorder | 26.24 | 11.59 | 22 | 80309 | 3816 | 110505152 |
| Peripheral swelling | 26.06 | 11.59 | 179 | 80152 | 403855 | 110105113 |
| Sleep disorder | 25.93 | 11.59 | 67 | 80264 | 198577 | 110310391 |
| Crush syndrome | 25.80 | 11.59 | 10 | 80321 | 385 | 110508583 |
| Skin pressure mark | 25.33 | 11.59 | 7 | 80324 | 89 | 110508879 |
| Hip arthroplasty | 25.09 | 11.59 | 5 | 80326 | 55808 | 110453160 |
| Genital abscess | 25.07 | 11.59 | 9 | 80322 | 279 | 110508689 |
| Suicide attempt | 24.90 | 11.59 | 23 | 80308 | 103371 | 110405597 |
| Penile swelling | 24.83 | 11.59 | 12 | 80319 | 794 | 110508174 |
| Electrolyte imbalance | 24.83 | 11.59 | 71 | 80260 | 36957 | 110472011 |
| Penile erythema | 24.74 | 11.59 | 8 | 80323 | 179 | 110508789 |
| Prostatic abscess | 24.72 | 11.59 | 11 | 80320 | 602 | 110508366 |
| Arrhythmia | 24.57 | 11.59 | 108 | 80223 | 69467 | 110439501 |
| Septic shock | 24.49 | 11.59 | 197 | 80134 | 157331 | 110351637 |
| Epilepsy | 24.48 | 11.59 | 22 | 80309 | 100187 | 110408781 |
| Ventricular tachycardia | 24.46 | 11.59 | 86 | 80245 | 49923 | 110459045 |
| Bone marrow failure | 24.35 | 11.59 | 6 | 80325 | 57842 | 110451126 |
| Stress | 24.23 | 11.59 | 145 | 80186 | 105203 | 110403765 |
| Frequent bowel movements | 23.85 | 11.59 | 109 | 80222 | 71281 | 110437687 |
| Lumbosacral radiculoplexus neuropathy | 23.62 | 11.59 | 7 | 80324 | 116 | 110508852 |
| Alcoholic ketoacidosis | 23.40 | 11.59 | 6 | 80325 | 56 | 110508912 |
| Tinea cruris | 23.35 | 11.59 | 10 | 80321 | 499 | 110508469 |
| Blood glucose normal | 23.11 | 11.59 | 5 | 80326 | 20 | 110508948 |
| Lower limb fracture | 23.06 | 11.59 | 13 | 80318 | 75335 | 110433633 |
| Osteoporosis | 22.68 | 11.59 | 18 | 80313 | 87134 | 110421834 |
| Infection | 22.60 | 11.59 | 162 | 80169 | 362038 | 110146930 |
| Urinary hesitation | 22.57 | 11.59 | 22 | 80309 | 4636 | 110504332 |
| Albumin urine present | 22.56 | 11.59 | 11 | 80320 | 742 | 110508226 |
| Embolic cerebellar infarction | 22.54 | 11.59 | 5 | 80326 | 23 | 110508945 |
| Leukocytosis | 22.50 | 11.59 | 88 | 80243 | 53740 | 110455228 |
| Limb amputation | 22.43 | 11.59 | 7 | 80324 | 139 | 110508829 |
| Bladder cancer | 22.25 | 11.59 | 47 | 80284 | 20245 | 110488723 |
| Intentional product misuse | 22.21 | 11.59 | 39 | 80292 | 132865 | 110376103 |
| Varicella zoster pneumonia | 21.89 | 11.59 | 9 | 80322 | 405 | 110508563 |
| Hypoaesthesia | 21.88 | 11.59 | 136 | 80195 | 314087 | 110194881 |
| Genital discomfort | 21.85 | 11.59 | 7 | 80324 | 152 | 110508816 |
| Back injury | 21.83 | 11.59 | 4 | 80327 | 47395 | 110461573 |
| Pyrexia | 21.75 | 11.59 | 492 | 79839 | 897773 | 109611195 |
| Oliguria | 21.37 | 11.59 | 44 | 80287 | 18613 | 110490355 |
| Orchidectomy | 21.16 | 11.59 | 5 | 80326 | 32 | 110508936 |
| Chronic coronary syndrome | 21.12 | 11.59 | 8 | 80323 | 289 | 110508679 |
| Stoma site ulcer | 21.04 | 11.59 | 8 | 80323 | 292 | 110508676 |
| Adverse event | 20.98 | 11.59 | 29 | 80302 | 108780 | 110400188 |
| Colitis ulcerative | 20.77 | 11.59 | 111 | 80220 | 77252 | 110431716 |
| Perineal necrosis | 20.66 | 11.59 | 7 | 80324 | 182 | 110508786 |
| Allergic sinusitis | 20.64 | 11.59 | 14 | 80317 | 1767 | 110507201 |
| Osteoarthritis | 20.61 | 11.59 | 66 | 80265 | 182557 | 110326411 |
| Malignant neoplasm progression | 20.47 | 11.59 | 62 | 80269 | 174505 | 110334463 |
| Lacunar infarction | 20.39 | 11.59 | 24 | 80307 | 6262 | 110502706 |
| Road traffic accident | 20.33 | 11.59 | 29 | 80302 | 107369 | 110401599 |
| Ischaemic cardiomyopathy | 20.26 | 11.59 | 27 | 80304 | 7984 | 110500984 |
| Drug resistance | 19.89 | 11.59 | 8 | 80323 | 56366 | 110452602 |
| Hypovolaemic shock | 19.87 | 11.59 | 37 | 80294 | 14546 | 110494422 |
| Pyuria | 19.74 | 11.59 | 16 | 80315 | 2647 | 110506321 |
| Leukocyturia | 19.59 | 11.59 | 15 | 80316 | 2285 | 110506683 |
| Coronary artery bypass | 19.49 | 11.59 | 23 | 80308 | 6019 | 110502949 |
| Type 2 diabetes mellitus | 19.34 | 11.59 | 65 | 80266 | 177167 | 110331801 |
| Spondylolysis | 19.23 | 11.59 | 7 | 80324 | 226 | 110508742 |
| Pericardial fibrosis | 19.08 | 11.59 | 7 | 80324 | 231 | 110508737 |
| Immune-mediated myositis | 19.05 | 11.59 | 23 | 80308 | 6163 | 110502805 |
| Peripheral ischaemia | 18.90 | 11.59 | 31 | 80300 | 11027 | 110497941 |
| Blood lactic acid decreased | 18.86 | 11.59 | 9 | 80322 | 579 | 110508389 |
| Perineal cellulitis | 18.67 | 11.59 | 5 | 80326 | 56 | 110508912 |
| Laryngitis | 18.65 | 11.59 | 4 | 80327 | 42407 | 110466561 |
| Joint stiffness | 18.65 | 11.59 | 13 | 80318 | 67230 | 110441738 |
| Sedation | 18.63 | 11.59 | 14 | 80317 | 69669 | 110439299 |
| Creatinine renal clearance | 18.59 | 11.59 | 5 | 80326 | 57 | 110508911 |
| Urine albumin/creatinine ratio increased | 18.53 | 11.59 | 11 | 80320 | 1102 | 110507866 |
| Extremity necrosis | 18.50 | 11.59 | 18 | 80313 | 3784 | 110505184 |
| Substance use | 18.46 | 11.59 | 15 | 80316 | 2491 | 110506477 |
| Non-compaction cardiomyopathy | 18.44 | 11.59 | 5 | 80326 | 59 | 110508909 |
| Onychomycosis | 18.29 | 11.59 | 3 | 80328 | 38528 | 110470440 |
| Decreased ventricular preload | 18.28 | 11.59 | 5 | 80326 | 61 | 110508907 |
| Fasting | 18.06 | 11.59 | 5 | 80326 | 64 | 110508904 |
| Genital tract inflammation | 18.01 | 11.59 | 6 | 80325 | 148 | 110508820 |
| Sensorimotor disorder | 18.00 | 11.59 | 11 | 80320 | 1161 | 110507807 |
| Blood bicarbonate abnormal | 17.82 | 11.59 | 6 | 80325 | 153 | 110508815 |
| Respiratory sinus arrhythmia magnitude | 17.79 | 11.59 | 5 | 80326 | 68 | 110508900 |
| Blood insulin decreased | 17.76 | 11.59 | 4 | 80327 | 20 | 110508948 |
| Measles | 17.73 | 11.59 | 9 | 80322 | 662 | 110508306 |
| Hypocapnia | 17.71 | 11.59 | 10 | 80321 | 912 | 110508056 |
| Lupus-like syndrome | 17.63 | 11.59 | 4 | 80327 | 40788 | 110468180 |
| Cardio-respiratory arrest | 17.59 | 11.59 | 36 | 80295 | 115800 | 110393168 |
| Dry mouth | 17.56 | 11.59 | 80 | 80251 | 199868 | 110309100 |
| Perineal pain | 17.56 | 11.59 | 12 | 80319 | 1533 | 110507435 |
| Bronchitis | 17.54 | 11.59 | 57 | 80274 | 156975 | 110351993 |
| Postprandial hypoglycaemia | 17.42 | 11.59 | 6 | 80325 | 164 | 110508804 |
| Blood pressure decreased | 17.38 | 11.59 | 143 | 80188 | 114948 | 110394020 |
| Microalbuminuria | 17.36 | 11.59 | 11 | 80320 | 1238 | 110507730 |
| Drug ineffective for unapproved indication | 17.34 | 11.59 | 30 | 80301 | 102808 | 110406160 |
| Acidosis hyperchloraemic | 17.27 | 11.59 | 12 | 80319 | 1574 | 110507394 |
| Neoplasm progression | 17.24 | 11.59 | 13 | 80318 | 64582 | 110444386 |
| Application site haematoma | 17.15 | 11.59 | 5 | 80326 | 78 | 110508890 |
| Muscle spasms | 17.06 | 11.59 | 125 | 80206 | 278032 | 110230936 |
| Pneumocystis jirovecii pneumonia | 16.92 | 11.59 | 5 | 80326 | 42730 | 110466238 |
| Starvation | 16.74 | 11.59 | 10 | 80321 | 1013 | 110507955 |
| Penis disorder | 16.68 | 11.59 | 10 | 80321 | 1020 | 110507948 |
| Presyncope | 16.59 | 11.59 | 75 | 80256 | 48812 | 110460156 |
| Chest wall haematoma | 16.59 | 11.59 | 8 | 80323 | 527 | 110508441 |
| Product quality issue | 16.57 | 11.59 | 19 | 80312 | 77280 | 110431688 |
| Hyperventilation | 16.55 | 11.59 | 26 | 80305 | 8921 | 110500047 |
| Nail disorder | 16.33 | 11.59 | 11 | 80320 | 57924 | 110451044 |
| Left atrial enlargement | 16.33 | 11.59 | 12 | 80319 | 1719 | 110507249 |
| Gait disturbance | 16.13 | 11.59 | 127 | 80204 | 278081 | 110230887 |
| Scrotal pain | 15.93 | 11.59 | 8 | 80323 | 575 | 110508393 |
| Generalised tonic-clonic seizure | 15.93 | 11.59 | 10 | 80321 | 54670 | 110454298 |
| Troponin I abnormal | 15.93 | 11.59 | 4 | 80327 | 34 | 110508934 |
| Drug withdrawal syndrome | 15.91 | 11.59 | 4 | 80327 | 38050 | 110470918 |
| Dyspepsia | 15.83 | 11.59 | 78 | 80253 | 190887 | 110318081 |
| Circumcision | 15.83 | 11.59 | 4 | 80327 | 35 | 110508933 |
| Lipase increased | 15.76 | 11.59 | 39 | 80292 | 18633 | 110490335 |
| N-terminal prohormone brain natriuretic peptide decreased | 15.73 | 11.59 | 4 | 80327 | 36 | 110508932 |
| Ascites | 15.72 | 11.59 | 27 | 80304 | 92781 | 110416187 |
| Electrocardiogram abnormal | 15.71 | 11.59 | 39 | 80292 | 18670 | 110490298 |
| Toxic epidermal necrolysis | 15.68 | 11.59 | 11 | 80320 | 56716 | 110452252 |
| Perirectal abscess | 15.67 | 11.59 | 13 | 80318 | 2221 | 110506747 |
| Fatigue | 15.67 | 11.59 | 723 | 79608 | 1215235 | 109293733 |
| Abortion spontaneous | 15.56 | 11.59 | 3 | 80328 | 34279 | 110474689 |
| Orthopaedic procedure | 15.43 | 11.59 | 6 | 80325 | 233 | 110508735 |
| Blood creatine increased | 15.41 | 11.59 | 29 | 80302 | 11492 | 110497476 |
| Foot deformity | 15.36 | 11.59 | 8 | 80323 | 48472 | 110460496 |
| Posterior reversible encephalopathy syndrome | 15.29 | 11.59 | 3 | 80328 | 33858 | 110475110 |
| Neoplasm skin | 15.28 | 11.59 | 15 | 80316 | 3189 | 110505779 |
| Alanine aminotransferase increased | 15.27 | 11.59 | 75 | 80256 | 183698 | 110325270 |
| Urinary tract infection enterococcal | 15.22 | 11.59 | 16 | 80315 | 3686 | 110505282 |
| Gastrooesophageal reflux disease | 15.22 | 11.59 | 73 | 80258 | 179903 | 110329065 |
| Hyperlactacidaemia | 15.22 | 11.59 | 24 | 80307 | 8262 | 110500706 |
| Eyelid haematoma | 15.17 | 11.59 | 5 | 80326 | 119 | 110508849 |
| Adrenal insufficiency | 15.12 | 11.59 | 66 | 80265 | 42324 | 110466644 |
| Amnesia | 14.98 | 11.59 | 34 | 80297 | 105374 | 110403594 |
| Neck pain | 14.96 | 11.59 | 43 | 80288 | 123087 | 110385881 |
| Intensive care | 14.96 | 11.59 | 13 | 80318 | 2366 | 110506602 |
| Post procedural complication | 14.94 | 11.59 | 48 | 80283 | 26610 | 110482358 |
| Multiple sclerosis relapse | 14.90 | 11.59 | 9 | 80322 | 50231 | 110458737 |
| Micturition urgency | 14.90 | 11.59 | 39 | 80292 | 19281 | 110489687 |
| Lymphocyte count decreased | 14.67 | 11.59 | 12 | 80319 | 57231 | 110451737 |
| Escherichia pyelonephritis | 14.66 | 11.59 | 9 | 80322 | 958 | 110508010 |
| Anaemia | 14.56 | 11.59 | 295 | 80036 | 546791 | 109962177 |
| Urine alcohol test positive | 14.54 | 11.59 | 4 | 80327 | 50 | 110508918 |
| Spermatic cord inflammation | 14.53 | 11.59 | 3 | 80328 | 9 | 110508959 |
| Stevens-Johnson syndrome | 14.48 | 11.59 | 8 | 80323 | 46893 | 110462075 |
| Unevaluable event | 14.47 | 11.59 | 13 | 80318 | 59214 | 110449754 |
| Penile abscess | 14.37 | 11.59 | 5 | 80326 | 141 | 110508827 |
| Urinary tract infection bacterial | 14.31 | 11.59 | 23 | 80308 | 8044 | 110500924 |
| Encephalopathy | 14.27 | 11.59 | 23 | 80308 | 81032 | 110427936 |
| Blood triglycerides increased | 14.26 | 11.59 | 44 | 80287 | 23882 | 110485086 |
| Synovial disorder | 14.19 | 11.59 | 14 | 80317 | 2993 | 110505975 |
| Vulvovaginal discomfort | 14.16 | 11.59 | 12 | 80319 | 2112 | 110506856 |
| Agitation | 14.09 | 11.59 | 39 | 80292 | 113012 | 110395956 |
| Blood thyroid stimulating hormone increased | 14.08 | 11.59 | 29 | 80302 | 12272 | 110496696 |
| Morganella infection | 14.01 | 11.59 | 10 | 80321 | 1369 | 110507599 |
| Prescribed underdose | 13.99 | 11.59 | 16 | 80315 | 65158 | 110443810 |
| Genital pain | 13.88 | 11.59 | 10 | 80321 | 1390 | 110507578 |
| Oxygen saturation increased | 13.86 | 11.59 | 8 | 80323 | 760 | 110508208 |
| Ear pain | 13.84 | 11.59 | 11 | 80320 | 53215 | 110455753 |
| Polycythaemia vera | 13.75 | 11.59 | 7 | 80324 | 518 | 110508450 |
| Left ventricular hypertrophy | 13.74 | 11.59 | 30 | 80301 | 13214 | 110495754 |
| Limb injury | 13.73 | 11.59 | 59 | 80272 | 37577 | 110471391 |
| Vitamin B12 decreased | 13.73 | 11.59 | 18 | 80313 | 5239 | 110503729 |
| Skin ulcer | 13.62 | 11.59 | 86 | 80245 | 63559 | 110445409 |
| Vasoconstriction | 13.52 | 11.59 | 9 | 80322 | 1101 | 110507867 |
| Intentional overdose | 13.52 | 11.59 | 50 | 80281 | 132451 | 110376517 |
| Adenocarcinoma pancreas | 13.50 | 11.59 | 12 | 80319 | 2251 | 110506717 |
| Skin sensitisation | 13.45 | 11.59 | 9 | 80322 | 1110 | 110507858 |
| Prostatomegaly | 13.44 | 11.59 | 16 | 80315 | 4226 | 110504742 |
| Penile infection | 13.40 | 11.59 | 4 | 80327 | 68 | 110508900 |
| Low density lipoprotein abnormal | 13.27 | 11.59 | 7 | 80324 | 558 | 110508410 |
| Hydronephrosis | 13.25 | 11.59 | 39 | 80292 | 20626 | 110488342 |
| Urinary incontinence | 13.24 | 11.59 | 70 | 80261 | 48517 | 110460451 |
| Eyelid injury | 13.14 | 11.59 | 5 | 80326 | 183 | 110508785 |
| Hypoxia | 13.13 | 11.59 | 49 | 80282 | 129466 | 110379502 |
| Upper respiratory tract infection | 13.11 | 11.59 | 50 | 80281 | 131278 | 110377690 |
| Drug-disease interaction | 13.03 | 11.59 | 11 | 80320 | 1925 | 110507043 |
| Venous pressure jugular | 13.01 | 11.59 | 3 | 80328 | 17 | 110508951 |
| Urinary retention | 13.01 | 11.59 | 91 | 80240 | 69592 | 110439376 |
| Penile pain | 12.99 | 11.59 | 9 | 80322 | 1175 | 110507793 |
| Ear infection | 12.83 | 11.59 | 16 | 80315 | 62716 | 110446252 |
| Nocturia | 12.80 | 11.59 | 34 | 80297 | 16956 | 110492012 |
| Blood calcium decreased | 12.79 | 11.59 | 5 | 80326 | 35840 | 110473128 |
| Bronchopulmonary aspergillosis | 12.76 | 11.59 | 3 | 80328 | 29860 | 110479108 |
| Renal cell carcinoma | 12.72 | 11.59 | 21 | 80310 | 7509 | 110501459 |
| Nephrogenic diabetes insipidus | 12.70 | 11.59 | 12 | 80319 | 2433 | 110506535 |
| Meralgia paraesthetica | 12.69 | 11.59 | 7 | 80324 | 610 | 110508358 |
| Neutrophilia | 12.59 | 11.59 | 25 | 80306 | 10304 | 110498664 |
| Ejection fraction abnormal | 12.56 | 11.59 | 14 | 80317 | 3446 | 110505522 |
| Hepatocellular injury | 12.51 | 11.59 | 11 | 80320 | 50631 | 110458337 |
| Fluid intake reduced | 12.51 | 11.59 | 20 | 80311 | 6966 | 110502002 |
| Oedematous pancreatitis | 12.39 | 11.59 | 10 | 80321 | 1644 | 110507324 |
| Therapy interrupted | 12.38 | 11.59 | 70 | 80261 | 49752 | 110459216 |
| Herpes zoster | 12.34 | 11.59 | 39 | 80292 | 108340 | 110400628 |
| Genital burning sensation | 12.33 | 11.59 | 6 | 80325 | 403 | 110508565 |
| Physical deconditioning | 12.31 | 11.59 | 14 | 80317 | 3523 | 110505445 |
| Poisoning | 12.29 | 11.59 | 3 | 80328 | 29102 | 110479866 |
| Systemic infection | 12.26 | 11.59 | 24 | 80307 | 9795 | 110499173 |
| Diabetes mellitus management | 12.22 | 11.59 | 3 | 80328 | 23 | 110508945 |
| Serotonin syndrome | 12.19 | 11.59 | 15 | 80316 | 59138 | 110449830 |
| Panic attack | 12.18 | 11.59 | 3 | 80328 | 28937 | 110480031 |
| Infarction | 12.18 | 11.59 | 17 | 80314 | 5252 | 110503716 |
| Pneumonia | 12.15 | 11.59 | 517 | 79814 | 876197 | 109632771 |
| Incorrect product formulation administered | 12.00 | 11.59 | 5 | 80326 | 233 | 110508735 |
| Insulin resistance | 11.98 | 11.59 | 10 | 80321 | 1724 | 110507244 |
| Status epilepticus | 11.95 | 11.59 | 4 | 80327 | 31567 | 110477401 |
| Haemophagocytic lymphohistiocytosis | 11.94 | 11.59 | 4 | 80327 | 31555 | 110477413 |
| Myocardial infarction | 11.93 | 11.59 | 201 | 80130 | 191882 | 110317086 |
| Cardiac ventricular thrombosis | 11.88 | 11.59 | 13 | 80318 | 3134 | 110505834 |
| Atrial pressure increased | 11.88 | 11.59 | 4 | 80327 | 102 | 110508866 |
| Ventricular internal diameter abnormal | 11.82 | 11.59 | 5 | 80326 | 242 | 110508726 |
| Dizziness postural | 11.79 | 11.59 | 30 | 80301 | 14579 | 110494389 |
| Scrotal ulcer | 11.79 | 11.59 | 6 | 80325 | 444 | 110508524 |
| Periorbital haematoma | 11.69 | 11.59 | 8 | 80323 | 1024 | 110507944 |
None
| Source | Code | Description |
|---|---|---|
| ATC | A10BD19 | ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs |
| ATC | A10BD20 | ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs |
| ATC | A10BD27 | ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs |
| ATC | A10BK03 | ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Sodium-glucose co-transporter 2 (SGLT2) inhibitors |
| MeSH PA | D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| MeSH PA | D007004 | Hypoglycemic Agents |
| FDA MoA | N0000187058 | Sodium-Glucose Transporter 2 Inhibitors |
| FDA EPC | N0000187059 | Sodium-Glucose Cotransporter 2 Inhibitor |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:35469 | antidepressant |
| CHEBI has role | CHEBI:35526 | hypoglycemic agent |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35623 | anticonvulsant |
| CHEBI has role | CHEBI:35674 | antihypertensive agent |
| CHEBI has role | CHEBI:50864 | insulin-sensitizing drug |
| CHEBI has role | CHEBI:67079 | anti-inflammatory agent |
| CHEBI has role | CHEBI:73273 | sodium-glucose transport protein subtype 2 inhibitor |
| CHEBI has role | CHEBI:76916 | hyperglycemic agent |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Diabetes mellitus type 2 | indication | 44054006 | DOID:9352 |
| Chronic heart failure | indication | 48447003 | |
| Cardiovascular event | reduce risk | 405617006 |
None
None
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.62 | acidic |
| pKa2 | 13.26 | acidic |
| pKa3 | 13.7 | acidic |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 8673927 | May 4, 2027 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 9173859 | May 4, 2027 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 8673927 | May 4, 2027 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 9173859 | May 4, 2027 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN |
| 10MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10022379 | April 2, 2029 | METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID |
| 12.5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10022379 | April 2, 2029 | METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID |
| 25MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10022379 | April 2, 2029 | METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID |
| 5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10022379 | April 2, 2029 | METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 8551957 | Oct. 14, 2029 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 8551957 | Oct. 14, 2029 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 8551957 | Oct. 14, 2029 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 8551957 | Oct. 14, 2029 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN |
| 10MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 8551957 | Oct. 14, 2029 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 12.5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 8551957 | Oct. 14, 2029 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 25MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 8551957 | Oct. 14, 2029 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 8551957 | Oct. 14, 2029 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 10MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 12.5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 25MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 12115179 | Feb. 11, 2030 | TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 10MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10406172 | June 15, 2030 | METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 12.5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10406172 | June 15, 2030 | METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 25MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10406172 | June 15, 2030 | METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10406172 | June 15, 2030 | METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN |
| 10MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN |
| 10MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN |
| 10MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564886 | March 7, 2032 | TREATMENT OF A TYPE 2 DIABETES PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN |
| 12.5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN |
| 12.5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN |
| 12.5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564886 | March 7, 2032 | TREATMENT OF A TYPE 2 DIABETES PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN |
| 25MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN |
| 25MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN |
| 5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN |
| 5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10596120 | March 7, 2032 | TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN |
| 5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564886 | March 7, 2032 | TREATMENT OF A TYPE 2 DIABETES PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12527810 | April 22, 2033 | USE OF EMPAGLIFLOZIN AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PEDIATRIC PATIENTS AGED 10 YEARS TO 17 YEARS WITH TYPE 2 DIABETES MELLITUS |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12527810 | April 22, 2033 | USE OF EMPAGLIFLOZIN AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PEDIATRIC PATIENTS AGED 10 YEARS TO 17 YEARS WITH TYPE 2 DIABETES MELLITUS |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12527810 | April 22, 2033 | USE OF EMPAGLIFLOZIN AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PEDIATRIC PATIENTS AGED 10 YEARS TO 17 YEARS WITH TYPE 2 DIABETES MELLITUS |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12527810 | April 22, 2033 | USE OF EMPAGLIFLOZIN AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PEDIATRIC PATIENTS AGED 10 YEARS TO 17 YEARS WITH TYPE 2 DIABETES MELLITUS |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12527810 | April 22, 2033 | USE OF EMPAGLIFLOZIN AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PEDIATRIC PATIENTS AGED 10 YEARS TO 17 YEARS WITH TYPE 2 DIABETES MELLITUS |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12527810 | April 22, 2033 | USE OF EMPAGLIFLOZIN AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PEDIATRIC PATIENTS AGED 10 YEARS TO 17 YEARS WITH TYPE 2 DIABETES MELLITUS |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 11666590 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 11813275 | April 3, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN PATIENTS WITH HEART FAILURE AND TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 11813275 | April 3, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION IN PATIENTS WITH HEART FAILURE BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12263153 | April 3, 2034 | USE OF EMPAGLIFLOZIN TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12427162 | April 3, 2034 | DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2 |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2 |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12263153 | April 3, 2034 | USE OF EMPAGLIFLOZIN TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12427162 | April 3, 2034 | DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2 |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2 |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2 |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2 |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2 |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2 |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2 |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11666590 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12263153 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12427162 | April 3, 2034 | DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2 |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2 |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2 |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11666590 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12263153 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12427162 | April 3, 2034 | DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2 |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2 |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2 |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11666590 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11813275 | April 3, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN PATIENTS WITH HEART FAILURE AND TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12263153 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12427162 | April 3, 2034 | DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2 |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2 |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2 |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11666590 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11813275 | April 3, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN PATIENTS WITH HEART FAILURE AND TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12263153 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12427162 | April 3, 2034 | DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2 |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2 |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2 |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11666590 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11813275 | April 3, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN PATIENTS WITH HEART FAILURE AND TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12263153 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12427162 | April 3, 2034 | DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2 |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2 |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2 |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11666590 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12263153 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12427162 | April 3, 2034 | DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2 |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2 |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2 |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11666590 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12263153 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12427162 | April 3, 2034 | DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2 |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2 |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2 |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11666590 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11813275 | April 3, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN PATIENTS WITH HEART FAILURE AND TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12263153 | April 3, 2034 | TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12427162 | April 3, 2034 | DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2 |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2 |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 12433906 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN |
| 10MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN |
| 10MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2 |
| 10MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 10MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 12.5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN |
| 12.5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2 |
| 12.5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 12.5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 25MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN |
| 25MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2 |
| 25MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 25MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 10258637 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN |
| 5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11090323 | April 3, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2 |
| 5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 11833166 | April 3, 2034 | TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND HEART FAILURE BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH PLUS HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS, HEART FAILURE AND REDUCED EJECTION FRACTION BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 9949997 | May 17, 2034 | METHOD OF REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 9949997 | May 17, 2034 | METHOD OF REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949997 | May 17, 2034 | METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 9949998 | June 11, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | 9949998 | June 11, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 9949998 | June 11, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 9949998 | June 11, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949998 | June 11, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949998 | June 11, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949998 | June 11, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949998 | June 11, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN |
| 10MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949998 | June 11, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN |
| 12.5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949998 | June 11, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN |
| 25MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949998 | June 11, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN |
| 5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 9949998 | June 11, 2034 | METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN |
| 10MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12364700 | June 8, 2037 | TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN |
| 25MG;5MG | GLYXAMBI | BOEHRINGER INGELHEIM | N206073 | Jan. 30, 2015 | RX | TABLET | ORAL | 12364700 | June 8, 2037 | TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN |
| 10MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 12364700 | June 8, 2037 | TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN |
| 12.5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 12364700 | June 8, 2037 | TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN |
| 25MG;5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 12364700 | June 8, 2037 | TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN |
| 5MG;2.5MG;1GM | TRIJARDY XR | BOEHRINGER INGELHEIM | N212614 | Jan. 27, 2020 | RX | TABLET, EXTENDED RELEASE | ORAL | 12364700 | June 8, 2037 | TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | June 20, 2026 | NEW PATIENT POPULATION |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | June 20, 2026 | NEW PATIENT POPULATION |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | June 20, 2026 | NEW PATIENT POPULATION |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | June 20, 2026 | NEW PATIENT POPULATION |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | June 20, 2026 | NEW PATIENT POPULATION |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | June 20, 2026 | NEW PATIENT POPULATION |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | June 20, 2026 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091 |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | June 20, 2026 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091 |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | June 20, 2026 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091 |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | June 20, 2026 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091 |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | Sept. 21, 2026 | USE OF EMPAGLIFLOZIN TO REDUCE THE RISK OF SUSTAINED DECLINE IN EGFR, END-STAGE KIDNEY DISEASE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| 10MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | Dec. 20, 2026 | PEDIATRIC EXCLUSIVITY |
| 25MG | JARDIANCE | BOEHRINGER INGELHEIM | N204629 | Aug. 1, 2014 | RX | TABLET | ORAL | Dec. 20, 2026 | PEDIATRIC EXCLUSIVITY |
| 12.5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | Dec. 20, 2026 | PEDIATRIC EXCLUSIVITY |
| 12.5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | Dec. 20, 2026 | PEDIATRIC EXCLUSIVITY |
| 5MG;1GM | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | Dec. 20, 2026 | PEDIATRIC EXCLUSIVITY |
| 5MG;500MG | SYNJARDY | BOEHRINGER INGELHEIM | N206111 | Aug. 26, 2015 | RX | TABLET | ORAL | Dec. 20, 2026 | PEDIATRIC EXCLUSIVITY |
| 10MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | Dec. 20, 2026 | PEDIATRIC EXCLUSIVITY |
| 12.5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | Dec. 20, 2026 | PEDIATRIC EXCLUSIVITY |
| 25MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | Dec. 20, 2026 | PEDIATRIC EXCLUSIVITY |
| 5MG;1GM | SYNJARDY XR | BOEHRINGER INGELHEIM | N208658 | Dec. 9, 2016 | RX | TABLET, EXTENDED RELEASE | ORAL | Dec. 20, 2026 | PEDIATRIC EXCLUSIVITY |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Sodium/glucose cotransporter 2 | Transporter | INHIBITOR | Kd | 7.24 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| Sodium/glucose cotransporter 4 | Transporter | IC50 | 4.96 | SCIENTIFIC LITERATURE | |||||
| Sodium/glucose cotransporter 5 | Transporter | IC50 | 5.96 | SCIENTIFIC LITERATURE | |||||
| Sodium/glucose cotransporter 1 | Transporter | IC50 | 5.08 | SCIENTIFIC LITERATURE | |||||
| Sodium/myo-inositol cotransporter 2 | Transporter | IC50 | 5.70 | SCIENTIFIC LITERATURE |
| ID | Source |
|---|---|
| HDC1R2M35U | UNII |
| D10459 | KEGG_DRUG |
| 4033569 | VUID |
| N0000190927 | NUI |
| 4033569 | VANDF |
| C3490348 | UMLSCUI |
| CHEBI:82720 | CHEBI |
| 7R3 | PDB_CHEM_ID |
| CHEMBL2107830 | ChEMBL_ID |
| 11949646 | PUBCHEM_CID |
| DB09038 | DRUGBANK_ID |
| 9398 | INN_ID |
| C570240 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4754 | IUPHAR_LIGAND_ID |
| 1545653 | RXNORM |
| 227183 | MMSL |
| 30461 | MMSL |
| d08275 | MMSL |
| 015572 | NDDF |
| 703894008 | SNOMEDCT_US |
| 703895009 | SNOMEDCT_US |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Jardiance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0597-0152 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 32 sections |
| Jardiance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0597-0152 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 32 sections |
| Jardiance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0597-0153 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 32 sections |
| Jardiance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0597-0153 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 32 sections |
| Synjardy | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0159 | TABLET | 5 mg | ORAL | NDA | 34 sections |
| Synjardy | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0159 | TABLET | 5 mg | ORAL | NDA | 34 sections |
| Glyxambi | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0164 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 32 sections |
| Glyxambi | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0164 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 32 sections |
| Synjardy | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0168 | TABLET | 12.50 mg | ORAL | NDA | 34 sections |
| Synjardy | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0168 | TABLET | 12.50 mg | ORAL | NDA | 34 sections |
| Synjardy | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0175 | TABLET | 5 mg | ORAL | NDA | 34 sections |
| Synjardy | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0175 | TABLET | 5 mg | ORAL | NDA | 34 sections |
| Synjardy | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0180 | TABLET | 12.50 mg | ORAL | NDA | 34 sections |
| Synjardy | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0180 | TABLET | 12.50 mg | ORAL | NDA | 34 sections |
| Glyxambi | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0182 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 32 sections |
| Glyxambi | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0182 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 32 sections |
| SynjardyXR | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0280 | TABLET, EXTENDED RELEASE | 10 mg | ORAL | NDA | 34 sections |
| SynjardyXR | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0280 | TABLET, EXTENDED RELEASE | 10 mg | ORAL | NDA | 34 sections |
| SynjardyXR | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0290 | TABLET, EXTENDED RELEASE | 5 mg | ORAL | NDA | 34 sections |
| SynjardyXR | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0290 | TABLET, EXTENDED RELEASE | 5 mg | ORAL | NDA | 34 sections |
| SynjardyXR | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0295 | TABLET, EXTENDED RELEASE | 25 mg | ORAL | NDA | 34 sections |
| SynjardyXR | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0295 | TABLET, EXTENDED RELEASE | 25 mg | ORAL | NDA | 34 sections |
| SynjardyXR | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0300 | TABLET, EXTENDED RELEASE | 12.50 mg | ORAL | NDA | 34 sections |
| SynjardyXR | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0597-0300 | TABLET, EXTENDED RELEASE | 12.50 mg | ORAL | NDA | 34 sections |
| Trijardy XR | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0597-0380 | TABLET, EXTENDED RELEASE | 10 mg | ORAL | NDA | 34 sections |
| Trijardy XR | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0597-0380 | TABLET, EXTENDED RELEASE | 10 mg | ORAL | NDA | 34 sections |
| Trijardy XR | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0597-0385 | TABLET, EXTENDED RELEASE | 12.50 mg | ORAL | NDA | 34 sections |
| Trijardy XR | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0597-0385 | TABLET, EXTENDED RELEASE | 12.50 mg | ORAL | NDA | 34 sections |
| Trijardy XR | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0597-0390 | TABLET, EXTENDED RELEASE | 25 mg | ORAL | NDA | 34 sections |
| Trijardy XR | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0597-0390 | TABLET, EXTENDED RELEASE | 25 mg | ORAL | NDA | 34 sections |