irbesartan 🐶 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) 1481 138402-11-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • irbesartan
  • aprovel
  • irbesartan hydrochloride
  • karvea
  • ifirmasta
  • irbesartan HCl
A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.
  • Molecular weight: 428.54
  • Formula: C25H28N6O
  • CLOGP: 4.69
  • LIPINSKI: 1
  • HAC: 7
  • HDO: 1
  • TPSA: 87.13
  • ALOGS: -4.70
  • ROTB: 7
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.15 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.08 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 10 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 70 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.94 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.10 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 14 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,EIF2AK3,GRK2,ITK,MAPKAPK2,PDK1,PDK4,PRKDC 9
kinase-selectivity-class EIF2AK3,GRK2 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 11.092 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
rat-kpuu-brain Rat brain Kpuu 0.015 % High 1

Approvals:

DateAgencyCompanyOrphan
Sept. 30, 1997 FDA SANOFI AVENTIS US
Aug. 26, 1997 EMA SANOFI WINTHROP INDUSTRIE

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
Acute kidney injury 803.19 10.76 1138 72756 319249 90235304
Carotid artery thrombosis 598.87 10.76 239 73655 8853 90545700
Neurologic neglect syndrome 587.74 10.76 234 73660 8613 90545940
Personality disorder 568.05 10.76 252 73642 12192 90542361
Adjustment disorder 558.08 10.76 231 73663 9411 90545142
Hemiplegia 537.96 10.76 263 73631 15897 90538656
Affect lability 487.26 10.76 255 73639 17808 90536745
Sensory loss 458.76 10.76 245 73649 17830 90536723
Motor dysfunction 419.92 10.76 236 73658 18994 90535559
Coordination abnormal 407.38 10.76 240 73654 21116 90533437
Hemiparesis 400.60 10.76 275 73619 31544 90523009
Hyponatraemia 381.31 10.76 506 73388 133032 90421521
Eating disorder 375.73 10.76 252 73642 27821 90526732
Aphasia 359.34 10.76 290 73604 42522 90512031
Muscle spasticity 328.09 10.76 254 73640 35068 90519485
Blood pressure increased 315.80 10.76 572 73322 196645 90357908
Fall 298.24 10.76 966 72928 480844 90073709
Arterial occlusive disease 294.33 10.76 161 73733 12285 90542268
Dysarthria 291.42 10.76 286 73608 54196 90500357
Hyperkalaemia 289.38 10.76 309 73585 64655 90489898
Cerebrovascular accident 282.56 10.76 421 73473 123112 90431441
Gangrene 275.63 10.76 156 73738 12720 90541833
Skin haemorrhage 264.88 10.76 183 73711 21197 90533356
Sinus congestion 262.98 10.76 201 73693 27223 90527330
Systemic lupus erythematosus 242.02 10.76 13 73881 361883 90192670
Respiratory tract congestion 224.32 10.76 183 73711 27227 90527326
Sneezing 218.72 10.76 187 73707 29682 90524871
Hand deformity 217.63 10.76 5 73889 296357 90258196
Lactic acidosis 210.67 10.76 232 73662 50231 90504322
Angina pectoris 210.19 10.76 206 73688 38954 90515599
Glossodynia 202.02 10.76 16 73878 321763 90232790
Sinus disorder 191.99 10.76 185 73709 34262 90520291
Dysphagia 187.65 10.76 332 73562 111946 90442607
Cystitis 164.95 10.76 236 73658 66482 90488071
Maternal exposure during pregnancy 164.60 10.76 45 73849 360018 90194535
Synovitis 162.88 10.76 35 73859 329717 90224836
Treatment failure 159.08 10.76 28 73866 303900 90250653
Therapeutic product effect decreased 158.08 10.76 20 73874 277551 90277002
Pericarditis 154.99 10.76 19 73875 270132 90284421
Drug interaction 154.36 10.76 536 73358 275917 90278636
Duodenal ulcer perforation 154.21 10.76 6 73888 221282 90333271
Drug ineffective 146.42 10.76 608 73286 1383690 89170863
Hypotension 143.57 10.76 585 73309 324812 90229741
Cataract 141.40 10.76 229 73665 71863 90482690
Skin exfoliation 140.44 10.76 221 73673 67692 90486861
Wound 138.20 10.76 38 73856 302942 90251611
Blood pressure systolic increased 134.95 10.76 200 73694 58145 90496408
Rhinorrhoea 134.64 10.76 251 73643 88065 90466488
Helicobacter infection 130.00 10.76 16 73878 226834 90327719
Muscle injury 129.56 10.76 3 73891 176651 90377902
Palpitations 129.21 10.76 320 73574 136408 90418145
Alopecia 128.01 10.76 129 73765 494942 90059611
Swelling 120.44 10.76 99 73795 418959 90135594
Psoriatic arthropathy 119.53 10.76 21 73873 228314 90326239
Chest discomfort 117.45 10.76 311 73583 138054 90416499
Ischaemic stroke 115.95 10.76 115 73779 22051 90532502
Contraindicated product administered 114.57 10.76 59 73835 320080 90234473
Bradycardia 113.96 10.76 227 73667 83620 90470933
Irritable bowel syndrome 110.97 10.76 18 73876 207430 90347123
Muscular weakness 108.66 10.76 393 73501 206273 90348280
Type 2 diabetes mellitus 107.91 10.76 18 73876 203226 90351327
Influenza 107.20 10.76 302 73592 138962 90415591
Amyloid arthropathy 106.58 10.76 43 73851 1637 90552916
Abdominal discomfort 104.44 10.76 142 73752 477186 90077367
Hepatic enzyme increased 103.91 10.76 85 73809 360651 90193902
Influenza like illness 102.14 10.76 212 73682 80399 90474154
Renal failure 97.82 10.76 281 73613 130726 90423827
Fibromyalgia 97.60 10.76 24 73870 206245 90348308
Drug intolerance 95.06 10.76 136 73758 447455 90107098
Infection 93.93 10.76 94 73800 362000 90192553
Discomfort 93.13 10.76 54 73840 274281 90280272
Pulmonary pain 91.06 10.76 55 73839 5059 90549494
Drug hypersensitivity 88.79 10.76 151 73743 463458 90091095
Sleep disorder due to general medical condition, insomnia type 87.93 10.76 4 73890 128690 90425863
Gastrointestinal procedural complication 87.60 10.76 27 73867 455 90554098
Product use in unapproved indication 87.53 10.76 87 73807 336149 90218404
Liver injury 86.44 10.76 17 73877 170550 90384003
Pemphigoid 83.98 10.76 65 73829 8961 90545592
Blister 82.63 10.76 53 73841 254945 90299608
Exposure during pregnancy 82.24 10.76 46 73848 238364 90316189
Hypoglycaemia 81.90 10.76 178 73716 69670 90484883
Impaired healing 81.06 10.76 45 73849 234154 90320399
Joint swelling 79.13 10.76 184 73710 503116 90051437
Rhabdomyolysis 78.50 10.76 146 73748 51110 90503443
Product use issue 77.43 10.76 93 73801 329826 90224727
Arthropathy 77.02 10.76 112 73782 366130 90188423
Inappropriate antidiuretic hormone secretion 76.78 10.76 87 73807 19418 90535135
Renal impairment 76.64 10.76 224 73670 105197 90449356
Asthenia 75.72 10.76 715 73179 533036 90021517
Off label use 74.13 10.76 561 73333 1101691 89452862
Ill-defined disorder 72.42 10.76 30 73864 184861 90369692
Hypersensitivity 71.63 10.76 166 73728 454511 90100042
Stomatitis 71.57 10.76 71 73823 274627 90279926
Injury 71.11 10.76 36 73858 197313 90357240
Blood pressure systolic abnormal 70.17 10.76 83 73811 19395 90535158
Mobility decreased 69.80 10.76 61 73833 250673 90303880
Lip dry 69.42 10.76 3 73891 100952 90453601
Heart rate decreased 69.28 10.76 142 73752 53363 90501190
Body mass index abnormal 68.74 10.76 25 73869 714 90553839
Cough 68.52 10.76 525 73369 368437 90186116
Infusion related reaction 68.22 10.76 149 73745 416631 90137922
Joint range of motion decreased 67.72 10.76 14 73880 135629 90418924
Sinus bradycardia 67.39 10.76 76 73818 16876 90537677
Hepatic cytolysis 65.83 10.76 102 73792 30814 90523739
Blood pressure diastolic abnormal 65.55 10.76 81 73813 19800 90534753
Dehydration 64.16 10.76 321 73573 194126 90360427
Therapeutic product effect incomplete 63.22 10.76 40 73854 193856 90360697
Bursitis 62.88 10.76 15 73879 131639 90422914
Anxiety 62.73 10.76 450 73444 309322 90245231
Night sweats 60.86 10.76 15 73879 128751 90425802
C-reactive protein abnormal 58.02 10.76 16 73878 127413 90427140
Gait inability 56.97 10.76 24 73870 146432 90408121
Serositis 54.77 10.76 25 73869 1292 90553261
Central nervous system lupus 53.95 10.76 25 73869 1338 90553215
Rash 53.95 10.76 404 73490 795696 89758857
Psoriasis 53.83 10.76 251 73643 147503 90407050
Confusional state 53.02 10.76 514 73380 385691 90168862
Hepatocellular injury 52.74 10.76 89 73805 28869 90525684
Angioedema 52.17 10.76 143 73751 64733 90489820
Peripheral venous disease 50.37 10.76 5 73889 83916 90470637
Pain 50.31 10.76 545 73349 995796 89558757
Atrial fibrillation 50.17 10.76 229 73665 133382 90421171
Oxygen saturation decreased 48.68 10.76 195 73699 107288 90447265
Migraine 48.67 10.76 50 73844 190342 90364211
Lower limb fracture 48.66 10.76 6 73888 85007 90469546
Cardiac failure 47.48 10.76 196 73698 109300 90445253
Blood pressure diastolic decreased 46.94 10.76 81 73813 26745 90527808
Vulvovaginal burning sensation 46.44 10.76 28 73866 2567 90551986
Blood cholesterol increased 46.31 10.76 61 73833 207951 90346602
Wound infection 45.46 10.76 15 73879 106387 90448166
Tubulointerstitial nephritis 44.97 10.76 77 73817 25266 90529287
Prescribed overdose 44.93 10.76 12 73882 97613 90456940
Rhinalgia 44.62 10.76 27 73867 2491 90552062
Adverse drug reaction 44.00 10.76 20 73874 116681 90437872
Intentional product use issue 43.93 10.76 68 73826 216824 90337729
Malaise 43.56 10.76 695 73199 585291 89969262
Cholestasis 43.10 10.76 93 73801 36206 90518347
Hypokalaemia 42.20 10.76 215 73679 130901 90423652
Syncope 41.63 10.76 216 73678 132447 90422106
Torsade de pointes 40.92 10.76 56 73838 15126 90539427
Blood pressure fluctuation 40.62 10.76 114 73780 52299 90502254
Arteriovenous fistula occlusion 39.99 10.76 14 73880 357 90554196
Vulvovaginal pruritus 39.88 10.76 30 73864 3963 90550590
Liver function test increased 39.87 10.76 10 73884 84845 90469708
Hypoaesthesia 38.11 10.76 130 73764 314080 90240473
Intra-abdominal haematoma 38.02 10.76 23 73871 2121 90552432
Fear of eating 37.91 10.76 14 73880 418 90554135
Musculoskeletal stiffness 37.82 10.76 120 73774 296412 90258141
Injection site reaction 37.59 10.76 14 73880 92066 90462487
Anuria 37.46 10.76 53 73841 14765 90539788
Hypercholesterolaemia 36.94 10.76 18 73876 100874 90453679
Hypertensive crisis 36.92 10.76 58 73836 17726 90536827
Blue toe syndrome 36.30 10.76 14 73880 472 90554081
Inflammation 36.16 10.76 56 73838 178536 90376017
Autoimmune disorder 36.14 10.76 9 73885 76735 90477818
Paranasal sinus discomfort 35.82 10.76 34 73860 6176 90548377
Shock haemorrhagic 35.80 10.76 47 73847 12198 90542355
Muscle tension dysphonia 35.00 10.76 12 73882 287 90554266
Botryomycosis 34.94 10.76 8 73886 38 90554515
Blood pressure inadequately controlled 33.86 10.76 33 73861 6191 90548362
Memory impairment 33.49 10.76 69 73825 197175 90357378
Depression 33.39 10.76 129 73765 300472 90254081
Haematoma muscle 33.20 10.76 20 73874 1830 90552723
Sciatica 32.91 10.76 21 73873 101361 90453192
Completed suicide 32.83 10.76 42 73852 145016 90409537
Condition aggravated 32.74 10.76 319 73575 595226 89959327
Vertigo 32.68 10.76 128 73766 69683 90484870
Myocardial infarction 32.18 10.76 171 73723 105801 90448752
Blepharospasm 31.52 10.76 4 73890 55441 90499112
Pulmonary fibrosis 31.32 10.76 25 73869 107478 90447075
Keratitis 31.21 10.76 26 73868 3980 90550573
Coronary artery disease 30.99 10.76 78 73816 33545 90521008
Product administration error 30.58 10.76 67 73827 26356 90528197
Hip arthroplasty 30.42 10.76 12 73882 76196 90478357
Trisomy 21 30.01 10.76 12 73882 446 90554107
Atrioventricular block complete 29.22 10.76 38 73856 9773 90544780
Upper respiratory tract infection 29.20 10.76 37 73857 128281 90426272
Lupus nephritis 28.91 10.76 27 73867 4805 90549748
Sebaceous gland infection 28.70 10.76 9 73885 161 90554392
Atrioventricular block first degree 28.58 10.76 35 73859 8476 90546077
Erysipelas 28.43 10.76 36 73858 9016 90545537
International normalised ratio increased 28.32 10.76 94 73800 47222 90507331
Sinus node dysfunction 28.15 10.76 28 73866 5384 90549169
Adverse event 27.62 10.76 33 73861 117385 90437168
Taste disorder 27.50 10.76 8 73886 61538 90493015
Neurofibrosarcoma 27.26 10.76 9 73885 191 90554362
Lichen planopilaris 27.26 10.76 9 73885 191 90554362
Blood creatinine increased 27.06 10.76 158 73736 101228 90453325
Gout 27.04 10.76 49 73845 16810 90537743
Injection site extravasation 26.96 10.76 35 73859 8984 90545569
Sleep disorder 26.76 10.76 78 73816 197952 90356601
Vascular purpura 26.66 10.76 17 73877 1721 90552832
Incision site haemorrhage 26.55 10.76 12 73882 606 90553947
Wheezing 26.54 10.76 102 73792 237978 90316575
Prescribed underdose 26.54 10.76 14 73880 75005 90479548
Skin sensitisation 26.43 10.76 14 73880 1001 90553552
Haematuria 26.11 10.76 75 73819 34862 90519691
Body temperature decreased 26.00 10.76 59 73835 23757 90530796
Wrong patient received product 25.92 10.76 22 73872 3455 90551098
Intestinal angioedema 25.83 10.76 13 73881 835 90553718
Drug ineffective for unapproved indication 25.78 10.76 11 73883 66633 90487920
Eosinophilic cellulitis 25.76 10.76 9 73885 228 90554325
Oliguria 25.39 10.76 37 73857 10587 90543966
Death 25.30 10.76 244 73650 456307 90098246
Contraindicated product prescribed 25.21 10.76 16 73878 1606 90552947
Eosinophilia 25.06 10.76 65 73829 28468 90526085
Mixed liver injury 25.04 10.76 31 73863 7592 90546961
Back injury 25.02 10.76 4 73890 46618 90507935
Diabetic metabolic decompensation 24.82 10.76 17 73877 1940 90552613
Onychomadesis 24.56 10.76 4 73890 45994 90508559
Lupus-like syndrome 24.46 10.76 5 73889 48841 90505712
Blood potassium increased 24.45 10.76 53 73841 20696 90533857
Osteoarthritis 24.39 10.76 80 73814 195650 90358903
General physical health deterioration 24.06 10.76 180 73714 354935 90199618
Haematoma 23.74 10.76 78 73816 38970 90515583
Sleep disorder due to a general medical condition 23.64 10.76 4 73890 44734 90509819
Exostosis 23.57 10.76 7 73887 53127 90501426
Arthritis 23.56 10.76 224 73670 167091 90387462
Electrocardiogram QT prolonged 23.44 10.76 119 73775 72337 90482216
C-reactive protein increased 23.39 10.76 73 73821 181316 90373237
Subacute cutaneous lupus erythematosus 23.35 10.76 21 73873 3561 90550992
Meningorrhagia 23.31 10.76 8 73886 192 90554361
Electrolyte imbalance 22.85 10.76 56 73838 23689 90530864
Contusion 22.36 10.76 117 73777 251099 90303454
Blood sodium decreased 22.32 10.76 61 73833 27552 90527001
X-ray abnormal 22.03 10.76 5 73889 45419 90509134
Amnesia 21.98 10.76 34 73860 108471 90446082
Parotid gland enlargement 21.74 10.76 12 73882 931 90553622
Shock 21.72 10.76 62 73832 28716 90525837
Acidosis 21.69 10.76 38 73856 12698 90541855
Peripheral swelling 21.54 10.76 224 73670 412882 90141671
Cardiac failure congestive 20.88 10.76 145 73749 98549 90456004
Circulating anticoagulant positive 20.86 10.76 5 73889 30 90554523
Hyperlactacidaemia 20.78 10.76 21 73873 4115 90550438
Immunisation reaction 20.73 10.76 11 73883 789 90553764
Anal polyp 20.70 10.76 6 73888 81 90554472
Dermatitis bullous 20.53 10.76 33 73861 10283 90544270
Fibrous histiocytoma 20.35 10.76 10 73884 610 90553943
Hypergammaglobulinaemia 20.34 10.76 10 73884 611 90553942
Haemodialysis 20.23 10.76 30 73864 8717 90545836
Sedation 20.21 10.76 7 73887 48164 90506389
Incorrect route of product administration 20.16 10.76 8 73886 50618 90503935
Impaired work ability 20.13 10.76 47 73847 19279 90535274
Liver disorder 20.09 10.76 43 73851 121226 90433327
Product substitution issue 20.09 10.76 45 73849 17963 90536590
Hospitalisation 19.94 10.76 47 73847 128053 90426500
Encephalocele 19.15 10.76 7 73887 203 90554350
Metabolic acidosis 19.11 10.76 93 73801 55583 90498970
Hypomagnesaemia 18.94 10.76 68 73826 35520 90519033
Histoplasmosis 18.63 10.76 15 73879 2189 90552364
Pregnancy 18.61 10.76 14 73880 62033 90492520
Potentiating drug interaction 18.55 10.76 23 73871 5639 90548914
Prothrombin time ratio decreased 18.49 10.76 11 73883 984 90553569
Ultrasound kidney abnormal 18.44 10.76 5 73889 52 90554501
Arthralgia 18.33 10.76 489 73405 778033 89776520
Febrile neutropenia 18.19 10.76 67 73827 158282 90396271
Disease progression 18.16 10.76 66 73828 156549 90398004
Hepatic cirrhosis 18.06 10.76 15 73879 63238 90491315
Jaundice 18.05 10.76 63 73831 32454 90522099
Overdose 17.86 10.76 202 73692 157507 90397046
Urticaria 17.79 10.76 166 73728 312568 90241985
Restrictive pulmonary disease 17.72 10.76 15 73879 2347 90552206
Laboratory test abnormal 17.70 10.76 6 73888 41848 90512705
Left atrial volume increased 17.64 10.76 5 73889 62 90554491
Gastrointestinal haemorrhage 17.59 10.76 130 73764 90118 90464435
Glomerular filtration rate decreased 17.44 10.76 41 73853 16891 90537662
Epilepsy 17.38 10.76 25 73869 82181 90472372
Hemianopia homonymous 17.22 10.76 10 73884 855 90553698
Cerebral fungal infection 17.21 10.76 7 73887 272 90554281
Pancreatitis acute 16.78 10.76 61 73833 32054 90522499
Cockroach allergy 16.76 10.76 5 73889 75 90554478
Insomnia 16.50 10.76 183 73711 333291 90221262
Dry mouth 16.22 10.76 86 73808 183973 90370580
Blood immunoglobulin E increased 16.17 10.76 19 73875 4406 90550147
Weight abnormal 16.16 10.76 13 73881 1894 90552659
Ear pain 16.09 10.76 14 73880 57688 90496865
Dysgeusia 16.08 10.76 85 73809 52475 90502078
Malignant neoplasm progression 16.01 10.76 40 73854 106830 90447723
Milk-alkali syndrome 16.01 10.76 11 73883 1262 90553291
Brucellosis 15.97 10.76 5 73889 89 90554464
Myocardial ischaemia 15.95 10.76 35 73859 13779 90540774
Drug-induced liver injury 15.83 10.76 31 73863 90287 90464266
Enterococcal sepsis 15.83 10.76 12 73882 1604 90552949
Aortic valve incompetence 15.73 10.76 23 73871 6601 90547952
Weaning failure 15.72 10.76 8 73886 526 90554027
Respiratory tract infection 15.68 10.76 15 73879 59063 90495490
Hepatotoxicity 15.57 10.76 9 73885 45833 90508720
Reversible cerebral vasoconstriction syndrome 15.54 10.76 18 73876 4112 90550441
Drug resistance 15.49 10.76 3 73891 30446 90524107
Bundle branch block left 15.38 10.76 25 73869 7860 90546693
Oral allergy syndrome 15.24 10.76 5 73889 104 90554449
Thyroglossal cyst 15.05 10.76 3 73891 6 90554547
Bone swelling 14.98 10.76 12 73882 1739 90552814
Necrotising myositis 14.96 10.76 9 73885 822 90553731
Sinus arrest 14.82 10.76 13 73881 2133 90552420
Oedema 14.79 10.76 99 73795 200196 90354357
Onychomycosis 14.73 10.76 6 73888 37370 90517183
Loss of consciousness 14.71 10.76 177 73717 140061 90414492
Respiratory gas exchange disorder 14.64 10.76 7 73887 402 90554151
Electrocardiogram PR prolongation 14.58 10.76 9 73885 861 90553692
Blood pressure abnormal 14.51 10.76 42 73852 19603 90534950
Physical assault 14.42 10.76 9 73885 877 90553676
Blood glucose decreased 14.42 10.76 47 73847 23382 90531171
Dysuria 14.38 10.76 67 73827 39334 90515219
Acute coronary syndrome 14.35 10.76 29 73865 10784 90543769
Therapy non-responder 14.32 10.76 60 73834 136644 90417909
Mitral valve calcification 14.24 10.76 10 73884 1188 90553365
Subacute kidney injury 14.19 10.76 3 73891 9 90554544
Altered state of consciousness 14.10 10.76 57 73837 31475 90523078
Road traffic accident 14.09 10.76 43 73851 107583 90446970
Abortion spontaneous 14.03 10.76 14 73880 54042 90500511
Localised oedema 13.98 10.76 21 73873 6173 90548380
Oropharyngeal swelling 13.95 10.76 9 73885 929 90553624
Blood pressure orthostatic decreased 13.84 10.76 6 73888 274 90554279
Persecutory delusion 13.82 10.76 15 73879 3193 90551360
Paraesthesia 13.75 10.76 134 73760 250192 90304361
Grip strength decreased 13.59 10.76 35 73859 92541 90462012
Weight increased 13.39 10.76 250 73644 417677 90136876
Cold urticaria 13.33 10.76 6 73888 300 90554253
Visual impairment 13.31 10.76 59 73835 132306 90422247
Talipes 13.29 10.76 11 73883 1669 90552884
Disorientation 13.26 10.76 71 73823 44043 90510510
Vascular access site pain 13.23 10.76 7 73887 499 90554054
Lung disorder 13.22 10.76 70 73824 149813 90404740
Myalgia 13.06 10.76 208 73686 174917 90379636
Renal pain 13.02 10.76 23 73871 7736 90546817
Blood pressure decreased 12.99 10.76 105 73789 74790 90479763
Brain stem haematoma 12.98 10.76 3 73891 15 90554538
Vaccination complication 12.96 10.76 9 73885 1050 90553503
Device issue 12.91 10.76 4 73890 29533 90525020
Livedo reticularis 12.89 10.76 15 73879 3444 90551109
Acetonaemia 12.86 10.76 6 73888 326 90554227
Cerebral haemorrhage 12.82 10.76 59 73835 34463 90520090
Fundoscopy abnormal 12.81 10.76 3 73891 16 90554537
Injection site pruritus 12.79 10.76 15 73879 53819 90500734
Photopsia 12.74 10.76 18 73876 5006 90549547
Hypochromic anaemia 12.74 10.76 12 73882 2159 90552394
Nasal dryness 12.70 10.76 19 73875 5564 90548989
Subdural haematoma 12.70 10.76 36 73858 16609 90537944
Immunodeficiency 12.66 10.76 10 73884 43224 90511329
Sense of oppression 12.65 10.76 9 73885 1091 90553462
Amyloidoma 12.52 10.76 3 73891 18 90554535
Breast tumour excision 12.52 10.76 3 73891 18 90554535
Nail disorder 12.45 10.76 18 73876 59049 90495504
Injection site erythema 12.44 10.76 40 73854 98462 90456091
Oxygen saturation increased 12.43 10.76 6 73888 352 90554201
Cardiac ventricular thrombosis 12.41 10.76 9 73885 1125 90553428
Agranulocytosis 12.40 10.76 59 73835 34943 90519610
Tendon injury 12.36 10.76 12 73882 2241 90552312
Lower respiratory tract infection 12.21 10.76 138 73756 250521 90304032
Extrapyramidal disorder 12.18 10.76 35 73859 16268 90538285
Optic nerve infarction 12.12 10.76 3 73891 21 90554532
Dizziness 11.92 10.76 591 73303 588693 89965860
Acute pulmonary oedema 11.90 10.76 25 73869 9555 90544998
Injection site swelling 11.88 10.76 19 73875 59820 90494733
Bronchopulmonary aspergillosis allergic 11.86 10.76 15 73879 3751 90550802
Kidney small 11.86 10.76 5 73889 213 90554340
Aphthous ulcer 11.86 10.76 36 73858 17251 90537302
Finger deformity 11.84 10.76 6 73888 32891 90521662
Movement disorder 11.83 10.76 51 73843 28968 90525585
Tympanic membrane perforation 11.73 10.76 12 73882 2385 90552168
Fungal infection 11.71 10.76 67 73827 42594 90511959
Oedema peripheral 11.67 10.76 284 73610 257631 90296922
Cutaneous vasculitis 11.65 10.76 21 73873 7172 90547381
Myelosuppression 11.63 10.76 16 73878 53575 90500978
Respiratory rate increased 11.62 10.76 34 73860 15967 90538586
Anaemia 11.62 10.76 373 73521 352429 90202124
Abdominal pain upper 11.60 10.76 196 73698 332478 90222075
Bronchial hyperreactivity 11.59 10.76 11 73883 1997 90552556
Increased appetite 11.59 10.76 28 73866 11737 90542816
Tachypnoea 11.58 10.76 41 73853 21268 90533285
Lipase increased 11.55 10.76 27 73867 11084 90543469
White blood cell analysis abnormal 11.45 10.76 3 73891 27 90554526
Intraventricular haemorrhage 11.44 10.76 12 73882 2457 90552096
Hepatorenal syndrome 11.41 10.76 11 73883 2037 90552516
Inflammatory marker increased 11.39 10.76 24 73870 9190 90545363
Ventricular asystole 11.25 10.76 4 73890 107 90554446
Hip fracture 11.17 10.76 55 73839 33022 90521531
Renal vasculitis 11.16 10.76 6 73888 442 90554111
Product dose omission issue 11.12 10.76 169 73725 291518 90263035
Foetal growth restriction 11.10 10.76 24 73870 9356 90545197
Ureteric obstruction 11.10 10.76 11 73883 2107 90552446
Rash maculo-papular 11.05 10.76 64 73830 40869 90513684
Arthropod bite 11.03 10.76 23 73871 8744 90545809
Multiple sclerosis relapse 10.97 10.76 16 73878 52289 90502264
Mitral valve stenosis 10.96 10.76 9 73885 1350 90553203
Device dislocation 10.95 10.76 6 73888 31476 90523077
Somnolence 10.94 10.76 235 73659 208849 90345704
Rheumatoid lung 10.85 10.76 15 73879 4088 90550465
Hypochloraemia 10.84 10.76 12 73882 2610 90551943
Diabetic ketoacidosis 10.82 10.76 44 73850 24363 90530190

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
Acute kidney injury 429.16 10.92 1099 44534 366238 42209464
Hyperkalaemia 189.33 10.92 322 45311 80136 42495566
Lactic acidosis 140.85 10.92 206 45427 45055 42530647
Hyponatraemia 113.78 10.92 300 45333 101162 42474540
Death 84.73 10.92 243 45390 470942 42104760
Off label use 68.98 10.92 402 45231 637933 41937769
Drug ineffective 68.03 10.92 397 45236 629800 41945902
Hypotension 67.90 10.92 490 45143 257141 42318561
Seronegative arthritis 65.24 10.92 30 45603 1194 42574508
Anorectal discomfort 63.70 10.92 36 45597 2219 42573483
Oesophageal pain 60.56 10.92 27 45606 999 42574703
Syncope 60.16 10.92 238 45395 99168 42476534
Lipoma 54.70 10.92 32 45601 2106 42573596
Drug interaction 54.01 10.92 478 45155 266521 42309181
Radiation inflammation 53.72 10.92 25 45608 1023 42574679
Hypoglycaemia 52.43 10.92 162 45471 59692 42516010
Disease progression 52.41 10.92 46 45587 143610 42432092
Febrile neutropenia 49.90 10.92 76 45557 185627 42390075
Failure to suspend medication 49.64 10.92 18 45615 384 42575318
Bradycardia 47.21 10.92 199 45434 85285 42490417
Fractured coccyx 46.50 10.92 14 45619 162 42575540
Fall 44.91 10.92 415 45218 234105 42341597
Pulmonary pain 44.06 10.92 25 45608 1553 42574149
Rhabdomyolysis 43.38 10.92 182 45451 77837 42497865
Completed suicide 42.88 10.92 25 45608 96440 42479262
Atrial fibrillation 42.32 10.92 275 45358 139318 42436384
Treatment failure 42.08 10.92 8 45625 62616 42513086
Pneumonia 41.70 10.92 273 45360 421876 42153826
Ischaemic stroke 40.81 10.92 80 45553 22153 42553549
Presyncope 39.23 10.92 79 45554 22308 42553394
N-terminal prohormone brain natriuretic peptide abnormal 38.22 10.92 13 45620 228 42575474
Product use in unapproved indication 37.68 10.92 89 45544 184367 42391335
Cholestasis 37.58 10.92 98 45535 32781 42542921
Blood pressure systolic increased 36.85 10.92 88 45545 27880 42547822
Myocardial infarction 36.78 10.92 243 45390 123766 42451936
Loss of control of legs 36.66 10.92 18 45615 831 42574871
Foetal exposure during pregnancy 36.52 10.92 4 45629 47307 42528395
Mycobacterium test positive 36.24 10.92 15 45618 461 42575241
Lung diffusion test decreased 36.06 10.92 18 45615 861 42574841
Blood pressure increased 35.40 10.92 208 45425 101720 42473982
Tachyarrhythmia 35.11 10.92 31 45602 3901 42571801
SARS-CoV-2 sepsis 33.67 10.92 12 45621 243 42575459
Eosinophilia 32.55 10.92 93 45540 32806 42542896
Left atrial dilatation 32.18 10.92 24 45609 2378 42573324
Brain natriuretic peptide abnormal 32.12 10.92 13 45620 377 42575325
Blood creatinine increased 31.68 10.92 214 45419 109789 42465913
Blood thyroid stimulating hormone abnormal 31.61 10.92 13 45620 393 42575309
Oxygen saturation increased 31.54 10.92 12 45621 294 42575408
Wrong patient received product 31.50 10.92 28 45605 3555 42572147
Pulmonary arterial pressure abnormal 30.31 10.92 12 45621 328 42575374
Nail bed bleeding 30.10 10.92 13 45620 445 42575257
Mucosal dryness 30.00 10.92 20 45613 1658 42574044
Electrocardiogram QRS complex abnormal 29.91 10.92 13 45620 452 42575250
Congenital diaphragmatic anomaly 29.65 10.92 7 45626 28 42575674
Renal failure 29.33 10.92 258 45375 143468 42432234
Tongue abscess 29.20 10.92 5 45628 0 42575702
Arrhythmia 28.92 10.92 102 45531 40215 42535487
Agranulocytosis 28.81 10.92 85 45548 30527 42545175
Hypovolaemia 28.33 10.92 47 45586 11438 42564264
Inflammation 28.14 10.92 90 45543 33757 42541945
Cerebrovascular accident 27.96 10.92 189 45444 96971 42478731
Muscular dystrophy 27.76 10.92 9 45624 135 42575567
Pancreatitis acute 27.68 10.92 89 45544 33475 42542227
Neutrophil count decreased 27.38 10.92 17 45616 63398 42512304
Nephrectomy 27.03 10.92 15 45618 892 42574810
Therapeutic product effect incomplete 26.72 10.92 22 45611 70917 42504785
Musculoskeletal discomfort 26.41 10.92 41 45592 9435 42566267
Gastrointestinal motility disorder 26.02 10.92 23 45610 2898 42572804
Drug abuse 25.22 10.92 46 45587 104725 42470977
Supraventricular extrasystoles 25.15 10.92 26 45607 3980 42571722
Granuloma 24.96 10.92 26 45607 4015 42571687
Malignant neoplasm progression 24.86 10.92 49 45584 108351 42467351
Haematocrit increased 24.46 10.92 21 45612 2546 42573156
Carotid arteriosclerosis 24.12 10.92 20 45613 2312 42573390
Goitre 23.88 10.92 18 45615 1812 42573890
Shock 23.82 10.92 77 45556 29044 42546658
Rash maculo-papular 23.63 10.92 91 45542 37412 42538290
Lymphoma 23.27 10.92 49 45584 14272 42561430
Gastrointestinal pain 23.06 10.92 26 45607 4389 42571313
Leukopenia 22.65 10.92 28 45605 74718 42500984
Sedation 22.48 10.92 3 45630 30472 42545230
Hypomagnesaemia 22.11 10.92 74 45559 28414 42547288
Preternatural anus 22.03 10.92 7 45626 98 42575604
Subarachnoid haematoma 22.01 10.92 9 45624 268 42575434
Haemorrhagic stroke 22.01 10.92 33 45600 7369 42568333
Antiphospholipid antibodies positive 21.84 10.92 10 45623 394 42575308
Anuria 21.78 10.92 42 45591 11490 42564212
Left ventricular dilatation 21.71 10.92 13 45620 893 42574809
Dizziness 21.67 10.92 381 45252 248873 42326829
Genital pain 21.66 10.92 13 45620 897 42574805
Sepsis 21.64 10.92 125 45508 199209 42376493
Hypoparathyroidism 21.64 10.92 12 45621 713 42574989
Ear discomfort 21.23 10.92 22 45611 3377 42572325
Orthostatic hypotension 20.78 10.92 76 45557 30494 42545208
Vestibular neuronitis 20.73 10.92 9 45624 312 42575390
Neutropenia 20.62 10.92 127 45506 199304 42376398
Procedural failure 20.29 10.92 6 45627 65 42575637
Myelosuppression 20.19 10.92 9 45624 40452 42535250
Sprue-like enteropathy 20.11 10.92 11 45622 636 42575066
Drug resistance 19.82 10.92 6 45627 34242 42541460
Diabetes mellitus inadequate control 19.81 10.92 48 45585 15342 42560360
Hospitalisation 19.38 10.92 31 45602 74299 42501403
Genital ulceration 19.34 10.92 12 45621 879 42574823
Haemochromatosis 19.27 10.92 13 45620 1099 42574603
Hypoxia 19.26 10.92 28 45605 69758 42505944
Toxicity to various agents 19.25 10.92 155 45478 228981 42346721
Renal haemorrhage 19.11 10.92 15 45618 1604 42574098
Extrasystoles 19 10.92 23 45610 4186 42571516
Toxic skin eruption 18.95 10.92 44 45589 13686 42562016
Conduction disorder 18.87 10.92 18 45615 2500 42573202
Lividity 18.77 10.92 7 45626 162 42575540
Pyrexia 18.75 10.92 303 45330 393739 42181963
Victim of chemical submission 18.73 10.92 7 45626 163 42575539
Blood pressure inadequately controlled 18.70 10.92 19 45614 2849 42572853
Inflammatory marker increased 18.51 10.92 29 45604 6727 42568975
Renal cyst 18.27 10.92 36 45597 10003 42565699
Respiratory failure 18.18 10.92 73 45560 128059 42447643
Renal impairment 18.08 10.92 189 45444 110039 42465663
Morganella infection 17.80 10.92 10 45623 609 42575093
Enterocutaneous fistula 17.79 10.92 13 45620 1248 42574454
Coronary artery disease 17.59 10.92 108 45525 53612 42522090
Foetal renal impairment 17.52 10.92 3 45630 0 42575702
Muscle strain 17.47 10.92 23 45610 4554 42571148
Metabolic acidosis 17.45 10.92 105 45528 51753 42523949
Atrial thrombosis 17.43 10.92 17 45616 2427 42573275
Chronic kidney disease 17.42 10.92 98 45535 47143 42528559
Mental status changes 17.22 10.92 12 45621 42103 42533599
Platelet count decreased 17.21 10.92 83 45550 138498 42437204
Pseudoporphyria 17.04 10.92 9 45624 485 42575217
Blood lactic acid 16.95 10.92 8 45625 338 42575364
Angiocardiogram 16.68 10.92 7 45626 223 42575479
Cerebral haematoma 16.66 10.92 25 45608 5585 42570117
Bundle branch block left 16.64 10.92 27 45606 6449 42569253
Bronchial haemorrhage 16.61 10.92 10 45623 694 42575008
Peptic ulcer perforation 16.59 10.92 8 45625 355 42575347
Drug ineffective for unapproved indication 16.55 10.92 15 45618 46148 42529554
Herpes simplex reactivation 16.49 10.92 9 45624 518 42575184
Arthropathy 16.40 10.92 69 45564 29528 42546174
Asbestosis 16.39 10.92 7 45626 233 42575469
Periorbital haematoma 16.22 10.92 8 45625 373 42575329
Dysgeusia 16.14 10.92 76 45557 34113 42541589
Enterochromaffin cell hyperplasia 16.06 10.92 4 45629 21 42575681
Intentional product use issue 16.01 10.92 33 45600 71800 42503902
Hepatic cytolysis 15.99 10.92 64 45569 26780 42548922
Accidental death 15.84 10.92 18 45615 3065 42572637
Oesophageal adenocarcinoma 15.80 10.92 11 45622 979 42574723
Hypokalaemia 15.79 10.92 131 45502 71590 42504112
Acute pulmonary oedema 15.72 10.92 31 45602 8620 42567082
Myopathy 15.70 10.92 41 45592 13720 42561982
Lung disorder 15.47 10.92 96 45537 47827 42527875
B-cell type acute leukaemia 15.34 10.92 10 45623 798 42574904
Drug dependence 15.27 10.92 6 45627 29088 42546614
Dermatitis exfoliative 15.25 10.92 27 45606 6920 42568782
Thrombocytosis 15.22 10.92 22 45611 4753 42570949
Haemoglobin increased 15.18 10.92 23 45610 5183 42570519
Product dose omission issue 15.08 10.92 100 45533 154265 42421437
Histamine level increased 15.07 10.92 5 45628 81 42575621
Eczema 14.82 10.92 74 45559 34012 42541690
Acute coronary syndrome 14.68 10.92 42 45591 14823 42560879
Emphysematous pyelonephritis 14.54 10.92 6 45627 183 42575519
Product substitution issue 14.30 10.92 35 45598 11255 42564447
Tenoplasty 14.23 10.92 3 45630 6 42575696
Clang associations 14.09 10.92 4 45629 37 42575665
Malaise 13.94 10.92 311 45322 211845 42363857
Blood creatine phosphokinase increased 13.87 10.92 94 45539 48244 42527458
Gingival hypertrophy 13.84 10.92 15 45618 2424 42573278
Rhinorrhoea 13.81 10.92 69 45564 31725 42543977
Spinal epidural haemorrhage 13.64 10.92 4 45629 42 42575660
Distributive shock 13.55 10.92 15 45618 2481 42573221
Dyspnoea exertional 13.50 10.92 96 45537 50052 42525650
Mycobacterium tuberculosis complex test positive 13.50 10.92 12 45621 1524 42574178
Hyperlactacidaemia 13.23 10.92 20 45613 4496 42571206
Dysmetria 13.10 10.92 9 45624 784 42574918
Vomiting projectile 13.08 10.92 9 45624 786 42574916
Sneezing 13.04 10.92 24 45609 6339 42569363
Neurogenic bladder 13.00 10.92 14 45619 2246 42573456
Full blood count abnormal 12.91 10.92 8 45625 29868 42545834
Gait disturbance 12.89 10.92 161 45472 97839 42477863
Appetite disorder 12.84 10.92 16 45617 2999 42572703
Dyslipidaemia 12.80 10.92 30 45603 9388 42566314
Cardiac failure congestive 12.74 10.92 144 45489 85458 42490244
Multiple organ dysfunction syndrome 12.70 10.92 57 45576 96978 42478724
FEV1/FVC ratio decreased 12.55 10.92 5 45628 139 42575563
Injection site pain 12.50 10.92 27 45606 57771 42517931
Obstruction 12.48 10.92 16 45617 3087 42572615
Bronchiolitis 12.46 10.92 18 45615 3888 42571814
Medication error 12.37 10.92 69 45564 33085 42542617
Prostatic specific antigen increased 12.29 10.92 43 45590 16882 42558820
Grip strength decreased 12.13 10.92 17 45616 3571 42572131
White blood cell count decreased 12.08 10.92 69 45564 110327 42465375
Angina unstable 11.95 10.92 33 45600 11415 42564287
Foreign body in respiratory tract 11.86 10.92 5 45628 161 42575541
Meningitis cryptococcal 11.77 10.92 16 45617 3267 42572435
Condition aggravated 11.56 10.92 203 45430 260551 42315151
Proteinuria 11.52 10.92 52 45581 22931 42552771
Melaena 11.51 10.92 76 45557 38670 42537032
Wound decomposition 11.51 10.92 4 45629 75 42575627
Myalgia 11.44 10.92 155 45478 95925 42479777
Loss of consciousness 11.42 10.92 150 45483 92204 42483498
Intercepted medication error 11.37 10.92 7 45626 506 42575196
Product use issue 11.34 10.92 43 45590 76708 42498994
Urinary tract candidiasis 11.34 10.92 7 45626 508 42575194
Bacterial infection 11.32 10.92 8 45625 27871 42547831
Angina pectoris 11.32 10.92 67 45566 32829 42542873
Alkalosis hypochloraemic 11.26 10.92 6 45627 329 42575373
Asthma 11.24 10.92 109 45524 62205 42513497
Antipsychotic drug level above therapeutic 11.22 10.92 10 45623 1274 42574428
Cardiac ablation 11.18 10.92 10 45623 1280 42574422
Bradyarrhythmia 11.08 10.92 14 45619 2661 42573041
Palatal oedema 11.04 10.92 9 45624 1015 42574687
Tumour lysis syndrome 11.00 10.92 5 45628 22226 42553476
Atrial flutter 10.98 10.92 42 45591 17209 42558493
Food poisoning 10.95 10.92 14 45619 2692 42573010
Pemphigoid 10.94 10.92 32 45601 11435 42564267

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
Acute kidney injury 1132.43 10.51 2121 104781 633309 109849088
Carotid artery thrombosis 559.06 10.51 243 106659 9395 110473002
Neurologic neglect syndrome 547.74 10.51 237 106665 9061 110473336
Personality disorder 522.47 10.51 253 106649 12584 110469813
Adjustment disorder 504.44 10.51 234 106668 10561 110471836
Hyperkalaemia 470.26 10.51 617 106285 135179 110347218
Hyponatraemia 467.18 10.51 790 106112 216863 110265534
Hemiplegia 459.40 10.51 282 106620 22500 110459897
Affect lability 444.35 10.51 257 106645 18380 110464017
Sensory loss 393.32 10.51 250 106652 21207 110461190
Coordination abnormal 368.18 10.51 255 106647 24973 110457424
Motor dysfunction 347.53 10.51 243 106659 24163 110458234
Lactic acidosis 335.70 10.51 431 106471 92380 110390017
Hemiparesis 321.66 10.51 296 106606 43607 110438790
Eating disorder 317.95 10.51 253 106649 30605 110451792
Muscle spasticity 312.65 10.51 267 106635 35648 110446749
Fall 300.47 10.51 1266 105636 602216 109880181
Aphasia 287.55 10.51 319 106583 58678 110423719
Blood pressure increased 280.45 10.51 708 106194 257665 110224732
Cerebrovascular accident 261.89 10.51 556 106346 180728 110301669
Arterial occlusive disease 247.80 10.51 165 106737 15143 110467254
Sneezing 229.16 10.51 213 106689 31771 110450626
Gangrene 226.36 10.51 160 106742 16181 110466216
Skin haemorrhage 223.11 10.51 188 106714 24639 110457758
Sinus congestion 222.40 10.51 205 106697 30254 110452143
Hypotension 196.98 10.51 1013 105889 522836 109959561
Systemic lupus erythematosus 191.99 10.51 14 106888 254324 110228073
Pemphigus 191.90 10.51 3 106899 214567 110267830
Respiratory tract congestion 189.90 10.51 189 106713 30668 110451729
Dysarthria 187.75 10.51 311 106591 83810 110398587
Hand deformity 187.70 10.51 5 106897 218501 110263896
Sinus disorder 185.97 10.51 192 106710 32536 110449861
Drug interaction 185.78 10.51 964 105938 499219 109983178
Angina pectoris 185.12 10.51 263 106639 62032 110420365
Drug ineffective 178.04 10.51 812 106090 1519728 108962669
Treatment failure 168.24 10.51 32 106870 277202 110205195
Maternal exposure during pregnancy 159.91 10.51 27 106875 254856 110227541
Synovitis 157.34 10.51 36 106866 274056 110208341
Rhinorrhoea 151.77 10.51 318 106584 102348 110380049
Blood pressure systolic increased 150.40 10.51 280 106622 82711 110399686
Ischaemic stroke 149.71 10.51 192 106710 41071 110441326
Bradycardia 149 10.51 407 106495 155110 110327287
Folliculitis 147.21 10.51 3 106899 167650 110314747
Glossodynia 144.97 10.51 21 106881 221983 110260414
Duodenal ulcer perforation 139.37 10.51 8 106894 177692 110304705
Off label use 137.24 10.51 870 106032 1499315 108983082
Cystitis 136.55 10.51 236 106666 65800 110416597
Pulmonary pain 132.23 10.51 80 106822 6213 110476184
Hypoglycaemia 130.88 10.51 323 106579 115781 110366616
Therapeutic product effect decreased 128.93 10.51 38 106864 244278 110238119
Renal failure 119.92 10.51 485 106417 226089 110256308
Cataract 117.23 10.51 246 106656 79239 110403158
Dysphagia 114.72 10.51 368 106534 153232 110329165
Rheumatoid factor positive 113.08 10.51 3 106899 131637 110350760
Helicobacter infection 112.45 10.51 20 106882 181857 110300540
Alopecia 112.42 10.51 112 106790 364641 110117756
Pericarditis 110.40 10.51 37 106865 219077 110263320
Product use in unapproved indication 107.85 10.51 166 106736 447211 110035186
Chest discomfort 107.46 10.51 391 106511 173457 110308940
Rhabdomyolysis 103.47 10.51 303 106599 120098 110362299
Swelling 103.43 10.51 112 106790 350929 110131468
Psoriatic arthropathy 103.08 10.51 31 106871 196730 110285667
Fibromyalgia 100.99 10.51 21 106881 170888 110311509
Drug hypersensitivity 99.70 10.51 179 106723 453911 110028486
Amyloid arthropathy 99.51 10.51 43 106859 1637 110480760
Palpitations 97.48 10.51 357 106545 158855 110323542
Atrial fibrillation 93.07 10.51 454 106448 229188 110253209
Influenza 91.86 10.51 365 106537 168736 110313661
Hepatic enzyme increased 91.65 10.51 105 106797 320787 110161610
Drug intolerance 91.26 10.51 158 106744 406354 110076043
Skin exfoliation 90.59 10.51 236 106666 87415 110394982
Sleep disorder due to general medical condition, insomnia type 88.58 10.51 3 106899 105640 110376757
Therapeutic product effect incomplete 86.14 10.51 55 106847 223750 110258647
Completed suicide 86.09 10.51 65 106837 242316 110240081
Muscular weakness 85.96 10.51 470 106432 247998 110234399
Syncope 81.76 10.51 400 106502 202136 110280261
Bursitis 80.93 10.51 14 106888 129904 110352493
Lip dry 80.04 10.51 4 106898 100079 110382318
Gastrointestinal procedural complication 79.95 10.51 26 106876 439 110481958
Exposure during pregnancy 79.69 10.51 31 106871 167393 110315004
Influenza like illness 79.33 10.51 226 106676 88186 110394211
Infection 79.28 10.51 143 106759 362057 110120340
Wound 78.10 10.51 67 106835 234370 110248027
Cholestasis 77.51 10.51 184 106718 64334 110418063
Irritable bowel syndrome 77.18 10.51 31 106871 164184 110318213
Psoriasis 76.69 10.51 303 106599 139690 110342707
Pemphigoid 75.12 10.51 94 106808 19613 110462784
Ill-defined disorder 74.73 10.51 29 106873 156824 110325573
Renal impairment 73.80 10.51 369 106533 188076 110294321
Death 73.35 10.51 387 106515 698482 109783915
Contraindicated product administered 72.22 10.51 80 106822 248187 110234210
Stomatitis 69.26 10.51 96 106806 270146 110212251
Type 2 diabetes mellitus 68.96 10.51 43 106859 177189 110305208
Impaired healing 65.78 10.51 56 106846 196661 110285736
Hepatic cytolysis 65.04 10.51 156 106746 54897 110427500
Liver injury 63.52 10.51 33 106869 150380 110332017
Febrile neutropenia 63.28 10.51 132 106770 316635 110165762
Hypersensitivity 61.68 10.51 193 106709 403805 110078592
Product use issue 61.33 10.51 131 106771 311564 110170833
Abdominal discomfort 60.24 10.51 188 106714 393670 110088727
Anuria 59.75 10.51 94 106808 24247 110458150
Asthenia 59.27 10.51 965 105937 688034 109794363
Body mass index abnormal 59.09 10.51 25 106877 903 110481494
Infusion related reaction 58.96 10.51 181 106721 380981 110101416
Inappropriate antidiuretic hormone secretion 57.33 10.51 111 106791 33740 110448657
Peripheral venous disease 57.17 10.51 7 106895 84110 110398287
Anorectal discomfort 56.21 10.51 40 106862 4086 110478311
Radiation inflammation 56.16 10.51 25 106877 1023 110481374
Blood pressure systolic abnormal 55.58 10.51 92 106810 24758 110457639
Blister 55.08 10.51 84 106818 227292 110255105
Intentional product use issue 55.01 10.51 97 106805 247809 110234588
Eosinophilia 54.82 10.51 151 106751 57785 110424612
Wrong patient received product 54.79 10.51 48 106854 6626 110475771
Lower limb fracture 54.46 10.51 5 106897 75343 110407054
Mobility decreased 53.49 10.51 92 106810 237330 110245067
Disease progression 52.79 10.51 97 106805 243937 110238460
C-reactive protein abnormal 52.51 10.51 30 106872 129665 110352732
Cough 52.51 10.51 679 106223 460962 110021435
Discomfort 51.36 10.51 80 106822 214627 110267770
Injection site reaction 50.48 10.51 12 106890 89058 110393339
Blood pressure diastolic abnormal 50.42 10.51 90 106812 25725 110456672
Sinus bradycardia 50.33 10.51 97 106805 29386 110453011
Central nervous system lupus 50.07 10.51 25 106877 1328 110481069
Dehydration 49.90 10.51 450 106452 279061 110203336
Injury 49.51 10.51 59 106843 177206 110305191
Serositis 49.40 10.51 26 106876 1543 110480854
Migraine 49.16 10.51 56 106846 171596 110310801
Wound infection 49.07 10.51 16 106886 96449 110385948
Heart rate decreased 48.48 10.51 183 106719 82573 110399824
Anxiety 47.77 10.51 527 106375 344551 110137846
Hypokalaemia 47.71 10.51 321 106581 182127 110300270
Blood creatinine increased 47.36 10.51 321 106581 182568 110299829
Myocardial infarction 47.29 10.51 333 106569 191750 110290647
Hepatocellular injury 46.93 10.51 131 106771 50511 110431886
Joint swelling 46.51 10.51 245 106657 442600 110039797
Night sweats 46.20 10.51 37 106865 133946 110348451
Vulvovaginal burning sensation 45.28 10.51 27 106875 2042 110480355
Failure to suspend medication 44.48 10.51 17 106885 469 110481928
Gait inability 44.16 10.51 40 106862 136336 110346061
Lipoma 44.13 10.51 34 106868 3921 110478476
Fear of eating 43.11 10.51 17 106885 511 110481886
Shock 42.37 10.51 131 106771 53457 110428940
Confusional state 42.33 10.51 662 106240 468018 110014379
Blepharospasm 41.42 10.51 3 106899 54848 110427549
Condition aggravated 40.89 10.51 484 106418 734352 109748045
Agranulocytosis 40.77 10.51 142 106760 61618 110420779
Angioedema 40.77 10.51 196 106706 98304 110384093
Blood cholesterol increased 40.35 10.51 73 106829 184712 110297685
Blood pressure inadequately controlled 40.18 10.51 43 106859 7590 110474807
Vulvovaginal pruritus 40.18 10.51 30 106872 3301 110479096
Oxygen saturation increased 40.13 10.51 18 106884 750 110481647
Malaise 39.54 10.51 888 106014 670931 109811466
Depression 39.53 10.51 165 106737 317170 110165227
Myelosuppression 39.38 10.51 21 106881 94319 110388078
Drug ineffective for unapproved indication 38.57 10.51 26 106876 102812 110379585
Pancreatitis acute 38.43 10.51 137 106765 60137 110422260
Sedation 38.30 10.51 10 106892 69673 110412724
Hypercholesterolaemia 38.24 10.51 20 106882 90817 110391580
Coronary artery disease 37.51 10.51 153 106749 71537 110410860
Tubulointerstitial nephritis 36.87 10.51 126 106776 54158 110428239
Joint range of motion decreased 36.82 10.51 38 106864 121794 110360603
Autoimmune disorder 36.76 10.51 9 106893 65474 110416923
Hypomagnesaemia 36.61 10.51 135 106767 60235 110422162
Hypertensive crisis 36.58 10.51 76 106826 24296 110458101
Adverse drug reaction 36.58 10.51 29 106873 105530 110376867
Liver function test increased 36.54 10.51 20 106882 88528 110393869
Pain 36.16 10.51 678 106224 954277 109528120
N-terminal prohormone brain natriuretic peptide abnormal 35.79 10.51 13 106889 310 110482087
Muscular dystrophy 35.20 10.51 12 106890 236 110482161
Metabolic acidosis 34.67 10.51 189 106713 99555 110382842
Lung diffusion test decreased 34.55 10.51 21 106881 1644 110480753
Memory impairment 34.52 10.51 88 106814 196856 110285541
SARS-CoV-2 sepsis 34.42 10.51 12 106890 253 110482144
Hospitalisation 34.16 10.51 53 106849 142440 110339957
Sciatica 33.80 10.51 24 106878 92375 110390022
Rhinalgia 33.75 10.51 29 106873 3900 110478497
Mycobacterium test positive 33.42 10.51 15 106887 626 110481771
Shock haemorrhagic 33.03 10.51 78 106824 27169 110455228
Prescribed overdose 33.03 10.51 22 106880 87559 110394838
Arteriovenous fistula occlusion 32.35 10.51 14 106888 535 110481862
Malignant neoplasm progression 32.16 10.51 76 106826 174491 110307906
Atrioventricular block complete 31.77 10.51 64 106838 20018 110462379
Inflammatory marker increased 31.60 10.51 53 106849 14416 110467981
Drug resistance 31.16 10.51 8 106894 56366 110426031
Cardiac failure congestive 31.08 10.51 251 106651 150749 110331648
Torsade de pointes 31.07 10.51 68 106834 22532 110459865
Oesophageal pain 30.80 10.51 31 106871 5094 110477303
Haematoma muscle 30.77 10.51 28 106874 4062 110478335
Electrocardiogram QRS complex abnormal 30.58 10.51 15 106887 767 110481630
Onychomadesis 30.54 10.51 4 106898 45659 110436738
Incorrect route of product administration 30.25 10.51 12 106890 64049 110418348
Presyncope 30.21 10.51 110 106792 48777 110433620
Osteoarthritis 30.19 10.51 84 106818 182539 110299858
Paranasal sinus discomfort 30.10 10.51 34 106868 6371 110476026
Left atrial dilatation 30.02 10.51 26 106876 3534 110478863
Neutrophil count decreased 29.94 10.51 44 106858 120897 110361500
Arrhythmia 29.92 10.51 140 106762 69435 110412962
Body temperature decreased 29.86 10.51 91 106811 36844 110445553
Toxicity to various agents 29.67 10.51 309 106593 480246 110002151
Muscle tension dysphonia 29.57 10.51 11 106891 281 110482116
Blue toe syndrome 29.32 10.51 14 106888 674 110481723
Hyperlactacidaemia 29.18 10.51 38 106864 8248 110474149
Lupus-like syndrome 28.71 10.51 3 106899 40789 110441608
Upper respiratory tract infection 28.56 10.51 52 106850 131276 110351121
Arthropathy 28.55 10.51 162 106740 287360 110195037
Botryomycosis 28.53 10.51 8 106894 79 110482318
Rash maculo-papular 28.09 10.51 144 106758 74078 110408319
Acute pulmonary oedema 27.89 10.51 55 106847 16941 110465456
Lupus nephritis 27.74 10.51 28 106874 4617 110477780
Orthostatic hypotension 27.54 10.51 132 106770 66117 110416280
Loss of control of legs 27.51 10.51 20 106882 2112 110480285
Blood pressure fluctuation 27.51 10.51 144 106758 74680 110407717
Tongue abscess 27.37 10.51 5 106897 3 110482394
Sebaceous gland infection 27.25 10.51 9 106893 160 110482237
Lichen planopilaris 27.19 10.51 9 106893 161 110482236
Rash 27.12 10.51 596 106306 820368 109662029
Neurofibrosarcoma 26.79 10.51 10 106892 258 110482139
Vascular purpura 26.78 10.51 25 106877 3746 110478651
Vertigo 26.51 10.51 159 106743 86711 110395686
Nail bed bleeding 26.43 10.51 14 106888 842 110481555
Sleep disorder 26.17 10.51 101 106801 198543 110283854
Platelet count decreased 26.17 10.51 124 106778 230319 110252078
Extrasystoles 26.01 10.51 36 106866 8282 110474115
Blood pressure diastolic decreased 25.88 10.51 85 106817 35800 110446597
Brain natriuretic peptide abnormal 25.65 10.51 14 106888 894 110481503
Blood thyroid stimulating hormone abnormal 25.40 10.51 15 106887 1114 110481283
Loss of consciousness 24.97 10.51 295 106607 196011 110286386
Product substitution issue 24.75 10.51 63 106839 22998 110459399
Acute coronary syndrome 24.66 10.51 63 106839 23049 110459348
Adverse event 24.64 10.51 42 106860 108767 110373630
Muscle strain 24.42 10.51 41 106861 11161 110471236
Angina unstable 24.38 10.51 51 106851 16381 110466016
Hypoaesthesia 24.20 10.51 191 106711 314032 110168365
Hypovolaemia 24.09 10.51 60 106842 21614 110460783
Product administration error 24.07 10.51 85 106817 37132 110445265
Musculoskeletal stiffness 23.99 10.51 165 106737 279657 110202740
Bundle branch block left 23.98 10.51 44 106858 12844 110469553
Mental status changes 23.85 10.51 23 106879 76099 110406298
Retro-orbital neoplasm 23.80 10.51 7 106895 83 110482314
International normalised ratio increased 23.47 10.51 154 106748 86618 110395779
Pregnancy 23.41 10.51 10 106892 51057 110431340
Tachyarrhythmia 23.25 10.51 34 106868 8227 110474170
Subacute kidney injury 23.05 10.51 5 106897 14 110482383
Skin sensitisation 22.93 10.51 14 106888 1105 110481292
Preternatural anus 22.74 10.51 7 106895 98 110482299
Intra-abdominal haematoma 22.72 10.51 22 106880 3450 110478947
Urticaria 22.66 10.51 198 106704 318659 110163738
Prescribed underdose 22.46 10.51 18 106884 65156 110417241
Therapy non-responder 22.02 10.51 78 106824 157229 110325168
Keratitis 21.98 10.51 26 106876 5118 110477279
Eosinophilic cellulitis 21.95 10.51 9 106893 300 110482097
X-ray abnormal 21.86 10.51 5 106897 38112 110444285
Subarachnoid haematoma 21.70 10.51 9 106893 309 110482088
Fractured coccyx 21.43 10.51 14 106888 1244 110481153
Carotid arteriosclerosis 21.20 10.51 20 106882 3037 110479360
Cerebral haemorrhage 21.17 10.51 121 106781 64847 110417550
Oliguria 21.11 10.51 52 106850 18605 110463792
Diabetes mellitus inadequate control 21.00 10.51 70 106832 29705 110452692
Liver disorder 20.95 10.51 69 106833 142174 110340223
Antipsychotic drug level above therapeutic 20.94 10.51 18 106884 2422 110479975
Renal cyst 20.93 10.51 51 106851 18121 110464276
Leukopenia 20.68 10.51 74 106828 148717 110333680
Intestinal angioedema 20.64 10.51 13 106889 1084 110481313
Back injury 20.60 10.51 10 106892 47389 110435008
Intraventricular haemorrhage 20.56 10.51 26 106876 5481 110476916
Gastrointestinal motility disorder 20.55 10.51 30 106872 7246 110475151
Lymphoma 20.51 10.51 54 106848 20117 110462280
Taste disorder 20.20 10.51 20 106882 65367 110417030
Pneumonia 20.19 10.51 670 106232 876044 109606353
Wheezing 20.18 10.51 154 106748 255076 110227321
Respiratory failure 19.96 10.51 124 106778 215208 110267189
Blood creatine phosphokinase increased 19.95 10.51 130 106772 72947 110409450
C-reactive protein increased 19.93 10.51 126 106776 217793 110264604
Circulating anticoagulant positive 19.87 10.51 5 106897 31 110482366
Chronic kidney disease 19.79 10.51 134 106768 76157 110406240
Hip arthroplasty 19.76 10.51 15 106887 55798 110426599
Necrotising myositis 19.73 10.51 16 106886 1986 110480411
Pulmonary arterial pressure abnormal 19.73 10.51 12 106890 941 110481456
General physical health deterioration 19.63 10.51 291 106611 425004 110057393
Bradyarrhythmia 19.55 10.51 24 106878 4910 110477487
Dizziness 19.52 10.51 843 106059 697350 109785047
Amnesia 19.33 10.51 46 106856 105362 110377035
Drug-induced liver injury 19.27 10.51 56 106846 120011 110362386
Anal polyp 19.05 10.51 6 106896 91 110482306
Immunisation reaction 18.86 10.51 11 106891 798 110481599
Dysgeusia 18.80 10.51 124 106778 69861 110412536
Prostatic specific antigen increased 18.76 10.51 39 106863 12472 110469925
Haemochromatosis 18.73 10.51 14 106888 1543 110480854
Atrioventricular block first degree 18.65 10.51 42 106860 14183 110468214
Respiratory rate increased 18.62 10.51 60 106842 25023 110457374
Dry mouth 18.60 10.51 115 106787 199833 110282564
Subdural haematoma 18.44 10.51 77 106825 36377 110446020
Heart valve incompetence 18.36 10.51 21 106881 3988 110478409
Hepatic cirrhosis 18.35 10.51 23 106879 67603 110414794
Myalgia 18.13 10.51 309 106593 222072 110260325
Exostosis 18.07 10.51 11 106891 45945 110436452
Injection site extravasation 18.02 10.51 34 106868 10135 110472262
Injection site pruritus 17.86 10.51 14 106888 51244 110431153
Contraindicated product prescribed 17.84 10.51 16 106886 2277 110480120
Respiratory tract infection 17.78 10.51 26 106876 71591 110410806
Dyspnoea exertional 17.77 10.51 166 106736 103894 110378503
Genital pain 17.77 10.51 13 106889 1387 110481010
Psychotic disorder 17.64 10.51 14 106888 50923 110431474
Sepsis 17.62 10.51 217 106685 327129 110155268
Left ventricular dilatation 17.58 10.51 13 106889 1409 110480988
Pulmonary fibrosis 17.56 10.51 46 106856 101996 110380401
Parotid gland enlargement 17.52 10.51 12 106890 1153 110481244
Oxygen saturation decreased 17.42 10.51 230 106672 156752 110325645
Sinus arrest 17.40 10.51 21 106881 4221 110478176
Myocardial ischaemia 17.30 10.51 61 106841 26623 110455774
Blood urine present 17.10 10.51 57 106845 24188 110458209
Haematuria 17.09 10.51 138 106764 82867 110399530
Sinus node dysfunction 16.98 10.51 31 106871 9016 110473381
Onychomycosis 16.95 10.51 8 106894 38523 110443874
Meningorrhagia 16.88 10.51 8 106894 379 110482018
Injection site swelling 16.79 10.51 21 106881 61769 110420628
Peripheral swelling 16.78 10.51 282 106620 403752 110078645
Weight increased 16.75 10.51 295 106607 419349 110063048
Electrocardiogram QT prolonged 16.73 10.51 170 106732 108790 110373607
Oesophageal adenocarcinoma 16.73 10.51 11 106891 988 110481409
Goitre 16.69 10.51 25 106877 6179 110476218
Interstitial lung disease 16.67 10.51 207 106695 139127 110343270
Device dislocation 16.59 10.51 5 106897 31699 110450698
Dermatitis exfoliative 16.58 10.51 35 106867 11312 110471085
Road traffic accident 16.58 10.51 51 106851 107347 110375050
Conduction disorder 16.52 10.51 20 106882 4035 110478362
Cardiac failure 16.51 10.51 264 106638 187362 110295035
Nail disorder 16.47 10.51 19 106883 57916 110424481
Renal pain 16.39 10.51 32 106870 9785 110472612
Procedural failure 16.07 10.51 6 106896 155 110482242
Finger deformity 15.95 10.51 6 106896 33086 110449311
Fibrous histiocytoma 15.93 10.51 10 106892 829 110481568
Asbestosis 15.93 10.51 6 106896 159 110482238
Nephrectomy 15.92 10.51 16 106886 2624 110479773
Therapy partial responder 15.84 10.51 8 106894 37053 110445344
Incision site haemorrhage 15.78 10.51 11 106891 1087 110481310
Mitral valve incompetence 15.77 10.51 69 106833 33260 110449137
Escherichia peritonitis 15.75 10.51 3 106899 3 110482394
Enterocutaneous fistula 15.73 10.51 15 106887 2308 110480089
Mucosal dryness 15.72 10.51 20 106882 4243 110478154
Melaena 15.64 10.51 117 106785 68640 110413757
Product dose omission issue 15.60 10.51 218 106684 321564 110160833
Angiocardiogram 15.60 10.51 7 106895 292 110482105
Product quality issue 15.59 10.51 32 106870 77267 110405130
Sprue-like enteropathy 15.56 10.51 13 106889 1683 110480714
Diabetic metabolic decompensation 15.54 10.51 19 106883 3870 110478527
Blood glucose decreased 15.47 10.51 63 106839 29425 110452972
Enterochromaffin cell hyperplasia 15.45 10.51 5 106897 83 110482314
Visual impairment 15.45 10.51 72 106830 134356 110348041
Blood lactic acid 15.27 10.51 8 106894 470 110481927
Insomnia 15.19 10.51 251 106651 360339 110122058
White blood cell count decreased 15.18 10.51 145 106757 229245 110253152
Lymphocyte count decreased 14.99 10.51 20 106882 57223 110425174
Haematocrit increased 14.82 10.51 21 106881 4938 110477459
Hypergammaglobulinaemia 14.72 10.51 10 106892 948 110481449
Injection site pain 14.71 10.51 106 106796 177816 110304581
Subacute cutaneous lupus erythematosus 14.70 10.51 21 106881 4973 110477424
Left atrial volume increased 14.68 10.51 5 106897 98 110482299
Haemodialysis 14.64 10.51 44 106858 17675 110464722
Rash morbilliform 14.61 10.51 27 106875 7924 110474473
Toxic skin eruption 14.61 10.51 59 106843 27456 110454941
Musculoskeletal discomfort 14.57 10.51 53 106849 23485 110458912
Dysuria 14.56 10.51 104 106798 60127 110422270
Thyroglossal cyst 14.54 10.51 3 106899 6 110482391
Clang associations 14.50 10.51 4 106898 37 110482360
Myopathy 14.45 10.51 55 106847 24905 110457492
Cerebral haematoma 14.41 10.51 30 106872 9602 110472795
Laboratory test abnormal 14.18 10.51 13 106889 44066 110438331
Erysipelas 14.18 10.51 36 106866 13122 110469275
Mixed liver injury 14.02 10.51 34 106868 12045 110470352
Appendicitis 13.99 10.51 5 106897 28459 110453938
Cutaneous vasculitis 13.90 10.51 35 106867 12694 110469703
Pseudoporphyria 13.83 10.51 9 106893 794 110481603
Blood bicarbonate decreased 13.69 10.51 22 106880 5775 110476622
Bundle branch block right 13.63 10.51 34 106868 12257 110470140
Granuloma 13.55 10.51 29 106873 9461 110472936
Morganella infection 13.55 10.51 11 106891 1368 110481029
Ear pain 13.53 10.51 19 106883 53207 110429190
Weaning failure 13.50 10.51 9 106893 827 110481570
Acute myocardial infarction 13.49 10.51 132 106770 83645 110398752
Delirium 13.44 10.51 76 106826 134949 110347448
Intentional self-injury 13.33 10.51 10 106892 37419 110444978
Muscle spasms 13.29 10.51 189 106713 277968 110204429
Musculoskeletal pain 13.28 10.51 113 106789 182910 110299487
Haemophagocytic lymphohistiocytosis 13.21 10.51 7 106895 31552 110450845
Gout 13.18 10.51 70 106832 36496 110445901
Restrictive pulmonary disease 13.15 10.51 16 106886 3243 110479154
Increased appetite 13.15 10.51 38 106864 14939 110467458
Haemoglobin increased 13.12 10.51 28 106874 9119 110473278
Underdose 13.08 10.51 26 106876 63528 110418869
Nephrotic syndrome 13.03 10.51 36 106866 13795 110468602
Tympanic membrane perforation 13.01 10.51 13 106889 2119 110480278
Renal artery stenosis 12.98 10.51 17 106885 3709 110478688
No adverse event 12.93 10.51 33 106869 73806 110408591
Blood potassium increased 12.92 10.51 65 106837 33184 110449213
Blood sodium decreased 12.90 10.51 72 106830 38247 110444150
Renal haemorrhage 12.90 10.51 14 106888 2511 110479886
Blood osmolarity decreased 12.88 10.51 11 106891 1467 110480930
Histamine level increased 12.88 10.51 5 106897 144 110482253
Renal tubular necrosis 12.86 10.51 61 106841 30414 110451983
Contusion 12.82 10.51 154 106748 233207 110249190
Hepatocellular carcinoma 12.76 10.51 29 106873 9851 110472546
Antiphospholipid antibodies positive 12.61 10.51 9 106893 924 110481473
Nasal dryness 12.59 10.51 21 106881 5685 110476712
Dyslipidaemia 12.59 10.51 39 106863 15926 110466471
Device issue 12.59 10.51 9 106893 34526 110447871
Cardio-respiratory arrest 12.56 10.51 169 106733 115667 110366730
Hypoparathyroidism 12.55 10.51 11 106891 1519 110480878
Epilepsy 12.53 10.51 52 106850 100157 110382240
Vestibular neuronitis 12.44 10.51 9 106893 944 110481453
Muscle mass 12.42 10.51 7 106895 476 110481921
Atrial thrombosis 12.39 10.51 18 106884 4328 110478069
Hypoxia 12.30 10.51 74 106828 129441 110352956
Gastric ulcer 12.21 10.51 73 106829 39754 110442643
Brucellosis 12.18 10.51 5 106897 167 110482230
Dermatitis bullous 12.18 10.51 41 106861 17488 110464909
Prothrombin time ratio decreased 12.17 10.51 11 106891 1581 110480816
Renal tubular disorder 12.14 10.51 24 106878 7405 110474992
Ureteric obstruction 12.10 10.51 15 106887 3099 110479298
Proteinuria 12.05 10.51 73 106829 39945 110442452
Flatulence 12.01 10.51 89 106813 52060 110430337
Breast tumour excision 12.01 10.51 3 106899 18 110482379
Neuropathy peripheral 11.99 10.51 113 106789 179164 110303233
Genital ulceration 11.97 10.51 12 106890 1963 110480434
Arthritis 11.94 10.51 228 106674 167358 110315039
Amyloidoma 11.87 10.51 3 106899 19 110482378
Bronchiolitis 11.83 10.51 20 106882 5473 110476924
Localised oedema 11.83 10.51 27 106875 9196 110473201
Neoplasm prostate 11.83 10.51 5 106897 180 110482217
Periorbital haematoma 11.80 10.51 9 106893 1023 110481374
Aortic valve incompetence 11.79 10.51 30 106872 10951 110471446
Libido disorder 11.72 10.51 6 106896 336 110482061
Ascites 11.70 10.51 48 106854 92760 110389637
Injection site erythema 11.69 10.51 49 106853 94127 110388270
Asthma 11.62 10.51 171 106731 250120 110232277
Glomerular filtration rate decreased 11.53 10.51 57 106845 28899 110453498
Electrolyte imbalance 11.44 10.51 68 106834 36960 110445437
Bronchial haemorrhage 11.44 10.51 10 106892 1377 110481020
Mitral valve calcification 11.40 10.51 11 106891 1717 110480680
Multiple organ dysfunction syndrome 11.31 10.51 93 106809 151617 110330780
Progressive multifocal leukoencephalopathy 11.26 10.51 5 106897 24951 110457446
Peptic ulcer perforation 11.17 10.51 8 106894 825 110481572
Sudden death 11.16 10.51 50 106852 24345 110458052
Reversible cerebral vasoconstriction syndrome 11.15 10.51 18 106884 4743 110477654
Meningitis cryptococcal 11.15 10.51 18 106884 4744 110477653
Histoplasmosis 11.12 10.51 14 106888 2939 110479458
Vascular access site pain 11.07 10.51 7 106895 588 110481809
Gastrointestinal haemorrhage 11.05 10.51 223 106679 165295 110317102
Overdose 11 10.51 300 106602 233494 110248903
B-cell type acute leukaemia 10.97 10.51 10 106892 1454 110480943
Bone swelling 10.92 10.51 11 106891 1810 110480587
Lividity 10.90 10.51 7 106895 604 110481793
Circulatory collapse 10.84 10.51 75 106827 42918 110439479
Multiple sclerosis relapse 10.83 10.51 20 106882 50220 110432177
Colitis microscopic 10.82 10.51 33 106869 13361 110469036
Weight abnormal 10.80 10.51 12 106890 2209 110480188
Supraventricular extrasystoles 10.77 10.51 24 106878 8049 110474348
Immunodeficiency 10.76 10.51 13 106889 38825 110443572
Movement disorder 10.70 10.51 66 106836 36338 110446059
Blood loss anaemia 10.67 10.51 40 106862 17985 110464412
Neutropenia 10.67 10.51 278 106624 374342 110108055
Full blood count abnormal 10.64 10.51 24 106878 56028 110426369
Respiratory gas exchange disorder 10.64 10.51 8 106894 890 110481507
Urinary tract candidiasis 10.61 10.51 9 106893 1190 110481207
Hepatotoxicity 10.59 10.51 29 106873 63371 110419026
Aortic aneurysm 10.57 10.51 27 106875 9877 110472520
Hemianopia homonymous 10.56 10.51 10 106892 1525 110480872

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C09CA04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
Angiotensin II receptor blockers (ARBs), plain
ATC C09DA04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and diuretics
ATC C09DB05 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 C09DX07 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
CHEBI has role CHEBI:22587 antiviral agent
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:35703 xenobiotic
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:61016 angiotensin receptor antagonist
CHEBI has role CHEBI:78298 environmental contaminant
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

C09CA Angiotensin II receptor blockers (ARBs), plain 9 drugs
azilsartan medoxomilcandesartan cilexetileprosartanfimasartanlosartanolmesartan medoxomiltasosartantelmisartanvalsartan
C09DA Angiotensin II receptor blockers (ARBs) and diuretics 8 drugs
azilsartan medoxomilcandesartan cilexetileprosartanfimasartanlosartanolmesartan medoxomiltelmisartanvalsartan
C09DB Angiotensin II receptor blockers (ARBs) and calcium channel blockers 8 drugs
amlodipinecandesartan cilexetilfimasartanlercanidipinelosartanolmesartan medoxomiltelmisartanvalsartan
C09DX Angiotensin II receptor blockers (ARBs), other combinations 10 drugs
aliskirenamlodipinecandesartan cilexetilhydrochlorothiazideindapamidenebivolololmesartan medoxomilsacubitriltelmisartanvalsartan

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

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Diabetic renal disease indication 127013003
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
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
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
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Disorder of muscle contraindication 129565002 DOID:423
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Rhabdomyolysis contraindication 240131006
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Azotemia contraindication 445009001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.37 acidic
pKa2 3.63 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 Ki 9.10 CHEMBL CHEMBL
Endothelin-1 receptor GPCR Ki 5 CHEMBL
Sodium/bile acid cotransporter Transporter INHIBITOR Ki 4.92 IUPHAR
Type-1B angiotensin II receptor GPCR Ki 9.10 CHEMBL
Angiotensin II receptor (AT-1) type-1 GPCR IC50 8.89 CHEMBL
Angiotensin II receptor GPCR IC50 8.89 CHEMBL

External reference:

IDSource
4021071 VUID
N0000148533 NUI
D00523 KEGG_DRUG
4021071 VANDF
C0288171 UMLSCUI
CHEBI:5959 CHEBI
CHEMBL1513 ChEMBL_ID
CHEMBL6068339 ChEMBL_ID
D000077405 MESH_DESCRIPTOR_UI
DB01029 DRUGBANK_ID
3749 PUBCHEM_CID
589 IUPHAR_LIGAND_ID
7229 INN_ID
329055-23-4 SECONDARY_CAS_RN
J0E2756Z7N UNII
83818 RXNORM
4917 MMSL
52343 MMSL
d04222 MMSL
006921 NDDF
108585000 SNOMEDCT_US
386877005 SNOMEDCT_US
734504000 SNOMEDCT_US
J0E2756Z7N INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Avapro HUMAN PRESCRIPTION DRUG LABEL 1 0024-5850 TABLET, FILM COATED 75 mg ORAL NDA 29 sections
Avapro HUMAN PRESCRIPTION DRUG LABEL 1 0024-5851 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
Avapro HUMAN PRESCRIPTION DRUG LABEL 1 0024-5851 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
Avapro HUMAN PRESCRIPTION DRUG LABEL 1 0024-5852 TABLET, FILM COATED 300 mg ORAL NDA 29 sections
Avapro HUMAN PRESCRIPTION DRUG LABEL 1 0024-5852 TABLET, FILM COATED 300 mg ORAL NDA 29 sections
Avalide HUMAN PRESCRIPTION DRUG LABEL 2 0024-5855 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
Avalide HUMAN PRESCRIPTION DRUG LABEL 2 0024-5855 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
Avalide HUMAN PRESCRIPTION DRUG LABEL 2 0024-5856 TABLET, FILM COATED 300 mg ORAL NDA 29 sections
Avalide HUMAN PRESCRIPTION DRUG LABEL 2 0024-5856 TABLET, FILM COATED 300 mg ORAL NDA 29 sections
Irbesartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0254 TABLET 150 mg ORAL ANDA 27 sections
Irbesartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0254 TABLET 150 mg ORAL ANDA 27 sections
Irbesartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0255 TABLET 300 mg ORAL ANDA 27 sections
Irbesartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0255 TABLET 300 mg ORAL ANDA 27 sections
Irbesartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0256 TABLET 300 mg ORAL ANDA 27 sections
Irbesartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0256 TABLET 300 mg ORAL ANDA 27 sections
Irbesartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0093-8232 TABLET, FILM COATED 300 mg ORAL ANDA 27 sections
Irbesartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0093-8238 TABLET, FILM COATED 150 mg ORAL ANDA 27 sections
Irbesartan HUMAN PRESCRIPTION DRUG LABEL 1 29300-212 TABLET 75 mg ORAL ANDA 23 sections
Irbesartan HUMAN PRESCRIPTION DRUG LABEL 1 29300-213 TABLET 150 mg ORAL ANDA 23 sections
Irbesartan HUMAN PRESCRIPTION DRUG LABEL 1 29300-214 TABLET 300 mg ORAL ANDA 23 sections
Irbesartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 29300-215 TABLET, FILM COATED 150 mg ORAL ANDA 25 sections
Irbesartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 29300-216 TABLET, FILM COATED 300 mg ORAL ANDA 25 sections
Irbesartan Human Prescription Drug Label 1 31722-160 TABLET 75 mg ORAL ANDA 27 sections
Irbesartan Human Prescription Drug Label 1 31722-161 TABLET 150 mg ORAL ANDA 27 sections
Irbesartan Human Prescription Drug Label 1 31722-162 TABLET 300 mg ORAL ANDA 27 sections
Irbesartan HUMAN PRESCRIPTION DRUG LABEL 1 31722-729 TABLET 75 mg ORAL ANDA 26 sections
Irbesartan HUMAN PRESCRIPTION DRUG LABEL 1 31722-730 TABLET 150 mg ORAL ANDA 26 sections
Irbesartan HUMAN PRESCRIPTION DRUG LABEL 1 31722-731 TABLET 300 mg ORAL ANDA 26 sections
Irbesartan Human Prescription Drug Label 1 33342-047 TABLET 75 mg ORAL ANDA 26 sections
Irbesartan Human Prescription Drug Label 1 33342-048 TABLET 150 mg ORAL ANDA 26 sections