telmisartan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
angiotensin II receptor antagonists, antihypertensive (non-peptidic) 2583 144701-48-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • telmisartan
  • tolura
  • micardis
  • pritor
A biphenyl compound and benzimidazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION.
  • Molecular weight: 514.63
  • Formula: C33H30N4O2
  • CLOGP: 7.29
  • LIPINSKI: 2
  • HAC: 6
  • HDO: 1
  • TPSA: 72.94
  • ALOGS: -5.17
  • ROTB: 7
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
40 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 2.22 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 5.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 8.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.00 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 20 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 2.426 High 0.90
caco2-efflux Caco-2 efflux ratio (BA/AB) 10.715 High 0.90
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 68.234 10^-6 cm/s High 0.90
dh-clint Dog hepatocyte intrinsic clearance 4.989 uL/min/10^6 cells High 0.90
dppb Dog plasma protein binding (% unbound) 0.830 % High 0.90
fcs-ppb Fetal calf serum protein binding (% unbound) 1.730 % High 0.90
herg hERG pIC50 4.669 pIC50 High 0.90
hh-clint Human hepatocyte intrinsic clearance 3.664 uL/min/10^6 cells High 0.90
hlm-clint Human liver microsomal intrinsic clearance 3.648 uL/min/mg protein High 0.90
hppb Human plasma protein binding (% unbound) 0.430 % High 0.90
kinase-safety-class ACVR2B,AURKA,AXL,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,PDK1,PDK2,PDK4,PRKDC 13
kinase-selectivity-class EIF2AK3,MAP2K6 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 8.851 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 19.320 High 0.90
mh-clint Mouse hepatocyte intrinsic clearance 3.656 High 0.90
mppb Mouse plasma protein binding (% unbound) 0.830 High 0.90
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 30.269 High 0.90
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 1.130 % High 0.90
rat-kpuu-brain Rat brain Kpuu 0.014 % High 1
rh-clint Rat hepatocyte intrinsic clearance 7.674 uL/min/10^6 cells High 0.90
rh-fuinc Rat hepatocyte fraction unbound in incubation 17.120 % High 0.90
rppb Rat plasma protein binding (% unbound) 0.560 % High 0.90
solubility-dd Solubility at pH 7.4 in DMSO 125.603 uM High 0.90

Approvals:

DateAgencyCompanyOrphan
Nov. 10, 1998 FDA BOEHRINGER INGELHEIM
Nov. 12, 1998 EMA KRKA, D.D., NOVO MESTO

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Carotid artery thrombosis 362.30 10.61 152 53164 8940 90566191
Neurologic neglect syndrome 349.50 10.61 147 53169 8700 90566431
Affect lability 345.91 10.61 182 53134 17881 90557250
Adjustment disorder 327.58 10.61 144 53172 9498 90565633
Hemiplegia 321.36 10.61 167 53149 15993 90559138
Arterial occlusive disease 316.54 10.61 152 53164 12294 90562837
Gangrene 311.63 10.61 152 53164 12724 90562407
Personality disorder 304.47 10.61 148 53168 12296 90562835
Sensory loss 268.46 10.61 154 53162 17921 90557210
Blood pressure increased 263.53 10.61 440 52876 196777 90378354
Sinus congestion 258.55 10.61 175 53141 27249 90547882
Skin haemorrhage 254.62 10.61 158 53158 21222 90553909
Motor dysfunction 254.39 10.61 152 53164 19078 90556053
Coordination abnormal 237.20 10.61 151 53165 21205 90553926
Sneezing 222.32 10.61 165 53151 29704 90545427
Eating disorder 220.05 10.61 160 53156 27913 90547218
Respiratory tract congestion 216.62 10.61 157 53159 27253 90547878
Hemiparesis 206.52 10.61 162 53154 31657 90543474
Arthritis 200.72 10.61 356 52960 166959 90408172
Angina pectoris 191.02 10.61 169 53147 38991 90536140
Aphasia 187.70 10.61 174 53142 42638 90532493
Sinus disorder 186.93 10.61 158 53158 34289 90540842
Cystitis 183.41 10.61 211 53105 66507 90508624
Hyponatraemia 175.65 10.61 296 53020 133242 90441889
Muscle spasticity 165.46 10.61 149 53167 35173 90539958
Cataract 148.19 10.61 197 53119 71895 90503236
Dysarthria 147.54 10.61 171 53145 54311 90520820
Influenza like illness 145.70 10.61 207 53109 80404 90494727
Pemphigus 136.80 10.61 16 53300 326848 90248283
Skin exfoliation 135.63 10.61 183 53133 67730 90507401
Fall 129.09 10.61 593 52723 481217 90093914
Palpitations 122.26 10.61 257 53059 136471 90438660
Rhinorrhoea 109.80 10.61 191 53125 88125 90487006
Cerebrovascular accident 109.05 10.61 231 53085 123302 90451829
Psoriasis 108.80 10.61 257 53059 147497 90427634
Dysphagia 107.38 10.61 217 53099 112061 90463070
Folliculitis 106.28 10.61 3 53313 204350 90370781
Glossodynia 106.14 10.61 29 53287 321750 90253381
Chest discomfort 102.23 10.61 241 53075 138124 90437007
Abdominal discomfort 99.48 10.61 81 53235 477247 90097884
Systemic lupus erythematosus 98.23 10.61 45 53271 361851 90213280
Impaired healing 96.64 10.61 12 53304 234187 90340944
Maternal exposure during pregnancy 95.83 10.61 46 53270 360017 90215114
Toxic epidermal necrolysis 94.67 10.61 106 53210 32422 90542709
Wound 89.78 10.61 33 53283 302947 90272184
Anti-cyclic citrullinated peptide antibody positive 88.63 10.61 16 53300 236417 90338714
Irritable bowel syndrome 87.14 10.61 10 53306 207438 90367693
Influenza 81.41 10.61 222 53094 139042 90436089
Muscle injury 80.90 10.61 6 53310 176648 90398483
Blood pressure systolic increased 80.21 10.61 132 53184 58213 90516918
Hypertensive crisis 79.32 10.61 73 53243 17711 90557420
Pericarditis 79.07 10.61 30 53286 270121 90305010
Hand deformity 78.63 10.61 38 53278 296324 90278807
Alopecia 78.43 10.61 106 53210 494965 90080166
Breath sounds abnormal 78.21 10.61 68 53248 15318 90559813
Granuloma skin 77.22 10.61 58 53258 10622 90564509
Duodenal ulcer perforation 72.83 10.61 20 53296 221268 90353863
Cough 72.05 10.61 416 52900 368546 90206585
Blood parathyroid hormone decreased 70.33 10.61 58 53258 12158 90562973
Swelling 70.20 10.61 86 53230 418972 90156159
Epidermal necrosis 69.79 10.61 32 53284 2329 90572802
Bradycardia 69.62 10.61 153 53163 83694 90491437
Hypercalcaemia 69.46 10.61 93 53223 34147 90540984
Labelled drug-drug interaction medication error 69.23 10.61 62 53254 14520 90560611
Endometriosis 68.92 10.61 44 53272 6204 90568927
Skin necrosis 66.88 10.61 65 53251 16876 90558255
Panniculitis 65.75 10.61 60 53256 14398 90560733
Helicobacter infection 63.42 10.61 27 53289 226823 90348308
Listless 62.93 10.61 33 53283 3216 90571915
Ill-defined disorder 62.18 10.61 16 53300 184875 90390256
Sleep disorder due to general medical condition, insomnia type 60.00 10.61 4 53312 128690 90446441
Head discomfort 59.53 10.61 60 53256 16273 90558858
Glaucoma 57.61 10.61 66 53250 20689 90554442
Stomatitis 56.68 10.61 47 53269 274651 90300480
C-reactive protein abnormal 56.47 10.61 5 53311 127424 90447707
Labile hypertension 55.83 10.61 18 53298 497 90574634
Isosthenuria 53.94 10.61 13 53303 116 90575015
Infection 52.90 10.61 82 53234 362012 90213119
Reduced facial expression 52.51 10.61 27 53289 2526 90572605
Fibromyalgia 52.37 10.61 28 53288 206241 90368890
Drug eruption 51.23 10.61 82 53234 35325 90539806
Basal cell carcinoma 50.62 10.61 79 53237 33310 90541821
Exposure during pregnancy 50.17 10.61 40 53276 238370 90336761
Lactic acidosis 49.97 10.61 99 53217 50364 90524767
Renal function test abnormal 49.66 10.61 38 53278 7153 90567978
Joint range of motion decreased 49.07 10.61 10 53306 135633 90439498
Death 48.17 10.61 125 53191 456426 90118705
Wound infection 47.63 10.61 4 53312 106398 90468733
Carcinoid tumour pulmonary 47.62 10.61 16 53300 504 90574627
Rheumatoid nodule 47.53 10.61 59 53257 20107 90555024
Lip dry 47.46 10.61 3 53313 100952 90474179
Chronic kidney disease 46.76 10.61 96 53220 50095 90525036
Atrial fibrillation 46.19 10.61 178 53138 133433 90441698
Lower respiratory tract infection 45.68 10.61 48 53268 250611 90324520
Blood pressure abnormal 45.54 10.61 57 53259 19588 90555543
Pyelitis 44.76 10.61 13 53303 250 90574881
Renal impairment 44.57 10.61 150 53166 105271 90469860
Drug specific antibody 44.38 10.61 24 53292 2488 90572643
Anxiety 44.29 10.61 323 52993 309449 90265682
Abdominal pain upper 43.38 10.61 81 53235 332593 90242538
Sleep apnoea syndrome 42.52 10.61 71 53245 31676 90543455
Rash papular 42.38 10.61 56 53260 20299 90554832
BRASH syndrome 41.94 10.61 21 53295 1858 90573273
Apathy 41.05 10.61 41 53275 10999 90564132
Hypersensitivity 41.03 10.61 134 53182 454543 90120588
Facet joint syndrome 40.66 10.61 5 53311 98384 90476747
Swollen joint count increased 40.64 10.61 8 53308 111198 90463933
Drug ineffective 40.14 10.61 574 52742 1383724 89191407
Muscular weakness 39.61 10.61 232 53084 206434 90368697
Hypoglycaemia 39.45 10.61 110 53206 69738 90505393
Injury 39.19 10.61 35 53281 197314 90377817
Rash 39.16 10.61 291 53025 795809 89779322
Urticaria 38.30 10.61 79 53237 312655 90262476
Infusion site streaking 38.18 10.61 14 53302 573 90574558
Acute kidney injury 38.03 10.61 320 52996 320067 90255064
Hypokalaemia 37.67 10.61 165 53151 130951 90444180
Carotid arteriosclerosis 37.26 10.61 17 53299 1223 90573908
Blister 36.98 10.61 58 53258 254940 90320191
Blood pressure inadequately controlled 36.77 10.61 30 53286 6194 90568937
Psoriatic arthropathy 35.98 10.61 49 53267 228286 90346845
Rheumatic fever 35.72 10.61 23 53293 153098 90422033
Obesity 35.72 10.61 9 53307 105498 90469633
Bladder hypertrophy 35.69 10.61 13 53303 522 90574609
Blood pressure decreased 35.66 10.61 111 53205 74784 90500347
Sciatica 35.60 10.61 8 53308 101374 90473757
Electrocardiogram PR shortened 35.55 10.61 13 53303 528 90574603
Mononeuropathy multiplex 35.30 10.61 12 53304 392 90574739
Completed suicide 34.93 10.61 21 53295 145037 90430094
Oxygen saturation decreased 34.57 10.61 140 53176 107343 90467788
Postprandial hypoglycaemia 34.20 10.61 9 53307 118 90575013
Chloropsia 34.08 10.61 8 53308 63 90575068
Rheumatoid arthritis 33.86 10.61 344 52972 362270 90212861
Deafness 33.75 10.61 53 53263 22461 90552670
Off label use 33.69 10.61 452 52864 1101800 89473331
Cerebral infarction 33.66 10.61 58 53258 26538 90548593
Skin ulcer 33.50 10.61 84 53232 49991 90525140
Night sweats 33.38 10.61 17 53299 128749 90446382
Confusional state 33.06 10.61 360 52956 385845 90189286
Discomfort 33.00 10.61 70 53246 274265 90300866
Lung disorder 32.98 10.61 24 53292 149859 90425272
Drug interaction 32.73 10.61 276 53040 276177 90298954
Hypotension 32.47 10.61 313 53003 325084 90250047
Malaise 32.40 10.61 504 52812 585482 89989649
Arthropathy 32.29 10.61 109 53207 366133 90208998
White blood cell count abnormal 31.91 10.61 30 53286 7474 90567657
Liver injury 31.82 10.61 32 53284 170535 90404596
Prescribed overdose 31.77 10.61 9 53307 97616 90477515
Lower limb fracture 31.31 10.61 6 53310 85007 90490124
Insulin-like growth factor decreased 31.21 10.61 11 53305 401 90574730
Foreign body 31.13 10.61 19 53297 2475 90572656
Deep vein thrombosis postoperative 30.78 10.61 3 53313 70806 90504325
Mayer-Rokitansky-Kuster-Hauser syndrome 30.33 10.61 6 53310 18 90575113
Administration site induration 29.85 10.61 6 53310 20 90575111
Administration site abscess 29.85 10.61 6 53310 20 90575111
Blood thyroid stimulating hormone normal 29.72 10.61 8 53308 115 90575016
Prescription drug used without a prescription 28.84 10.61 20 53296 3235 90571896
Product packaging confusion 28.80 10.61 9 53307 224 90574907
Administration site discharge 28.80 10.61 6 53310 25 90575106
Cranial nerve disorder 28.76 10.61 12 53304 695 90574436
Hypoaesthesia 28.74 10.61 92 53224 314118 90261013
Type 2 diabetes mellitus 28.73 10.61 47 53269 203197 90371934
Creatinine renal clearance increased 28.70 10.61 20 53296 3261 90571870
Small fibre neuropathy 28.49 10.61 12 53304 712 90574419
Compartment syndrome 28.43 10.61 19 53297 2893 90572238
Rhabdomyolysis 28.24 10.61 80 53236 51176 90523955
Blood pressure diastolic decreased 28.22 10.61 54 53262 26772 90548359
Road traffic accident 28.21 10.61 14 53302 107612 90467519
Joint noise 28.14 10.61 24 53292 5266 90569865
Ureteral disorder 28.05 10.61 10 53306 377 90574754
Inappropriate antidiuretic hormone secretion 27.98 10.61 45 53271 19460 90555671
Disease progression 27.40 10.61 31 53285 156584 90418547
Blood pressure diastolic abnormal 27.34 10.61 45 53271 19836 90555295
Optic neuropathy 27.30 10.61 18 53298 2680 90572451
Gouty arthritis 27.26 10.61 11 53305 585 90574546
Hypertensive angiopathy 27.24 10.61 7 53309 83 90575048
Fluid retention 27.09 10.61 9 53307 88082 90487049
Hyperkalaemia 27.07 10.61 92 53224 64872 90510259
Peripheral venous disease 26.83 10.61 8 53308 83913 90491218
Oedema 26.77 10.61 48 53268 200247 90374884
Vertigo 26.61 10.61 96 53220 69715 90505416
Administration site odour 26.57 10.61 6 53310 39 90575092
Oliguria 26.52 10.61 32 53284 10592 90564539
Product substitution issue 26.45 10.61 42 53274 17966 90557165
Product dose omission issue 26.26 10.61 86 53230 291601 90283530
Hepatic function abnormal 26.24 10.61 73 53243 46215 90528916
Ulcer 26.15 10.61 59 53257 32823 90542308
Drug tolerance decreased 25.95 10.61 58 53258 32072 90543059
Myalgia 25.80 10.61 184 53132 174941 90400190
Lower urinary tract symptoms 25.60 10.61 7 53309 107 90575024
Gastric pH increased 25.59 10.61 6 53310 47 90575084
Renal fusion anomaly 25.03 10.61 5 53311 16 90575115
Product monitoring error 24.96 10.61 21 53295 4523 90570608
Albuminuria 24.93 10.61 9 53307 352 90574779
Red blood cell sedimentation rate increased 24.53 10.61 105 53211 82490 90492641
Live birth 24.47 10.61 8 53308 79099 90496032
Grip strength decreased 24.33 10.61 12 53304 92564 90482567
Tracheal pain 24.28 10.61 6 53310 60 90575071
Scoliosis 24.17 10.61 28 53288 8879 90566252
Wheezing 23.71 10.61 67 53249 238013 90337118
Vascular purpura 23.66 10.61 14 53302 1724 90573407
Administration site haemorrhage 23.60 10.61 6 53310 68 90575063
Porphyrins urine increased 23.59 10.61 5 53311 23 90575108
Adjustment disorder with depressed mood 23.17 10.61 3 53313 56750 90518381
Memory impairment 23.15 10.61 51 53265 197193 90377938
Weight increased 22.83 10.61 148 53168 417779 90157352
Congenital central nervous system anomaly 22.55 10.61 9 53307 465 90574666
Porphyrins stool increased 22.48 10.61 5 53311 30 90575101
Carbohydrate antigen 15-3 increased 21.80 10.61 14 53302 1993 90573138
Product used for unknown indication 21.44 10.61 10 53306 757 90574374
Urinary retention 20.88 10.61 59 53257 37685 90537446
Autonomic neuropathy 20.76 10.61 12 53304 1415 90573716
Injection site cyst 20.68 10.61 6 53310 115 90575016
Menopausal symptoms 20.67 10.61 16 53300 3062 90572069
Subacute cutaneous lupus erythematosus 20.60 10.61 17 53299 3565 90571566
Urine calcium/creatinine ratio increased 20.58 10.61 6 53310 117 90575014
Skin dystrophy 20.51 10.61 5 53311 47 90575084
Muscle atrophy 20.47 10.61 25 53291 8376 90566755
Endophthalmitis 20.44 10.61 19 53297 4666 90570465
Body temperature decreased 20.37 10.61 44 53272 23772 90551359
Non-small cell lung cancer recurrent 20.16 10.61 6 53310 126 90575005
Autoimmune disorder 20.09 10.61 10 53306 76734 90498397
Oesophageal atresia 20.08 10.61 9 53307 621 90574510
Iodine allergy 20.06 10.61 10 53306 876 90574255
Loss of personal independence in daily activities 20.04 10.61 143 53173 135962 90439169
Carcinoid tumour 19.94 10.61 8 53308 419 90574712
Osteocalcin decreased 19.89 10.61 5 53311 54 90575077
Carcinoembryonic antigen increased 19.80 10.61 14 53302 2336 90572795
Staphylococcus test positive 19.69 10.61 18 53298 4327 90570804
Pregnancy 19.68 10.61 6 53310 62041 90513090
Infusion related reaction 19.65 10.61 154 53162 416626 90158505
Drug specific antibody present 19.63 10.61 20 53296 5494 90569637
Rash pruritic 19.59 10.61 98 53218 82116 90493015
Left ventricular hypertrophy 19.57 10.61 21 53295 6123 90569008
XIth nerve injury 19.48 10.61 5 53311 59 90575072
Bronchiolitis 19.22 10.61 16 53300 3396 90571735
Exposure keratitis 19.18 10.61 5 53311 63 90575068
Paraesthesia 19.11 10.61 79 53237 250247 90324884
Oral papilloma 19.04 10.61 5 53311 65 90575066
Blood pressure systolic abnormal 19.02 10.61 38 53278 19440 90555691
Alanine aminotransferase increased 19.00 10.61 127 53189 118211 90456920
Glomerular filtration rate decreased 18.95 10.61 35 53281 16897 90558234
Cognitive disorder 18.91 10.61 86 53230 69321 90505810
Atrioventricular block complete 18.91 10.61 26 53290 9785 90565346
Tracheo-oesophageal fistula 18.86 10.61 9 53307 717 90574414
Prostatic specific antigen abnormal 18.83 10.61 5 53311 68 90575063
Retinal infarction 18.83 10.61 5 53311 68 90575063
Respiratory sinus arrhythmia magnitude 18.83 10.61 5 53311 68 90575063
Meningioma surgery 18.63 10.61 5 53311 71 90575060
Diabetic nephropathy 18.60 10.61 12 53304 1722 90573409
Allergy to metals 18.55 10.61 10 53306 1030 90574101
Thalamus haemorrhage 18.55 10.61 9 53307 744 90574387
Clumsiness 18.50 10.61 14 53302 2593 90572538
Hyperaldosteronism 18.29 10.61 7 53309 323 90574808
Blood creatinine increased 18.24 10.61 112 53204 101274 90473857
Dry mouth 18.17 10.61 52 53264 184007 90391124
Aspartate aminotransferase increased 18.07 10.61 113 53203 102824 90472307
Synovitis 17.89 10.61 117 53199 329635 90245496
General physical health deterioration 17.78 10.61 129 53187 354986 90220145
Urethral caruncle 17.74 10.61 5 53311 86 90575045
No adverse event 17.58 10.61 9 53307 67973 90507158
Pemphigoid 17.52 10.61 24 53292 9002 90566129
Onychomadesis 17.47 10.61 3 53313 45995 90529136
Electrocardiogram PR prolongation 17.32 10.61 9 53307 861 90574270
Immobile 17.17 10.61 20 53296 6378 90568753
Myopathy toxic 17.14 10.61 8 53308 606 90574525
Eye pain 17.05 10.61 61 53255 44107 90531024
Dementia 16.99 10.61 41 53275 23820 90551311
Therapeutic product effect decreased 16.88 10.61 95 53221 277476 90297655
Haemoglobin decreased 16.73 10.61 157 53159 161799 90413332
Giant cell arteritis 16.64 10.61 14 53302 3015 90572116
Myelitis 16.63 10.61 12 53304 2066 90573065
Blood pressure fluctuation 16.63 10.61 68 53248 52345 90522786
Pelvic fracture 16.46 10.61 31 53285 15188 90559943
Urea cycle disorder 16.28 10.61 4 53312 39 90575092
Haemoglobin increased 16.22 10.61 21 53295 7460 90567671
Altered state of consciousness 16.19 10.61 48 53268 31484 90543647
Febrile neutropenia 16.18 10.61 44 53272 158305 90416826
Electrocardiogram T wave peaked 16.10 10.61 6 53310 257 90574874
Actinic keratosis 16.02 10.61 14 53302 3174 90571957
Treatment failure 15.90 10.61 109 53207 303819 90271312
Hyperparathyroidism secondary 15.80 10.61 11 53305 1790 90573341
Hypokinesia 15.78 10.61 31 53285 15666 90559465
Leukoplakia oral 15.78 10.61 6 53310 272 90574859
Hepatic enzyme increased 15.76 10.61 136 53180 360600 90214531
Hip arthroplasty 15.75 10.61 13 53303 76195 90498936
Concomitant disease aggravated 15.74 10.61 26 53290 11492 90563639
Clubbing 15.48 10.61 7 53309 493 90574638
Dyspepsia 15.46 10.61 62 53254 198098 90377033
Amnesia 15.41 10.61 25 53291 108480 90466651
Thyroid disorder 15.37 10.61 33 53283 17752 90557379
Uraemic encephalopathy 15.35 10.61 6 53310 293 90574838
Neutropenia 15.34 10.61 74 53242 224830 90350301
Porphyria non-acute 15.28 10.61 6 53310 297 90574834
Injection site reaction 15.28 10.61 19 53297 92061 90483070
Bite 15.17 10.61 7 53309 517 90574614
Uterine aplasia 15.16 10.61 3 53313 9 90575122
Vaginal hypoplasia 15.16 10.61 3 53313 9 90575122
Nail injury 15.16 10.61 8 53308 790 90574341
Hospitalisation 15.13 10.61 33 53283 128067 90447064
Blood parathyroid hormone increased 15.11 10.61 14 53302 3423 90571708
Rash erythematous 15.09 10.61 77 53239 65027 90510104
Left atrial dilatation 15.09 10.61 11 53305 1925 90573206
Vocal cord paralysis 14.96 10.61 12 53304 2418 90572713
Gait inability 14.73 10.61 41 53275 146415 90428716
Bursitis 14.67 10.61 35 53281 131619 90443512
Peripheral sensorimotor neuropathy 14.55 10.61 11 53305 2034 90573097
Diffuse alopecia 14.48 10.61 9 53307 1211 90573920
Nasopharyngitis 14.40 10.61 327 52989 406777 90168354
Cardiac failure 14.39 10.61 112 53204 109384 90465747
Ear pain 14.39 10.61 8 53308 57694 90517437
Drug ineffective for unapproved indication 14.23 10.61 11 53305 66633 90508498
Abortion spontaneous 14.21 10.61 7 53309 54049 90521082
Buttock injury 14.20 10.61 6 53310 359 90574772
Craniectomy 14.12 10.61 3 53313 14 90575117
Interstitial lung disease 14.12 10.61 85 53231 76320 90498811
Spinal claudication 14.09 10.61 5 53311 186 90574945
Myelosuppression 14.00 10.61 7 53309 53584 90521547
Pneumonia 13.99 10.61 482 52834 637577 89937554
Intentional product use issue 13.86 10.61 73 53243 216819 90358312
Paralysis recurrent laryngeal nerve 13.82 10.61 4 53312 76 90575055
Pulmonary malformation 13.81 10.61 6 53310 384 90574747
Forced expiratory volume increased 13.77 10.61 4 53312 77 90575054
Fungal infection 13.76 10.61 4 53312 42657 90532474
Metabolic acidosis 13.72 10.61 67 53249 55609 90519522
Pulmonary function test abnormal 13.71 10.61 12 53304 2727 90572404
Cerebral haemorrhage 13.60 10.61 48 53268 34474 90540657
Suicidal ideation 13.60 10.61 14 53302 73841 90501290
Epilepsy 13.60 10.61 17 53299 82189 90492942
Upper motor neurone lesion 13.51 10.61 5 53311 210 90574921
Tachypnoea 13.48 10.61 35 53281 21274 90553857
Proteinuria 13.46 10.61 37 53279 23254 90551877
Vasoplegia syndrome 13.43 10.61 12 53304 2802 90572329
Injection site bruising 13.41 10.61 7 53309 52300 90522831
Taste disorder 13.35 10.61 10 53306 61536 90513595
Renal tubular acidosis 13.34 10.61 11 53305 2304 90572827
Macular degeneration 13.32 10.61 3 53313 37967 90537164
Renal aplasia 13.31 10.61 6 53310 420 90574711
Shock 13.10 10.61 42 53274 28736 90546395
Catecholamine crisis 13.09 10.61 3 53313 21 90575110
Mobility decreased 13.07 10.61 90 53226 250644 90324487
Base excess decreased 13.06 10.61 4 53312 93 90575038
Mucosal inflammation 12.97 10.61 9 53307 57616 90517515
Knee arthroplasty 12.94 10.61 18 53298 83164 90491967
Injection site hypertrophy 12.86 10.61 4 53312 98 90575033
Haemophilia 12.82 10.61 4 53312 99 90575032
Disability 12.81 10.61 4 53312 40741 90534390
Breast cancer recurrent 12.80 10.61 16 53300 5487 90569644
Hypomagnesaemia 12.77 10.61 48 53268 35540 90539591
Compensatory sweating 12.74 10.61 3 53313 24 90575107
HLA-B*27 positive 12.70 10.61 5 53311 249 90574882
Frequent bowel movements 12.67 10.61 9 53307 56926 90518205
Angioedema 12.52 10.61 73 53243 64803 90510328
Pulse abnormal 12.50 10.61 12 53304 3067 90572064
Knee deformity 12.46 10.61 9 53307 1553 90573578
Hepatic encephalopathy 12.42 10.61 26 53290 13746 90561385
Joint swelling 12.35 10.61 215 53101 503085 90072046
Forced expiratory flow decreased 12.32 10.61 4 53312 113 90575018
Pterygium colli 12.14 10.61 3 53313 30 90575101
Walking aid user 12.07 10.61 3 53313 35503 90539628
Decreased appetite 11.94 10.61 153 53163 376387 90198744
Food interaction 11.75 10.61 8 53308 1256 90573875
Acute myocardial infarction 11.65 10.61 46 53270 34844 90540287
Meningitis aseptic 11.65 10.61 17 53299 6756 90568375
Bradypnoea 11.58 10.61 14 53302 4644 90570487
Product quality issue 11.53 10.61 18 53298 79307 90495824
Blood creatine phosphokinase increased 11.48 10.61 45 53271 33978 90541153
Rubber sensitivity 11.41 10.61 11 53305 2826 90572305
Near drowning 11.35 10.61 3 53313 40 90575091
Carotid sinus syndrome 11.34 10.61 4 53312 146 90574985
Gastrointestinal endoscopic therapy 11.28 10.61 3 53313 41 90575090
Disease recurrence 11.28 10.61 48 53268 37605 90537526
Metastatic neoplasm 11.20 10.61 14 53302 4801 90570330
Wound abscess 11.19 10.61 4 53312 152 90574979
Onychomycosis 11.17 10.61 4 53312 37372 90537759
Enteritis 11.13 10.61 21 53295 10300 90564831
Flushing 11.12 10.61 22 53294 88469 90486662
Lung adenocarcinoma 11.11 10.61 15 53301 5550 90569581
Ovarian epithelial cancer 11.09 10.61 5 53311 350 90574781
Dry gangrene 10.95 10.61 6 53310 639 90574492
Melaena 10.92 10.61 45 53271 34752 90540379
Product supply issue 10.92 10.61 11 53305 2981 90572150
Tender joint count 10.91 10.61 8 53308 1413 90573718
Asthenia 10.90 10.61 400 52916 533351 90041780
Blood osmolarity increased 10.89 10.61 5 53311 365 90574766
Therapeutic response decreased 10.82 10.61 90 53226 89639 90485492
Productive cough 10.78 10.61 80 53236 76983 90498148
Microphthalmos 10.72 10.61 4 53312 172 90574959
Multiple sclerosis relapse 10.71 10.61 9 53307 52296 90522835

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cerebral infarction 95.39 11.87 111 28467 31058 42561699
Pericardial disease 82.08 11.87 25 28553 497 42592260
Pulmonary valve disease 74.12 11.87 22 28556 399 42592358
Hyperkalaemia 68.09 11.87 160 28418 80298 42512459
Lactic acidosis 67.35 11.87 114 28464 45147 42547610
Dyspnoea at rest 60.74 11.87 37 28541 4212 42588545
Cardiac failure 60.47 11.87 183 28395 106673 42486084
Physical examination abnormal 59.57 11.87 19 28559 442 42592315
Acute kidney injury 58.21 11.87 433 28145 366904 42225853
Electrocardiogram Q wave abnormal 56.82 11.87 19 28559 515 42592242
Blood pressure increased 56.21 11.87 173 28405 101755 42491002
Rales 55.38 11.87 52 28526 11348 42581409
Completed suicide 52.54 11.87 3 28575 96462 42496295
Hepatojugular reflux 52.36 11.87 19 28559 660 42592097
Cardiac discomfort 50.84 11.87 19 28559 718 42592039
Occult blood 48.86 11.87 20 28558 966 42591791
Echocardiogram abnormal 47.17 11.87 21 28557 1249 42591508
Death 46.15 11.87 162 28416 471023 42121734
Growth hormone deficiency 44.37 11.87 14 28564 314 42592443
Altered state of consciousness 43.91 11.87 74 28504 29185 42563572
Helicobacter gastritis 42.72 11.87 20 28558 1337 42591420
Mitral valve disease 40.69 11.87 20 28558 1490 42591267
Platelet distribution width increased 39.97 11.87 11 28567 150 42592607
Interstitial lung disease 37.63 11.87 127 28451 78335 42514422
Stenosis 37.15 11.87 21 28557 2080 42590677
Carotid arteriosclerosis 35.12 11.87 21 28557 2311 42590446
Ventricular arrhythmia 35.11 11.87 31 28547 6248 42586509
Chronic kidney disease 33.65 11.87 88 28490 47153 42545604
Hemiparaesthesia 33.30 11.87 10 28568 189 42592568
Hyponatraemia 32.87 11.87 145 28433 101317 42491440
Bundle branch block left 32.34 11.87 30 28548 6446 42586311
Drug-induced liver injury 32.22 11.87 76 28502 38197 42554560
Carotid artery stenosis 30.72 11.87 27 28551 5409 42587348
Post micturition dribble 30.34 11.87 6 28572 15 42592742
Tricuspid valve incompetence 29.76 11.87 37 28541 11076 42581681
Injection site hypersensitivity 29.50 11.87 11 28567 413 42592344
Choroidal haemorrhage 29.50 11.87 8 28570 103 42592654
Narrow anterior chamber angle 28.75 11.87 8 28570 114 42592643
Dyslalia 28.49 11.87 12 28566 623 42592134
Renal impairment 28.08 11.87 147 28431 110081 42482676
Mitral valve incompetence 27.85 11.87 44 28534 16445 42576312
Systolic dysfunction 27.79 11.87 20 28558 3008 42589749
Daydreaming 27.00 11.87 12 28566 711 42592046
Diastolic dysfunction 26.77 11.87 28 28550 6955 42585802
Accident at work 26.71 11.87 13 28565 948 42591809
Left ventricular hypertrophy 26.53 11.87 32 28546 9287 42583470
Aortic valve incompetence 26.44 11.87 27 28551 6521 42586236
Staring 25.79 11.87 15 28563 1568 42591189
Blood pressure systolic increased 25.15 11.87 57 28521 27911 42564846
Neutropenia 24.94 11.87 61 28517 199370 42393387
Atrioventricular block complete 24.48 11.87 34 28544 11330 42581427
Labile blood pressure 23.54 11.87 11 28567 732 42592025
Anaemia macrocytic 22.83 11.87 19 28559 3536 42589221
Diabetic nephropathy 22.72 11.87 16 28562 2325 42590432
Infection parasitic 22.53 11.87 9 28569 408 42592349
Petit mal epilepsy 22.39 11.87 19 28559 3631 42589126
Choroidal effusion 22.26 11.87 8 28570 270 42592487
Incontinence 22.02 11.87 25 28553 6805 42585952
Victim of chemical submission 21.94 11.87 7 28571 163 42592594
Blood pressure decreased 21.71 11.87 87 28491 58245 42534512
Angiopathy 21.40 11.87 22 28556 5355 42587402
Oropharyngeal oedema 21.21 11.87 6 28572 91 42592666
Proctitis ulcerative 21.10 11.87 7 28571 185 42592572
Apallic syndrome 21.00 11.87 8 28570 319 42592438
Hypoglycaemia 20.49 11.87 87 28491 59767 42532990
Erectile dysfunction 20.45 11.87 49 28529 24864 42567893
Blood creatine phosphokinase increased 20.37 11.87 75 28503 48263 42544494
IgA nephropathy 20.24 11.87 15 28563 2359 42590398
Andropause 20.20 11.87 6 28572 109 42592648
Myocardial rupture 20.20 11.87 7 28571 212 42592545
Hypergastrinaemia 19.98 11.87 7 28571 219 42592538
Granulomatous lymphadenitis 19.98 11.87 7 28571 219 42592538
Pemphigoid 19.92 11.87 31 28547 11436 42581321
Renal artery restenosis 19.70 11.87 4 28574 12 42592745
Postrenal failure 19.62 11.87 9 28569 574 42592183
Drug ineffective 19.37 11.87 302 28276 629895 41962862
Hepatic function abnormal 19.26 11.87 77 28501 51490 42541267
BRASH syndrome 18.95 11.87 13 28565 1812 42590945
Sprue-like enteropathy 18.73 11.87 9 28569 638 42592119
Pneumonia cryptococcal 18.70 11.87 12 28566 1496 42591261
Nodal arrhythmia 18.69 11.87 10 28568 889 42591868
Left ventricular dysfunction 18.48 11.87 30 28548 11471 42581286
Syncope 18.46 11.87 122 28456 99284 42493473
Injection site discolouration 18.31 11.87 13 28565 1913 42590844
Haematuria 18.24 11.87 82 28496 57717 42535040
Gastrointestinal bacterial infection 18.16 11.87 9 28569 682 42592075
Cardiac failure chronic 18.16 11.87 27 28551 9574 42583183
Blindness transient 18.10 11.87 15 28563 2774 42589983
Coronary artery stenosis 17.95 11.87 28 28550 10351 42582406
Tubulointerstitial nephritis 17.78 11.87 54 28524 31494 42561263
Left ventricle outflow tract obstruction 17.49 11.87 6 28572 176 42592581
Hyperlipidaemia 17.32 11.87 42 28536 21474 42571283
Toxicity to various agents 17.24 11.87 87 28491 229049 42363708
Sepsis 17.18 11.87 72 28506 199262 42393495
Starvation 17.18 11.87 8 28570 528 42592229
Cardiomegaly 17.15 11.87 36 28542 16730 42576027
Haemorrhage subcutaneous 16.70 11.87 14 28564 2632 42590125
Ejection fraction decreased 16.60 11.87 42 28536 22045 42570712
Drug abuse 16.53 11.87 28 28550 104743 42488014
Sinus bradycardia 16.50 11.87 33 28545 14820 42577937
Ventricular tachycardia 16.42 11.87 51 28527 30109 42562648
Anaplastic astrocytoma 16.29 11.87 5 28573 102 42592655
Chylothorax 16.21 11.87 10 28568 1164 42591593
Off label use 16.05 11.87 317 28261 638018 41954739
Diabetes mellitus 15.89 11.87 81 28497 60006 42532751
Faeces soft 15.87 11.87 18 28560 4894 42587863
Product packaging confusion 15.81 11.87 5 28573 113 42592644
Acute myocardial infarction 15.79 11.87 79 28499 58086 42534671
Diverticulitis 15.78 11.87 42 28536 22731 42570026
Loss of consciousness 15.75 11.87 111 28467 92243 42500514
Foetal exposure during pregnancy 15.74 11.87 6 28572 47305 42545452
Arrhythmia 15.70 11.87 61 28517 40256 42552501
Hospitalisation 15.68 11.87 16 28562 74314 42518443
Polyneuropathy 15.64 11.87 37 28541 18624 42574133
Hypertension 15.56 11.87 176 28402 167028 42425729
Pulmonary valve stenosis 15.46 11.87 7 28571 433 42592324
Ventricular hypokinesia 15.44 11.87 21 28557 6863 42585894
Decreased appetite 15.23 11.87 197 28381 192940 42399817
Lens dislocation 14.97 11.87 5 28573 135 42592622
Hypertensive urgency 14.87 11.87 7 28571 474 42592283
Sinus arrest 14.84 11.87 12 28566 2144 42590613
Renal artery arteriosclerosis 14.78 11.87 4 28574 51 42592706
Pneumonitis chemical 14.77 11.87 6 28572 284 42592473
Leukopenia 14.76 11.87 17 28561 74729 42518028
Bulbar palsy 14.65 11.87 6 28572 290 42592467
Haemorrhagic transformation stroke 14.57 11.87 11 28567 1780 42590977
Progesterone increased 14.53 11.87 3 28575 10 42592747
Neuropathy peripheral 14.48 11.87 29 28549 101824 42490933
Prostatism 14.46 11.87 6 28572 300 42592457
Drug hypersensitivity 14.39 11.87 28 28550 99361 42493396
Performance enhancing product use 14.26 11.87 5 28573 157 42592600
Disease progression 14.24 11.87 49 28529 143607 42449150
Oropharyngitis fungal 14.20 11.87 5 28573 159 42592598
Alkalosis hypochloraemic 13.94 11.87 6 28572 329 42592428
Euglycaemic diabetic ketoacidosis 13.82 11.87 18 28560 5642 42587115
Product dose omission issue 13.77 11.87 55 28523 154310 42438447
Mucosal inflammation 13.76 11.87 8 28570 49366 42543391
Prostatic specific antigen increased 13.58 11.87 33 28545 16892 42575865
Face oedema 13.58 11.87 29 28549 13637 42579120
Hypomagnesaemia 13.54 11.87 46 28532 28442 42564315
Hyperphosphatasaemia 13.30 11.87 4 28574 76 42592681
Tender joint count increased 13.30 11.87 5 28573 192 42592565
Heart valve incompetence 13.29 11.87 10 28568 1609 42591148
Pancreatitis acute 13.24 11.87 51 28527 33513 42559244
Oliguria 13.24 11.87 23 28555 9290 42583467
Supraventricular tachycardia 13.11 11.87 27 28551 12381 42580376
Gastric ulcer 12.98 11.87 34 28544 18228 42574529
Trichosporon infection 12.87 11.87 8 28570 944 42591813
Vertebral end plate inflammation 12.85 11.87 5 28573 211 42592546
Colorectal cancer metastatic 12.80 11.87 8 28570 953 42591804
Thrombocytopenia 12.79 11.87 75 28503 190204 42402553
Loss of personal independence in daily activities 12.61 11.87 9 28569 49807 42542950
Vitamin B12 deficiency 12.56 11.87 16 28562 4906 42587851
Product substitution issue 12.44 11.87 25 28553 11265 42581492
Drug level increased 12.19 11.87 42 28536 26158 42566599
Blood testosterone free increased 12.14 11.87 3 28575 26 42592731
Chronic rhinosinusitis with nasal polyps 12.14 11.87 3 28575 26 42592731
Myelosuppression 12.08 11.87 6 28572 40455 42552302
Cerebral haemorrhage 12.08 11.87 55 28523 38911 42553846
Large intestine polyp 12.04 11.87 22 28556 9243 42583514
Blood uric acid decreased 11.95 11.87 6 28572 468 42592289

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Carotid artery thrombosis 336.26 10.28 154 76382 9484 110503279
Neurologic neglect syndrome 332.06 10.28 151 76385 9147 110503616
Affect lability 320.80 10.28 185 76351 18452 110494311
Adjustment disorder 298.57 10.28 147 76389 10648 110502115
Arterial occlusive disease 287.84 10.28 161 76375 15147 110497616
Personality disorder 285.80 10.28 151 76385 12686 110500077
Blood pressure increased 277.63 10.28 576 75960 257797 110254966
Hemiplegia 271.82 10.28 179 76357 22603 110490160
Gangrene 270.09 10.28 158 76378 16183 110496580
Sensory loss 228.23 10.28 157 76379 21300 110491463
Sinus congestion 223.00 10.28 178 76358 30281 110482482
Skin haemorrhage 221.05 10.28 163 76373 24664 110488099
Coordination abnormal 207.62 10.28 158 76378 25070 110487693
Motor dysfunction 201.17 10.28 153 76383 24253 110488510
Sneezing 194.78 10.28 168 76368 31816 110480947
Respiratory tract congestion 187.74 10.28 162 76374 30695 110482068
Eating disorder 187.74 10.28 162 76374 30696 110482067
Sinus disorder 179.50 10.28 162 76374 32566 110480197
Arthritis 175.63 10.28 370 76166 167216 110345547
Cystitis 157.65 10.28 211 76325 65825 110446938
Hemiparesis 156.69 10.28 172 76364 43731 110469032
Hyponatraemia 150.61 10.28 409 76127 217244 110295519
Muscle spasticity 148.20 10.28 152 76384 35763 110477000
Angina pectoris 135.06 10.28 190 76346 62105 110450658
Aphasia 133.98 10.28 184 76352 58813 110453950
Cataract 133.25 10.28 215 76321 79270 110433493
Cerebral infarction 125.82 10.28 167 76369 51671 110461092
Influenza like illness 119.06 10.28 217 76319 88195 110424568
Fall 112.21 10.28 758 75778 602724 109910039
Psoriasis 101.76 10.28 268 76268 139725 110373038
Completed suicide 99.18 10.28 23 76513 242358 110270405
Palpitations 98.14 10.28 287 76249 158925 110353838
Dysarthria 96.65 10.28 193 76343 83928 110428835
Skin exfoliation 93.48 10.28 195 76341 87456 110425307
Impaired healing 92.71 10.28 13 76523 196704 110316059
Pemphigus 92.63 10.28 18 76518 214552 110298211
Folliculitis 89.45 10.28 7 76529 167646 110345117
Lactic acidosis 89.25 10.28 198 76338 92613 110420150
Blood pressure systolic increased 88.93 10.28 185 76351 82806 110429957
Hyperkalaemia 83.88 10.28 245 76291 135551 110377212
Chronic kidney disease 82.85 10.28 171 76365 76120 110436643
Rhinorrhoea 82.33 10.28 204 76332 102462 110410301
Maternal exposure during pregnancy 81.74 10.28 37 76499 254846 110257917
Death 80.18 10.28 234 76302 698635 109814128
Pulmonary valve disease 76.89 10.28 22 76514 337 110512426
Anti-cyclic citrullinated peptide antibody positive 74.98 10.28 17 76519 181967 110330796
Muscle injury 74.78 10.28 6 76530 140801 110371962
Glossodynia 74.74 10.28 30 76506 221974 110290789
Acute kidney injury 74.26 10.28 718 75818 634712 109878051
Pericardial disease 73.29 10.28 25 76511 698 110512065
Head discomfort 72.27 10.28 77 76459 18923 110493840
Altered state of consciousness 72.01 10.28 137 76399 57489 110455274
Hypertensive crisis 70.99 10.28 86 76450 24286 110488477
Systemic lupus erythematosus 69.76 10.28 45 76491 254293 110258470
Chest discomfort 69.52 10.28 271 76265 173577 110339186
Endometriosis 66.63 10.28 40 76496 4294 110508469
Irritable bowel syndrome 66.34 10.28 16 76520 164199 110348564
Granuloma skin 66.13 10.28 58 76478 11225 110501538
Pericarditis 63.96 10.28 36 76500 219078 110293685
Dysphagia 63.50 10.28 242 76294 153358 110359405
Blood parathyroid hormone decreased 62.51 10.28 60 76476 13029 110499734
Abdominal discomfort 62.03 10.28 111 76425 393747 110119016
Duodenal ulcer perforation 61.49 10.28 23 76513 177677 110335086
Hand deformity 60.82 10.28 38 76498 218468 110294295
Influenza 59.20 10.28 253 76283 168848 110343915
Infection 58.01 10.28 101 76435 362099 110150664
Swelling 57.95 10.28 96 76440 350945 110161818
C-reactive protein abnormal 57.86 10.28 10 76526 129685 110383078
Renal impairment 57.75 10.28 271 76265 188174 110324589
Cardiac failure 57.63 10.28 270 76266 187356 110325407
Joint range of motion decreased 57.51 10.28 8 76528 121824 110390939
Epidermal necrosis 57.11 10.28 32 76504 3018 110509745
Carotid arteriosclerosis 57.05 10.28 32 76504 3025 110509738
Bradycardia 57.03 10.28 236 76300 155281 110357482
Lip dry 56.88 10.28 3 76533 100080 110412683
Off label use 56.48 10.28 717 75819 1499468 109013295
BRASH syndrome 56.30 10.28 34 76502 3689 110509074
Physical examination abnormal 56.16 10.28 19 76517 517 110512246
Labile hypertension 54.09 10.28 19 76517 580 110512183
Panniculitis 53.78 10.28 60 76476 15522 110497241
Alopecia 53.73 10.28 107 76429 364646 110148117
Electrocardiogram Q wave abnormal 53.71 10.28 20 76516 724 110512039
Hypercalcaemia 53.52 10.28 107 76429 46550 110466213
Helicobacter infection 52.91 10.28 30 76506 181847 110330916
Breath sounds abnormal 52.86 10.28 76 76460 25328 110487435
Listless 52.69 10.28 35 76501 4480 110508283
Hypoglycaemia 52.23 10.28 188 76348 115916 110396847
Cerebrovascular accident 52.15 10.28 256 76280 181028 110331735
Isosthenuria 51.55 10.28 13 76523 119 110512644
Stomatitis 51.34 10.28 67 76469 270175 110242588
Hepatojugular reflux 50.30 10.28 19 76517 716 110512047
Fibromyalgia 49.99 10.28 28 76508 170881 110341882
Sleep disorder due to general medical condition, insomnia type 49.72 10.28 7 76529 105636 110407127
Glaucoma 49.27 10.28 69 76467 22448 110490315
Facet joint syndrome 49.06 10.28 5 76531 96823 110415940
Carcinoid tumour pulmonary 48.27 10.28 16 76520 408 110512355
Blood pressure decreased 47.29 10.28 181 76355 114910 110397853
Toxic epidermal necrolysis 46.82 10.28 114 76422 56613 110456150
Wound infection 46.33 10.28 6 76530 96459 110416304
Skin necrosis 45.70 10.28 65 76471 21447 110491316
Rash 45.57 10.28 357 76179 820607 109692156
Rheumatoid arthritis 45.01 10.28 358 76178 299255 110213508
Exposure during pregnancy 44.04 10.28 31 76505 167393 110345370
Postprandial hypoglycaemia 43.62 10.28 12 76524 158 110512605
Diabetic nephropathy 42.90 10.28 28 76508 3480 110509283
Lung disorder 42.73 10.28 37 76499 180010 110332753
Neutropenia 42.46 10.28 126 76410 374494 110138269
Wound 41.64 10.28 61 76475 234376 110278387
Product packaging confusion 41.59 10.28 14 76522 375 110512388
Drug eruption 41.30 10.28 105 76431 53554 110459209
Renal function test abnormal 40.83 10.28 40 76496 8906 110503857
Interstitial lung disease 40.23 10.28 197 76339 139137 110373626
Drug ineffective 40.15 10.28 777 75759 1519763 108993000
Platelet distribution width increased 39.56 10.28 11 76525 151 110512612
Disease progression 39.09 10.28 68 76468 243966 110268797
Growth hormone deficiency 38.79 10.28 14 76522 463 110512300
Rheumatoid nodule 38.31 10.28 58 76478 20238 110492525
Injury 37.90 10.28 40 76496 177225 110335538
Electrocardiogram PR shortened 37.64 10.28 13 76523 377 110512386
Dyspnoea at rest 37.50 10.28 37 76499 8309 110504454
Atrioventricular block complete 37.35 10.28 57 76479 20025 110492738
Reduced facial expression 37.14 10.28 26 76510 3625 110509138
Blood pressure abnormal 36.67 10.28 60 76476 22364 110490399
Pyelitis 36.46 10.28 13 76523 415 110512348
Occult blood 36.19 10.28 20 76516 1836 110510927
Oliguria 36.19 10.28 54 76482 18603 110494160
Lower respiratory tract infection 36.05 10.28 71 76465 243035 110269728
Infusion site streaking 35.90 10.28 14 76522 576 110512187
Drug specific antibody 35.63 10.28 23 76513 2805 110509958
Obesity 35.48 10.28 17 76519 113334 110399429
Sciatica 35.41 10.28 10 76526 92389 110420374
Cardiac discomfort 35.23 10.28 18 76518 1410 110511353
Night sweats 34.99 10.28 25 76511 133958 110378805
Drug interaction 34.36 10.28 511 76025 499672 110013091
Product substitution issue 34.11 10.28 59 76477 23002 110489761
Rash papular 33.65 10.28 65 76471 27574 110485189
Labelled drug-drug interaction medication error 33.37 10.28 67 76469 29235 110483528
Malaise 33.29 10.28 651 75885 671168 109841595
Hypersensitivity 33.26 10.28 155 76381 403843 110108920
Psoriatic arthropathy 33.21 10.28 53 76483 196708 110316055
Product dose omission issue 33.11 10.28 113 76423 321669 110191094
Blood pressure inadequately controlled 32.75 10.28 33 76503 7600 110505163
Cough 32.63 10.28 474 76062 461167 110051596
Pemphigoid 32.59 10.28 53 76483 19654 110493109
Peripheral venous disease 32.43 10.28 9 76527 84108 110428655
Memory impairment 32.35 10.28 54 76482 196890 110315873
Helicobacter gastritis 32.28 10.28 21 76515 2595 110510168
Echocardiogram abnormal 31.86 10.28 21 76515 2653 110510110
Live birth 31.78 10.28 5 76531 69479 110443284
Atrial fibrillation 31.57 10.28 269 76267 229373 110283390
Myelosuppression 31.33 10.28 13 76523 94327 110418436
Drug ineffective for unapproved indication 31.31 10.28 16 76520 102822 110409941
Lower limb fracture 31.10 10.28 7 76529 75341 110437422
Sleep apnoea syndrome 30.97 10.28 79 76457 40368 110472395
Prescribed overdose 30.86 10.28 11 76525 87570 110425193
Blood pressure diastolic decreased 30.56 10.28 73 76463 35812 110476951
Rheumatic fever 30.56 10.28 24 76512 122555 110390208
Administration site induration 30.49 10.28 7 76529 41 110512722
Deep vein thrombosis postoperative 30.20 10.28 3 76533 59288 110453475
Grip strength decreased 30.13 10.28 9 76527 80165 110432598
Blood creatine phosphokinase increased 30.07 10.28 115 76421 72962 110439801
Rales 29.90 10.28 58 76478 24681 110488082
Stenosis 29.82 10.28 22 76514 3329 110509434
Ill-defined disorder 29.66 10.28 39 76497 156814 110355949
Joint noise 29.26 10.28 26 76510 5117 110507646
Basal cell carcinoma 29.21 10.28 83 76453 45187 110467576
Mucosal inflammation 29.21 10.28 15 76521 96126 110416637
Administration site abscess 28.88 10.28 6 76530 20 110512743
Hepatic function abnormal 28.50 10.28 130 76406 89165 110423598
Blister 28.34 10.28 73 76463 227303 110285460
Blood thyroid stimulating hormone normal 28.30 10.28 8 76528 117 110512646
Creatinine renal clearance increased 28.28 10.28 22 76514 3603 110509160
Left ventricular hypertrophy 28.11 10.28 40 76496 13204 110499559
White blood cell count abnormal 28.06 10.28 29 76507 6880 110505883
Deafness 27.97 10.28 59 76477 26650 110486113
Liver injury 27.83 10.28 38 76498 150375 110362388
Administration site discharge 27.82 10.28 6 76530 25 110512738
Eye pain 27.73 10.28 87 76449 50012 110462751
Serotonin syndrome 27.64 10.28 4 76532 59149 110453614
Abdominal pain upper 27.53 10.28 136 76400 348975 110163788
Urticaria 27.03 10.28 121 76415 318736 110194027
Drug tolerance decreased 26.74 10.28 59 76477 27481 110485282
Administration site odour 26.30 10.28 6 76530 34 110512729
Leukopenia 26.14 10.28 39 76497 148752 110364011
Hemiparaesthesia 25.95 10.28 10 76526 398 110512365
Haematuria 25.87 10.28 120 76416 82885 110429878
Narrow anterior chamber angle 25.51 10.28 8 76528 170 110512593
Swollen joint count increased 25.49 10.28 13 76523 83648 110429115
Drug hypersensitivity 25.35 10.28 197 76339 453893 110058870
Insulin-like growth factor decreased 25.23 10.28 11 76525 602 110512161
Administration site haemorrhage 25.21 10.28 6 76530 42 110512721
Product monitoring error 25.18 10.28 31 76505 8896 110503867
Hypertensive angiopathy 25.11 10.28 7 76529 97 110512666
Arthropathy 25.04 10.28 108 76428 287414 110225349
Mitral valve disease 25.03 10.28 20 76516 3405 110509358
Ulcer 24.91 10.28 76 76460 43040 110469723
Muscular weakness 24.75 10.28 272 76264 248196 110264567
Choroidal haemorrhage 24.63 10.28 8 76528 191 110512572
Apathy 24.61 10.28 42 76494 16197 110496566
Mononeuropathy multiplex 24.60 10.28 12 76524 851 110511912
Hypoaesthesia 24.43 10.28 123 76413 314100 110198663
Bladder hypertrophy 24.39 10.28 13 76523 1111 110511652
Myalgia 24.28 10.28 248 76288 222133 110290630
Amaurosis fugax 24.27 10.28 17 76519 2373 110510390
Prescription drug used without a prescription 24.02 10.28 24 76512 5472 110507291
Ventricular arrhythmia 23.71 10.28 32 76504 10055 110502708
Type 2 diabetes mellitus 23.57 10.28 55 76481 177177 110335586
Daydreaming 23.57 10.28 13 76523 1189 110511574
Red blood cell sedimentation rate increased 23.52 10.28 112 76424 78190 110434573
Cerebral haemorrhage 23.34 10.28 98 76438 64870 110447893
Hypomagnesaemia 23.21 10.28 93 76443 60277 110452486
Hypokalaemia 23.14 10.28 210 76326 182238 110330525
Body temperature decreased 23.13 10.28 67 76469 36868 110475895
Accident at work 23.09 10.28 13 76523 1237 110511526
Foreign body 22.98 10.28 18 76518 2977 110509786
Small fibre neuropathy 22.90 10.28 12 76524 991 110511772
Gastric pH increased 22.88 10.28 6 76530 65 110512698
Carbohydrate antigen 15-3 increased 22.73 10.28 14 76522 1573 110511190
Anxiety 22.68 10.28 350 76186 344728 110168035
Cranial nerve disorder 22.65 10.28 13 76523 1284 110511479
Pregnancy 22.63 10.28 4 76532 51063 110461700
Hospitalisation 22.54 10.28 40 76496 142453 110370310
Endophthalmitis 22.41 10.28 28 76508 8159 110504604
Product used for unknown indication 22.38 10.28 15 76521 1948 110510815
Paraesthesia 22.21 10.28 107 76429 276414 110236349
Oedema 22.10 10.28 73 76463 209903 110302860
Pulmonary valve stenosis 22.01 10.28 7 76529 156 110512607
Bursitis 21.91 10.28 35 76501 129883 110382880
Porphyrins urine increased 21.82 10.28 5 76531 29 110512734
Erectile dysfunction 21.81 10.28 43 76493 18513 110494250
Drug resistance 21.79 10.28 6 76530 56368 110456395
Bundle branch block left 21.77 10.28 35 76501 12853 110499910
Dyslalia 21.75 10.28 13 76523 1384 110511379
Taste disorder 21.73 10.28 9 76527 65378 110447385
Diabetes mellitus 21.57 10.28 130 76406 99251 110413512
Hypotension 21.50 10.28 494 76042 523355 109989408
Staphylococcus test positive 21.45 10.28 26 76510 7344 110505419
Condition aggravated 21.32 10.28 369 76167 734467 109778296
Menopausal symptoms 21.32 10.28 16 76520 2485 110510278
Hypertension 21.24 10.28 482 76054 509602 110003161
Carotid artery stenosis 21.19 10.28 29 76507 9234 110503529
Blood creatinine increased 20.95 10.28 206 76330 182683 110330080
Dry mouth 20.70 10.28 70 76466 199878 110312885
Systolic dysfunction 20.63 10.28 20 76516 4395 110508368
Drug-induced liver injury 20.55 10.28 148 76388 119919 110392844
Adjustment disorder with depressed mood 20.43 10.28 3 76533 43880 110468883
Rhabdomyolysis 20.37 10.28 148 76388 120253 110392510
Cardiomegaly 20.37 10.28 55 76481 29075 110483688
No adverse event 20.32 10.28 13 76523 73826 110438937
Injection site reaction 20.29 10.28 19 76517 89051 110423712
Andropause 20.02 10.28 6 76530 109 110512654
Thalamus haemorrhage 20.01 10.28 14 76522 1950 110510813
Albuminuria 20.01 10.28 11 76525 1000 110511763
Porphyrins stool increased 20.00 10.28 5 76531 44 110512719
Neuropathy peripheral 19.79 10.28 61 76475 179216 110333547
Glomerular filtration rate decreased 19.58 10.28 54 76482 28902 110483861
Renal artery restenosis 19.57 10.28 4 76532 12 110512751
Scoliosis 19.46 10.28 27 76509 8706 110504057
Nasopharyngitis 19.44 10.28 382 76154 393979 110118784
Sprue-like enteropathy 19.44 10.28 13 76523 1683 110511080
Osteocalcin decreased 19.43 10.28 5 76531 50 110512713
Pancreatitis acute 19.42 10.28 88 76448 60186 110452577
Neurotoxicity 19.39 10.28 3 76533 42204 110470559
Blood pressure diastolic abnormal 19.33 10.28 50 76486 25765 110486998
Product supply issue 19.31 10.28 18 76518 3768 110508995
Labile blood pressure 19.28 10.28 15 76521 2456 110510307
Staring 19.26 10.28 16 76520 2876 110509887
Ureteral disorder 19.20 10.28 9 76527 584 110512179
Skin ulcer 19.09 10.28 91 76445 63554 110449209
Product use in unapproved indication 18.94 10.28 208 76328 447169 110065594
Euglycaemic diabetic ketoacidosis 18.87 10.28 31 76505 11592 110501171
Autoimmune disorder 18.75 10.28 11 76525 65472 110447291
Cardiac failure chronic 18.71 10.28 34 76502 13777 110498986
Skin dystrophy 18.68 10.28 5 76531 59 110512704
Wheezing 18.66 10.28 102 76434 255128 110257635
Agitation 18.56 10.28 31 76505 113020 110399743
Injection site cyst 18.45 10.28 6 76530 144 110512619
Hyperaldosteronism 18.35 10.28 9 76527 646 110512117
Melaena 18.28 10.28 95 76441 68662 110444101
Urine calcium/creatinine ratio increased 18.25 10.28 6 76530 149 110512614
Intentional product use issue 18.17 10.28 99 76437 247807 110264956
Respiratory sinus arrhythmia magnitude 18.03 10.28 5 76531 68 110512695
Pneumonitis chemical 17.93 10.28 9 76527 679 110512084
Urethral caruncle 17.83 10.28 5 76531 71 110512692
Arrhythmia 17.72 10.28 95 76441 69480 110443283
Diverticulum intestinal haemorrhagic 17.58 10.28 19 76517 4744 110508019
Sinus arrest 17.58 10.28 18 76518 4224 110508539
Carcinoembryonic antigen increased 17.53 10.28 15 76521 2809 110509954
Infusion related reaction 17.44 10.28 174 76362 380988 110131775
Lower urinary tract symptoms 17.38 10.28 8 76528 498 110512265
Gouty arthritis 17.31 10.28 12 76524 1647 110511116
Haemoglobin increased 17.06 10.28 26 76510 9121 110503642
Diffuse alopecia 17.06 10.28 11 76525 1339 110511424
Oral papilloma 16.94 10.28 5 76531 86 110512677
Sepsis 16.89 10.28 145 76391 327201 110185562
Toxicity to various agents 16.73 10.28 233 76303 480322 110032441
Discomfort 16.71 10.28 84 76452 214623 110298140
Hypergastrinaemia 16.67 10.28 7 76529 349 110512414
Non-small cell lung cancer recurrent 16.47 10.28 6 76530 204 110512559
Blood pressure systolic abnormal 16.46 10.28 46 76490 24804 110487959
Urinary retention 16.31 10.28 93 76443 69590 110443173
Buttock injury 16.28 10.28 6 76530 211 110512552
Road traffic accident 16.23 10.28 31 76505 107367 110405396
Aortic valve incompetence 16.12 10.28 28 76508 10953 110501810
Actinic keratosis 16.11 10.28 22 76514 6991 110505772
Therapeutic product effect decreased 16.07 10.28 101 76435 244215 110268548
IgA nephropathy 16.02 10.28 15 76521 3158 110509605
Renal tubular acidosis 16.00 10.28 18 76518 4697 110508066
Vertigo 15.99 10.28 109 76427 86761 110426002
Prostatic specific antigen increased 15.94 10.28 30 76506 12481 110500282
Postrenal failure 15.89 10.28 9 76527 867 110511896
Mitral valve incompetence 15.87 10.28 55 76481 33274 110479489
Infection parasitic 15.72 10.28 9 76527 885 110511878
Synovitis 15.71 10.28 118 76418 273974 110238789
Faeces soft 15.70 10.28 28 76508 11182 110501581
Inappropriate antidiuretic hormone secretion 15.37 10.28 55 76481 33796 110478967
Breast cancer recurrent 15.36 10.28 16 76520 3830 110508933
Immunodeficiency 15.26 10.28 4 76532 38834 110473929
Haemorrhage subcutaneous 15.25 10.28 19 76517 5520 110507243
Drug abuse 15.22 10.28 67 76469 177344 110335419
Prostatic specific antigen abnormal 15.15 10.28 8 76528 671 110512092
Onychomycosis 15.08 10.28 4 76532 38527 110474236
Lipids abnormal 15.08 10.28 8 76528 677 110512086
Granulomatous lymphadenitis 15.00 10.28 7 76529 450 110512313
Neck pain 14.98 10.28 40 76496 123090 110389673
Diastolic dysfunction 14.89 10.28 29 76507 12375 110500388
Hypersensitivity vasculitis 14.79 10.28 21 76515 6916 110505847
Pneumonia cryptococcal 14.76 10.28 13 76523 2529 110510234
Proctitis ulcerative 14.70 10.28 7 76529 471 110512292
Respiratory failure 14.69 10.28 88 76448 215244 110297519
Musculoskeletal pain 14.59 10.28 71 76465 182952 110329811
Food interaction 14.53 10.28 12 76524 2140 110510623
Myocardial rupture 14.53 10.28 6 76530 287 110512476
Abortion spontaneous 14.53 10.28 3 76533 34279 110478484
Pelvic fracture 14.51 10.28 31 76505 14123 110498640
Cytomegalovirus infection 14.42 10.28 10 76526 54434 110458329
Anaplastic astrocytoma 14.38 10.28 5 76531 148 110512615
Nodal arrhythmia 14.37 10.28 12 76524 2172 110510591
Enteritis 14.24 10.28 37 76499 19119 110493644
Acute myocardial infarction 14.18 10.28 103 76433 83674 110429089
HLA-B*27 positive 14.13 10.28 5 76531 156 110512607
Chronic gastritis 14.01 10.28 18 76518 5393 110507370
Gait inability 13.94 10.28 48 76488 136328 110376435
Syncope 13.90 10.28 207 76329 202329 110310434
Clubbing 13.87 10.28 8 76528 797 110511966
Vascular purpura 13.84 10.28 15 76521 3756 110509007
Autonomic neuropathy 13.83 10.28 12 76524 2288 110510475
Ear pain 13.80 10.28 10 76526 53216 110459547
Nail injury 13.80 10.28 8 76528 805 110511958
Bronchiolitis 13.79 10.28 18 76518 5475 110507288
Performance enhancing product use 13.78 10.28 5 76531 168 110512595
Thrombocytopenia 13.67 10.28 165 76371 348720 110164043
Staphylococcal infection 13.62 10.28 17 76519 69927 110442836
Fluid retention 13.58 10.28 28 76508 94279 110418484
Subacute cutaneous lupus erythematosus 13.54 10.28 17 76519 4977 110507786
Pulmonary function test abnormal 13.52 10.28 17 76519 4983 110507780
Drug dependence 13.50 10.28 9 76527 50011 110462752
Confusional state 13.47 10.28 422 76114 468258 110044505
Suicidal ideation 13.43 10.28 28 76508 93909 110418854
Renal artery arteriosclerosis 13.43 10.28 4 76532 71 110512692
Lacunar infarction 13.36 10.28 19 76517 6267 110506496
Pain in extremity 13.34 10.28 247 76289 486871 110025892
Treatment failure 13.34 10.28 125 76411 277109 110235654
Knee deformity 13.32 10.28 10 76526 1553 110511210
Lens dislocation 13.30 10.28 5 76531 186 110512577
Bulbar palsy 13.26 10.28 6 76530 359 110512404
Blood pressure fluctuation 13.25 10.28 93 76443 74731 110438032
Carcinoid tumour 13.24 10.28 7 76529 588 110512175
Choroidal effusion 13.13 10.28 8 76528 882 110511881
Hypokinesia 13.10 10.28 39 76497 21787 110490976
Heart valve incompetence 13.09 10.28 15 76521 3994 110508769
Drug specific antibody present 13.03 10.28 22 76514 8412 110504351
Bite 12.92 10.28 7 76529 618 110512145
Product quality issue 12.87 10.28 21 76515 77278 110435485
Drug level increased 12.73 10.28 66 76470 47653 110465110
Retinal infarction 12.72 10.28 5 76531 210 110512553
Weight increased 12.71 10.28 209 76327 419435 110093328
Vertebral end plate inflammation 12.70 10.28 5 76531 211 110512552
Pulse abnormal 12.67 10.28 15 76521 4134 110508629
Psychotic disorder 12.66 10.28 10 76526 50927 110461836
Sinus bradycardia 12.63 10.28 47 76489 29436 110483327
Concomitant disease aggravated 12.57 10.28 32 76504 16332 110496431
Anaemia macrocytic 12.57 10.28 20 76516 7283 110505480
Therapy non-responder 12.55 10.28 61 76475 157246 110355517
Dyspepsia 12.53 10.28 79 76457 190886 110321877
Tender joint count increased 12.48 10.28 6 76530 412 110512351
Hepatic enzyme increased 12.48 10.28 152 76384 320740 110192023
Angiopathy 12.48 10.28 22 76514 8708 110504055
Myopathy toxic 12.47 10.28 9 76527 1316 110511447
Blood parathyroid hormone increased 12.39 10.28 15 76521 4233 110508530
Multiple sclerosis relapse 12.31 10.28 10 76526 50230 110462533
Oropharyngitis fungal 12.31 10.28 5 76531 229 110512534
Paraesthesia oral 12.26 10.28 4 76532 33667 110479096
Giant cell arteritis 12.19 10.28 14 76522 3735 110509028
Back injury 12.17 10.28 9 76527 47390 110465373
Glycosylated haemoglobin increased 12.15 10.28 40 76496 23579 110489184
Bradyarrhythmia 12.13 10.28 16 76520 4918 110507845
Starvation 12.11 10.28 8 76528 1015 110511748
Clumsiness 12.10 10.28 14 76522 3766 110508997
Petit mal epilepsy 12.08 10.28 20 76516 7527 110505236
Injection site hypertrophy 12.03 10.28 4 76532 103 110512660
Blood testosterone increased 12.02 10.28 9 76527 1393 110511370
Ovarian epithelial cancer 12.01 10.28 5 76531 244 110512519
Ventricular hypokinesia 12.01 10.28 25 76511 11189 110501574
Unevaluable event 11.96 10.28 14 76522 59213 110453550
Gastrointestinal bacterial infection 11.93 10.28 9 76527 1409 110511354
Haemophilia 11.92 10.28 4 76532 106 110512657
Tricuspid valve incompetence 11.89 10.28 40 76496 23833 110488930
Dehydration 11.89 10.28 265 76271 279246 110233517
Oropharyngeal oedema 11.88 10.28 6 76530 459 110512304
Mobility decreased 11.87 10.28 106 76430 237316 110275447
Vasculitis 11.82 10.28 5 76531 35868 110476895
Laboratory test abnormal 11.80 10.28 8 76528 44071 110468692
Oxygen saturation decreased 11.79 10.28 163 76373 156819 110355944
Immobile 11.78 10.28 20 76516 7682 110505081
Tubulointerstitial nephritis 11.77 10.28 71 76465 54213 110458550
Leukoplakia oral 11.77 10.28 6 76530 468 110512295
Coronary artery stenosis 11.73 10.28 28 76508 13730 110499033
Leukocytosis 11.66 10.28 12 76524 53816 110458947
Injection site bruising 11.60 10.28 11 76525 51252 110461511
Choroidal detachment 11.54 10.28 7 76529 765 110511998
Apallic syndrome 11.54 10.28 8 76528 1098 110511665
Amnesia 11.53 10.28 36 76500 105372 110407391
Mental status changes 11.48 10.28 22 76514 76100 110436663
Spinal claudication 11.46 10.28 5 76531 274 110512489
Urinary tract disorder 11.46 10.28 17 76519 5827 110506936
Primary hyperaldosteronism 11.45 10.28 5 76531 275 110512488
Seizure 11.39 10.28 98 76438 221087 110291676
Accelerated hypertension 11.34 10.28 7 76529 790 110511973
Compartment syndrome 11.31 10.28 17 76519 5893 110506870
Optic neuropathy 11.29 10.28 15 76521 4643 110508120
Pericardial effusion 11.26 10.28 73 76463 57144 110455619
General physical health deterioration 11.23 10.28 217 76319 425078 110087685
Candida infection 11.22 10.28 10 76526 47999 110464764
Injection site hypersensitivity 11.19 10.28 11 76525 2460 110510303
Drug intolerance 11.17 10.28 206 76330 406306 110106457
Tinnitus 11.16 10.28 76 76460 60464 110452299
Parathyroid scan abnormal 11.16 10.28 3 76533 36 110512727
Lung adenocarcinoma 11.10 10.28 22 76514 9509 110503254
Forced expiratory volume increased 11.04 10.28 4 76532 134 110512629
Loss of consciousness 10.99 10.28 194 76342 196112 110316651
Antiangiogenic therapy 10.94 10.28 3 76533 39 110512724
Guttate psoriasis 10.92 10.28 6 76530 545 110512218
Hyperphosphatasaemia 10.90 10.28 4 76532 139 110512624
Face oedema 10.88 10.28 49 76487 33420 110479343
Cytokine release syndrome 10.88 10.28 20 76516 70286 110442477
Arterial stenosis 10.87 10.28 9 76527 1610 110511153
Febrile neutropenia 10.87 10.28 154 76382 316613 110196150
Device related infection 10.81 10.28 7 76529 39512 110473251
White blood cell count decreased 10.79 10.28 104 76432 229286 110283477
Dihydrotestosterone increased 10.74 10.28 3 76533 42 110512721
Disability assessment scale score increased 10.73 10.28 14 76522 4256 110508507
Immobilisation syndrome 10.73 10.28 7 76529 869 110511894
Victim of chemical submission 10.71 10.28 7 76529 872 110511891
Neutropenic sepsis 10.60 10.28 4 76532 30742 110482021
Starvation ketoacidosis 10.55 10.28 5 76531 333 110512430
Premature delivery 10.53 10.28 4 76532 30628 110482135
Bile duct stone 10.52 10.28 17 76519 6272 110506491
Hyperplasia adrenal 10.48 10.28 3 76533 46 110512717
Myelitis 10.45 10.28 12 76524 3201 110509562
Alkalosis hypochloraemic 10.43 10.28 6 76530 595 110512168
Urea cycle disorder 10.42 10.28 3 76533 47 110512716
Visual acuity reduced 10.38 10.28 47 76489 32126 110480637
Trichosporon infection 10.38 10.28 8 76528 1292 110511471
Spinal epidural haematoma 10.38 10.28 9 76527 1716 110511047
Disability 10.30 10.28 4 76532 30219 110482544

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Renal vein thrombosis 24.36 20.38 3 11 0 113939

Pharmacologic Action:

SourceCodeDescription
ATC C09CA07 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
Angiotensin II receptor blockers (ARBs), plain
ATC C09DA07 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and diuretics
ATC C09DB04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DX08 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C10BX20 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX24 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
FDA MoA N0000000070 Angiotensin 2 Receptor Antagonists
FDA EPC N0000175561 Angiotensin 2 Receptor Blocker
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D047228 Angiotensin II Type 1 Receptor Blockers
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35457 EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor
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:35674 antihypertensive agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:61016 angiotensin receptor antagonist
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:78298 environmental contaminant
CHEBI has role CHEBI:231911 renoprotective agent

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Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Cerebrovascular accident indication 230690007
Disorder due to type 2 diabetes mellitus indication 422014003
History of myocardial infarction due to atherothrombotic coronary artery disease indication 387786000000000000
Myocardial Infarction Prevention indication
Chronic heart failure off-label use 48447003
Atrial fibrillation off-label use 49436004 DOID:0060224
Diabetic renal disease off-label use 127013003
Diastolic heart failure off-label use 418304008 DOID:9775
Nondiabetic Proteinuric Nephropathy off-label use
Anuria contraindication 2472002 DOID:2983
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Secondary angle-closure glaucoma contraindication 21571006
Hypovolemia contraindication 28560003
Obstruction of bile duct contraindication 30144000
Cholestasis contraindication 33688009 DOID:13580
Dehydration contraindication 34095006
Hyperuricemia contraindication 35885006 DOID:1920
Third trimester pregnancy contraindication 41587001
Severe renal impairment contraindication 42399005 DOID:1074
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Second trimester pregnancy contraindication 59466002
Hepatic failure contraindication 59927004
Severe hepatic impairment contraindication 59927004
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Chronic idiopathic constipation contraindication 82934008
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Disease of liver contraindication 235856003 DOID:409
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Azotemia contraindication 445009001
Severe Aortic Valve Stenosis contraindication




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Systemic hypertension Indication

🐶 Veterinary products

ProductApplicantIngredients
Semintra Boehringer lngelheim Animal Health USA Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.65 acidic
pKa2 5.79 Basic
pKa3 5.13 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 2.5MG BASE;1.25MG;20MG WIDAPLIK AZURITY N219423 June 5, 2025 DISCN TABLET ORAL 10799487 Jan. 23, 2038 A METHOD OF TREATING HYPERTENSION

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 1.25MG BASE;0.625MG;10MG WIDAPLIK AZURITY N219423 June 5, 2025 DISCN TABLET ORAL June 5, 2028 NEW PRODUCT
EQ 2.5MG BASE;1.25MG;20MG WIDAPLIK AZURITY N219423 June 5, 2025 DISCN TABLET ORAL June 5, 2028 NEW PRODUCT
EQ 5MG BASE;2.5MG;40MG WIDAPLIK AZURITY N219423 June 5, 2025 DISCN TABLET ORAL June 5, 2028 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Type-1 angiotensin II receptor GPCR ANTAGONIST IC50 9.31 CHEMBL CHEMBL
ATP-binding cassette sub-family G member 2 Transporter IC50 4.77 CHEMBL
Glycine receptor subunit alpha-1 Ion channel EC50 5.49 CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor EC50 5.82 CHEMBL
Type-2 angiotensin II receptor GPCR IC50 9.48 CHEMBL
Angiotensin-converting enzyme Enzyme Ki 5.22 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 4.75 CHEMBL
Type-1B angiotensin II receptor GPCR IC50 8.52 CHEMBL
Type-1A angiotensin II receptor GPCR Ki 9.64 CHEMBL

External reference:

IDSource
4021146 VUID
N0000148599 NUI
D00627 KEGG_DRUG
4021146 VANDF
C0248719 UMLSCUI
CHEBI:9434 CHEBI
TLS PDB_CHEM_ID
CHEMBL1017 ChEMBL_ID
D000077333 MESH_DESCRIPTOR_UI
DB00966 DRUGBANK_ID
592 IUPHAR_LIGAND_ID
7144 INN_ID
U5SYW473RQ UNII
65999 PUBCHEM_CID
218353 RXNORM
13913 MMSL
53287 MMSL
7789 MMSL
d04364 MMSL
007683 NDDF
129487008 SNOMEDCT_US
387069000 SNOMEDCT_US
U5SYW473RQ INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Telmisartan and Amlodipine HUMAN PRESCRIPTION DRUG LABEL 2 0378-1075 TABLET 40 mg ORAL ANDA 28 sections
Telmisartan and Amlodipine HUMAN PRESCRIPTION DRUG LABEL 2 0378-1076 TABLET 40 mg ORAL ANDA 28 sections
Telmisartan and Amlodipine HUMAN PRESCRIPTION DRUG LABEL 2 0378-1077 TABLET 80 mg ORAL ANDA 28 sections
Telmisartan and Amlodipine HUMAN PRESCRIPTION DRUG LABEL 2 0378-1078 TABLET 80 mg ORAL ANDA 28 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-2920 TABLET 20 mg ORAL ANDA 28 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-2921 TABLET 40 mg ORAL ANDA 28 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-2922 TABLET 80 mg ORAL ANDA 28 sections
Micardis HCT HUMAN PRESCRIPTION DRUG LABEL 2 0597-0042 TABLET 80 mg ORAL NDA 30 sections
Micardis HCT HUMAN PRESCRIPTION DRUG LABEL 2 0597-0043 TABLET 40 mg ORAL NDA 30 sections
Micardis HCT HUMAN PRESCRIPTION DRUG LABEL 2 0597-0044 TABLET 80 mg ORAL NDA 30 sections
WIDAPLIK Human Prescription Drug Label 3 24338-001 TABLET 10 mg ORAL NDA 27 sections
WIDAPLIK Human Prescription Drug Label 3 24338-002 TABLET 20 mg ORAL NDA 27 sections
WIDAPLIK Human Prescription Drug Label 3 24338-003 TABLET 40 mg ORAL NDA 27 sections
Telmisartan Human Prescription Drug Label 1 33342-118 TABLET 20 mg ORAL ANDA 27 sections
Telmisartan Human Prescription Drug Label 1 33342-119 TABLET 40 mg ORAL ANDA 27 sections
Telmisartan Human Prescription Drug Label 1 33342-120 TABLET 80 mg ORAL ANDA 27 sections
Telmisartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 42291-462 TABLET 40 mg ORAL ANDA 20 sections
Telmisartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 42291-463 TABLET 80 mg ORAL ANDA 20 sections
Telmisartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 42291-464 TABLET 80 mg ORAL ANDA 20 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 42291-790 TABLET 20 mg ORAL ANDA 19 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 42291-791 TABLET 40 mg ORAL ANDA 19 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 42291-792 TABLET 80 mg ORAL ANDA 19 sections
TELMISARTAN HUMAN PRESCRIPTION DRUG LABEL 1 42571-226 TABLET 20 mg ORAL ANDA 27 sections
TELMISARTAN HUMAN PRESCRIPTION DRUG LABEL 1 42571-227 TABLET 40 mg ORAL ANDA 27 sections
TELMISARTAN HUMAN PRESCRIPTION DRUG LABEL 1 42571-228 TABLET 80 mg ORAL ANDA 27 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 43547-283 TABLET 20 mg ORAL ANDA 27 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 43547-284 TABLET 40 mg ORAL ANDA 27 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 43547-285 TABLET 80 mg ORAL ANDA 27 sections
TELMISARTAN AND HYDROCHLOROTHIAZIDE HUMAN PRESCRIPTION DRUG LABEL 2 43547-441 TABLET 40 mg ORAL ANDA 22 sections
TELMISARTAN AND HYDROCHLOROTHIAZIDE HUMAN PRESCRIPTION DRUG LABEL 2 43547-442 TABLET 80 mg ORAL ANDA 22 sections