olmesartan medoxomil ๐Ÿถ 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) 1985 144689-63-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • olmesartan medoxomil
  • olmetec
  • CS-866
  • CS866
Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle.
  • Molecular weight: 558.60
  • Formula: C29H30N6O6
  • CLOGP: 3.54
  • LIPINSKI: 2
  • HAC: 12
  • HDO: 2
  • TPSA: 154.34
  • ALOGS: -4.88
  • ROTB: 11

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 2 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.02 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 26 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.561 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 22.542 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 3.221 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 8.551 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 3.670 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 7.990 % High 1
herg hERG pIC50 4.409 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 49.091 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 64.269 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 3.220 % High 1
kinase-safety-class ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,ERBB2,GRK2,GSK3B,ITK,MAP3K21,MAP3K7,MAPK7,MAPKAPK2,MARK4,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PRKDC,STK33,TEK,TTK 31
kinase-selectivity-class EIF2AK3,GRK2,PDK1 3
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 6.966 High 1
mh-clint Mouse hepatocyte intrinsic clearance 110.154 High 1
mppb Mouse plasma protein binding (% unbound) 3.780 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 15.417 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 4.210 % High 1
rh-clint Rat hepatocyte intrinsic clearance 172.982 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 64.110 % High 1
rppb Rat plasma protein binding (% unbound) 2.210 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 885.116 uM High 1

Approvals:

DateAgencyCompanyOrphan
April 25, 2002 FDA DAIICHI SANKYO

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
Sprue-like enteropathy 805.73 11.40 161 37794 792 90589700
Malabsorption 408.64 11.40 131 37824 5047 90585445
Intestinal villi atrophy 177.84 11.40 39 37916 321 90590171
Colitis microscopic 166.32 11.40 85 37870 11074 90579418
Acute kidney injury 127.19 11.40 357 37598 320030 90270462
Dehydration 120.21 11.40 257 37698 194190 90396302
Hyperkalaemia 107.00 11.40 134 37821 64830 90525662
Renal failure 106.14 11.40 194 37761 130813 90459679
Wound 105.91 11.40 5 37950 302975 90287517
Blood pressure increased 105.43 11.40 246 37709 196971 90393521
Hyponatraemia 103.48 11.40 194 37761 133344 90457148
Systemic lupus erythematosus 102.11 11.40 15 37940 361881 90228611
Hypotension 86.48 11.40 316 37639 325081 90265411
Diarrhoea 85.58 11.40 678 37277 938512 89651980
Glossodynia 82.75 11.40 17 37938 321762 90268730
Infusion related reaction 81.97 11.40 36 37919 416744 90173748
Device related thrombosis 80.43 11.40 31 37924 2062 90588430
Off label use 77.13 11.40 223 37732 1102029 89488463
Helicobacter infection 72.54 11.40 6 37949 226844 90363648
Renal impairment 71.71 11.40 145 37810 105276 90485216
Lower respiratory tract infection 67.06 11.40 12 37943 250647 90339845
Synovitis 65.58 11.40 28 37927 329724 90260768
Hypertensive crisis 64.45 11.40 56 37899 17728 90572764
Drug intolerance 64.02 11.40 56 37899 447535 90142957
Maternal exposure during pregnancy 63.40 11.40 36 37919 360027 90230465
Oligohydramnios 61.31 11.40 38 37917 7163 90583329
Blood immunoglobulin M increased 58.77 11.40 22 37933 1350 90589142
Bradycardia 57.82 11.40 116 37839 83731 90506761
Cerebral infarction 55.61 11.40 62 37893 26534 90563958
Gallbladder polyp 54.45 11.40 19 37936 952 90589540
Hepatic enzyme abnormal 54.34 11.40 36 37919 7606 90582886
Hypokalaemia 53.77 11.40 148 37807 130968 90459524
Blood immunoglobulin A decreased 53.51 11.40 22 37933 1734 90588758
Gastritis 53.20 11.40 76 37879 41677 90548815
Impaired healing 53.16 11.40 16 37939 234183 90356309
Syncope 52.68 11.40 148 37807 132515 90457977
Discomfort 51.87 11.40 25 37930 274310 90316182
Blood immunoglobulin G increased 51.25 11.40 25 37930 2947 90587545
Treatment failure 51.22 11.40 32 37923 303896 90286596
Swelling 49.16 11.40 62 37893 418996 90171496
Chronic gastritis 48.61 11.40 26 37929 3715 90586777
Blood pressure inadequately controlled 48.37 11.40 31 37924 6193 90584299
Liver injury 48.23 11.40 7 37948 170560 90419932
Blood urea increased 47.32 11.40 61 37894 30352 90560140
Blood creatinine increased 47.21 11.40 120 37835 101266 90489226
Blood glucose increased 45.67 11.40 114 37841 95132 90495360
Metabolic acidosis 44.48 11.40 82 37873 55594 90534898
Therapeutic product effect decreased 44.37 11.40 31 37924 277540 90312952
Type 2 diabetes mellitus 44.14 11.40 15 37940 203229 90387263
Blood pressure decreased 43.94 11.40 97 37858 74798 90515694
Rheumatic disorder 42.37 11.40 23 37932 3385 90587107
Hypertensive emergency 42.33 11.40 20 37935 2197 90588295
General physical health deterioration 42.20 11.40 52 37903 355063 90235429
Arthropathy 42.10 11.40 55 37900 366187 90224305
Fibromyalgia 41.81 11.40 17 37938 206252 90384240
Cardiac failure congestive 41.05 11.40 112 37843 98582 90491910
Alopecia 40.76 11.40 92 37863 494979 90095513
Hepatic enzyme increased 40.62 11.40 55 37900 360681 90229811
Enteritis 40.46 11.40 34 37921 10287 90580205
Weight decreased 40.45 11.40 285 37670 379625 90210867
Collagen disorder 39.92 11.40 11 37944 248 90590244
Intentional product use issue 39.14 11.40 21 37934 216871 90373621
Hypocalvaria 39.12 11.40 8 37947 45 90590447
Ill-defined disorder 37.86 11.40 15 37940 184876 90405616
Microvillous inclusion disease 36.20 11.40 7 37948 28 90590464
Joint swelling 35.64 11.40 101 37854 503199 90087293
Heart rate irregular 35.16 11.40 47 37908 24221 90566271
Abdominal discomfort 35.13 11.40 94 37861 477234 90113258
Product use issue 34.48 11.40 53 37902 329866 90260626
Multiple fractures 34.43 11.40 30 37925 9532 90580960
Renal disorder 34.41 11.40 59 37896 37800 90552692
Blister 33.95 11.40 34 37921 254964 90335528
Gravitational oedema 32.76 11.40 14 37941 1215 90589277
Musculoskeletal stiffness 32.58 11.40 46 37909 296486 90294006
Irritable bowel syndrome 32.06 11.40 24 37931 207424 90383068
Sopor 31.60 11.40 45 37910 24599 90565893
Asthenia 31.59 11.40 352 37603 533399 90057093
Exposure during pregnancy 31.49 11.40 32 37923 238378 90352114
Contraindicated product administered 31.05 11.40 54 37901 320085 90270407
Chronic kidney disease 30.56 11.40 66 37889 50125 90540367
Lymphocytic infiltration 30.48 11.40 13 37942 1123 90589369
Hypersensitivity 30.18 11.40 94 37861 454583 90135909
Coronary artery disease 30.03 11.40 52 37903 33571 90556921
Alanine aminotransferase increased 29.75 11.40 113 37842 118225 90472267
Compartment syndrome 29.01 11.40 17 37938 2895 90587597
Dizziness 28.90 11.40 375 37580 588909 90001583
Lip dry 28.87 11.40 4 37951 100951 90489541
Night sweats 28.84 11.40 9 37946 128757 90461735
Inflammation 28.45 11.40 20 37935 178572 90411920
Diverticulum 28.40 11.40 30 37925 12083 90578409
Blood creatine phosphokinase increased 28.30 11.40 51 37904 33972 90556520
Azotaemia 28.25 11.40 21 37934 5327 90585165
Grip strength decreased 28.11 11.40 3 37952 92573 90497919
Bursitis 28.09 11.40 10 37945 131644 90458848
Prescribed overdose 27.61 11.40 4 37951 97621 90492871
Oesophagitis 27.46 11.40 35 37920 17214 90573278
Product use in unapproved indication 27.22 11.40 63 37892 336173 90254319
Diverticulitis 27.03 11.40 59 37896 45128 90545364
Renal impairment neonatal 26.68 11.40 6 37949 56 90590436
Eye disorder 26.64 11.40 44 37911 27346 90563146
Wound infection 26.55 11.40 6 37949 106396 90484096
Hypoalbuminaemia 26.49 11.40 33 37922 15864 90574628
Completed suicide 26.23 11.40 14 37941 145044 90445448
Infection 26.10 11.40 72 37883 362022 90228470
Pancreatic toxicity 25.87 11.40 6 37949 65 90590427
Sleep disorder 25.68 11.40 27 37928 198003 90392489
Psoriatic arthropathy 25.50 11.40 35 37920 228300 90362192
Glaucoma 25.30 11.40 37 37918 20718 90569774
Anaemia 25.27 11.40 242 37713 352560 90237932
Drug ineffective 25.03 11.40 419 37536 1383879 89206613
Pain 25.02 11.40 282 37673 996059 89594433
Myocardial infarction 24.85 11.40 99 37856 105873 90484619
Injury 24.38 11.40 28 37927 197321 90393171
Rhabdomyolysis 24.20 11.40 61 37894 51195 90539297
Inappropriate antidiuretic hormone secretion 24.11 11.40 35 37920 19470 90571022
Cerebrovascular accident 24.01 11.40 109 37846 123424 90467068
Atrial fibrillation 23.84 11.40 115 37840 133496 90456996
Renin increased 23.83 11.40 7 37948 200 90590292
Blood aldosterone increased 23.76 11.40 7 37948 202 90590290
Feeling abnormal 23.69 11.40 135 37820 167100 90423392
Putamen haemorrhage 23.50 11.40 7 37948 210 90590282
Condition aggravated 23.27 11.40 150 37805 595395 89995097
Spleen congestion 23.26 11.40 6 37949 104 90590388
Live birth 22.94 11.40 3 37952 79104 90511388
Lower limb fracture 22.87 11.40 4 37951 85009 90505483
Peripheral venous disease 22.47 11.40 4 37951 83917 90506575
Cystitis 22.25 11.40 70 37885 66648 90523844
Hepatic function abnormal 21.76 11.40 55 37900 46233 90544259
Skin exfoliation 21.51 11.40 70 37885 67843 90522649
Therapeutic product effect incomplete 21.37 11.40 30 37925 193866 90396626
Enterocolitis 21.15 11.40 24 37931 10466 90580026
Mobility decreased 21.09 11.40 46 37909 250688 90339804
Gamma-glutamyltransferase increased 20.96 11.40 48 37907 37904 90552588
Hypertension neonatal 20.68 11.40 4 37951 16 90590476
Autoimmune enteropathy 20.68 11.40 4 37951 16 90590476
Non-scarring alopecia 20.34 11.40 3 37952 0 90590492
Prerenal failure 20.16 11.40 12 37943 2103 90588389
Gastritis erosive 20.02 11.40 19 37936 6736 90583756
Large intestine polyp 19.82 11.40 22 37933 9364 90581128
Hiatus hernia 19.81 11.40 37 37918 25324 90565168
Hernia 19.76 11.40 27 37928 14204 90576288
Presyncope 19.56 11.40 42 37913 31763 90558729
Stomatitis 19.50 11.40 55 37900 274643 90315849
Cerebral haemorrhage 19.44 11.40 44 37911 34478 90556014
Hypercholesterolaemia 19.35 11.40 9 37946 100883 90489609
Joint range of motion decreased 19.32 11.40 17 37938 135626 90454866
Palpitations 19.11 11.40 110 37845 136618 90453874
Coeliac disease 18.91 11.40 51 37904 44559 90545933
Lung disorder 18.80 11.40 21 37934 149862 90440630
Toxicity to various agents 18.74 11.40 60 37895 287786 90302706
Lymphocytosis 18.65 11.40 13 37942 2984 90587508
Pulmonary fibrosis 18.54 11.40 11 37944 107492 90483000
Blood alkaline phosphatase increased 18.44 11.40 53 37902 48026 90542466
Hyperuricaemia 18.22 11.40 18 37937 6701 90583791
Intracranial haemangioma 18.12 11.40 4 37951 34 90590458
Obesity 17.91 11.40 11 37944 105496 90484996
Electrolyte imbalance 17.75 11.40 34 37921 23711 90566781
Cataract operation 17.63 11.40 17 37938 6146 90584346
Renal tubular dysfunction 17.60 11.40 7 37948 506 90589986
Hypomagnesaemia 17.48 11.40 43 37912 35545 90554947
Breast cancer metastatic 17.05 11.40 26 37929 15106 90575386
Oedema peripheral 17.03 11.40 174 37781 257741 90332751
Confabulation 16.94 11.40 6 37949 314 90590178
Nervousness 16.57 11.40 41 37914 34015 90556477
Aspartate aminotransferase increased 16.53 11.40 86 37869 102851 90487641
Cough 16.48 11.40 231 37724 368731 90221761
Bronchitis 16.39 11.40 115 37840 152812 90437680
Product administration error 16.38 11.40 35 37920 26388 90564104
Bradyphrenia 16.35 11.40 18 37937 7594 90582898
Angioedema 16.34 11.40 62 37893 64814 90525678
Taste disorder 16.33 11.40 3 37952 61543 90528949
Surfactant protein increased 16.18 11.40 3 37952 9 90590483
Aortic valve calcification 16.17 11.40 7 37948 627 90589865
Myalgia 16.11 11.40 127 37828 174998 90415494
Autoimmune disorder 16.08 11.40 6 37949 76738 90513754
Wheezing 15.93 11.40 49 37906 238031 90352461
Blood potassium increased 15.87 11.40 30 37925 20719 90569773
Decreased appetite 15.73 11.40 233 37722 376307 90214185
Nausea 15.68 11.40 590 37365 1109726 89480766
Skin reaction 15.67 11.40 28 37927 18525 90571967
Burn oesophageal 15.54 11.40 6 37949 401 90590091
Hepatorenal failure 15.53 11.40 7 37948 690 90589802
Eosinophil count 15.32 11.40 3 37952 13 90590479
Distributive shock 14.93 11.40 12 37943 3412 90587080
Reaction to preservatives 14.66 11.40 5 37950 234 90590258
Hypocalcaemia 14.63 11.40 45 37910 42323 90548169
Pregnancy 14.51 11.40 4 37951 62043 90528449
Blood cholesterol increased 14.50 11.40 42 37913 207970 90382522
Acquired oesophageal web 14.42 11.40 5 37950 246 90590246
Anti-transglutaminase antibody increased 14.37 11.40 3 37952 19 90590473
Duodenitis 14.34 11.40 13 37942 4350 90586142
Deep vein thrombosis 14.33 11.40 76 37879 91544 90498948
Urinary tract infection 14.31 11.40 193 37762 305439 90285053
Multiple allergies 14.28 11.40 24 37931 15122 90575370
Iron deficiency anaemia 14.27 11.40 31 37924 23631 90566861
Femur fracture 14.14 11.40 47 37908 46035 90544457
Aortic dissection 13.92 11.40 10 37945 2407 90588085
Abnormal dreams 13.62 11.40 20 37935 11237 90579255
Sinus bradycardia 13.58 11.40 25 37930 16927 90573565
Platelet count decreased 13.53 11.40 101 37854 136868 90453624
Hypovolaemia 13.50 11.40 21 37934 12410 90578082
Contusion 13.30 11.40 57 37898 251159 90339333
Metastases to liver 13.30 11.40 34 37921 28773 90561719
Purpura senile 13.15 11.40 6 37949 609 90589883
Urinary tract pain 12.87 11.40 5 37950 340 90590152
C-reactive protein abnormal 12.80 11.40 21 37934 127408 90463084
Aortic valve stenosis 12.71 11.40 12 37943 4228 90586264
Drug ineffective for unapproved indication 12.69 11.40 6 37949 66638 90523854
Fall 12.62 11.40 277 37678 481533 90108959
Atrial tachycardia 12.58 11.40 14 37941 5976 90584516
Renal artery stenosis 12.52 11.40 9 37946 2168 90588324
Gout 12.43 11.40 24 37931 16835 90573657
Glomerular filtration rate decreased 12.36 11.40 24 37931 16908 90573584
Shock 12.30 11.40 33 37922 28745 90561747
Steal syndrome 12.23 11.40 3 37952 42 90590450
Colitis ischaemic 12.23 11.40 20 37935 12326 90578166
Withdrawal hypertension 12.21 11.40 4 37951 165 90590327
Blood sodium decreased 12.14 11.40 32 37923 27581 90562911
Blood triglycerides increased 11.92 11.40 21 37934 13740 90576752
Neuropathy peripheral 11.87 11.40 98 37857 136872 90453620
Hepatitis D 11.86 11.40 3 37952 48 90590444
Muscle atrophy 11.75 11.40 16 37939 8385 90582107
Abortion spontaneous 11.71 11.40 4 37951 54052 90536440
Hair texture abnormal 11.69 11.40 12 37943 4675 90585817
Liver function test increased 11.65 11.40 11 37944 84844 90505648
Vitamin B12 deficiency 11.62 11.40 15 37940 7471 90583021
Obstruction 11.56 11.40 11 37944 3910 90586582
Generalised oedema 11.53 11.40 25 37930 19028 90571464

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
Sprue-like enteropathy 548.01 11.53 117 26240 530 42594448
Malabsorption 341.35 11.53 108 26249 2665 42592313
Gastrointestinal disorder 107.07 11.53 138 26219 46515 42548463
Colitis microscopic 104.85 11.53 47 26310 3086 42591892
Fractional exhaled nitric oxide increased 83.56 11.53 33 26324 1576 42593402
Off label use 79.97 11.53 173 26184 638162 41956816
Intestinal villi atrophy 79.31 11.53 19 26338 156 42594822
Renal impairment 64.17 11.53 181 26176 110047 42484931
Myoglobin blood increased 62.94 11.53 35 26322 3647 42591331
Blood pressure increased 59.94 11.53 168 26189 101760 42493218
Death 59.43 11.53 127 26230 471058 42123920
Sensation of foreign body 58.11 11.53 33 26324 3580 42591398
Plantar fasciitis 57.50 11.53 31 26326 3039 42591939
Brain natriuretic peptide increased 56.76 11.53 41 26316 6729 42588249
Coeliac disease 51.03 11.53 20 26337 936 42594042
Syncope 48.15 11.53 153 26204 99253 42495725
Toxicity to various agents 46.42 11.53 44 26313 229092 42365886
Dehydration 45.61 11.53 191 26166 141576 42453402
Drug ineffective 41.09 11.53 226 26131 629971 41965007
Hypotension 40.96 11.53 286 26071 257345 42337633
Exostosis 40.27 11.53 31 26326 5600 42589378
Hepatic function abnormal 38.50 11.53 93 26264 51474 42543504
Diarrhoea 38.33 11.53 444 25913 460405 42134573
Right atrial hypertrophy 37.87 11.53 15 26342 722 42594256
Dizziness 37.46 11.53 273 26084 248981 42345997
Weight decreased 37.34 11.53 238 26119 207710 42387268
Hyperkalaemia 35.49 11.53 120 26237 80338 42514640
Cerebral infarction 34.55 11.53 66 26291 31103 42563875
Blood pressure decreased 34.11 11.53 96 26261 58236 42536742
Interstitial lung disease 32.84 11.53 115 26242 78347 42516631
Obstructive airways disorder 31.96 11.53 56 26301 24703 42570275
Pulmonary hypoplasia 31.89 11.53 12 26345 502 42594476
Coronary artery disease 29.08 11.53 86 26271 53634 42541344
Bronchial wall thickening 29.06 11.53 15 26342 1345 42593633
Hyperkinetic heart syndrome 29.01 11.53 8 26349 120 42594858
Pneumothorax 28.78 11.53 52 26305 23491 42571487
Dysphonia 27.63 11.53 57 26300 28393 42566585
Foreign body in throat 27.47 11.53 11 26346 545 42594433
Neutropenia 27.39 11.53 51 26306 199380 42395598
Increased upper airway secretion 27.37 11.53 18 26339 2538 42592440
Right ventricular hypertrophy 27.20 11.53 15 26342 1537 42593441
Atrial fibrillation 27.05 11.53 163 26194 139430 42455548
Febrile neutropenia 26.84 11.53 46 26311 185657 42409321
Bronchial secretion retention 26.71 11.53 15 26342 1592 42593386
Acute kidney injury 26.60 11.53 345 26012 366992 42227986
Hypertensive crisis 26.27 11.53 32 26325 10174 42584804
Gastrointestinal erosion 26.16 11.53 10 26347 437 42594541
Drug abuse 25.09 11.53 17 26340 104754 42490224
Product use in unapproved indication 24.60 11.53 48 26309 184408 42410570
Microvillous inclusion disease 23.95 11.53 8 26349 235 42594743
Lip oedema 23.81 11.53 18 26339 3166 42591812
Hyperuricaemia 23.37 11.53 29 26328 9395 42585583
Gastrooesophageal reflux disease 22.41 11.53 70 26287 44953 42550025
Aortic valve stenosis 22.36 11.53 17 26340 3015 42591963
Pulmonary function test abnormal 21.87 11.53 16 26341 2678 42592300
Coronary artery occlusion 21.34 11.53 30 26327 10967 42584011
Ischaemic enteritis 21.21 11.53 5 26352 38 42594940
Hypokalaemia 21.01 11.53 94 26263 71627 42523351
Loss of consciousness 20.60 11.53 112 26245 92242 42502736
Hypovolaemia 20.34 11.53 30 26327 11455 42583523
Erosive duodenitis 20.14 11.53 13 26344 1776 42593202
Completed suicide 20.12 11.53 18 26339 96447 42498531
Tropical sprue 19.17 11.53 3 26354 0 42594978
Hepatitis syphilitic 19.17 11.53 3 26354 0 42594978
Renal failure 19.06 11.53 153 26204 143573 42451405
Disease progression 18.62 11.53 38 26319 143618 42451360
Hypertensive emergency 18.61 11.53 11 26346 1286 42593692
Neonatal anuria 18.45 11.53 5 26352 70 42594908
Chest X-ray abnormal 18.37 11.53 18 26339 4490 42590488
Treatment failure 18.13 11.53 8 26349 62616 42532362
Obstruction 17.77 11.53 15 26342 3088 42591890
Papillary renal cell carcinoma 17.44 11.53 7 26350 349 42594629
Intestinal intraepithelial lymphocytes increased 16.88 11.53 6 26351 213 42594765
Decreased appetite 16.81 11.53 188 26169 192949 42402029
Anaplastic astrocytoma 16.69 11.53 5 26352 102 42594876
Hypertension 16.54 11.53 167 26190 167037 42427941
Pemphigus 16.48 11.53 12 26345 1994 42592984
Infective exacerbation of chronic obstructive airways disease 16.33 11.53 12 26345 2021 42592957
Chest discomfort 16.15 11.53 80 26277 63536 42531442
Cardiac failure congestive 15.95 11.53 99 26258 85503 42509475
Drug intolerance 15.61 11.53 16 26341 80408 42514570
Pancytopenia 15.38 11.53 31 26326 117712 42477266
Collagen disorder 15.37 11.53 5 26352 135 42594843
Cerebral haemorrhage 15.34 11.53 56 26301 38910 42556068
Gastric cancer 15.16 11.53 20 26337 6883 42588095
Haemorrhoids 15.14 11.53 33 26324 17064 42577914
Secretion discharge 15.07 11.53 21 26336 7614 42587364
Drug ineffective for unapproved indication 14.85 11.53 5 26352 46158 42548820
Atrophy 14.52 11.53 9 26348 1146 42593832
Product dose omission issue 14.50 11.53 48 26309 154317 42440661
Hospitalisation 14.19 11.53 15 26342 74315 42520663
Intestinal ulcer perforation 14.15 11.53 3 26354 13 42594965
Histology abnormal 14.15 11.53 6 26351 344 42594634
Sleep apnoea syndrome 14.06 11.53 37 26320 21571 42573407
Cytokine release syndrome 14.02 11.53 5 26352 44522 42550456
Lymphangiectasia intestinal 13.80 11.53 3 26354 15 42594963
Renal disorder 13.46 11.53 44 26313 28936 42566042
Chronic gastritis 13.37 11.53 11 26346 2186 42592792
Oligohydramnios 13.31 11.53 6 26351 399 42594579
Jealous delusion 13.20 11.53 6 26351 407 42594571
Intentional product use issue 13.15 11.53 15 26342 71818 42523160
Nasopharyngitis 13.14 11.53 93 26264 83903 42511075
Rectal ulcer haemorrhage 13.03 11.53 4 26353 89 42594889
Herpes ophthalmic 12.85 11.53 7 26350 700 42594278
Blood pressure inadequately controlled 12.72 11.53 12 26345 2856 42592122
Myalgia 12.57 11.53 102 26255 95978 42499000
Chronic kidney disease 12.41 11.53 60 26297 47181 42547797
Prerenal failure 12.39 11.53 11 26346 2422 42592556
Diastolic dysfunction 12.02 11.53 18 26339 6965 42588013
Exercise lack of 11.77 11.53 4 26353 124 42594854
Erectile dysfunction 11.72 11.53 38 26319 24875 42570103
Insulin-like growth factor increased 11.71 11.53 9 26348 1622 42593356
Condition aggravated 11.70 11.53 104 26253 260650 42334328
Paranasal sinus haematoma 11.65 11.53 3 26354 34 42594944
General physical health deterioration 11.64 11.53 51 26306 151195 42443783
Gout 11.62 11.53 41 26316 28014 42566964
Muscle spasms 11.61 11.53 92 26265 85952 42509026

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
Sprue-like enteropathy 1309.71 10.83 272 52913 1424 110534690
Malabsorption 579.56 10.83 186 52999 6239 110529875
Colitis microscopic 261.21 10.83 128 53057 13266 110522848
Intestinal villi atrophy 246.83 10.83 57 53128 520 110535594
Dehydration 148.84 10.83 379 52806 279132 110256982
Renal impairment 139.48 10.83 291 52894 188154 110347960
Hyperkalaemia 136.66 10.83 239 52946 135557 110400557
Off label use 127.82 10.83 339 52846 1499846 109036268
Diarrhoea 125.01 10.83 955 52230 1138550 109397564
Hypotension 116.84 10.83 530 52655 523319 110012795
Acute kidney injury 116.02 10.83 607 52578 634823 109901291
Blood pressure increased 116.00 10.83 329 52856 258044 110278070
Renal failure 110.10 10.83 297 52888 226277 110309837
Syncope 107.09 10.83 274 52911 202262 110333852
Cerebral infarction 90.46 10.83 118 53067 51720 110484394
Pericarditis 88.39 10.83 4 53181 219110 110317004
Hypertensive crisis 87.34 10.83 81 53104 24291 110511823
Systemic lupus erythematosus 80.29 10.83 13 53172 254325 110281789
Maternal exposure during pregnancy 76.18 10.83 15 53170 254868 110281246
Hypokalaemia 75.75 10.83 226 52959 182222 110353892
Wound 73.96 10.83 12 53173 234425 110301689
Infusion related reaction 72.52 10.83 47 53138 381115 110154999
Drug intolerance 70.93 10.83 55 53130 406457 110129657
Weight decreased 69.95 10.83 424 52761 467633 110068481
Glossodynia 66.48 10.83 13 53172 221991 110314123
Hyponatraemia 64.83 10.83 241 52944 217412 110318702
Chronic gastritis 63.83 10.83 37 53148 5374 110530740
Synovitis 63.72 10.83 26 53159 274066 110262048
Lower respiratory tract infection 63.48 10.83 19 53166 243087 110293027
Pemphigus 63.34 10.83 13 53172 214557 110321557
Blood pressure decreased 63.18 10.83 158 53027 114933 110421181
Device related thrombosis 61.32 10.83 31 53154 3431 110532683
Hepatic function abnormal 60.37 10.83 133 53052 89162 110446952
Fractional exhaled nitric oxide increased 60.00 10.83 20 53165 756 110535358
Hypertensive emergency 59.34 10.83 30 53155 3321 110532793
Helicobacter infection 58.06 10.83 9 53176 181868 110354246
Gastrointestinal disorder 57.72 10.83 250 52935 241702 110294412
Microvillous inclusion disease 55.89 10.83 15 53170 264 110535850
Blood pressure inadequately controlled 54.49 10.83 38 53147 7595 110528519
Collagen disorder 53.99 10.83 15 53170 302 110535812
Cardiac failure congestive 53.41 10.83 177 53008 150823 110385291
Gastritis 53.31 10.83 94 53091 53605 110482509
Drug ineffective 53.26 10.83 472 52713 1520068 109016046
Treatment failure 52.96 10.83 34 53151 277200 110258914
Blood immunoglobulin M increased 52.06 10.83 22 53163 1615 110534499
Toxicity to various agents 51.83 10.83 95 53090 480460 110055654
Blood immunoglobulin G increased 50.20 10.83 28 53157 3780 110532334
Swelling 50.05 10.83 57 53128 350984 110185130
Hyperuricaemia 49.58 10.83 47 53138 14484 110521630
Atrial fibrillation 47.84 10.83 228 52957 229414 110306700
Completed suicide 47.30 10.83 29 53156 242352 110293762
Enteritis 47.23 10.83 52 53133 19104 110517010
Fibromyalgia 47.15 10.83 12 53173 170897 110365217
Product use in unapproved indication 46.86 10.83 90 53095 447287 110088827
Impaired healing 46.79 10.83 18 53167 196699 110339415
Gallbladder polyp 46.68 10.83 19 53166 1268 110534846
Intentional product use issue 46.54 10.83 31 53154 247875 110288239
Exposure during pregnancy 45.72 10.83 12 53173 167412 110368702
Blood immunoglobulin A decreased 45.37 10.83 22 53163 2226 110533888
Myoglobin blood increased 44.84 10.83 27 53158 4205 110531909
Interstitial lung disease 44.61 10.83 158 53027 139176 110396938
Bradycardia 44.46 10.83 170 53015 155347 110380767
Ill-defined disorder 43.29 10.83 11 53174 156842 110379272
Renal disorder 43.28 10.83 82 53103 49397 110486717
Chronic kidney disease 42.14 10.83 105 53080 76186 110459928
Coronary artery disease 41.00 10.83 100 53085 71590 110464524
Cerebral haemorrhage 40.82 10.83 94 53091 64874 110471240
Autoimmune enteropathy 40.25 10.83 9 53176 70 110536044
Hypersensitivity 39.13 10.83 85 53100 403913 110132201
Metabolic acidosis 38.97 10.83 121 53064 99623 110436491
Abdominal discomfort 38.87 10.83 82 53103 393776 110142338
Rheumatic disorder 38.28 10.83 23 53162 3568 110532546
Hepatic enzyme abnormal 38.02 10.83 34 53151 9729 110526385
Therapeutic product effect decreased 37.81 10.83 37 53148 244279 110291835
Blood creatinine increased 37.66 10.83 181 53004 182708 110353406
General physical health deterioration 37.57 10.83 94 53091 425201 110110913
Musculoskeletal stiffness 37.16 10.83 48 53137 279774 110256340
Joint swelling 36.74 10.83 101 53084 442744 110093370
Diverticulum 36.31 10.83 41 53144 15485 110520629
Discomfort 36.23 10.83 30 53155 214677 110321437
Hepatic enzyme increased 35.87 10.83 62 53123 320830 110215284
Alopecia 35.11 10.83 77 53108 364676 110171438
Blood urea increased 35.06 10.83 80 53105 54877 110481237
Right atrial hypertrophy 35 10.83 13 53172 678 110535436
Type 2 diabetes mellitus 34.86 10.83 21 53164 177211 110358903
Lip dry 34.20 10.83 4 53181 100079 110436035
Myocardial infarction 33.87 10.83 182 53003 191901 110344213
Prerenal failure 33.72 10.83 23 53162 4436 110531678
Death 33.51 10.83 198 52987 698671 109837443
Pain 33.49 10.83 296 52889 954659 109581455
Tropical sprue 33.20 10.83 5 53180 0 110536114
Arthropathy 32.64 10.83 55 53130 287467 110248647
Blood glucose increased 32.41 10.83 138 53047 132358 110403756
Bursitis 32.40 10.83 11 53174 129907 110406207
Blister 32.31 10.83 37 53148 227339 110308775
Night sweats 32.29 10.83 12 53173 133971 110402143
Condition aggravated 32.24 10.83 214 52971 734622 109801492
Brain natriuretic peptide increased 32.19 10.83 33 53152 11176 110524938
Sleep disorder 32.00 10.83 29 53156 198615 110337499
Dizziness 31.58 10.83 491 52694 697702 109838412
Enterocolitis 31.30 10.83 42 53143 18907 110517207
Erosive duodenitis 30.62 10.83 17 53168 2274 110533840
Increased upper airway secretion 30.41 10.83 23 53162 5209 110530905
Decreased appetite 30.31 10.83 356 52829 475490 110060624
Hyperkinetic heart syndrome 29.85 10.83 8 53177 140 110535974
Product use issue 29.83 10.83 66 53119 311629 110224485
Hypovolaemia 29.80 10.83 44 53141 21630 110514484
Coeliac disease 28.81 10.83 64 53121 43123 110492991
Drug ineffective for unapproved indication 28.79 10.83 7 53178 102831 110433283
Multiple fractures 28.77 10.83 28 53157 8912 110527202
Febrile neutropenia 28.76 10.83 69 53116 316698 110219416
Plantar fasciitis 28.72 10.83 22 53163 5079 110531035
Aortic valve stenosis 28.54 10.83 24 53161 6326 110529788
Hiatus hernia 28.27 10.83 49 53136 27557 110508557
Wound infection 28.14 10.83 6 53179 96459 110439655
Inflammation 27.93 10.83 31 53154 193207 110342907
Rhabdomyolysis 27.61 10.83 123 53062 120278 110415836
Peripheral venous disease 27.21 10.83 4 53181 84113 110452001
Lymphocytic infiltration 26.99 10.83 15 53170 2010 110534104
Heart rate irregular 26.58 10.83 54 53131 34220 110501894
Hypoalbuminaemia 26.56 10.83 49 53136 28925 110507189
Prescribed overdose 26.48 10.83 5 53180 87576 110448538
Obstruction 26.39 10.83 22 53163 5730 110530384
Sensation of foreign body 25.71 10.83 25 53160 7950 110528164
Infection 25.49 10.83 89 53096 362111 110174003
Anaemia 25.20 10.83 386 52799 546700 109989414
Gravitational oedema 25.14 10.83 14 53171 1884 110534230
Diverticulitis 24.80 10.83 69 53116 53453 110482661
Pulmonary function test abnormal 24.77 10.83 20 53165 4980 110531134
Presyncope 24.63 10.83 65 53120 48822 110487292
Blood creatine phosphokinase increased 24.36 10.83 84 53101 72993 110463121
Contraindicated product administered 24.22 10.83 52 53133 248215 110287899
Large intestine polyp 24.20 10.83 33 53152 15084 110521030
Asthenia 23.75 10.83 464 52721 688535 109847579
Right ventricular hypertrophy 23.65 10.83 13 53172 1706 110534408
Foreign body in throat 23.27 10.83 11 53174 1052 110535062
Coronary artery occlusion 23.11 10.83 33 53152 15739 110520375
Putamen haemorrhage 23.09 10.83 9 53176 536 110535578
Aortic dissection 22.91 10.83 19 53166 4914 110531200
Alanine aminotransferase increased 22.80 10.83 159 53026 183614 110352500
Platelet count decreased 22.24 10.83 188 52997 230255 110305859
Loss of consciousness 21.58 10.83 165 53020 196141 110339973
Adverse drug reaction 21.47 10.83 12 53173 105547 110430567
Blood cholesterol increased 21.28 10.83 35 53150 184750 110351364
Irritable bowel syndrome 20.95 10.83 29 53156 164186 110371928
Azotaemia 20.85 10.83 25 53160 10060 110526054
Hypocalcaemia 20.81 10.83 74 53111 65292 110470822
Liver injury 20.80 10.83 25 53160 150388 110385726
Gastric cancer 20.68 10.83 26 53159 10982 110525132
Joint range of motion decreased 20.57 10.83 17 53168 121815 110414299
Pulmonary fibrosis 20.19 10.83 12 53173 102030 110434084
Hepatitis syphilitic 19.92 10.83 3 53182 0 110536114
Non-scarring alopecia 19.92 10.83 3 53182 0 110536114
Exercise lack of 19.90 10.83 8 53177 517 110535597
Sopor 19.86 10.83 50 53135 36496 110499618
Gout 19.84 10.83 50 53135 36516 110499598
Grip strength decreased 19.62 10.83 7 53178 80167 110455947
Haemorrhoids 19.59 10.83 49 53136 35623 110500491
Gastrointestinal erosion 19.52 10.83 10 53175 1138 110534976
Lymphocytosis 19.42 10.83 18 53167 5393 110530721
Bradyphrenia 19.38 10.83 26 53159 11702 110524412
Migraine 19.32 10.83 33 53152 171619 110364495
Gamma-glutamyltransferase increased 19.17 10.83 69 53116 61240 110474874
Hypoglycaemia 19.11 10.83 108 53077 115996 110420118
Mobility decreased 19.04 10.83 55 53130 237367 110298747
Hypercholesterolaemia 18.95 10.83 10 53175 90827 110445287
Gastritis erosive 18.91 10.83 26 53159 11974 110524140
Papillary renal cell carcinoma 18.90 10.83 7 53178 362 110535752
Generalised oedema 18.82 10.83 44 53141 30660 110505454
Breast cancer metastatic 18.80 10.83 25 53160 11156 110524958
Incorrect route of product administration 18.65 10.83 4 53181 64057 110472057
Psoriatic arthropathy 18.54 10.83 42 53143 196719 110339395
Infective exacerbation of chronic obstructive airways disease 18.49 10.83 14 53171 3176 110532938
Multiple allergies 18.47 10.83 26 53159 12237 110523877
Aspartate aminotransferase increased 18.46 10.83 136 53049 159800 110376314
Muscle atrophy 18.36 10.83 27 53158 13227 110522887
Hospitalisation 18.34 10.83 25 53160 142468 110393646
Lung disorder 18.15 10.83 37 53148 180010 110356104
Cataract operation 18.14 10.83 18 53167 5865 110530249
Glaucoma 18.08 10.83 36 53149 22481 110513633
Hypomagnesaemia 18.08 10.83 67 53118 60303 110475811
Cystitis 17.89 10.83 71 53114 65965 110470149
Disease progression 17.82 10.83 59 53126 243975 110292139
Intestinal intraepithelial lymphocytes increased 17.75 10.83 6 53179 237 110535877
Duodenitis 17.72 10.83 22 53163 9174 110526940
Lip oedema 17.65 10.83 20 53165 7580 110528534
Intracranial haemangioma 17.57 10.83 4 53181 34 110536080
Blood potassium increased 17.56 10.83 45 53140 33204 110502910
Gastrooesophageal reflux disease 17.45 10.83 147 53038 179829 110356285
Cytokine release syndrome 17.45 10.83 6 53179 70300 110465814
Diabetic nephropathy 17.31 10.83 14 53171 3494 110532620
Cytomegalovirus infection 16.69 10.83 3 53182 54441 110481673
Gluten sensitivity 16.67 10.83 7 53178 506 110535608
Bronchial wall thickening 16.26 10.83 13 53172 3194 110532920
Dysphonia 16.24 10.83 76 53109 75853 110460261
Frequent bowel movements 16.21 10.83 7 53178 71383 110464731
Eye disorder 16.18 10.83 40 53145 28866 110507248
Anaplastic astrocytoma 16.17 10.83 5 53180 148 110535966
Lower limb fracture 16.16 10.83 8 53177 75340 110460774
Skin exfoliation 16.09 10.83 84 53101 87567 110448547
Blood alkaline phosphatase increased 15.91 10.83 72 53113 70863 110465251
Pulmonary hypoplasia 15.89 10.83 4 53181 54 110536060
Oligohydramnios 15.73 10.83 14 53171 3980 110532134
C-reactive protein abnormal 15.47 10.83 24 53161 129671 110406443
Diabetes mellitus inadequate control 15.42 10.83 40 53145 29735 110506379
Leukocyturia 15.37 10.83 11 53174 2289 110533825
Palmar-plantar erythrodysaesthesia syndrome 15.31 10.83 49 53136 40976 110495138
Cerebrovascular accident 14.97 10.83 143 53042 181141 110354973
Bradykinesia 14.97 10.83 22 53163 10766 110525348
Haematuria 14.86 10.83 79 53106 82926 110453188
Autoimmune hepatitis 14.80 10.83 26 53159 14778 110521336
Histology abnormal 14.79 10.83 6 53179 397 110535717
Road traffic accident 14.69 10.83 18 53167 107380 110428734
Upper respiratory tract inflammation 14.65 10.83 14 53171 4357 110531757
Angioplasty 14.51 10.83 10 53175 1961 110534153
Carotid artery stenosis 14.49 10.83 20 53165 9243 110526871
Ear infection 14.48 10.83 6 53179 62726 110473388
Erectile dysfunction 14.11 10.83 29 53156 18527 110517587
Intestinal ulcer perforation 14.09 10.83 3 53182 18 110536096
Inappropriate antidiuretic hormone secretion 14.09 10.83 42 53143 33809 110502305
Shock 14.03 10.83 57 53128 53531 110482583
Renal cyst haemorrhage 14.02 10.83 7 53178 754 110535360
Autoimmune disorder 13.97 10.83 7 53178 65476 110470638
Confusional state 13.96 10.83 151 53034 468529 110067585
Embolic stroke 13.86 10.83 19 53166 8724 110527390
Jealous delusion 13.86 10.83 6 53179 467 110535647
Angina pectoris 13.80 10.83 63 53122 62232 110473882
Vertigo 13.76 10.83 80 53105 86790 110449324
Injury 13.54 10.83 42 53143 177223 110358891
Obesity 13.49 10.83 21 53164 113330 110422784
Contusion 13.46 10.83 62 53123 233299 110302815
Reaction to preservatives 13.42 10.83 5 53180 263 110535851
Confabulation 13.31 10.83 6 53179 515 110535599
Oedema peripheral 13.27 10.83 227 52958 328433 110207681
Orthostatic hypotension 13.22 10.83 65 53120 66184 110469930
Hernia 13.12 10.83 29 53156 19471 110516643
Gastrointestinal ischaemia 13.09 10.83 6 53179 535 110535579
Pneumothorax 13.04 10.83 42 53143 35243 110500871
Product substitution issue 13.00 10.83 32 53153 23029 110513085
Iron deficiency anaemia 12.99 10.83 39 53146 31520 110504594
Aortic valve calcification 12.93 10.83 7 53178 891 110535223
Ileal ulcer 12.86 10.83 9 53176 1808 110534306
Colon cancer 12.86 10.83 26 53159 16417 110519697
Colitis ulcerative 12.81 10.83 11 53174 77352 110458762
Chest X-ray abnormal 12.79 10.83 18 53167 8469 110527645
Chest pain 12.77 10.83 253 52932 376122 110159992
Atrophy 12.51 10.83 10 53175 2454 110533660
Peripheral swelling 12.51 10.83 129 53056 403905 110132209
Anti-transglutaminase antibody increased 12.48 10.83 3 53182 33 110536081
Gastroenteritis 12.41 10.83 44 53141 38756 110497358
Acquired oesophageal web 12.37 10.83 5 53180 328 110535786
Arrhythmia 12.30 10.83 66 53119 69509 110466605
Feeling abnormal 12.28 10.83 137 53048 180574 110355540
Leukopenia 12.27 10.83 34 53151 148757 110387357
Thalamus haemorrhage 12.23 10.83 9 53176 1955 110534159
Surfactant protein increased 12.17 10.83 3 53182 37 110536077
Metastases to liver 12.08 10.83 41 53144 35345 110500769
Duodenal ulcer haemorrhage 12.05 10.83 17 53168 8020 110528094
Melaena 12.01 10.83 65 53120 68692 110467422
Hypokinesia 12.00 10.83 30 53155 21796 110514318
Polyp 11.94 10.83 19 53166 9961 110526153
Ischaemic enteritis 11.93 10.83 4 53181 154 110535960
Back injury 11.84 10.83 4 53181 47395 110488719
Gastrointestinal hypermotility 11.82 10.83 5 53180 368 110535746
Paranasal sinus haematoma 11.82 10.83 3 53182 42 110536072
Cholangitis 11.80 10.83 25 53160 16310 110519804
Cell marker increased 11.78 10.83 6 53179 675 110535439
Sinus bradycardia 11.73 10.83 36 53149 29447 110506667
Brain stem infarction 11.57 10.83 9 53176 2125 110533989
Transient aphasia 11.55 10.83 6 53179 703 110535411
Occult blood positive 11.54 10.83 16 53169 7429 110528685
Blepharospasm 11.50 10.83 6 53179 54845 110481269
Therapeutic product effect incomplete 11.45 10.83 62 53123 223743 110312371
Immune-mediated pancreatitis 11.43 10.83 6 53179 718 110535396
Diastolic dysfunction 11.40 10.83 21 53164 12383 110523731
Lymphangiectasia intestinal 11.33 10.83 3 53182 50 110536064
Cardiac failure 11.31 10.83 139 53046 187487 110348627
Disturbance in attention 11.30 10.83 8 53177 61987 110474127
Rheumatoid arthritis 11.30 10.83 91 53094 299522 110236592
Bronchial secretion retention 11.29 10.83 13 53172 5011 110531103
Bronchitis 11.11 10.83 120 53065 156912 110379202
Myalgia 11.03 10.83 159 53026 222222 110313892
Electrolyte imbalance 11.00 10.83 41 53144 36987 110499127
Palpitations 10.96 10.83 121 53064 159091 110377023
Cough 10.91 10.83 295 52890 461346 110074768
Disseminated intravascular coagulation 10.87 10.83 44 53141 41242 110494872

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C09CA08 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
Angiotensin II receptor blockers (ARBs), plain
ATC C09DA08 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and diuretics
ATC C09DB02 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 C09DX03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
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
MeSH PA D057911 Angiotensin Receptor Antagonists
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:76595 nephroprotective agent
CHEBI has role CHEBI:145947 antiatherosclerotic agent
CHEBI has role CHEBI:231911 renoprotective agent
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:61016 angiotensin receptor antagonist

Related Drugs by ATC class:

C09CA Angiotensin II receptor blockers (ARBs), plain 9 drugs
C09DA Angiotensin II receptor blockers (ARBs) and diuretics 8 drugs
C09DB Angiotensin II receptor blockers (ARBs) and calcium channel blockers 8 drugs
C09DX Angiotensin II receptor blockers (ARBs), other combinations 10 drugs

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

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Chronic heart failure off-label use 48447003
Atrial fibrillation off-label use 49436004 DOID:0060224
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
Dehydration contraindication 34095006
Hyperuricemia contraindication 35885006 DOID:1920
Angioedema contraindication 41291007 DOID:1558
Hypokalemia contraindication 43339004
Diabetes mellitus type 2 contraindication 44054006 DOID:9352
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Hepatic failure 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
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Azotemia contraindication 445009001
Severe Aortic Valve Stenosis contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.25 acidic
pKa2 5.76 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Type-1 angiotensin II receptor GPCR ANTAGONIST IC50 8.10 IUPHAR CHEMBL
Type-1 angiotensin II receptor GPCR IC50 8.09 CHEMBL

External reference:

IDSource
4021345 VUID
N0000179505 NUI
D01204 KEGG_DRUG
4021344 VANDF
4021345 VANDF
C0386393 UMLSCUI
CHEBI:31932 CHEBI
OLM PDB_CHEM_ID
CHEMBL1200692 ChEMBL_ID
D000068557 MESH_DESCRIPTOR_UI
7787 INN_ID
6M97XTV3HD UNII
130881 PUBCHEM_CID
DB00275 DRUGBANK_ID
118463 RXNORM
16642 MMSL
245076 MMSL
d04801 MMSL
009634 NDDF
009635 NDDF
385540001 SNOMEDCT_US
412259001 SNOMEDCT_US
412260006 SNOMEDCT_US
C1098320 UMLSCUI
CHEMBL1516 ChEMBL_ID
144689-24-7 SECONDARY_CAS_RN
158781 PUBCHEM_CID
591 IUPHAR_LIGAND_ID
8612 INN_ID
C437965 MESH_SUPPLEMENTAL_RECORD_UI
8W1IQP3U10 UNII
CHEBI:48416 CHEBI
6M97XTV3HD INXIGHT DRUGS
8W1IQP3U10 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 3 0093-5002 TABLET, FILM COATED 40 mg ORAL ANDA 26 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 3 0093-5003 TABLET, FILM COATED 40 mg ORAL ANDA 26 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 3 0093-5004 TABLET, FILM COATED 40 mg ORAL ANDA 26 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 3 0093-5005 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 3 0093-5006 TABLET, FILM COATED 40 mg ORAL ANDA 26 sections
OLMESARTAN MEDOXOMIL HUMAN PRESCRIPTION DRUG LABEL 1 0527-2425 TABLET, FILM COATED 5 mg ORAL ANDA 31 sections
OLMESARTAN MEDOXOMIL HUMAN PRESCRIPTION DRUG LABEL 1 0527-2426 TABLET, FILM COATED 20 mg ORAL ANDA 31 sections
OLMESARTAN MEDOXOMIL HUMAN PRESCRIPTION DRUG LABEL 1 0527-2427 TABLET, FILM COATED 40 mg ORAL ANDA 31 sections
Benicar HUMAN PRESCRIPTION DRUG LABEL 1 0713-0860 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Benicar HUMAN PRESCRIPTION DRUG LABEL 1 0713-0861 TABLET, FILM COATED 20 mg ORAL NDA 32 sections
Benicar HUMAN PRESCRIPTION DRUG LABEL 1 0713-0862 TABLET, FILM COATED 40 mg ORAL NDA 32 sections
Benicar HCT HUMAN PRESCRIPTION DRUG LABEL 2 0713-0863 TABLET, FILM COATED 20 mg ORAL NDA 26 sections
Benicar HCT HUMAN PRESCRIPTION DRUG LABEL 2 0713-0864 TABLET, FILM COATED 40 mg ORAL NDA 26 sections
Benicar HCT HUMAN PRESCRIPTION DRUG LABEL 2 0713-0865 TABLET, FILM COATED 40 mg ORAL NDA 26 sections
Azor HUMAN PRESCRIPTION DRUG LABEL 2 0713-0870 TABLET, FILM COATED 20 mg ORAL NDA 26 sections
Azor HUMAN PRESCRIPTION DRUG LABEL 2 0713-0871 TABLET, FILM COATED 20 mg ORAL NDA 26 sections
Azor HUMAN PRESCRIPTION DRUG LABEL 2 0713-0872 TABLET, FILM COATED 40 mg ORAL NDA 26 sections
Azor HUMAN PRESCRIPTION DRUG LABEL 2 0713-0873 TABLET, FILM COATED 40 mg ORAL NDA 26 sections
Tribenzor HUMAN PRESCRIPTION DRUG LABEL 3 0713-0874 TABLET, FILM COATED 20 mg ORAL NDA 28 sections
Tribenzor HUMAN PRESCRIPTION DRUG LABEL 3 0713-0875 TABLET, FILM COATED 40 mg ORAL NDA 28 sections
Tribenzor HUMAN PRESCRIPTION DRUG LABEL 3 0713-0876 TABLET, FILM COATED 40 mg ORAL NDA 28 sections
Tribenzor HUMAN PRESCRIPTION DRUG LABEL 3 0713-0877 TABLET, FILM COATED 40 mg ORAL NDA 28 sections
Tribenzor HUMAN PRESCRIPTION DRUG LABEL 3 0713-0878 TABLET, FILM COATED 40 mg ORAL NDA 28 sections
Benicar HUMAN PRESCRIPTION DRUG LABEL 1 0713-0940 TABLET, FILM COATED 5 mg ORAL NDA 31 sections
Benicar HUMAN PRESCRIPTION DRUG LABEL 1 0713-0941 TABLET, FILM COATED 20 mg ORAL NDA 31 sections
Benicar HUMAN PRESCRIPTION DRUG LABEL 1 0713-0942 TABLET, FILM COATED 40 mg ORAL NDA 31 sections
Benicar HCT HUMAN PRESCRIPTION DRUG LABEL 2 0713-0943 TABLET, FILM COATED 20 mg ORAL NDA 26 sections
Benicar HCT HUMAN PRESCRIPTION DRUG LABEL 2 0713-0944 TABLET, FILM COATED 40 mg ORAL NDA 26 sections
Benicar HCT HUMAN PRESCRIPTION DRUG LABEL 2 0713-0945 TABLET, FILM COATED 40 mg ORAL NDA 26 sections
olmesartan medoxomil HUMAN PRESCRIPTION DRUG LABEL 1 16729-320 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections