valsartan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
angiotensin II receptor antagonists, antihypertensive (non-peptidic) 2806 137862-53-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • diovan
  • cardopan
  • valsartanin
  • valsartan
  • CGP 48933
  • CGP-48933
A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION. It has been approved in combination with sacubitril (under the name ENTRESTO) for the treatment of heart failure.
  • Molecular weight: 435.53
  • Formula: C24H29N5O3
  • CLOGP: 4.86
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 2
  • TPSA: 112.07
  • ALOGS: -4.28
  • ROTB: 10
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
80 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.18 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 13 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 10.50 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 23 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.22 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.49 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.04 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 22, 2000 PMDA Ciba-Geigy Japan
Dec. 23, 1996 FDA
Nov. 19, 2015 EMA Novartis Europharm Limited

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
Blood pressure inadequately controlled 389.15 9.66 189 115856 4335 56171687
Blood pressure increased 352.67 9.66 864 115181 144312 56031710
Macular degeneration 309.36 9.66 279 115766 18629 56157393
Pemphigus 279.73 9.66 10 116035 157202 56018820
Rheumatoid arthritis 242.53 9.66 259 115786 382345 55793677
Glossodynia 242.35 9.66 19 116026 152439 56023583
Hyponatraemia 239.52 9.66 600 115445 101539 56074483
Hypertension 227.90 9.66 1052 114993 243226 55932796
Hand deformity 227.88 9.66 12 116033 134480 56041542
Systemic lupus erythematosus 209.74 9.66 56 115989 180022 55996000
Off label use 209.24 9.66 530 115515 555650 55620372
Myocardial infarction 197.55 9.66 526 115519 92344 56083678
Oligohydramnios 186.00 9.66 129 115916 5865 56170157
Cardiac failure congestive 181.70 9.66 492 115553 87228 56088794
Hyperkalaemia 168.60 9.66 343 115702 50522 56125500
Alopecia 150.25 9.66 233 115812 293225 55882797
Wound 147.42 9.66 51 115994 138753 56037269
Product use issue 146.77 9.66 102 115943 185939 55990083
Infusion related reaction 145.37 9.66 130 115915 208801 55967221
Oedema peripheral 143.19 9.66 715 115330 170539 56005483
Pericarditis 142.66 9.66 26 116019 108897 56067125
Contraindicated product administered 141.91 9.66 106 115939 186180 55989842
Acute kidney injury 141.17 9.66 914 115131 239849 55936173
Cerebral infarction 140.19 9.66 201 115844 22304 56153718
Arthropathy 140.07 9.66 124 115921 200151 55975871
Coronary artery disease 134.87 9.66 234 115811 30562 56145460
Completed suicide 134.03 9.66 54 115991 133779 56042243
Maternal exposure during pregnancy 131.79 9.66 118 115927 189435 55986587
Therapeutic product effect decreased 125.77 9.66 99 115946 169353 56006669
Dizziness 125.21 9.66 1254 114791 374886 55801136
Duodenal ulcer perforation 119.27 9.66 5 116040 68337 56107685
Cardiac failure 117.88 9.66 405 115640 81688 56094334
Hypertensive crisis 109.71 9.66 140 115905 13896 56162126
Blood creatinine increased 106.00 9.66 385 115660 79806 56096216
Renal failure 105.84 9.66 480 115565 110020 56066002
Treatment failure 104.78 9.66 118 115927 170274 56005748
Joint swelling 104.15 9.66 282 115763 289518 55886504
Glaucoma 99.57 9.66 149 115896 17180 56158842
Blood glucose increased 99.50 9.66 361 115684 74790 56101232
Discomfort 98.80 9.66 88 115957 141673 56034349
Cerebrovascular accident 97.90 9.66 435 115610 98835 56077187
Pain 97.40 9.66 887 115158 662297 55513725
Colitis microscopic 96.26 9.66 99 115946 7776 56168246
Thyroid disorder 95.01 9.66 130 115915 13808 56162214
Helicobacter infection 94.83 9.66 18 116027 73250 56102772
Diabetes mellitus 94.69 9.66 281 115764 52454 56123568
Swelling 93.31 9.66 224 115821 239547 55936475
Syncope 91.23 9.66 453 115592 107746 56068276
Hypotension 89.97 9.66 849 115196 249659 55926363
Rash 89.63 9.66 622 115423 492425 55683597
Folliculitis 86.90 9.66 7 116038 54972 56121050
Synovitis 86.40 9.66 124 115921 161181 56014841
Atrial fibrillation 83.50 9.66 444 115601 108453 56067569
Rheumatoid factor positive 83.18 9.66 20 116025 69040 56106982
Muscle injury 82.10 9.66 7 116038 52493 56123529
Drug intolerance 80.62 9.66 278 115767 264540 55911482
Product use in unapproved indication 79.69 9.66 104 115941 140718 56035304
Toxicity to various agents 79.52 9.66 220 115825 224344 55951678
Blood pressure decreased 71.76 9.66 276 115769 58774 56117248
Angina pectoris 67.22 9.66 166 115879 27810 56148212
Fall 66.41 9.66 1070 114975 356440 55819582
Bronchial haemorrhage 65.79 9.66 29 116016 528 56175494
Condition aggravated 65.61 9.66 429 115616 344469 55831553
Blood urea increased 65.03 9.66 151 115894 24322 56151700
Intentional product use issue 64.69 9.66 66 115979 99667 56076355
Infection 64.46 9.66 205 115840 200001 55976021
Blister 64.11 9.66 78 115967 108809 56067213
Bronchial neoplasm 63.92 9.66 27 116018 441 56175581
Psoriatic arthropathy 63.21 9.66 37 116008 73971 56102051
Diabetes mellitus inadequate control 60.90 9.66 106 115939 13874 56162148
Drug ineffective 60.39 9.66 1440 114605 917549 55258473
Diverticulitis 56.88 9.66 183 115862 35669 56140353
Nasal turbinate hypertrophy 55.99 9.66 28 116017 685 56175337
Exposure during pregnancy 54.89 9.66 125 115920 136217 56039805
Renal impairment 54.47 9.66 318 115727 80395 56095627
Fatigue 54.41 9.66 1226 114819 787326 55388696
Abdominal discomfort 53.14 9.66 344 115701 276930 55899092
Bronchial disorder 50.26 9.66 31 116014 1152 56174870
Diverticulum intestinal 49.96 9.66 64 115981 6376 56169646
Musculoskeletal stiffness 49.32 9.66 161 115884 155846 56020176
Hyperuricaemia 48.44 9.66 56 115989 5017 56171005
Arthralgia 47.89 9.66 737 115308 500932 55675090
Mitral valve incompetence 47.13 9.66 111 115934 18042 56157980
Endometrial ablation 47.02 9.66 27 116018 878 56175144
Haematoma 46.83 9.66 159 115886 31860 56144162
Product prescribing error 45.91 9.66 128 115917 23058 56152964
Irritable bowel syndrome 45.89 9.66 44 116001 68414 56107608
Chest pain 45.86 9.66 595 115450 189202 55986820
Blood pressure diastolic decreased 45.73 9.66 114 115931 19209 56156813
Asthenia 45.67 9.66 975 115070 341998 55834024
Transient ischaemic attack 45.01 9.66 162 115883 33415 56142607
Hepatic enzyme increased 44.94 9.66 191 115854 171193 56004829
Dehydration 44.93 9.66 513 115532 158312 56017710
Labile hypertension 44.11 9.66 21 116024 460 56175562
Lower respiratory tract infection 44.00 9.66 108 115937 114686 56061336
Cardiovascular disorder 42.87 9.66 79 115966 10810 56165212
Ill-defined disorder 42.60 9.66 47 115998 68496 56107526
Rhonchi 42.34 9.66 37 116008 2367 56173655
Cardiomegaly 42.00 9.66 100 115945 16367 56159655
Chronic kidney disease 41.96 9.66 185 115860 41871 56134151
Fear of disease 41.92 9.66 26 116019 976 56175046
Abortion spontaneous 41.62 9.66 19 116026 43734 56132288
Skin reaction 40.80 9.66 86 115959 12977 56163045
Total lung capacity increased 40.41 9.66 25 116020 934 56175088
Anaemia 40.40 9.66 775 115270 266736 55909286
Acute myocardial infarction 40.20 9.66 146 115899 30247 56145775
Obstructive airways disorder 39.89 9.66 101 115944 17181 56158841
Tachyarrhythmia 39.30 9.66 46 115999 4175 56171847
Sinusitis 38.91 9.66 243 115802 197338 55978684
Forced expiratory volume decreased 38.83 9.66 48 115997 4612 56171410
Product dose omission issue 38.70 9.66 255 115790 204498 55971524
Drug hypersensitivity 38.49 9.66 372 115673 274833 55901189
Angioedema 38.11 9.66 178 115867 41275 56134747
Hip arthroplasty 37.96 9.66 16 116029 38607 56137415
Impaired healing 37.95 9.66 76 115969 86765 56089257
COVID-19 37.93 9.66 60 115985 74998 56101024
Blood uric acid increased 37.47 9.66 45 116000 4197 56171825
Pulmonary hypoplasia 37.19 9.66 16 116029 274 56175748
Pregnancy 37.06 9.66 11 116034 33022 56143000
Lymphatic fistula 37.01 9.66 22 116023 764 56175258
Femoral hernia incarcerated 36.62 9.66 22 116023 779 56175243
Arrhythmia 36.27 9.66 156 115889 34927 56141095
Febrile neutropenia 36.13 9.66 105 115940 105440 56070582
Stomatitis 35.91 9.66 128 115917 120682 56055340
Pancreatic steatosis 35.22 9.66 23 116022 945 56175077
Gastrointestinal disorder 35.13 9.66 117 115928 112585 56063437
Blood sodium decreased 34.52 9.66 113 115932 22221 56153801
Neutropenia 34.07 9.66 189 115856 157978 56018044
Bradycardia 33.93 9.66 247 115798 67257 56108765
Adverse drug reaction 33.93 9.66 51 115994 65081 56110941
Blood pressure abnormal 33.82 9.66 82 115963 13578 56162444
Blood pressure systolic increased 32.99 9.66 169 115876 40667 56135355
Migraine 32.99 9.66 82 115963 86715 56089307
Angina unstable 32.73 9.66 54 115991 6767 56169255
Arterial haemorrhage 32.70 9.66 27 116018 1598 56174424
Drug abuse 32.34 9.66 56 115989 67554 56108468
Nervousness 32.32 9.66 132 115913 28883 56147139
Blood lactate dehydrogenase increased 32.31 9.66 105 115940 20570 56155452
Product impurity 32.07 9.66 9 116036 37 56175985
Hypokalaemia 31.81 9.66 316 115729 94121 56081901
Hypochromic anaemia 31.79 9.66 28 116017 1810 56174212
Death 31.36 9.66 505 115540 340921 55835101
Nasopharyngitis 31.17 9.66 298 115747 220661 55955361
Tricuspid valve incompetence 31.16 9.66 78 115967 13175 56162847
Vascular resistance pulmonary decreased 30.74 9.66 10 116035 74 56175948
Venous pressure jugular increased 29.79 9.66 17 116028 546 56175476
Brain stem stroke 29.43 9.66 14 116031 306 56175716
Recalled product administered 29.40 9.66 16 116029 468 56175554
Wound infection pseudomonas 28.89 9.66 23 116022 1292 56174730
Intentional overdose 28.59 9.66 61 115984 68056 56107966
Altered state of consciousness 28.28 9.66 108 115937 22913 56153109
Peripheral swelling 28.06 9.66 329 115716 234397 55941625
Antinuclear antibody negative 27.97 9.66 12 116033 204 56175818
Gamma-glutamyltransferase increased 27.67 9.66 132 115913 30873 56145149
Injection site reaction 27.44 9.66 42 116003 53205 56122817
Bundle branch block left 27.40 9.66 48 115997 6314 56169708
Blood potassium increased 27.28 9.66 88 115957 17173 56158849
Blood creatine phosphokinase increased 27.15 9.66 122 115923 27830 56148192
Seroma 27.01 9.66 26 116019 1885 56174137
Gastrointestinal haemorrhage 26.98 9.66 257 115788 75694 56100328
Rhabdomyolysis 26.65 9.66 159 115886 40499 56135523
Atrioventricular block complete 26.57 9.66 52 115993 7442 56168580
Spinal osteoarthritis 26.56 9.66 79 115966 14757 56161265
Hiatus hernia 26.49 9.66 95 115950 19557 56156465
Renal cyst 26.46 9.66 59 115986 9250 56166772
Hypoglycaemia 26.22 9.66 201 115844 55614 56120408
Hospitalisation 26.11 9.66 74 115971 74926 56101096
Myocardial ischaemia 26.10 9.66 69 115976 12047 56163975
Lymphocyte stimulation test positive 26.03 9.66 15 116030 491 56175531
Thrombotic stroke 26.03 9.66 15 116030 491 56175531
Left-to-right cardiac shunt 26.02 9.66 10 116035 126 56175896
Product contamination chemical 25.93 9.66 5 116040 0 56176022
Aortic valve stenosis 25.56 9.66 32 116013 3115 56172907
Coombs positive haemolytic anaemia 25.52 9.66 13 116032 331 56175691
Product odour abnormal 25.47 9.66 20 116025 1101 56174921
Hypertensive cardiomyopathy 25.38 9.66 11 116034 192 56175830
Dyschezia 25.33 9.66 26 116019 2037 56173985
Hypersensitivity 25.30 9.66 374 115671 256034 55919988
Gastric ulcer haemorrhage 25.30 9.66 39 116006 4614 56171408
Sinus node dysfunction 25.29 9.66 38 116007 4396 56171626
Disease progression 25.28 9.66 121 115924 105052 56070970
Basal ganglion degeneration 24.99 9.66 14 116031 434 56175588
Live birth 24.97 9.66 5 116040 19600 56156422
Injection site pain 24.64 9.66 141 115904 116977 56059045
Drug resistance 24.63 9.66 6 116039 20536 56155486
Cough 24.37 9.66 705 115340 259256 55916766
Renal artery stenosis 24.26 9.66 24 116021 1799 56174223
Breast cancer 24.15 9.66 178 115867 48655 56127367
Coronary artery stenosis 23.66 9.66 37 116008 4431 56171591
Loss of consciousness 23.59 9.66 336 115709 109013 56067009
Ventricular extrasystoles 23.51 9.66 62 115983 10808 56165214
Concomitant disease progression 23.35 9.66 25 116020 2057 56173965
Gastritis haemorrhagic 23.32 9.66 21 116024 1398 56174624
Tissue infiltration 23.11 9.66 15 116030 610 56175412
Therapy interrupted 23.05 9.66 12 116033 25613 56150409
Forced vital capacity decreased 22.97 9.66 18 116027 988 56175034
Coronary arterial stent insertion 22.72 9.66 28 116017 2682 56173340
Liver function test increased 22.72 9.66 15 116030 28118 56147904
Liver injury 22.55 9.66 32 116013 41816 56134206
Loss of personal independence in daily activities 22.36 9.66 89 115956 81280 56094742
Intestinal polyp 22.13 9.66 20 116025 1338 56174684
Faecaloma 22.10 9.66 48 115997 7393 56168629
Acral lentiginous melanoma 22.00 9.66 5 116040 6 56176016
Cardiac failure chronic 21.99 9.66 34 116011 4033 56171989
Metastatic bronchial carcinoma 21.94 9.66 9 116036 136 56175886
Myalgia 21.81 9.66 388 115657 131637 56044385
Hypochloraemia 21.79 9.66 22 116023 1690 56174332
Hepatic cyst 21.74 9.66 37 116008 4756 56171266
Dementia Alzheimer's type 21.69 9.66 18 116027 1073 56174949
Hemiplegia 21.39 9.66 51 115994 8353 56167669
Complex regional pain syndrome 21.22 9.66 24 116021 2099 56173923
Multiple injuries 21.22 9.66 22 116023 1744 56174278
Colon cancer 21.16 9.66 55 115990 9506 56166516
Iron deficiency anaemia 21.14 9.66 83 115962 17836 56158186
Aortic arteriosclerosis 21.10 9.66 40 116005 5590 56170432
Lacunar infarction 20.93 9.66 29 116016 3116 56172906
Pneumothorax traumatic 20.93 9.66 9 116036 154 56175868
Renin decreased 20.88 9.66 8 116037 100 56175922
Coronary artery occlusion 20.87 9.66 48 115997 7681 56168341
Drug ineffective for unapproved indication 20.34 9.66 14 116031 25679 56150343
Impaired work ability 20.13 9.66 3 116042 14569 56161453
Diabetic nephropathy 20.11 9.66 19 116026 1345 56174677
Frustration tolerance decreased 20.04 9.66 42 116003 6311 56169711
Lung diffusion test decreased 19.90 9.66 14 116031 651 56175371
Mobility decreased 19.86 9.66 121 115924 98870 56077152
Psychotic disorder 19.79 9.66 12 116033 23546 56152476
Feeling abnormal 19.76 9.66 386 115659 133216 56042806
Neonatal seizure 19.67 9.66 12 116033 437 56175585
Retrograde amnesia 19.62 9.66 12 116033 439 56175583
Angiotensin converting enzyme inhibitor foetopathy 19.38 9.66 6 116039 37 56175985
Malaise 19.28 9.66 935 115110 366925 55809097
Bronchitis 19.24 9.66 332 115713 111979 56064043
Hypertensive emergency 19.21 9.66 20 116025 1593 56174429
Inguinal hernia 19.20 9.66 21 116024 1770 56174252
Monoplegia 19.16 9.66 27 116018 2947 56173075
Hypertensive heart disease 19.15 9.66 24 116021 2339 56173683
Monocyte count abnormal 19.12 9.66 9 116036 192 56175830
Ischaemic stroke 19.06 9.66 77 115968 16765 56159257
Multiple sclerosis relapse 19.02 9.66 40 116005 44863 56131159
Withdrawal hypertension 18.98 9.66 8 116037 130 56175892
Ear infection 18.85 9.66 22 116023 31273 56144749
Asthma 18.83 9.66 332 115713 112438 56063584
Melaena 18.77 9.66 111 115934 28179 56147843
Haemarthrosis 18.68 9.66 27 116018 3017 56173005
Injection site erythema 18.67 9.66 89 115956 77359 56098663
Multi-organ disorder 18.58 9.66 18 116027 1315 56174707
Cardiac failure acute 18.58 9.66 50 115995 8823 56167199
Neutrophil function disorder 18.56 9.66 5 116040 17 56176005
Peak expiratory flow rate decreased 18.55 9.66 13 116032 601 56175421
Herpes simplex reactivation 18.49 9.66 12 116033 488 56175534
Uterine enlargement 18.45 9.66 17 116028 1166 56174856
Rectal prolapse 18.42 9.66 21 116024 1853 56174169
Dyspnoea 18.33 9.66 1438 114607 591139 55584883
Interstitial lung disease 18.27 9.66 189 115856 56874 56119148
Cardiac disorder 18.18 9.66 159 115886 45728 56130294
Cardiac pacemaker insertion 18.18 9.66 30 116015 3760 56172262
Nephrogenic anaemia 18.15 9.66 21 116024 1883 56174139
Ophthalmic vein thrombosis 18.12 9.66 9 116036 217 56175805
Anaesthesia 18.10 9.66 11 116034 398 56175624
Kyphosis 18.05 9.66 23 116022 2279 56173743
Palpitations 17.93 9.66 297 115748 99375 56076647
Prescribed overdose 17.85 9.66 12 116033 22284 56153738
Intentional product misuse 17.79 9.66 51 115994 51453 56124569
Glycosylated haemoglobin increased 17.71 9.66 57 115988 11108 56164914
Therapy non-responder 17.57 9.66 66 115979 61289 56114733
Hyponatraemic syndrome 17.57 9.66 12 116033 532 56175490
Arteriosclerosis 17.56 9.66 51 115994 9402 56166620
Fear 17.55 9.66 69 115976 14839 56161183
Body height decreased 17.49 9.66 50 115995 9135 56166887
Ventricular hypertrophy 17.41 9.66 27 116018 3211 56172811
Chronic sinusitis 17.33 9.66 47 115998 8331 56167691
Brain contusion 17.31 9.66 12 116033 545 56175477
Gout 17.26 9.66 60 115985 12161 56163861
Cerebral haemorrhage 16.94 9.66 109 115936 28497 56147525
Infarction 16.77 9.66 23 116022 2448 56173574
Stenosis 16.72 9.66 17 116028 1317 56174705
Arrhythmogenic right ventricular dysplasia 16.71 9.66 5 116040 27 56175995
No adverse event 16.61 9.66 31 116014 36343 56139679
Hepatic function abnormal 16.53 9.66 125 115920 34433 56141589
Coronary artery bypass 16.48 9.66 22 116023 2281 56173741
Urine albumin/creatinine ratio increased 16.33 9.66 9 116036 270 56175752
Respiration abnormal 16.31 9.66 36 116009 5605 56170417
Breast neoplasm 16.28 9.66 17 116028 1359 56174663
Visual acuity reduced 16.20 9.66 85 115960 20641 56155381
Lipoedema 16.18 9.66 9 116036 275 56175747
Hyperlipidaemia 16.08 9.66 77 115968 18032 56157990
Cataract 16.06 9.66 169 115876 51078 56124944
Transitional cell cancer of the renal pelvis and ureter 16.05 9.66 4 116041 9 56176013
Carotid artery disease 16.05 9.66 18 116027 1560 56174462
Therapeutic drug monitoring analysis incorrectly performed 16.02 9.66 8 116037 195 56175827
Anaphylactic reaction 15.91 9.66 65 115980 58930 56117092
Knee arthroplasty 15.90 9.66 43 116002 44216 56131806
C-reactive protein increased 15.87 9.66 239 115806 78445 56097577
Left ventricular hypertrophy 15.78 9.66 33 116012 4951 56171071
Device dislocation 15.77 9.66 14 116031 22592 56153430
Post-anoxic myoclonus 15.73 9.66 5 116040 34 56175988
Intentional self-injury 15.68 9.66 17 116028 24975 56151047
Nodal rhythm 15.56 9.66 18 116027 1613 56174409
Chronic obstructive pulmonary disease 15.56 9.66 184 115861 57231 56118791
Diapedesis 15.56 9.66 3 116042 0 56176022
Stress cardiomyopathy 15.51 9.66 45 116000 8291 56167731
Eye haemorrhage 15.22 9.66 43 116002 7804 56168218
Incorrect route of product administration 15.13 9.66 13 116032 21316 56154706
Gingival ulceration 15.06 9.66 13 116032 818 56175204
Pollakiuria 14.91 9.66 96 115949 25106 56150916
Sedation 14.80 9.66 31 116014 34823 56141199
Skin texture abnormal 14.79 9.66 10 116035 436 56175586
Cranial sutures widening 14.76 9.66 4 116041 14 56176008
Granuloma 14.73 9.66 34 116011 5453 56170569
Dyspnoea exertional 14.70 9.66 175 115870 54514 56121508
Subarachnoid haemorrhage 14.57 9.66 54 115991 11293 56164729
Product contamination 14.54 9.66 11 116034 573 56175449
Gastroenteritis 14.44 9.66 93 115952 24319 56151703
Ulcer 14.43 9.66 15 116030 22470 56153552
Coronary angioplasty 14.37 9.66 6 116039 95 56175927
Pyometra 14.37 9.66 6 116039 95 56175927
Blood aldosterone increased 14.31 9.66 7 116038 163 56175859
Eructation 14.15 9.66 41 116004 7547 56168475
Disease recurrence 14.13 9.66 17 116028 23843 56152179
Grip strength decreased 14.06 9.66 8 116037 16248 56159774
Antiphospholipid syndrome 14.00 9.66 17 116028 1604 56174418
Acute phosphate nephropathy 13.96 9.66 4 116041 18 56176004
Bezold-Jarisch reflex 13.96 9.66 4 116041 18 56176004
Bone marrow failure 13.92 9.66 23 116022 28263 56147759
Pulmonary oedema 13.90 9.66 164 115881 50979 56125043
Diabetic retinopathy 13.87 9.66 20 116025 2229 56173793
Thyroxine decreased 13.85 9.66 11 116034 616 56175406
Bladder transitional cell carcinoma 13.82 9.66 11 116034 618 56175404
Adverse event 13.72 9.66 63 115982 55313 56120709
Pulmonary thrombosis 13.64 9.66 42 116003 7995 56168027
Device issue 13.64 9.66 14 116031 21092 56154930
Haematochezia 13.62 9.66 144 115901 43574 56132448
Swollen tongue 13.57 9.66 108 115937 30216 56145806
Suicidal ideation 13.54 9.66 67 115978 57675 56118347
Brain natriuretic peptide increased 13.49 9.66 30 116015 4696 56171326
Renal cell carcinoma 13.46 9.66 25 116020 3440 56172582
Product taste abnormal 13.46 9.66 18 116027 1870 56174152
Cerebral arteriosclerosis 13.40 9.66 8 116037 280 56175742
Gastric cancer 13.35 9.66 27 116018 3956 56172066
Groin pain 13.32 9.66 46 115999 9294 56166728
Asthmatic crisis 13.27 9.66 17 116028 1693 56174329
Carpal tunnel syndrome 13.22 9.66 73 115972 18071 56157951
Low density lipoprotein increased 13.21 9.66 34 116011 5840 56170182
Malignant neoplasm progression 13.21 9.66 93 115952 73494 56102528
Affective disorder 13.20 9.66 33 116012 5570 56170452
Myelosuppression 13.18 9.66 10 116035 17445 56158577
Ischaemic cardiomyopathy 13.18 9.66 20 116025 2334 56173688
Deafness 13.14 9.66 68 115977 16426 56159596
Duodenal polyp 13.10 9.66 6 116039 120 56175902
Blood pressure fluctuation 13.07 9.66 134 115911 40226 56135796
Joint range of motion decreased 13.07 9.66 20 116025 25345 56150677
Renal neoplasm 13.06 9.66 14 116031 1153 56174869
Mouth ulceration 12.89 9.66 26 116019 29614 56146408
Hyperglycaemia 12.83 9.66 128 115917 38153 56137869
Sinus arrest 12.83 9.66 17 116028 1750 56174272
Occult blood positive 12.80 9.66 24 116021 3327 56172695
Cardiogenic shock 12.79 9.66 67 115978 16258 56159764
Prerenal failure 12.77 9.66 16 116029 1559 56174463
Bradycardia neonatal 12.76 9.66 12 116033 845 56175177
Merycism 12.73 9.66 7 116038 209 56175813
Ankle fracture 12.63 9.66 67 115978 16336 56159686
Gastritis 12.60 9.66 118 115927 34584 56141438
Metastases to bone 12.54 9.66 13 116032 19495 56156527
Ligament injury 12.52 9.66 13 116032 1032 56174990
Cardiac myxoma 12.52 9.66 7 116038 216 56175806
Paraesthesia oral 12.52 9.66 61 115984 14388 56161634
Inflammatory marker increased 12.43 9.66 34 116011 6056 56169966
Speech disorder 12.39 9.66 125 115920 37368 56138654
Urticaria chronic 12.36 9.66 10 116035 575 56175447
Blood sodium increased 12.35 9.66 20 116025 2468 56173554
Status epilepticus 12.32 9.66 8 116037 15133 56160889
Lymphostasis 12.28 9.66 3 116042 6 56176016
Hypertensive encephalopathy 12.27 9.66 10 116035 581 56175441
Postural tremor 12.24 9.66 7 116038 226 56175796
Product substitution issue 12.20 9.66 61 115984 14538 56161484
Circulatory collapse 12.15 9.66 79 115966 20724 56155298
Prosthesis implantation 12.10 9.66 5 116040 77 56175945
Peritoneal haematoma 12.05 9.66 5 116040 78 56175944
Catheterisation cardiac 12.04 9.66 27 116018 4248 56171774
Haematuria 12.02 9.66 96 115949 26891 56149131
Microangiopathy 11.95 9.66 13 116032 1089 56174933
Multiple drug therapy 11.94 9.66 21 116024 2771 56173251
Anuria 11.93 9.66 52 115993 11708 56164314
Gastrointestinal stromal tumour 11.91 9.66 14 116031 1277 56174745
Fibromyalgia 11.87 9.66 73 115972 59530 56116492
Mydriasis 11.86 9.66 4 116041 11067 56164955
Marasmus 11.83 9.66 9 116036 473 56175549
Coronary artery restenosis 11.80 9.66 8 116037 350 56175672
Fixed eruption 11.79 9.66 12 116033 931 56175091
Duodenal ulcer 11.78 9.66 37 116008 7118 56168904
Glomerulosclerosis 11.76 9.66 8 116037 352 56175670
Injection site swelling 11.76 9.66 48 115997 43530 56132492
Ankylosing spondylitis 11.71 9.66 3 116042 9927 56166095
Carotid artery stenosis 11.65 9.66 29 116016 4881 56171141
Gastrointestinal cancer metastatic 11.60 9.66 5 116040 86 56175936
Dysaesthesia 11.60 9.66 26 116019 4090 56171932
Erysipelas 11.60 9.66 37 116008 7176 56168846
Panniculitis 11.56 9.66 3 116042 9839 56166183
Polyuria 11.48 9.66 38 116007 7513 56168509
Cutaneous lymphoma 11.46 9.66 6 116039 162 56175860
Perihepatic discomfort 11.42 9.66 3 116042 9 56176013
Upper-airway cough syndrome 11.36 9.66 44 116001 9394 56166628
Heat illness 11.36 9.66 6 116039 165 56175857
Movement disorder 11.27 9.66 73 115972 19125 56156897
Microalbuminuria 11.26 9.66 8 116037 378 56175644
Large intestine polyp 11.26 9.66 38 116007 7589 56168433
Atrial flutter 11.25 9.66 43 116002 9126 56166896
Emotional distress 11.21 9.66 102 115943 29661 56146361
Fabry's disease 11.18 9.66 3 116042 10 56176012
Dementia 11.18 9.66 67 115978 17091 56158931
Cytomegalovirus infection 11.16 9.66 14 116031 19282 56156740
Cell marker increased 11.14 9.66 7 116038 269 56175753
Ear pain 11.10 9.66 30 116015 30860 56145162
Rhinitis 11.09 9.66 42 116003 8874 56167148
Neutropenic sepsis 11.09 9.66 9 116036 15176 56160846
Blood alkaline phosphatase increased 11.08 9.66 126 115919 38819 56137203
Renal atrophy 11.05 9.66 14 116031 1379 56174643
Pulmonary hypertension 11.01 9.66 118 115927 35826 56140196
Tenosynovitis 10.96 9.66 6 116039 12455 56163567
C-reactive protein abnormal 10.93 9.66 39 116006 36770 56139252
Renal disorder 10.92 9.66 101 115944 29504 56146518
Dysuria 10.91 9.66 104 115941 30625 56145397
Prescribed underdose 10.87 9.66 16 116029 20601 56155421
Weight increased 10.86 9.66 376 115669 229327 55946695
Adverse reaction 10.83 9.66 3 116042 9424 56166598
Exercise tolerance decreased 10.80 9.66 29 116016 5109 56170913
Atrioventricular block 10.78 9.66 35 116010 6852 56169170
Skin ulcer 10.75 9.66 42 116003 38566 56137456
Wound dehiscence 10.68 9.66 27 116018 4588 56171434
Oesophageal food impaction 10.68 9.66 6 116039 187 56175835
Glomerular filtration rate decreased 10.64 9.66 52 115993 12277 56163745
Anxiety disorder 10.62 9.66 24 116021 3796 56172226
Dyslipidaemia 10.60 9.66 33 116012 6320 56169702
Cutaneous listeriosis 10.59 9.66 4 116041 48 56175974
Decreased appetite 10.58 9.66 553 115492 218678 55957344
Haemorrhage subcutaneous 10.58 9.66 20 116025 2790 56173232
Diverticulum 10.52 9.66 48 115997 11018 56165004
Inappropriate antidiuretic hormone secretion 10.47 9.66 56 115989 13700 56162322
Large intestinal ulcer haemorrhage 10.44 9.66 5 116040 111 56175911
Gastric mucosa erythema 10.40 9.66 7 116038 303 56175719
Hypercholesterolaemia 10.39 9.66 58 115987 14415 56161607
General physical health deterioration 10.38 9.66 439 115606 169571 56006451
Tumour rupture 10.36 9.66 5 116040 113 56175909
Azotaemia 10.33 9.66 25 116020 4133 56171889
Oesophageal achalasia 10.32 9.66 8 116037 432 56175590
Intracranial aneurysm 10.32 9.66 22 116023 3345 56172677
Blood chloride decreased 10.32 9.66 29 116016 5248 56170774
Joint contracture 10.30 9.66 15 116030 1687 56174335
Haemodialysis 10.30 9.66 40 116005 8551 56167471
Carotid artery occlusion 10.29 9.66 19 116026 2604 56173418
Affect lability 10.27 9.66 4 116041 10121 56165901
Procedural pain 10.26 9.66 63 115982 16208 56159814
Brain stem haemorrhage 10.22 9.66 10 116035 740 56175282
Seizure 10.18 9.66 189 115856 124930 56051092
Meniere's disease 10.18 9.66 6 116039 205 56175817
Therapy cessation 10.17 9.66 26 116019 27238 56148784
Renal artery stent placement 10.16 9.66 5 116040 118 56175904
Lymphocyte count decreased 10.14 9.66 27 116018 27912 56148110
Nocturia 10.14 9.66 35 116010 7071 56168951
Pyrexia 10.12 9.66 735 115310 418038 55757984
Carcinogenicity 10.06 9.66 3 116042 16 56176006
Breath sounds abnormal 10.05 9.66 41 116004 8966 56167056
Eczema 10.04 9.66 90 115955 26063 56149959
Periodontal disease 10.03 9.66 14 116031 1514 56174508
Varicose vein ruptured 10.03 9.66 4 116041 56 56175966
Hypersensitivity pneumonitis 10.00 9.66 18 116027 2419 56173603
Multiple sclerosis 9.99 9.66 27 116018 27775 56148247
Mesothelioma malignant 9.97 9.66 4 116041 57 56175965
Hepatic steatosis 9.95 9.66 90 115955 26124 56149898
Hepatotoxicity 9.94 9.66 32 116013 31121 56144901
Stool analysis abnormal 9.90 9.66 4 116041 58 56175964
Liver iron concentration abnormal 9.90 9.66 4 116041 58 56175964
Parkinson's disease 9.87 9.66 13 116032 1331 56174691
Urticaria 9.86 9.66 225 115820 144451 56031571
Pemphigoid 9.85 9.66 32 116013 6268 56169754
Mood swings 9.85 9.66 12 116033 16735 56159287
Injection site vesicles 9.83 9.66 19 116026 2694 56173328
Gait disturbance 9.80 9.66 421 115624 162900 56013122
Airway remodelling 9.78 9.66 4 116041 60 56175962
Haemorrhagic tumour necrosis 9.76 9.66 3 116042 18 56176004
Device related infection 9.68 9.66 19 116026 21861 56154161
Pigmentation disorder 9.66 9.66 24 116021 4035 56171987

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
Off label use 257.54 10.32 316 82136 346958 31267934
Blood pressure inadequately controlled 208.96 10.32 110 82342 2359 31612533
Drug abuse 181.22 10.32 12 82440 87746 31527146
Blood pressure increased 175.70 10.32 530 81922 79103 31535789
Blood creatinine increased 128.52 10.32 515 81937 88563 31526329
Death 125.84 10.32 498 81954 360071 31254821
Hypertension 116.14 10.32 647 81805 127453 31487439
Drug ineffective 113.69 10.32 587 81865 394986 31219906
Cerebral infarction 113.38 10.32 225 82227 25752 31589140
Toxicity to various agents 112.41 10.32 187 82265 181300 31433592
Cardiac failure 98.70 10.32 464 81988 85489 31529403
Hyperkalaemia 95.13 10.32 375 82077 63976 31550916
Myocardial infarction 94.26 10.32 560 81892 112894 31501998
Completed suicide 91.49 10.32 63 82389 91451 31523441
Blood urea increased 89.91 10.32 219 82233 28793 31586099
Renal failure 74.25 10.32 562 81890 122768 31492124
Hypertensive crisis 72.36 10.32 98 82354 8149 31606743
Product use in unapproved indication 69.23 10.32 94 82358 99077 31515815
Febrile neutropenia 68.66 10.32 133 82319 121716 31493176
Cerebrovascular accident 66.38 10.32 393 82059 79091 31535801
Dizziness 66.18 10.32 800 81652 198347 31416545
Fear of disease 65.44 10.32 26 82426 280 31614612
Neutropenia 63.88 10.32 172 82280 140192 31474700
Cardiac failure congestive 59.04 10.32 381 82071 79006 31535886
Syncope 58.05 10.32 400 82052 84782 31530110
Renal impairment 52.20 10.32 394 82058 85955 31528937
Acute myocardial infarction 51.59 10.32 265 82187 50558 31564334
Angina pectoris 51.48 10.32 182 82270 29459 31585433
Product dose omission issue 49.83 10.32 127 82325 105459 31509433
Treatment failure 49.54 10.32 22 82430 40770 31574122
Cardiac failure chronic 48.39 10.32 76 82376 7227 31607665
Interstitial lung disease 47.06 10.32 297 82155 61106 31553786
Angioedema 46.51 10.32 192 82260 33426 31581466
Sepsis 41.96 10.32 228 82224 151701 31463191
Acute kidney injury 41.66 10.32 986 81466 278728 31336164
Blood creatine phosphokinase increased 40.62 10.32 216 82236 41758 31573134
Blood lactic acid 39.85 10.32 19 82433 327 31614565
Blood pressure decreased 39.61 10.32 237 82215 47854 31567038
Sprue-like enteropathy 39.61 10.32 21 82431 457 31614435
Product use issue 39.38 10.32 54 82398 56705 31558187
Mitral valve incompetence 39.34 10.32 102 82350 13931 31600961
Hospitalisation 39.18 10.32 43 82409 49764 31565128
Coronary artery disease 39.17 10.32 229 82223 45858 31569034
Eosinophilic colitis 37.87 10.32 16 82436 204 31614688
Oxygen saturation increased 36.49 10.32 17 82435 277 31614615
Plasma cell myeloma 36.08 10.32 57 82395 56474 31558418
Glomerular filtration rate decreased 35.09 10.32 88 82364 11777 31603115
Hypotension 34.73 10.32 735 81717 203883 31411009
Disease progression 34.59 10.32 120 82332 90344 31524548
Lymphocyte stimulation test positive 34.58 10.32 22 82430 680 31614212
Blood pressure diastolic decreased 34.46 10.32 69 82383 7944 31606948
Infusion related reaction 34.07 10.32 45 82407 48010 31566882
Product impurity 33.96 10.32 10 82442 38 31614854
Rheumatoid arthritis 33.66 10.32 45 82407 47764 31567128
Bundle branch block left 33.25 10.32 55 82397 5463 31609429
Aortic aneurysm 33.15 10.32 60 82392 6405 31608487
Drug dependence 32.87 10.32 9 82443 22570 31592322
Hyponatraemia 32.57 10.32 314 82138 73485 31541407
Gamma-glutamyltransferase increased 32.46 10.32 151 82301 27674 31587218
Intentional product use issue 32.21 10.32 49 82403 49298 31565594
Blood glucose increased 32.12 10.32 270 82182 60813 31554079
Brain natriuretic peptide abnormal 31.99 10.32 16 82436 307 31614585
Fractured coccyx 31.85 10.32 13 82439 151 31614741
Hemiplegia 31.48 10.32 60 82392 6662 31608230
Arrhythmia 31.17 10.32 169 82283 32908 31581984
Sinus arrest 31.07 10.32 28 82424 1473 31613419
Cerebral haemorrhage 30.49 10.32 167 82285 32645 31582247
Oedema peripheral 30.40 10.32 427 82025 109412 31505480
Pancreatic neoplasm 30.23 10.32 22 82430 851 31614041
Blood potassium increased 29.96 10.32 98 82354 15247 31599645
Arteriosclerosis 29.91 10.32 78 82374 10689 31604203
N-terminal prohormone brain natriuretic peptide abnormal 29.11 10.32 13 82439 191 31614701
COVID-19 29 10.32 62 82390 54759 31560133
Pulmonary arterial pressure abnormal 28.99 10.32 13 82439 193 31614699
Atrial fibrillation 28.60 10.32 435 82017 113348 31501544
Aggression 28.45 10.32 33 82419 37258 31577634
Adrenal adenoma 27.70 10.32 15 82437 341 31614551
Cell marker increased 27.62 10.32 16 82436 416 31614476
Type 2 diabetes mellitus 27.60 10.32 93 82359 14691 31600201
Blood triglycerides increased 27.46 10.32 87 82365 13310 31601582
Chronic kidney disease 27.43 10.32 181 82271 37794 31577098
Conduction disorder 27.08 10.32 29 82423 1885 31613007
Left ventricular dilatation 26.95 10.32 19 82433 699 31614193
Pulmonary valve stenosis congenital 26.93 10.32 11 82441 128 31614764
Clostridium difficile infection 26.87 10.32 6 82446 17273 31597619
Diabetes mellitus 26.72 10.32 196 82256 42360 31572532
Orthostatic intolerance 26.25 10.32 19 82433 729 31614163
Painful respiration 26.19 10.32 23 82429 1169 31613723
Intentional overdose 26.15 10.32 42 82410 41347 31573545
Drug ineffective for unapproved indication 26.06 10.32 7 82445 17783 31597109
Suicidal ideation 25.90 10.32 34 82418 36372 31578520
Shock 25.76 10.32 122 82330 22523 31592369
Mucosal inflammation 25.69 10.32 31 82421 34396 31580496
Condition aggravated 25.57 10.32 288 82164 163721 31451171
Cardiac failure acute 25.47 10.32 69 82383 9672 31605220
Lymphocyte count abnormal 25.34 10.32 19 82433 770 31614122
Ejection fraction abnormal 25.30 10.32 20 82432 877 31614015
Sedation 25.03 10.32 9 82443 18956 31595936
Agitation 24.88 10.32 66 82386 54103 31560789
Foetal exposure during pregnancy 24.42 10.32 43 82409 40833 31574059
Ventricular extrasystoles 24.36 10.32 74 82378 11068 31603824
Cerebellar ischaemia 24.36 10.32 10 82442 118 31614774
Intentional self-injury 24.30 10.32 3 82449 13312 31601580
Blood uric acid increased 24.05 10.32 52 82400 6318 31608574
Periarthritis calcarea 23.98 10.32 9 82443 82 31614810
Breast discomfort 23.87 10.32 6 82446 10 31614882
Articular calcification 23.70 10.32 9 82443 85 31614807
Gastritis erosive 23.58 10.32 48 82404 5591 31609301
Electrocardiogram QRS complex abnormal 23.34 10.32 13 82439 313 31614579
Microalbuminuria 23.08 10.32 17 82435 670 31614222
Lung diffusion disorder 22.98 10.32 9 82443 93 31614799
Blood cholesterol increased 22.98 10.32 96 82356 16797 31598095
Quality of life decreased 22.95 10.32 36 82416 3419 31611473
Thrombocytopenia 22.91 10.32 249 82203 142498 31472394
Goitre 22.73 10.32 24 82428 1535 31613357
Colon cancer 22.51 10.32 61 82391 8552 31606340
Pancytopenia 22.47 10.32 134 82318 87182 31527710
Blood thyroid stimulating hormone abnormal 22.44 10.32 13 82439 338 31614554
Drug resistance 22.30 10.32 17 82435 23436 31591456
Melaena 22.01 10.32 153 82299 32501 31582391
Pneumonia 21.92 10.32 685 81767 334627 31280265
Chronic pigmented purpura 21.86 10.32 9 82443 107 31614785
Merycism 21.80 10.32 8 82444 68 31614824
Walking aid user 21.77 10.32 24 82428 1612 31613280
Status epilepticus 21.44 10.32 3 82449 12103 31602789
Bradycardia 21.43 10.32 275 82177 69052 31545840
Atrioventricular block 21.36 10.32 54 82398 7261 31607631
Myocardial ischaemia 21.35 10.32 93 82359 16574 31598318
Subacute hepatic failure 21.21 10.32 8 82444 74 31614818
Immature granulocyte count increased 21.14 10.32 9 82443 117 31614775
Pemphigoid 21.04 10.32 58 82394 8213 31606679
Deep vein thrombosis 20.96 10.32 84 82368 60652 31554240
Aortic valve incompetence 20.65 10.32 45 82407 5496 31609396
Urine albumin/creatinine ratio increased 20.57 10.32 10 82442 180 31614712
Haemophagocytic lymphohistiocytosis 20.44 10.32 3 82449 11675 31603217
Ventricular hypokinesia 20.20 10.32 41 82411 4765 31610127
Gastric cancer 20.19 10.32 47 82405 5998 31608894
Chest injury 20.17 10.32 22 82430 1460 31613432
Psychotic disorder 20.14 10.32 17 82435 22276 31592616
Hyperglycaemia 20.11 10.32 163 82289 36313 31578579
Hepatitis E antibody positive 20.08 10.32 11 82441 256 31614636
Blood lactate dehydrogenase increased 19.89 10.32 105 82347 20234 31594658
Drug intolerance 19.89 10.32 69 82383 51964 31562928
Myelosuppression 19.83 10.32 7 82445 14913 31599979
Lateropulsion 19.82 10.32 4 82448 0 31614892
Vertigo 19.79 10.32 115 82337 22970 31591922
Vomiting 19.78 10.32 438 82014 223535 31391357
Hyperuricaemia 19.76 10.32 53 82399 7385 31607507
Osteoarthritis 19.74 10.32 100 82352 18967 31595925
Synovitis 19.64 10.32 4 82448 12279 31602613
Renal artery stenosis 19.62 10.32 26 82426 2116 31612776
Pyrexia 19.53 10.32 622 81830 303218 31311674
Coronary artery stenosis 19.48 10.32 59 82393 8811 31606081
Patent ductus arteriosus 19.47 10.32 32 82420 3161 31611731
Dyslipidaemia 19.45 10.32 48 82404 6358 31608534
Malignant neoplasm progression 19.41 10.32 123 82329 78875 31536017
Rhythm idioventricular 19.38 10.32 11 82441 275 31614617
Pulmonary hypoplasia 19.26 10.32 13 82439 445 31614447
Gouty arthritis 19.09 10.32 18 82434 1004 31613888
Hepatitis E virus test positive 19.06 10.32 11 82441 284 31614608
Coronary artery restenosis 18.94 10.32 18 82434 1014 31613878
Adrenal cyst 18.92 10.32 9 82443 154 31614738
Transient ischaemic attack 18.81 10.32 117 82335 23939 31590953
Coronary arterial stent insertion 18.79 10.32 36 82416 4012 31610880
Pyonephrosis 18.63 10.32 7 82445 64 31614828
Bundle branch block right 18.61 10.32 50 82402 6974 31607918
Renal failure neonatal 18.39 10.32 8 82444 110 31614782
Seizure 18.08 10.32 169 82283 99599 31515293
Neuropathy peripheral 17.96 10.32 119 82333 75530 31539362
Angioplasty 17.85 10.32 17 82435 960 31613932
Ejection fraction decreased 17.74 10.32 91 82361 17343 31597549
Bursitis 17.71 10.32 40 82412 5005 31609887
Oscillopsia 17.61 10.32 6 82446 40 31614852
Hypertrophic osteoarthropathy 17.41 10.32 7 82445 78 31614814
Lacunar infarction 17.31 10.32 29 82423 2911 31611981
Brain stem infarction 17.22 10.32 18 82434 1138 31613754
Blood pressure abnormal 17.11 10.32 50 82402 7319 31607573
Fear 17.10 10.32 61 82391 9913 31604979
Nephrogenic anaemia 16.96 10.32 24 82428 2079 31612813
Chest pain 16.93 10.32 411 82041 116546 31498346
Hypoparathyroidism 16.89 10.32 13 82439 548 31614344
Liver function test increased 16.84 10.32 6 82446 12708 31602184
Urticaria chronic 16.51 10.32 7 82445 90 31614802
Neurotoxicity 16.42 10.32 11 82441 16215 31598677
Retinopathy 16.24 10.32 22 82430 1829 31613063
Therapeutic product effect incomplete 16.00 10.32 59 82393 43637 31571255
Blood pressure systolic decreased 15.98 10.32 34 82418 4085 31610807
Idiopathic pulmonary fibrosis 15.92 10.32 34 82418 4096 31610796
Cardiac vein perforation 15.88 10.32 5 82447 25 31614867
Leukopenia 15.81 10.32 87 82365 57741 31557151
Surfactant protein increased 15.79 10.32 4 82448 7 31614885
Bile duct cancer 15.51 10.32 13 82439 620 31614272
Pericardial haemorrhage 15.47 10.32 28 82424 2989 31611903
Intentional product misuse 15.41 10.32 49 82403 37902 31576990
Chronic coronary syndrome 15.37 10.32 7 82445 108 31614784
Dyspnoea 15.33 10.32 1063 81389 342416 31272476
Osteochondrosis 15.27 10.32 15 82437 880 31614012
Septic shock 15.24 10.32 105 82347 66053 31548839
Peripheral arterial occlusive disease 15.19 10.32 39 82413 5294 31609598
Colitis 15.02 10.32 42 82410 33845 31581047
Nausea 14.95 10.32 652 81800 307295 31307597
Blepharochalasis 14.86 10.32 3 82449 0 31614892
Acquired C1 inhibitor deficiency 14.83 10.32 4 82448 10 31614882
Cardiac pacemaker insertion 14.81 10.32 26 82426 2709 31612183
Generalised tonic-clonic seizure 14.81 10.32 18 82434 19913 31594979
Product substitution issue 14.76 10.32 56 82396 9376 31605516
Diabetic nephropathy 14.75 10.32 22 82430 1999 31612893
Cytomegalovirus infection 14.75 10.32 26 82426 24681 31590211
Angina unstable 14.74 10.32 63 82389 11132 31603760
Psoriatic arthropathy 14.73 10.32 18 82434 19865 31595027
Dyspnoea exertional 14.62 10.32 160 82292 38677 31576215
Atrial thrombosis 14.46 10.32 22 82430 2035 31612857
Abnormal behaviour 14.29 10.32 25 82427 23803 31591089
Carotid artery stenosis 14.28 10.32 35 82417 4617 31610275
Kounis syndrome 14.24 10.32 22 82430 2062 31612830
Nephrocalcinosis 14.21 10.32 12 82440 578 31614314
Erectile dysfunction 14.08 10.32 92 82360 19143 31595749
Glycosylated haemoglobin increased 14.06 10.32 59 82393 10341 31604551
Protein urine present 14.03 10.32 36 82416 4884 31610008
Serotonin syndrome 13.90 10.32 17 82435 18756 31596136
Renal dysplasia 13.78 10.32 8 82444 209 31614683
Palpitations 13.72 10.32 144 82308 34439 31580453
Graft versus host disease 13.71 10.32 5 82447 10442 31604450
Abdominal tenderness 13.58 10.32 30 82422 3698 31611194
Sacroiliac joint dysfunction 13.58 10.32 5 82447 43 31614849
Atrioventricular block complete 13.52 10.32 51 82401 8514 31606378
Hypertensive heart disease 13.49 10.32 22 82430 2159 31612733
Therapy non-responder 13.49 10.32 44 82408 33767 31581125
Tricuspid valve incompetence 13.47 10.32 52 82400 8777 31606115
Loss of consciousness 13.44 10.32 279 82173 77076 31537816
Bronchitis 13.44 10.32 157 82295 38560 31576332
Diabetic retinopathy 13.42 10.32 19 82433 1647 31613245
Post streptococcal glomerulonephritis 13.38 10.32 5 82447 45 31614847
Cardiovascular disorder 13.31 10.32 54 82398 9324 31605568
Extrapyramidal disorder 13.31 10.32 7 82445 11771 31603121
Eyelid ptosis congenital 13.27 10.32 6 82446 91 31614801
Dystonia 13.24 10.32 5 82447 10220 31604672
Respiratory depression 13.19 10.32 11 82441 14499 31600393
Chest wall haematoma 13.17 10.32 7 82445 153 31614739
Lipid metabolism disorder 13.16 10.32 9 82443 315 31614577
Malabsorption 13.04 10.32 21 82431 2040 31612852
Blood pressure systolic increased 12.98 10.32 91 82361 19379 31595513
Electrocardiogram ST segment depression 12.96 10.32 22 82430 2231 31612661
Ischaemic stroke 12.93 10.32 82 82370 16889 31598003
Chest discomfort 12.87 10.32 190 82262 49179 31565713
Hypocapnia 12.81 10.32 7 82445 162 31614730
Stress urinary incontinence 12.81 10.32 6 82446 99 31614793
Ischaemic cardiomyopathy 12.74 10.32 39 82413 5858 31609034
Coronary artery occlusion 12.67 10.32 57 82395 10299 31604593
Costal cartilage fracture 12.61 10.32 8 82444 246 31614646
Hepatic calcification 12.60 10.32 9 82443 338 31614554
Loss of personal independence in daily activities 12.59 10.32 35 82417 28253 31586639
Tachycardia 12.58 10.32 132 82320 76075 31538817
Lower respiratory tract infection 12.52 10.32 35 82417 28202 31586690
Influenza 12.49 10.32 66 82386 44259 31570633
Lip oedema 12.47 10.32 22 82430 2302 31612590
Intermittent claudication 12.46 10.32 21 82431 2118 31612774
Atrioventricular block first degree 12.44 10.32 38 82414 5699 31609193
Renal cyst 12.38 10.32 49 82403 8367 31606525
Adrenomegaly 12.33 10.32 9 82443 350 31614542
Malignant melanoma 12.26 10.32 46 82406 7661 31607231
Thrombotic stroke 12.19 10.32 8 82444 261 31614631
Abdominal compartment syndrome 12.13 10.32 13 82439 846 31614046
Extrasystoles 12.13 10.32 28 82424 3554 31611338
Oedema neonatal 12.10 10.32 4 82448 24 31614868
Bacteraemia 12.00 10.32 17 82435 17617 31597275
Myosclerosis 11.98 10.32 8 82444 269 31614623
Constipation 11.94 10.32 239 82213 123752 31491140
Activated partial thromboplastin time shortened 11.93 10.32 10 82442 477 31614415
Small intestine carcinoma 11.92 10.32 11 82441 597 31614295
Coronary angioplasty 11.91 10.32 9 82443 369 31614523
Primary hyperaldosteronism 11.89 10.32 5 82447 63 31614829
Injection site pain 11.88 10.32 48 82404 34586 31580306
Erythema multiforme 11.88 10.32 47 82405 8024 31606868
Nodal rhythm 11.86 10.32 16 82436 1325 31613567
Haematocrit decreased 11.85 10.32 125 82327 29936 31584956
Arteriosclerosis coronary artery 11.75 10.32 59 82393 11149 31603743
Metamyelocyte count increased 11.74 10.32 9 82443 377 31614515
Neutropenic sepsis 11.73 10.32 9 82443 12370 31602522
Aneurysm 11.72 10.32 18 82434 1678 31613214
Carcinoid tumour 11.72 10.32 8 82444 279 31614613
Ventricular hypertrophy 11.72 10.32 31 82421 4285 31610607
Miscarriage of partner 11.58 10.32 3 82449 6 31614886
Legionella test positive 11.58 10.32 3 82449 6 31614886
Genital candidiasis 11.54 10.32 5 82447 68 31614824
Myoglobin blood increased 11.46 10.32 22 82430 2455 31612437
Osteitis deformans 11.45 10.32 4 82448 29 31614863
Choroidal detachment 11.42 10.32 9 82443 393 31614499
Lymphocyte count 11.41 10.32 5 82447 70 31614822
Inguinal hernia 11.40 10.32 42 82410 6933 31607959
pH body fluid increased 11.35 10.32 5 82447 71 31614821
Adverse drug reaction 11.35 10.32 31 82421 25170 31589722
Emotional distress 11.33 10.32 70 82382 14286 31600606
Appendicitis 11.30 10.32 8 82444 11457 31603435
Dyslalia 11.28 10.32 10 82442 515 31614377
Diastolic dysfunction 11.26 10.32 35 82417 5300 31609592
Joint stiffness 11.26 10.32 6 82446 10015 31604877
Hypercholesterolaemia 11.21 10.32 46 82406 7984 31606908
Acute coronary syndrome 11.15 10.32 64 82388 12725 31602167
Pancreatitis chronic 11.09 10.32 20 82432 2128 31612764
Haemangioma 11.06 10.32 18 82434 1764 31613128
Cardiac valve sclerosis 11.05 10.32 5 82447 76 31614816
Hallucination 11.02 10.32 73 82379 46337 31568555
Paranoia 10.89 10.32 7 82445 10548 31604344
Pulmonary arterial hypertension 10.86 10.32 6 82446 9815 31605077
Small intestinal haemorrhage 10.83 10.32 19 82433 1979 31612913
Concomitant disease progression 10.79 10.32 21 82431 2368 31612524
Aortic aneurysm rupture 10.73 10.32 13 82439 967 31613925
Neuromyopathy 10.72 10.32 13 82439 968 31613924
Venoocclusive liver disease 10.70 10.32 3 82449 7409 31607483
Transplant rejection 10.63 10.32 6 82446 9702 31605190
Pulmonary embolism 10.59 10.32 149 82303 81497 31533395
Blood cholesterol decreased 10.56 10.32 13 82439 983 31613909
Product residue present 10.54 10.32 22 82430 2608 31612284
Feeling cold 10.52 10.32 51 82401 9503 31605389
Blood zinc decreased 10.49 10.32 3 82449 10 31614882
Proteinuria 10.40 10.32 77 82375 16686 31598206

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
Off label use 314.18 9.74 700 150366 742360 70035018
Blood pressure inadequately controlled 312.68 9.74 177 150889 5415 70771963
Blood pressure increased 255.28 9.74 932 150134 187585 70589793
Cardiac failure congestive 250.96 9.74 745 150321 134712 70642666
Hyperkalaemia 234.47 9.74 624 150442 105967 70671411
Myocardial infarction 234.40 9.74 851 150215 170794 70606584
Hypertension 229.05 9.74 1238 149828 294795 70482583
Hyponatraemia 228.23 9.74 805 150261 159282 70618096
Completed suicide 211.30 9.74 110 150956 227025 70550353
Rheumatoid arthritis 180.96 9.74 213 150853 291592 70485786
Cerebral infarction 180.90 9.74 327 150739 42682 70734696
Acute kidney injury 175.65 9.74 1660 149406 472964 70304414
Coronary artery disease 161.59 9.74 390 150676 62346 70715032
Hand deformity 154.41 9.74 7 151059 86475 70690903
Drug ineffective 152.86 9.74 1276 149790 938476 69838902
Cardiac failure 152.51 9.74 658 150408 142883 70634495
Hypertensive crisis 148.52 9.74 194 150872 19068 70758310
Toxicity to various agents 148.21 9.74 376 150690 381796 70395582
Drug abuse 148.12 9.74 64 151002 147192 70630186
Renal failure 147.58 9.74 793 150273 188277 70589101
Blood creatinine increased 136.48 9.74 635 150431 142366 70635012
Syncope 131.32 9.74 698 150368 165011 70612367
Glossodynia 124.43 9.74 18 151048 86469 70690909
Pemphigus 120.12 9.74 17 151049 83019 70694359
Systemic lupus erythematosus 120.12 9.74 34 151032 101868 70675510
Product use issue 115.09 9.74 128 150938 179809 70597569
Death 114.33 9.74 629 150437 509432 70267946
Product use in unapproved indication 113.62 9.74 166 150900 207312 70570066
Oedema peripheral 111.77 9.74 850 150216 227241 70550137
Infusion related reaction 110.18 9.74 156 150910 197378 70580000
Dizziness 100.60 9.74 1465 149601 462676 70314702
Alopecia 99.01 9.74 169 150897 198321 70579057
Hypotension 97.97 9.74 1302 149764 403079 70374299
Renal impairment 97.91 9.74 582 150484 143355 70634023
Cerebrovascular accident 97.52 9.74 580 150486 142890 70634488
Pericarditis 96.66 9.74 30 151036 84675 70692703
Febrile neutropenia 95.60 9.74 181 150885 204137 70573241
Acute myocardial infarction 94.01 9.74 355 150711 72532 70704846
Oligohydramnios 89.94 9.74 66 151000 3174 70774204
Atrial fibrillation 89.71 9.74 686 150380 183662 70593716
Blood urea increased 88.25 9.74 256 150810 45653 70731725
Arthropathy 87.19 9.74 115 150951 149942 70627436
Duodenal ulcer perforation 85.51 9.74 6 151060 51106 70726272
Joint swelling 82.05 9.74 271 150795 252940 70524438
Blood glucose increased 81.67 9.74 434 150632 102548 70674830
Treatment failure 81.19 9.74 113 150953 144029 70633349
Colitis microscopic 79.43 9.74 97 150969 8908 70768470
Angina pectoris 79.17 9.74 255 150811 48128 70729250
Mitral valve incompetence 76.27 9.74 173 150893 26555 70750823
Maternal exposure during pregnancy 76.00 9.74 80 150986 115265 70662113
Therapeutic product effect decreased 75.77 9.74 117 150949 142901 70634477
Wound 75.11 9.74 60 151006 98672 70678706
Condition aggravated 74.03 9.74 570 150496 427065 70350313
Cardiac failure chronic 70.87 9.74 98 150968 10171 70767207
Drug intolerance 67.42 9.74 250 150816 225437 70551941
Intentional product use issue 66.84 9.74 95 150971 120047 70657331
Helicobacter infection 66.64 9.74 18 151048 55638 70721740
Angioedema 65.87 9.74 299 150767 66311 70711067
Synovitis 65.36 9.74 109 150957 129119 70648259
Bronchial neoplasm 62.63 9.74 27 151039 449 70776929
Bundle branch block left 62.61 9.74 93 150973 10306 70767072
Pain 61.13 9.74 957 150109 627859 70149519
Neutropenia 60.88 9.74 311 150755 256845 70520533
Sleep disorder due to general medical condition, insomnia type 60.34 9.74 4 151062 35728 70741650
Bradycardia 59.62 9.74 462 150604 124153 70653225
Psoriatic arthropathy 59.23 9.74 32 151034 64739 70712639
Nasal turbinate hypertrophy 59.23 9.74 28 151038 583 70776795
Interstitial lung disease 59.21 9.74 404 150662 104281 70673097
Folliculitis 58.64 9.74 10 151056 42560 70734818
Blood creatine phosphokinase increased 56.89 9.74 270 150796 60993 70716385
Anaemia 56.82 9.74 1189 149877 402234 70375144
Contraindicated product administered 56.38 9.74 127 150939 134485 70642893
Chest pain 53.46 9.74 791 150275 250469 70526909
Thyroid disorder 53.22 9.74 97 150969 12735 70764643
Labile hypertension 53.22 9.74 25 151041 513 70776865
Product dose omission issue 53.18 9.74 260 150806 217208 70560170
Swelling 51.74 9.74 216 150850 188323 70589055
Intentional overdose 51.68 9.74 81 150985 98354 70679024
Exposure during pregnancy 51.16 9.74 67 150999 87650 70689728
Chronic kidney disease 50.93 9.74 261 150805 60796 70716582
Product prescribing error 50.44 9.74 190 150876 38762 70738616
Glaucoma 50.39 9.74 116 150950 17976 70759402
Rheumatoid factor positive 50.31 9.74 20 151046 48380 70728998
Product impurity 50.11 9.74 15 151051 78 70777300
Blood pressure decreased 49.29 9.74 349 150717 91166 70686212
Infection 48.15 9.74 258 150808 210527 70566851
Endometrial ablation 48.07 9.74 27 151039 813 70776565
Melaena 47.07 9.74 241 150825 56114 70721264
Muscle injury 46.94 9.74 12 151054 38482 70738896
Angina unstable 46.60 9.74 104 150962 15789 70761589
COVID-19 46.58 9.74 97 150969 105660 70671718
Rash 46.25 9.74 787 150279 509775 70267603
Diabetes mellitus inadequate control 46.17 9.74 129 150937 22516 70754862
Transient ischaemic attack 45.99 9.74 207 150859 45737 70731641
Discomfort 44.53 9.74 99 150967 105337 70672041
Sinus arrest 42.86 9.74 43 151023 3172 70774206
Blood lactate dehydrogenase increased 42.75 9.74 168 150898 34959 70742419
Bronchial haemorrhage 42.56 9.74 29 151037 1238 70776140
Diverticulitis 42.50 9.74 189 150877 41545 70735833
Arthralgia 42.40 9.74 786 150280 502604 70274774
Cardiac failure acute 42.13 9.74 106 150960 17381 70759997
Cerebral haemorrhage 42.00 9.74 226 150840 53638 70723740
Hospitalisation 41.41 9.74 70 150996 82498 70694880
Gamma-glutamyltransferase increased 41.12 9.74 215 150851 50470 70726908
Asthenia 40.54 9.74 1268 149798 456398 70320980
Blister 40.35 9.74 97 150969 100429 70676949
Total lung capacity increased 40.00 9.74 25 151041 920 70776458
Blood potassium increased 39.37 9.74 138 150928 27188 70750190
Arteriosclerosis 39.19 9.74 100 150966 16538 70760840
Coronary arterial stent insertion 38.86 9.74 55 151011 5832 70771546
Tricuspid valve incompetence 38.81 9.74 104 150962 17713 70759665
Stomatitis 38.58 9.74 142 150924 128369 70649009
Disease progression 38.47 9.74 187 150879 156485 70620893
Blood lactic acid 38.20 9.74 19 151047 444 70776934
Obstructive airways disorder 36.87 9.74 131 150935 25982 70751396
Foetal disorder 36.65 9.74 13 151053 124 70777254
Forced expiratory volume decreased 36.50 9.74 60 151006 7254 70770124
Musculoskeletal stiffness 36.49 9.74 176 150890 147584 70629794
Lymphatic fistula 35.98 9.74 22 151044 778 70776600
Femoral hernia incarcerated 35.81 9.74 22 151044 785 70776593
Arrhythmia 35.59 9.74 223 150843 55920 70721458
Atrioventricular block complete 35.58 9.74 91 150975 15072 70762306
Ischaemic stroke 35.58 9.74 145 150921 30675 70746703
Myocardial ischaemia 35.54 9.74 123 150943 24077 70753301
Drug ineffective for unapproved indication 35.29 9.74 19 151047 38519 70738859
Dehydration 35.27 9.74 677 150389 225465 70551913
N-terminal prohormone brain natriuretic peptide abnormal 35.04 9.74 15 151051 245 70777133
Drug resistance 34.72 9.74 19 151047 38171 70739207
Aortic aneurysm 34.55 9.74 61 151005 7812 70769566
Dyspnoea 34.36 9.74 1985 149081 768075 70009303
Rhabdomyolysis 34.26 9.74 333 150733 95427 70681951
Hypoglycaemia 34.18 9.74 329 150737 94035 70683343
Lower respiratory tract infection 34.03 9.74 123 150943 111790 70665588
Fall 33.85 9.74 1209 149857 442887 70334491
Fear of disease 33.76 9.74 23 151043 982 70776396
Hip arthroplasty 33.70 9.74 9 151057 28031 70749347
Diverticulum intestinal 33.62 9.74 61 151005 7980 70769398
Injection site pain 33.35 9.74 133 150933 117486 70659892
Rhonchi 33.26 9.74 40 151026 3615 70773763
Cardiovascular disorder 33.04 9.74 94 150972 16576 70760802
Drug hypersensitivity 32.82 9.74 379 150687 262080 70515298
Abortion spontaneous 32.78 9.74 8 151058 26471 70750907
Bronchitis 32.77 9.74 388 150678 116855 70660523
Hyperglycaemia 32.73 9.74 243 150823 64429 70712949
Irritable bowel syndrome 32.67 9.74 36 151030 50814 70726564
Pancreatic steatosis 32.65 9.74 23 151043 1037 70776341
Pancreatic neoplasm 32.59 9.74 26 151040 1417 70775961
Bronchial disorder 32.33 9.74 32 151034 2322 70775056
Lymphocyte stimulation test positive 31.75 9.74 23 151043 1084 70776294
Dyslipidaemia 31.74 9.74 67 150999 9793 70767585
Tachyarrhythmia 31.37 9.74 52 151014 6330 70771048
Macular degeneration 31.34 9.74 57 151009 7471 70769907
Intentional product misuse 31.00 9.74 78 150988 79517 70697861
Sinusitis 30.88 9.74 222 150844 168973 70608405
Eosinophilic colitis 30.65 9.74 16 151050 415 70776963
Coronary artery stenosis 30.62 9.74 73 150993 11571 70765807
Thrombotic stroke 30.43 9.74 19 151047 698 70776680
Diabetic retinopathy 30.20 9.74 34 151032 2863 70774515
Renal cyst 30.19 9.74 79 150987 13266 70764112
Sedation 30.11 9.74 33 151033 46698 70730680
Vascular resistance pulmonary decreased 30.07 9.74 10 151056 77 70777301
Haematoma 29.87 9.74 191 150875 48227 70729151
Pregnancy 29.80 9.74 7 151059 23774 70753604
Pemphigoid 29.69 9.74 81 150985 13941 70763437
Cardiomegaly 29.55 9.74 117 150949 24428 70752950
Status epilepticus 29.23 9.74 8 151058 24518 70752860
Liver function test increased 29.12 9.74 18 151048 33829 70743549
Myelosuppression 28.89 9.74 14 151052 30131 70747247
Adverse drug reaction 28.85 9.74 43 151023 53301 70724077
Gastrointestinal disorder 28.77 9.74 121 150945 105306 70672072
Atrioventricular block 28.59 9.74 75 150991 12613 70764765
Ischaemic cardiomyopathy 28.58 9.74 53 151013 7051 70770327
Coronary artery occlusion 28.54 9.74 81 150985 14264 70763114
Coronary artery restenosis 28.28 9.74 23 151043 1289 70776089
Hypokalaemia 28.25 9.74 414 150652 130774 70646604
Hemiplegia 28.17 9.74 79 150987 13816 70763562
Suicidal ideation 28.05 9.74 67 150999 69529 70707849
Drug dependence 27.98 9.74 23 151043 37298 70740080
Blood sodium decreased 27.60 9.74 135 150931 30863 70746515
Oxygen saturation increased 27.58 9.74 16 151050 513 70776865
Left-to-right cardiac shunt 27.51 9.74 10 151056 103 70777275
Glomerular filtration rate decreased 27.50 9.74 102 150964 20654 70756724
Impaired healing 27.35 9.74 75 150991 74299 70703079
Psychotic disorder 27.32 9.74 24 151042 37677 70739701
Sprue-like enteropathy 27.23 9.74 21 151045 1089 70776289
Cell marker increased 27.12 9.74 17 151049 629 70776749
Blood uric acid increased 27.06 9.74 60 151006 9069 70768309
Intentional self-injury 27.00 9.74 17 151049 31633 70745745
Renal artery stenosis 26.76 9.74 34 151032 3250 70774128
Blood pressure systolic increased 26.66 9.74 211 150855 57048 70720330
Wound infection pseudomonas 26.46 9.74 24 151042 1560 70775818
Left ventricular dilatation 26.43 9.74 20 151046 1008 70776370
Arterial haemorrhage 26.34 9.74 29 151037 2382 70774996
Ventricular hypertrophy 26.33 9.74 49 151017 6535 70770843
Venous pressure jugular increased 26.19 9.74 22 151044 1290 70776088
Injection site reaction 26.18 9.74 41 151025 49811 70727567
Lacunar infarction 26.12 9.74 45 151021 5651 70771727
Brain natriuretic peptide abnormal 26.02 9.74 17 151049 676 70776702
Periarthritis calcarea 25.74 9.74 9 151057 82 70777296
Hypocalvaria 25.71 9.74 7 151059 24 70777354
Device dislocation 25.62 9.74 8 151058 22499 70754879
Plasma cell myeloma 25.32 9.74 76 150990 73125 70704253
Inguinal hernia 25.28 9.74 45 151021 5800 70771578
Hypochromic anaemia 25.23 9.74 29 151037 2498 70774880
Hepatic function abnormal 25.08 9.74 238 150828 67758 70709620
Diabetes mellitus 24.83 9.74 248 150818 71576 70705802
Adrenal adenoma 24.82 9.74 20 151046 1106 70776272
Angiotensin converting enzyme inhibitor foetopathy 24.68 9.74 7 151059 29 70777349
Coronary angioplasty 24.33 9.74 13 151053 354 70777024
Migraine 24.27 9.74 76 150990 72162 70705216
Abdominal discomfort 24.17 9.74 317 150749 214341 70563037
Monoplegia 24.08 9.74 34 151032 3597 70773781
Ventricular extrasystoles 23.67 9.74 89 150977 18137 70759241
Cytomegalovirus infection 23.56 9.74 30 151036 39728 70737650
Shock 23.43 9.74 157 150909 40268 70737110
Clostridium difficile infection 23.30 9.74 29 151037 38787 70738591
Nodal rhythm 23.26 9.74 30 151036 2911 70774467
Haematochezia 23.20 9.74 248 150818 72833 70704545
Hepatic enzyme increased 23.16 9.74 218 150848 156772 70620606
Colon cancer 23.03 9.74 75 150991 14231 70763147
Vertigo 22.97 9.74 219 150847 62424 70714954
Skin reaction 22.93 9.74 74 150992 13975 70763403
Hyperuricaemia 22.88 9.74 63 151003 10903 70766475
Fibromyalgia 22.72 9.74 42 151024 47832 70729546
Disease recurrence 22.67 9.74 28 151038 37575 70739803
Orthostatic intolerance 22.40 9.74 23 151043 1744 70775634
Chronic pigmented purpura 22.33 9.74 10 151056 183 70777195
Eructation 22.31 9.74 58 151008 9702 70767676
Bundle branch block right 22.18 9.74 61 151005 10549 70766829
Hypertensive heart disease 22.12 9.74 34 151032 3882 70773496
Hepatitis E antibody positive 22.12 9.74 11 151055 257 70777121
Gastritis erosive 22.06 9.74 59 151007 10036 70767342
Graft versus host disease 21.90 9.74 3 151063 15020 70762358
Gastrointestinal haemorrhage 21.62 9.74 412 150654 136996 70640382
Fatigue 21.60 9.74 1489 149577 822830 69954548
Lung diffusion disorder 21.48 9.74 9 151057 139 70777239
Decreased appetite 21.31 9.74 822 150244 303958 70473420
Hepatitis E virus test positive 21.26 9.74 11 151055 280 70777098
Electrocardiogram QRS complex abnormal 21.16 9.74 14 151052 569 70776809
Atrial thrombosis 21.10 9.74 30 151036 3195 70774183
Blood aldosterone increased 20.99 9.74 10 151056 212 70777166
Carotid artery stenosis 20.98 9.74 51 151015 8185 70769193
Adrenomegaly 20.96 9.74 12 151054 375 70777003
Loss of consciousness 20.90 9.74 456 150610 155260 70622118
Lateropulsion 20.62 9.74 4 151062 0 70777378
Brain stem stroke 20.58 9.74 14 151052 596 70776782
Product substitution issue 20.50 9.74 86 150980 18427 70758951
Hepatic cyst 20.48 9.74 40 151026 5531 70771847
Brain contusion 20.44 9.74 19 151047 1275 70776103
Adrenal cyst 20.23 9.74 9 151057 162 70777216
Impaired work ability 20.10 9.74 5 151061 16335 70761043
Ventricular hypokinesia 20.01 9.74 50 151016 8162 70769216
Cytopenia 20 9.74 6 151060 17317 70760061
Prerenal failure 19.98 9.74 30 151036 3356 70774022
Blood triglycerides increased 19.98 9.74 89 150977 19575 70757803
Carotid artery disease 19.95 9.74 24 151042 2169 70775209
Rhythm idioventricular 19.94 9.74 13 151053 515 70776863
Dyspnoea exertional 19.94 9.74 255 150811 78175 70699203
Loss of personal independence in daily activities 19.89 9.74 103 150963 84807 70692571
Gastric ulcer haemorrhage 19.86 9.74 51 151015 8467 70768911
Myalgia 19.85 9.74 483 150583 167409 70609969
Chest injury 19.82 9.74 26 151040 2565 70774813
Renin decreased 19.74 9.74 8 151058 113 70777265
Low density lipoprotein increased 19.54 9.74 49 151017 8016 70769362
Fear 19.52 9.74 92 150974 20719 70756659
Tissue infiltration 19.51 9.74 14 151052 650 70776728
Retrograde amnesia 19.50 9.74 13 151053 535 70776843
Pyrexia 19.43 9.74 1076 149990 605876 70171502
Basal ganglion degeneration 19.34 9.74 12 151054 436 70776942
Neurotoxicity 19.29 9.74 21 151045 29805 70747573
Idiopathic pulmonary fibrosis 19.27 9.74 36 151030 4815 70772563
Aortic arteriosclerosis 19.27 9.74 48 151018 7821 70769557
Hypersensitivity 19.23 9.74 359 150707 229453 70547925
Articular calcification 19.19 9.74 9 151057 184 70777194
Septic shock 19.19 9.74 150 150916 112108 70665270
Pulmonary arterial pressure abnormal 19.17 9.74 14 151052 668 70776710
Bone marrow failure 19.10 9.74 48 151018 48962 70728416
Concomitant disease progression 19.03 9.74 29 151037 3286 70774092
Device issue 19.03 9.74 14 151052 24011 70753367
Malabsorption 18.98 9.74 35 151031 4635 70772743
Conduction disorder 18.93 9.74 28 151038 3090 70774288
Seroma 18.84 9.74 23 151043 2111 70775267
Renal cell carcinoma 18.78 9.74 45 151021 7156 70770222
Forced vital capacity decreased 18.71 9.74 20 151046 1589 70775789
Glycosylated haemoglobin increased 18.65 9.74 80 150986 17311 70760067
Nasopharyngitis 18.63 9.74 347 150719 221859 70555519
General physical health deterioration 18.29 9.74 644 150422 235387 70541991
Therapy non-responder 18.18 9.74 93 150973 76822 70700556
Uterine enlargement 17.97 9.74 15 151051 872 70776506
Neoplasm progression 17.86 9.74 44 151022 45184 70732194
Sinus node dysfunction 17.84 9.74 44 151022 7125 70770253
Blood alkaline phosphatase increased 17.84 9.74 197 150869 58324 70719054
Lipid metabolism disorder 17.78 9.74 10 151056 302 70777076
Neutropenic sepsis 17.76 9.74 16 151050 24814 70752564
Therapy interrupted 17.72 9.74 16 151050 24786 70752592
Pyonephrosis 17.66 9.74 7 151059 93 70777285
C-reactive protein increased 17.60 9.74 332 150734 110185 70667193
Aortic valve stenosis 17.50 9.74 35 151031 4924 70772454
Product odour abnormal 17.40 9.74 17 151049 1214 70776164
Neutrophil function disorder 17.38 9.74 5 151061 22 70777356
Hiatus hernia 17.38 9.74 90 150976 21044 70756334
Pericardial haemorrhage 17.37 9.74 32 151034 4236 70773142
Haemorrhage subcutaneous 17.34 9.74 33 151033 4476 70772902
Ophthalmic vein thrombosis 17.33 9.74 9 151057 231 70777147
Peak expiratory flow rate decreased 17.27 9.74 13 151053 650 70776728
Respiratory arrest 17.25 9.74 58 151008 53875 70723503
Peripheral swelling 16.98 9.74 379 150687 236184 70541194
Cardiac vein perforation 16.86 9.74 5 151061 25 70777353
Seizure 16.82 9.74 272 150794 177690 70599688
Altered state of consciousness 16.76 9.74 144 150922 39878 70737500
Chronic coronary syndrome 16.71 9.74 7 151059 108 70777270
Toxic skin eruption 16.68 9.74 86 150980 20076 70757302
Mucosal inflammation 16.63 9.74 81 150985 67769 70709609
Transplant rejection 16.58 9.74 9 151057 18162 70759216
Left ventricular dysfunction 16.56 9.74 79 150987 17878 70759500
Coronary artery bypass 16.53 9.74 38 151028 5882 70771496
Malignant melanoma 16.52 9.74 66 151000 13834 70763544
Rectal prolapse 16.52 9.74 21 151045 2008 70775370
Pneumothorax traumatic 16.52 9.74 9 151057 255 70777123
Goitre 16.51 9.74 35 151031 5131 70772247
Renal injury 16.47 9.74 73 150993 16021 70761357
Infective pulmonary exacerbation of cystic fibrosis 16.43 9.74 3 151063 12155 70765223
Rhinitis 16.36 9.74 58 151008 11489 70765889
Blood pressure abnormal 16.35 9.74 71 150995 15443 70761935
Abdominal tenderness 16.34 9.74 52 151014 9748 70767630
Gastric cancer 16.31 9.74 49 151017 8906 70768472
Pigmentation disorder 16.28 9.74 34 151032 4932 70772446
Gout 16.25 9.74 94 150972 22912 70754466
Hypertensive emergency 16.24 9.74 23 151043 2440 70774938
Injection site erythema 16.22 9.74 90 150976 72834 70704544
Blood thyroid stimulating hormone abnormal 16.21 9.74 14 151052 853 70776525
Multiple sclerosis relapse 16.10 9.74 43 151023 42974 70734404
Cardiac myxoma 15.99 9.74 7 151059 121 70777257
Hypertrophic osteoarthropathy 15.99 9.74 7 151059 121 70777257
Arrhythmogenic right ventricular dysplasia 15.97 9.74 5 151061 31 70777347
Dementia Alzheimer's type 15.96 9.74 15 151051 1021 70776357
Adverse event 15.95 9.74 53 151013 49408 70727970
Immune reconstitution inflammatory syndrome 15.93 9.74 4 151062 12986 70764392
Hyperlipidaemia 15.89 9.74 96 150970 23767 70753611
Erectile dysfunction 15.81 9.74 64 151002 13498 70763880
Microalbuminuria 15.77 9.74 14 151052 885 70776493
Schizophrenia 15.75 9.74 8 151058 16760 70760618
Gouty arthritis 15.66 9.74 17 151049 1375 70776003
Neuropathy peripheral 15.55 9.74 184 150882 126712 70650666
Live birth 15.50 9.74 5 151061 13774 70763604
Urticaria 15.47 9.74 249 150817 162800 70614578
Carotid artery occlusion 15.46 9.74 30 151036 4129 70773249
Ill-defined disorder 15.45 9.74 62 151004 54679 70722699
Subacute hepatic failure 15.34 9.74 8 151058 207 70777171
Acute hepatic failure 15.26 9.74 22 151044 27650 70749728
Acute phosphate nephropathy 15.21 9.74 5 151061 37 70777341
Therapy partial responder 15.00 9.74 4 151062 12470 70764908
Pyometra 14.98 9.74 6 151060 82 70777296
Premature delivery 14.92 9.74 14 151052 21290 70756088
Pleural disorder 14.88 9.74 13 151053 804 70776574
Aggression 14.88 9.74 53 151013 48393 70728985
Joint stiffness 14.87 9.74 33 151033 35143 70742235
Acquired C1 inhibitor deficiency 14.86 9.74 4 151062 13 70777365
Extrasystoles 14.85 9.74 40 151026 6834 70770544
Acral lentiginous melanoma 14.76 9.74 5 151061 41 70777337
Cardio-respiratory arrest 14.76 9.74 140 150926 100537 70676841
Mydriasis 14.74 9.74 8 151058 16145 70761233
Fractured coccyx 14.68 9.74 14 151052 970 70776408
Azotaemia 14.67 9.74 43 151023 7710 70769668
Aortic valve incompetence 14.62 9.74 47 151019 8857 70768521
Hypercreatininaemia 14.59 9.74 13 151053 826 70776552
Nephrogenic anaemia 14.56 9.74 27 151039 3591 70773787
Merycism 14.45 9.74 8 151058 234 70777144
Faecaloma 14.38 9.74 52 151014 10399 70766979
Anaphylactic reaction 14.34 9.74 97 150969 74877 70702501
Painful respiration 14.26 9.74 25 151041 3183 70774195
Sepsis 14.26 9.74 404 150662 244141 70533237
Iron deficiency anaemia 14.22 9.74 91 150975 22981 70754397
Progressive multifocal leukoencephalopathy 14.20 9.74 12 151054 19202 70758176
Anhedonia 14.19 9.74 64 151002 14149 70763229
Emotional distress 14.13 9.74 131 150935 37057 70740321
Diverticulum intestinal haemorrhagic 14.11 9.74 26 151040 3441 70773937
Haematocrit decreased 14.06 9.74 185 150881 57073 70720305
Hypochloraemia 14.06 9.74 20 151046 2131 70775247
Surfactant protein increased 14.02 9.74 4 151062 17 70777361
Grip strength decreased 13.97 9.74 8 151058 15677 70761701
Ejection fraction abnormal 13.97 9.74 18 151048 1745 70775633
Duodenal ulcer 13.93 9.74 67 150999 15213 70762165
Diastolic dysfunction 13.90 9.74 48 151018 9385 70767993
Myoglobin blood increased 13.88 9.74 24 151042 3023 70774355
Nephrotic syndrome 13.85 9.74 52 151014 10588 70766790
Hepatic calcification 13.84 9.74 9 151057 355 70777023
Drug interaction 13.76 9.74 966 150100 380475 70396903
Pulmonary oedema 13.73 9.74 249 150817 82029 70695349
Anaesthesia 13.72 9.74 10 151056 476 70776902
Thrombocytopenia 13.69 9.74 396 150670 238714 70538664
Cognitive disorder 13.68 9.74 75 150991 60881 70716497
Kyphosis 13.68 9.74 21 151045 2395 70774983
Venoocclusive liver disease 13.67 9.74 3 151063 10675 70766703
Costal cartilage fracture 13.67 9.74 8 151058 261 70777117
Panniculitis 13.66 9.74 3 151063 10673 70766705
Lung diffusion test decreased 13.65 9.74 15 151051 1230 70776148
Post streptococcal glomerulonephritis 13.63 9.74 5 151061 53 70777325
Activated partial thromboplastin time prolonged 13.63 9.74 61 151005 13444 70763934
Haemophagocytic lymphohistiocytosis 13.60 9.74 13 151053 19599 70757779
Post-anoxic myoclonus 13.46 9.74 5 151061 55 70777323
Cerebral arteriosclerosis 13.44 9.74 12 151054 764 70776614
Somnolence 13.39 9.74 353 150713 215253 70562125
Miscarriage of partner 13.39 9.74 3 151063 3 70777375
Metastatic bronchial carcinoma 13.29 9.74 8 151058 275 70777103
Malignant neoplasm progression 13.25 9.74 181 150885 121558 70655820
Erythema multiforme 13.25 9.74 70 150996 16494 70760884
Peripheral vascular disorder 13.19 9.74 41 151025 7591 70769787
Transitional cell cancer of the renal pelvis and ureter 13.15 9.74 5 151061 59 70777319
Metastases to bone 13.14 9.74 17 151049 22359 70755019
Mouth ulceration 13.11 9.74 34 151032 34315 70743063
Multiple injuries 13.06 9.74 25 151041 3406 70773972
Recalled product administered 13.00 9.74 12 151054 798 70776580
Hepatic cytolysis 12.99 9.74 13 151053 19179 70758199
Immunodeficiency 12.93 9.74 11 151055 17544 70759834
Bezold-Jarisch reflex 12.88 9.74 4 151062 24 70777354
Acute coronary syndrome 12.87 9.74 80 150986 19999 70757379
Foot deformity 12.86 9.74 15 151051 20640 70756738
Incorrect route of product administration 12.79 9.74 23 151043 26469 70750909
Hypercholesterolaemia 12.78 9.74 74 150992 18043 70759335
Electrocardiogram ST segment depression 12.73 9.74 29 151037 4462 70772916
Multi-organ disorder 12.72 9.74 20 151046 2329 70775049
Body height decreased 12.71 9.74 41 151025 7742 70769636
Breast cancer metastatic 12.69 9.74 3 151063 10143 70767235
Arteriosclerosis coronary artery 12.61 9.74 68 150998 16147 70761231
Dystonia 12.60 9.74 14 151052 19692 70757686
Anuria 12.41 9.74 78 150988 19575 70757803
Pancytopenia 12.34 9.74 237 150829 150870 70626508
Product monitoring error 12.27 9.74 37 151029 6739 70770639
Haemangioma 12.20 9.74 20 151046 2412 70774966
Protein urine present 12.18 9.74 46 151020 9394 70767984
Aortic valve sclerosis 12.18 9.74 16 151050 1581 70775797
Sudden cardiac death 12.18 9.74 30 151036 4855 70772523
Skin texture abnormal 12.17 9.74 9 151057 438 70776940
Gait disturbance 12.16 9.74 496 150570 184610 70592768
Accidental exposure to product 12.12 9.74 26 151040 28025 70749353
Aspartate aminotransferase increased 12.05 9.74 355 150711 126623 70650755
Osteochondrosis 11.97 9.74 16 151050 1607 70775771
Chronic obstructive pulmonary disease 11.93 9.74 232 150834 77409 70699969
Lower respiratory tract inflammation 11.92 9.74 6 151060 144 70777234
Therapeutic drug monitoring analysis incorrectly performed 11.90 9.74 8 151058 334 70777044
Eye haemorrhage 11.87 9.74 44 151022 8905 70768473
Cytomegalovirus viraemia 11.86 9.74 5 151061 11680 70765698
Stress cardiomyopathy 11.86 9.74 47 151019 9815 70767563
Staphylococcal infection 11.83 9.74 66 151000 53338 70724040
Brain stem infarction 11.76 9.74 17 151049 1838 70775540
Large intestine polyp 11.70 9.74 52 151014 11424 70765954
Hyponatraemic syndrome 11.66 9.74 11 151055 752 70776626
Stenosis 11.66 9.74 18 151048 2063 70775315
Infusion site pain 11.66 9.74 5 151061 11559 70765819
Haemodialysis 11.65 9.74 70 150996 17296 70760082
Ear infection 11.64 9.74 27 151039 28309 70749069
Asthmatic crisis 11.56 9.74 17 151049 1867 70775511
Actinic keratosis 11.55 9.74 32 151034 5558 70771820
Haemoglobin decreased 11.54 9.74 541 150525 204618 70572760
Putamen haemorrhage 11.48 9.74 9 151057 478 70776900
Cerebellar ischaemia 11.48 9.74 6 151060 156 70777222
Epistaxis 11.45 9.74 293 150773 102334 70675044
Orthopnoea 11.45 9.74 45 151021 9363 70768015
Sleep disorder due to a general medical condition 11.44 9.74 4 151062 10472 70766906
Basal ganglia haemorrhage 11.43 9.74 15 151051 1480 70775898
Device related infection 11.43 9.74 33 151033 32152 70745226
Proteinuria 11.42 9.74 104 150962 29270 70748108
Metamyelocyte count increased 11.40 9.74 10 151056 622 70776756
Thyroxine decreased 11.36 9.74 11 151055 777 70776601
Nail disorder 11.35 9.74 4 151062 10420 70766958
Low density lipoprotein decreased 11.33 9.74 13 151053 1117 70776261
Hepatobiliary cancer 11.32 9.74 3 151063 9 70777369
Perihepatic discomfort 11.32 9.74 3 151063 9 70777369
Exercise tolerance decreased 11.32 9.74 41 151025 8207 70769171
Withdrawal hypertension 11.27 9.74 8 151058 365 70777013
Tenosynovitis 11.26 9.74 8 151058 13968 70763410
Mobility decreased 11.26 9.74 153 150913 102846 70674532
Monoclonal gammopathy 11.24 9.74 11 151055 787 70776591
Renal artery stent placement 11.20 9.74 4 151062 39 70777339
Palpitations 11.16 9.74 312 150754 110441 70666937
Cutaneous lymphoma 11.14 9.74 7 151059 260 70777118
Glomerulosclerosis 11.11 9.74 12 151054 965 70776413
Aspergillus infection 11.10 9.74 13 151053 17855 70759523
Chronic leukaemia 11.08 9.74 3 151063 10 70777368
Respiration abnormal 11.06 9.74 36 151030 6828 70770550
Right ventricular failure 11.06 9.74 19 151047 22255 70755123
Subdural haematoma 11.03 9.74 103 150963 29195 70748183
Left ventricular hypertrophy 10.99 9.74 47 151019 10155 70767223
Chest wall haematoma 10.90 9.74 8 151058 385 70776993
Eczema 10.89 9.74 115 150951 33666 70743712
Peripheral arterial occlusive disease 10.88 9.74 38 151028 7471 70769907
Subarachnoid haemorrhage 10.86 9.74 75 150991 19429 70757949
Peritoneal haematoma 10.83 9.74 6 151060 176 70777202
Dry eye 10.82 9.74 34 151032 32248 70745130
Kounis syndrome 10.77 9.74 23 151043 3388 70773990
Blood chloride decreased 10.75 9.74 39 151027 7811 70769567
Nausea 10.75 9.74 1622 149444 850466 69926912
Hepatic cancer 10.74 9.74 45 151021 9638 70767740
Renal neoplasm 10.74 9.74 16 151050 1778 70775600
Pulmonary arterial hypertension 10.73 9.74 35 151031 32820 70744558
Hypersensitivity pneumonitis 10.72 9.74 23 151043 3399 70773979
Amoebic colitis 10.71 9.74 5 151061 101 70777277
Product complaint 10.70 9.74 53 151013 12178 70765200
Angioplasty 10.69 9.74 16 151050 1784 70775594
Brain stem haemorrhage 10.69 9.74 15 151051 1578 70775800
Hallucination, auditory 10.68 9.74 14 151052 18314 70759064
No adverse event 10.68 9.74 34 151032 32119 70745259
Blood phosphorus abnormal 10.63 9.74 7 151059 282 70777096
Bradyarrhythmia 10.63 9.74 25 151041 3928 70773450
Nephrocalcinosis 10.63 9.74 14 151052 1387 70775991
Mood swings 10.63 9.74 14 151052 18272 70759106
Eosinophil count increased 10.62 9.74 62 151004 15160 70762218
Circulatory collapse 10.62 9.74 119 150947 35355 70742023
Lactic acidosis 10.58 9.74 196 150870 64828 70712550
Lipase increased 10.57 9.74 62 151004 15184 70762194
Oscillopsia 10.55 9.74 6 151060 185 70777193
Cough 10.54 9.74 817 150249 324560 70452818
Nervousness 10.53 9.74 107 150959 31013 70746365
Infarction 10.52 9.74 26 151040 4216 70773162
Frustration tolerance decreased 10.47 9.74 35 151031 6730 70770648
Laryngeal haemorrhage 10.46 9.74 4 151062 48 70777330
Cutaneous listeriosis 10.46 9.74 4 151062 48 70777330
Hypoxia 10.44 9.74 138 150928 93206 70684172
Immature granulocyte count increased 10.44 9.74 9 151057 547 70776831
Rash maculo-papular 10.38 9.74 64 151002 50481 70726897
Cardiac valve sclerosis 10.37 9.74 5 151061 109 70777269
Cardiac pacemaker insertion 10.36 9.74 30 151036 5342 70772036
Activated partial thromboplastin time shortened 10.33 9.74 11 151055 870 70776508
Suspected suicide 10.31 9.74 3 151063 8831 70768547
Diabetic nephropathy 10.30 9.74 20 151046 2753 70774625
Injection site swelling 10.30 9.74 52 151014 43105 70734273
Illness 10.29 9.74 34 151032 31757 70745621
Ankylosing spondylitis 10.29 9.74 6 151060 11640 70765738
Incision site oedema 10.29 9.74 3 151063 14 70777364
Paraesthesia oral 10.25 9.74 62 151004 15355 70762023
Therapy cessation 10.24 9.74 37 151029 33639 70743739
Labelled drug-drug interaction medication error 10.20 9.74 87 150979 24040 70753338
Hypoventilation 10.14 9.74 34 151032 6548 70770830
Lipoedema 10.13 9.74 6 151060 200 70777178
Haemarthrosis 10.13 9.74 30 151036 5409 70771969
Atrial flutter 10.07 9.74 76 150990 20251 70757127
Blood pressure systolic decreased 10.00 9.74 44 151022 9627 70767751
Nephrogenic systemic fibrosis 9.99 9.74 32 151034 6020 70771358
Aortic dissection 9.99 9.74 24 151042 3823 70773555
Reaction to colouring 9.96 9.74 3 151063 16 70777362
Hepatotoxicity 9.94 9.74 54 151012 43932 70733446
Neutrophil count decreased 9.91 9.74 122 150944 83434 70693944
Choroidal detachment 9.90 9.74 9 151057 587 70776791
Cerebrovascular disorder 9.88 9.74 23 151043 3590 70773788
Speech disorder 9.87 9.74 157 150909 50423 70726955
Colitis ulcerative 9.84 9.74 38 151028 33885 70743493
Gastrointestinal submucosal tumour 9.82 9.74 5 151061 123 70777255
Liver iron concentration abnormal 9.78 9.74 4 151062 58 70777320
Intestinal polyp 9.76 9.74 16 151050 1929 70775449
Aneurysm 9.75 9.74 21 151045 3113 70774265

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Renal failure 38.00 29.74 19 318 254 89201

Pharmacologic Action:

SourceCodeDescription
ATC C09CA03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
Angiotensin II receptor blockers (ARBs), plain
ATC C09DA03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and diuretics
ATC C09DB01 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 C09DB08 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 C09DX01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX02 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX05 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C10BX10 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
FDA MoA N0000000070 Angiotensin 2 Receptor Antagonists
FDA EPC N0000175561 Angiotensin 2 Receptor Blocker
MeSH PA D047228 Angiotensin II Type 1 Receptor Blockers
MeSH PA D057911 Angiotensin Receptor Antagonists
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
CHEBI has role CHEBI:35674 antihypertensive drugs
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:61016 angiotensin receptor antagonists
CHEBI has role CHEBI:78298 environmental contaminants

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

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Chronic heart failure indication 48447003
Left ventricular cardiac dysfunction indication 429589006
Atrial fibrillation off-label use 49436004 DOID:0060224
Diabetic renal disease off-label use 127013003
Diastolic heart failure off-label use 418304008 DOID:9775
Nondiabetic Proteinuric Nephropathy off-label use
Anuria contraindication 2472002 DOID:2983
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Secondary angle-closure glaucoma contraindication 21571006
Hypovolemia contraindication 28560003
Obstruction of bile duct contraindication 30144000
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
Acute nephropathy contraindication 58574008
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
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Neutropenic disorder contraindication 303011007 DOID:1227
Azotemia contraindication 445009001
Severe Aortic Valve Stenosis contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.8 acidic
pKa2 4.44 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 8796331 Jan. 14, 2023 TREATMENT OF HEART FAILURE
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 8796331 Jan. 14, 2023 TREATMENT OF HEART FAILURE
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 8796331 Jan. 14, 2023 TREATMENT OF HEART FAILURE
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9388134 Nov. 8, 2026 TREATMENT OF HEART FAILURE
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9388134 Nov. 8, 2026 TREATMENT OF HEART FAILURE
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9388134 Nov. 8, 2026 TREATMENT OF HEART FAILURE
EQ 5MG BASE;80MG BYVALSON ALLERGAN N206302 June 3, 2016 DISCN TABLET ORAL 7838552 Oct. 4, 2027 METHOD OF TREATING HYPERTENSION
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 11135192 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9517226 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9937143 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 11135192 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9517226 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9937143 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 11135192 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9517226 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9937143 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 11058667 May 9, 2036 TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 11058667 May 9, 2036 TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 11058667 May 9, 2036 TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Oct. 1, 2022 NEW PATIENT POPULATION
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Oct. 1, 2022 NEW PATIENT POPULATION
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Oct. 1, 2022 NEW PATIENT POPULATION
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL April 1, 2023 PEDIATRIC EXCLUSIVITY
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL April 1, 2023 PEDIATRIC EXCLUSIVITY
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL April 1, 2023 PEDIATRIC EXCLUSIVITY
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Feb. 16, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Feb. 16, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Feb. 16, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
160MG DIOVAN NOVARTIS N021283 July 18, 2001 RX TABLET ORAL April 19, 2024 NEW PATIENT POPULATION
40MG DIOVAN NOVARTIS N021283 Aug. 14, 2002 RX TABLET ORAL April 19, 2024 NEW PATIENT POPULATION
80MG DIOVAN NOVARTIS N021283 July 18, 2001 RX TABLET ORAL April 19, 2024 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Type-1 angiotensin II receptor GPCR ANTAGONIST Ki 5.33 CHEMBL CHEMBL
Platelet glycoprotein VI Unclassified Kd 4 CHEMBL
Type-1B angiotensin II receptor GPCR IC50 8.72 CHEMBL
Type-1A angiotensin II receptor GPCR IC50 8.47 CHEMBL
Angiotensin II receptor (AT-1) type-1 GPCR IC50 8.57 CHEMBL

External reference:

IDSource
D00400 KEGG_DRUG
4020986 VANDF
C0216784 UMLSCUI
CHEBI:9927 CHEBI
U35 PDB_CHEM_ID
CHEMBL1069 ChEMBL_ID
D000068756 MESH_DESCRIPTOR_UI
DB00177 DRUGBANK_ID
3937 IUPHAR_LIGAND_ID
7016 INN_ID
80M03YXJ7I UNII
60846 PUBCHEM_CID
216652 RXNORM
53010 MMSL
5663 MMSL
8844 MMSL
d04113 MMSL
006279 NDDF
108581009 SNOMEDCT_US
386876001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0314 TABLET, FILM COATED 80 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0314 TABLET, FILM COATED 80 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0315 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0315 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0358 TABLET 80 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0358 TABLET 80 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0359 TABLET 160 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0359 TABLET 160 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0360 TABLET 320 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0360 TABLET 320 mg ORAL NDA 33 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0383 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0383 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0423 TABLET 40 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0423 TABLET 40 mg ORAL NDA 33 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0471 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0471 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0472 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0472 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0488 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0488 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0489 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0489 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0490 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0490 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0491 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0491 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0559 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0559 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0560 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0560 TABLET, FILM COATED 160 mg ORAL NDA 31 sections