valsartan ๐Ÿถ 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 ยตM/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 392.99 9.66 191 120195 4787 63363849
Blood pressure increased 354.52 9.66 880 119506 161182 63207454
Macular degeneration 349.58 9.66 322 120064 24054 63344582
Pemphigus 303.35 9.66 10 120376 183716 63184920
Glossodynia 262.99 9.66 20 120366 178856 63189780
Hyponatraemia 255.54 9.66 618 119768 111282 63257354
Hand deformity 251.99 9.66 12 120374 159445 63209191
Systemic lupus erythematosus 249.47 9.66 47 120339 208871 63159765
Off label use 228.26 9.66 598 119788 673864 62694772
Oligohydramnios 212.81 9.66 139 120247 6227 63362409
Myocardial infarction 205.24 9.66 530 119856 99363 63269273
Anti-cyclic citrullinated peptide antibody positive 204.66 9.66 3 120383 116209 63252427
Cardiac failure congestive 203.01 9.66 503 119883 91930 63276706
Hyperkalaemia 193.07 9.66 359 120027 53844 63314792
Alopecia 166.27 9.66 239 120147 337297 63031339
Wound 163.31 9.66 53 120333 163210 63205426
Pericarditis 160.46 9.66 28 120358 131551 63237085
Product use issue 160.32 9.66 111 120275 220409 63148227
Acute kidney injury 158.50 9.66 946 119440 262469 63106167
Oedema peripheral 156.68 9.66 743 119643 188768 63179868
Contraindicated product administered 153.70 9.66 113 120273 217535 63151101
Cerebral infarction 148.37 9.66 204 120182 23689 63344947
Arthropathy 144.79 9.66 139 120247 234653 63133983
Maternal exposure during pregnancy 143.16 9.66 124 120262 219938 63148698
Duodenal ulcer perforation 142.98 9.66 5 120381 87204 63281432
Coronary artery disease 141.96 9.66 235 120151 32142 63336494
Infusion related reaction 138.29 9.66 157 120229 245364 63123272
Completed suicide 137.59 9.66 52 120334 145621 63223015
Therapeutic product effect decreased 135.48 9.66 101 120285 193086 63175550
Hypertensive crisis 120.72 9.66 147 120239 15139 63353497
Renal failure 117.36 9.66 488 119898 117164 63251472
Dizziness 117.28 9.66 1288 119098 428637 62939999
Blood creatinine increased 117.22 9.66 400 119986 87444 63281192
Helicobacter infection 117.00 9.66 18 120368 92767 63275869
Treatment failure 114.55 9.66 125 120261 198918 63169718
Discomfort 110.43 9.66 93 120293 167281 63201355
Joint swelling 109.28 9.66 292 120094 327374 63041262
Thyroid disorder 108.84 9.66 139 120247 15023 63353613
Folliculitis 105.77 9.66 7 120379 70310 63298326
Blood glucose increased 105.34 9.66 374 120012 83382 63285254
Cerebrovascular accident 103.79 9.66 443 119943 107581 63261055
Hypotension 103.54 9.66 876 119510 271728 63096908
Diabetes mellitus 103.31 9.66 285 120101 55525 63313111
Glaucoma 102.04 9.66 151 120235 18754 63349882
Swelling 100.69 9.66 234 120152 275144 63093492
Synovitis 99.37 9.66 125 120261 186793 63181843
Syncope 98.94 9.66 463 119923 116922 63251714
Drug intolerance 98.48 9.66 281 120105 308380 63060256
Muscle injury 96.85 9.66 7 120379 65338 63303298
Atrial fibrillation 93.91 9.66 454 119932 116182 63252454
Rheumatoid factor positive 92.51 9.66 23 120363 84383 63284253
Product use in unapproved indication 90.84 9.66 124 120262 178956 63189680
Pain 89.93 9.66 935 119451 739693 62628943
Cardiac failure 89.85 9.66 371 120015 88771 63279865
Rash 89.79 9.66 659 119727 560212 62808424
Colitis microscopic 89.12 9.66 99 120287 9240 63359396
Intentional product use issue 80.79 9.66 74 120312 127818 63240818
Blood pressure decreased 77.21 9.66 285 120101 64737 63303899
Toxicity to various agents 76.71 9.66 228 120158 247022 63121614
Blister 76.35 9.66 80 120306 129734 63238902
Bronchial haemorrhage 76.33 9.66 32 120354 560 63368076
Psoriatic arthropathy 73.46 9.66 41 120345 91479 63277157
Blood urea increased 72.65 9.66 157 120229 26222 63342414
Condition aggravated 72.53 9.66 456 119930 401761 62966875
Fall 71.18 9.66 1091 119295 391243 62977393
Bronchial neoplasm 71.15 9.66 29 120357 471 63368165
Angina pectoris 68.43 9.66 166 120220 29912 63338724
Infection 66.37 9.66 218 120168 228955 63139681
Renal impairment 64.79 9.66 335 120051 88020 63280616
Abdominal discomfort 62.99 9.66 354 120032 320531 63048105
Nasal turbinate hypertrophy 62.41 9.66 30 120356 733 63367903
Diabetes mellitus inadequate control 61.27 9.66 106 120280 15020 63353616
Diverticulitis 59.81 9.66 188 120198 39369 63329267
Musculoskeletal stiffness 59.61 9.66 167 120219 184451 63184185
Fatigue 57.50 9.66 1266 119120 886762 62481874
Exposure during pregnancy 56.93 9.66 132 120254 155415 63213221
COVID-19 56.64 9.66 79 120307 113024 63255612
Rheumatoid arthritis 55.98 9.66 269 120117 253550 63115086
Hepatic enzyme increased 55.49 9.66 197 120189 202131 63166505
Bronchial disorder 55.32 9.66 33 120353 1257 63367379
Arthralgia 53.09 9.66 761 119625 568949 62799687
Chronic kidney disease 53.06 9.66 198 120188 45200 63323436
Endometrial ablation 52.99 9.66 29 120357 935 63367701
Irritable bowel syndrome 52.85 9.66 47 120339 82365 63286271
Diverticulum intestinal 52.10 9.66 64 120322 6649 63361987
Anaemia 52.00 9.66 813 119573 292617 63076019
Drug ineffective 50.76 9.66 1553 118833 1043212 62325424
Dehydration 49.69 9.66 525 119861 172829 63195807
Hyperuricaemia 49.65 9.66 56 120330 5314 63363322
Asthenia 48.59 9.66 1008 119378 382596 62986040
Mitral valve incompetence 47.66 9.66 111 120275 19483 63349153
Impaired healing 47.10 9.66 76 120310 102466 63266170
Rhonchi 46.91 9.66 39 120347 2537 63366099
Haematoma 46.80 9.66 159 120227 34661 63333975
Cardiomegaly 46.42 9.66 103 120283 17511 63351125
Tachyarrhythmia 45.64 9.66 49 120337 4401 63364235
Labile hypertension 45.57 9.66 21 120365 465 63368171
Product prescribing error 45.45 9.66 131 120255 26158 63342478
Acute myocardial infarction 45.23 9.66 149 120237 31975 63336661
Chest pain 45.20 9.66 616 119770 215343 63153293
Bradycardia 45.19 9.66 265 120121 72962 63295674
Hip arthroplasty 44.97 9.66 17 120369 47629 63321007
Adverse drug reaction 44.78 9.66 51 120335 79663 63288973
Lower respiratory tract infection 44.71 9.66 117 120269 132190 63236446
Arrhythmia 44.28 9.66 166 120220 37974 63330662
Cardiovascular disorder 44.26 9.66 80 120306 11732 63356904
Sinusitis 43.92 9.66 251 120135 226402 63142234
Blood pressure diastolic decreased 43.04 9.66 117 120269 22589 63346047
Transient ischaemic attack 42.75 9.66 163 120223 37590 63331046
Ill-defined disorder 42.04 9.66 56 120330 81699 63286937
Pulmonary hypoplasia 41.71 9.66 17 120369 276 63368360
Forced expiratory volume decreased 41.23 9.66 49 120337 4919 63363717
Abortion spontaneous 41.07 9.66 19 120367 47176 63321460
Liver injury 40.66 9.66 33 120353 60487 63308149
Hypertension 40.42 9.66 749 119637 278554 63090082
Drug hypersensitivity 40.09 9.66 386 120000 310301 63058335
Gastrointestinal disorder 39.95 9.66 122 120264 131117 63237519
Fear of disease 39.46 9.66 27 120359 1307 63367329
Lymphatic fistula 38.72 9.66 22 120364 764 63367872
Obstructive airways disorder 38.58 9.66 106 120280 20593 63348043
Pregnancy 38.53 9.66 11 120375 36825 63331811
Migraine 38.37 9.66 87 120299 103259 63265377
Blood uric acid increased 38.20 9.66 49 120337 5318 63363318
Skin reaction 38.20 9.66 86 120300 14763 63353873
Stomatitis 38.06 9.66 135 120251 138590 63230046
Product dose omission issue 37.49 9.66 275 120111 234038 63134598
Femoral hernia incarcerated 37.33 9.66 22 120364 819 63367817
Blood pressure systolic increased 36.33 9.66 182 120204 47215 63321421
Pancreatic steatosis 35.96 9.66 23 120363 993 63367643
Blood creatine phosphokinase increased 35.79 9.66 133 120253 30297 63338339
Blood sodium decreased 35.50 9.66 114 120272 24138 63344498
Breast cancer 35.14 9.66 183 120203 48200 63320436
Febrile neutropenia 34.72 9.66 112 120274 118337 63250299
Tricuspid valve incompetence 34.66 9.66 82 120304 14539 63354097
Angina unstable 34.51 9.66 54 120332 7041 63361595
Nervousness 34.45 9.66 133 120253 30846 63337790
Multi-organ disorder 34.20 9.66 26 120360 1486 63367150
Hypoglycaemia 33.65 9.66 212 120174 59853 63308783
Blood pressure abnormal 33.63 9.66 83 120303 15115 63353521
Arterial haemorrhage 33.37 9.66 27 120359 1690 63366946
Hypokalaemia 32.90 9.66 321 120065 103483 63265153
Product impurity 32.82 9.66 9 120377 37 63368599
Ventricular extrasystoles 32.68 9.66 70 120316 11617 63357019
Angioedema 32.50 9.66 178 120208 47787 63320849
Hypochromic anaemia 32.49 9.66 28 120358 1914 63366722
Blood lactate dehydrogenase increased 32.34 9.66 107 120279 23009 63345627
Live birth 32.24 9.66 5 120381 25625 63343011
Drug abuse 32.14 9.66 55 120331 72463 63296173
Vascular resistance pulmonary decreased 31.56 9.66 10 120376 74 63368562
Nasopharyngitis 31.48 9.66 319 120067 253938 63114698
Antinuclear antibody negative 31.35 9.66 13 120373 221 63368415
Hiatus hernia 31.15 9.66 101 120285 21493 63347143
Prescribed overdose 30.90 9.66 13 120373 34140 63334496
Renal artery stenosis 30.88 9.66 27 120359 1882 63366754
Venous pressure jugular increased 30.73 9.66 17 120369 560 63368076
Wound infection pseudomonas 30.40 9.66 23 120363 1305 63367331
Rhabdomyolysis 30.39 9.66 164 120222 43787 63324849
Altered state of consciousness 30.28 9.66 111 120275 25119 63343517
Disease progression 30.10 9.66 125 120261 122633 63246003
Hypersensitivity 30.05 9.66 383 120003 292302 63076334
Therapy interrupted 29.93 9.66 12 120374 32443 63336193
Loss of personal independence in daily activities 29.92 9.66 90 120296 97200 63271436
Lymphocyte stimulation test positive 29.60 9.66 16 120370 503 63368133
Recalled product administered 29.43 9.66 16 120370 509 63368127
Thrombotic stroke 29.29 9.66 16 120370 514 63368122
Gastrointestinal haemorrhage 29.23 9.66 258 120128 80918 63287718
Mobility decreased 28.71 9.66 125 120261 121034 63247602
Neutropenia 28.66 9.66 204 120182 174801 63193835
Blood potassium increased 28.58 9.66 88 120298 18221 63350415
Coombs positive haemolytic anaemia 28.58 9.66 14 120372 357 63368279
Brain stem stroke 28.36 9.66 14 120372 363 63368273
Spinal osteoarthritis 28.31 9.66 81 120305 16105 63352531
Myocardial ischaemia 28.22 9.66 70 120316 12789 63355847
Injection site reaction 28.18 9.66 42 120344 58482 63310154
Hospitalisation 28.15 9.66 76 120310 85005 63283631
Bundle branch block left 27.98 9.66 49 120337 7010 63361626
Intentional overdose 27.86 9.66 62 120324 74090 63294546
Hepatic cyst 27.57 9.66 41 120345 5113 63363523
Death 27.55 9.66 522 119864 373859 62994777
Myalgia 27.45 9.66 410 119976 146119 63222517
Atrioventricular block complete 27.32 9.66 53 120333 8198 63360438
Chronic sinusitis 27.22 9.66 69 120317 12774 63355862
Gamma-glutamyltransferase increased 27.02 9.66 132 120254 33899 63334737
Peripheral swelling 26.93 9.66 349 120037 265593 63103043
Renal cyst 26.87 9.66 60 120326 10242 63358394
Left-to-right cardiac shunt 26.84 9.66 10 120376 126 63368510
Dyschezia 26.65 9.66 27 120359 2267 63366369
Aortic valve stenosis 26.49 9.66 32 120354 3267 63365369
Seroma 26.45 9.66 26 120360 2105 63366531
Loss of consciousness 26.37 9.66 341 120045 117780 63250856
Product contamination chemical 26.35 9.66 5 120381 0 63368636
Drug ineffective for unapproved indication 26.27 9.66 16 120370 34047 63334589
Gastric ulcer haemorrhage 26.19 9.66 39 120347 4869 63363767
Sinus node dysfunction 26.12 9.66 38 120348 4647 63363989
Basal ganglion degeneration 26.08 9.66 14 120372 434 63368202
Liver function test increased 25.89 9.66 15 120371 32796 63335840
Hypochloraemia 25.85 9.66 25 120361 1984 63366652
Coronary artery stenosis 25.75 9.66 38 120348 4706 63363930
Hypertensive cardiomyopathy 25.70 9.66 11 120375 203 63368433
Pulmonary oedema 25.54 9.66 185 120201 54688 63313948
Forced vital capacity decreased 25.39 9.66 19 120367 1060 63367576
Gastritis haemorrhagic 25.29 9.66 22 120364 1523 63367113
Cough 25.18 9.66 730 119656 292013 63076623
Therapy non-responder 24.96 9.66 68 120318 75833 63292803
Cardiac failure chronic 24.87 9.66 36 120350 4382 63364254
Concomitant disease progression 24.57 9.66 25 120361 2109 63366527
Injection site pain 24.45 9.66 145 120241 129655 63238981
Product odour abnormal 24.39 9.66 20 120366 1276 63367360
Complex regional pain syndrome 24.25 9.66 26 120360 2331 63366305
Tissue infiltration 24.17 9.66 15 120371 614 63368022
Metastatic bronchial carcinoma 24.11 9.66 9 120377 114 63368522
Eye haemorrhage 23.89 9.66 51 120335 8445 63360191
Coronary arterial stent insertion 23.64 9.66 28 120358 2801 63365835
Fibromyalgia 23.59 9.66 76 120310 80344 63288292
Dementia Alzheimer's type 23.47 9.66 18 120368 1042 63367594
Paraesthesia oral 23.35 9.66 85 120301 19171 63349465
Colon cancer 22.98 9.66 55 120331 9823 63358813
Impaired work ability 22.93 9.66 3 120383 17472 63351164
Total lung capacity increased 22.93 9.66 25 120361 2285 63366351
Faecaloma 22.71 9.66 48 120338 7893 63360743
Multiple injuries 22.43 9.66 22 120364 1776 63366860
Acral lentiginous melanoma 22.42 9.66 5 120381 6 63368630
Arteriosclerosis 22.30 9.66 55 120331 10011 63358625
Ear infection 21.95 9.66 24 120362 38189 63330447
Lacunar infarction 21.87 9.66 29 120357 3251 63365385
Hemiplegia 21.79 9.66 52 120334 9271 63359365
Coronary artery occlusion 21.70 9.66 48 120338 8143 63360493
Hypertensive emergency 21.59 9.66 22 120364 1860 63366776
Pneumothorax traumatic 21.49 9.66 9 120377 157 63368479
Intestinal polyp 21.46 9.66 20 120366 1515 63367121
Feeling abnormal 21.44 9.66 398 119988 147994 63220642
Renin decreased 21.17 9.66 8 120378 105 63368531
Type 2 diabetes mellitus 21.17 9.66 57 120329 63811 63304825
Incorrect route of product administration 21.03 9.66 13 120373 27439 63341197
Grip strength decreased 20.95 9.66 8 120378 22279 63346357
Asthma 20.88 9.66 349 120037 127212 63241424
Iron deficiency anaemia 20.81 9.66 84 120302 19885 63348751
Aortic arteriosclerosis 20.70 9.66 40 120346 6169 63362467
Malaise 20.59 9.66 975 119411 414979 62953657
Intentional product misuse 20.47 9.66 54 120332 60863 63307773
Diabetic nephropathy 20.43 9.66 19 120367 1435 63367201
Adverse event 20.41 9.66 63 120323 67496 63301140
Interstitial lung disease 20.37 9.66 193 120193 61715 63306921
Lung diffusion test decreased 20.35 9.66 14 120372 684 63367952
Fear 20.32 9.66 71 120315 15695 63352941
Drug resistance 20.31 9.66 9 120377 22924 63345712
Dyspnoea 20.31 9.66 1485 118901 659828 62708808
Prescribed underdose 20.17 9.66 16 120370 29673 63338963
Hyperlipidaemia 20.13 9.66 82 120304 19489 63349147
Melaena 20.11 9.66 112 120274 30253 63338383
Hypertensive heart disease 20.04 9.66 24 120362 2428 63366208
Ischaemic stroke 19.89 9.66 77 120309 17880 63350756
Knee arthroplasty 19.81 9.66 46 120340 54160 63314476
Monocyte count abnormal 19.75 9.66 9 120377 194 63368442
Frustration tolerance decreased 19.71 9.66 42 120344 6946 63361690
Haemarthrosis 19.63 9.66 27 120359 3134 63365502
Cardiac pacemaker insertion 19.51 9.66 31 120355 4095 63364541
Bronchitis 19.43 9.66 339 120047 124596 63244040
Retrograde amnesia 19.41 9.66 12 120374 488 63368148
Palpitations 19.37 9.66 311 120075 112459 63256177
Monoplegia 19.37 9.66 27 120359 3174 63365462
Product contamination 19.27 9.66 14 120372 746 63367890
Peak expiratory flow rate decreased 19.25 9.66 13 120373 616 63368020
Withdrawal hypertension 19.08 9.66 8 120378 140 63368496
Nephrogenic anaemia 19.07 9.66 22 120364 2140 63366496
Cardiac failure acute 18.99 9.66 50 120336 9473 63359163
Angiotensin converting enzyme inhibitor foetopathy 18.98 9.66 6 120380 44 63368592
Neutrophil function disorder 18.97 9.66 5 120381 17 63368619
Neonatal seizure 18.93 9.66 12 120374 510 63368126
Rectal prolapse 18.88 9.66 21 120365 1962 63366674
Ophthalmic vein thrombosis 18.83 9.66 9 120377 217 63368419
Procedural pain 18.83 9.66 86 120300 21483 63347153
Inguinal hernia 18.68 9.66 21 120365 1986 63366650
Gastritis 18.67 9.66 128 120258 37175 63331461
Uterine enlargement 18.66 9.66 17 120369 1251 63367385
Gastrointestinal stromal tumour 18.57 9.66 16 120370 1093 63367543
Stenosis 18.53 9.66 18 120368 1436 63367200
Chronic obstructive pulmonary disease 18.48 9.66 191 120195 62495 63306141
Anaesthesia 18.32 9.66 11 120375 424 63368212
Hyponatraemic syndrome 18.26 9.66 12 120374 543 63368093
Gout 18.18 9.66 61 120325 13210 63355426
Body height decreased 18.18 9.66 51 120335 10027 63358609
Herpes simplex reactivation 18.01 9.66 12 120374 556 63368080
Joint range of motion decreased 17.94 9.66 21 120365 32407 63336229
Ventricular hypertrophy 17.90 9.66 27 120359 3409 63365227
Glycosylated haemoglobin increased 17.89 9.66 58 120328 12340 63356296
Granuloma 17.86 9.66 36 120350 5725 63362911
Kyphosis 17.78 9.66 23 120363 2517 63366119
Brain contusion 17.68 9.66 12 120374 573 63368063
Post-anoxic myoclonus 17.61 9.66 5 120381 24 63368612
Visual acuity reduced 17.57 9.66 85 120301 21741 63346895
Coronary artery bypass 17.45 9.66 22 120364 2347 63366289
Psychotic disorder 17.29 9.66 14 120372 25698 63342938
Device dislocation 17.28 9.66 14 120372 25691 63342945
Hepatic function abnormal 17.16 9.66 125 120261 37017 63331619
Arrhythmogenic right ventricular dysplasia 17.12 9.66 5 120381 27 63368609
Infarction 17.07 9.66 23 120363 2618 63366018
Anaphylactic reaction 17.02 9.66 66 120320 66034 63302602
Cardiac disorder 17.01 9.66 159 120227 50657 63317979
Dyspnoea exertional 16.96 9.66 182 120204 60120 63308516
C-reactive protein abnormal 16.94 9.66 39 120347 46057 63322579
Breast neoplasm 16.90 9.66 17 120369 1415 63367221
Carotid artery disease 16.63 9.66 18 120368 1631 63367005
Lipoedema 16.48 9.66 9 120377 289 63368347
Cerebral haemorrhage 16.31 9.66 107 120279 30622 63338014
Left ventricular hypertrophy 16.22 9.66 33 120353 5282 63363354
Haematochezia 16.19 9.66 164 120222 53380 63315256
Urine albumin/creatinine ratio increased 16.17 9.66 9 120377 300 63368336
Oesophageal food impaction 16.15 9.66 8 120378 209 63368427
No adverse event 16.07 9.66 34 120352 41371 63327265
Pollakiuria 15.89 9.66 99 120287 27838 63340798
Nodal rhythm 15.82 9.66 18 120368 1725 63366911
Diapedesis 15.81 9.66 3 120383 0 63368636
Sedation 15.80 9.66 31 120355 38778 63329858
Renal cell carcinoma 15.69 9.66 25 120361 3310 63365326
Drug interaction 15.66 9.66 556 119830 228575 63140061
Transitional cell cancer of the renal pelvis and ureter 15.56 9.66 4 120382 12 63368624
Blood pressure fluctuation 15.54 9.66 145 120241 46172 63322464
Multiple sclerosis relapse 15.52 9.66 44 120342 48434 63320202
Cataract 15.49 9.66 171 120215 56882 63311754
Lip dry 15.49 9.66 5 120381 15465 63353171
Ulcer 15.44 9.66 16 120370 26091 63342545
Antiphospholipid syndrome 15.43 9.66 18 120368 1772 63366864
Stress cardiomyopathy 15.29 9.66 46 120340 9404 63359232
Respiration abnormal 15.22 9.66 36 120350 6381 63362255
Ischaemic cardiomyopathy 15.15 9.66 21 120365 2456 63366180
Affective disorder 15.15 9.66 35 120351 6111 63362525
Cranial sutures widening 15.09 9.66 4 120382 14 63368622
Injection site erythema 15.09 9.66 94 120292 83080 63285556
Pyometra 14.98 9.66 6 120380 93 63368543
Anuria 14.88 9.66 55 120331 12496 63356140
Coronary angioplasty 14.86 9.66 6 120380 95 63368541
Oesophageal achalasia 14.77 9.66 10 120376 476 63368160
Gingival ulceration 14.73 9.66 13 120373 917 63367719
Skin texture abnormal 14.71 9.66 10 120376 479 63368157
Diabetic retinopathy 14.64 9.66 20 120366 2307 63366329
Disease recurrence 14.61 9.66 19 120367 28011 63340625
Tessellated fundus 14.46 9.66 5 120381 50 63368586
Gastroenteritis 14.36 9.66 93 120293 26497 63342139
Bezold-Jarisch reflex 14.29 9.66 4 120382 18 63368618
Acute phosphate nephropathy 14.29 9.66 4 120382 18 63368618
Dementia 14.28 9.66 72 120314 18722 63349914
Thyroxine decreased 14.27 9.66 11 120375 642 63367994
Dysuria 14.15 9.66 111 120275 33627 63335009
Product substitution issue 14.13 9.66 64 120322 15932 63352704
Bladder transitional cell carcinoma 14.06 9.66 11 120375 656 63367980
Ankle fracture 13.99 9.66 69 120317 17786 63350850
Eructation 13.90 9.66 41 120345 8292 63360344
Intentional self-injury 13.82 9.66 17 120369 25670 63342966
Deafness 13.79 9.66 69 120317 17888 63350748
Malignant neoplasm progression 13.79 9.66 95 120291 82026 63286610
Pulmonary thrombosis 13.74 9.66 42 120344 8660 63359976
Fabry's disease 13.74 9.66 3 120383 3 63368633
Cerebral arteriosclerosis 13.69 9.66 8 120378 293 63368343
Blood aldosterone increased 13.69 9.66 7 120379 196 63368440
Asthmatic crisis 13.61 9.66 17 120369 1796 63366840
Device issue 13.59 9.66 15 120371 23766 63344870
Hyperglycaemia 13.51 9.66 130 120256 41737 63326899
Haematuria 13.39 9.66 98 120288 29059 63339577
Anxiety disorder 13.39 9.66 26 120360 4024 63364612
Product taste abnormal 13.36 9.66 18 120368 2049 63366587
Low density lipoprotein increased 13.31 9.66 34 120352 6323 63362313
Varicose vein ruptured 13.28 9.66 5 120381 65 63368571
Circulatory collapse 13.27 9.66 79 120307 21859 63346777
Brain natriuretic peptide increased 13.19 9.66 30 120356 5183 63363453
Groin pain 13.19 9.66 46 120340 10157 63358479
Cardiogenic shock 13.14 9.66 68 120318 17864 63350772
Emotional distress 13.06 9.66 106 120280 32443 63336193
Speech disorder 13.04 9.66 126 120260 40503 63328133
Renal neoplasm 13.02 9.66 14 120372 1260 63367376
Sputum purulent 13.00 9.66 13 120373 1074 63367562
Duodenal polyp 12.97 9.66 6 120380 134 63368502
Ear pain 12.92 9.66 31 120355 36087 63332549
Prerenal failure 12.89 9.66 16 120370 1680 63366956
Pulmonary hypertension 12.85 9.66 117 120269 37006 63331630
Glomerular filtration rate decreased 12.80 9.66 55 120331 13386 63355250
Cardiac myxoma 12.75 9.66 7 120379 227 63368409
Inflammatory marker increased 12.72 9.66 35 120351 6804 63361832
Therapeutic drug monitoring analysis incorrectly performed 12.71 9.66 8 120378 336 63368300
Occult blood positive 12.67 9.66 24 120362 3646 63364990
Panniculitis 12.67 9.66 3 120383 11382 63357254
Hypersensitivity pneumonitis 12.65 9.66 20 120366 2630 63366006
Deep vein thrombosis postoperative 12.64 9.66 3 120383 11366 63357270
Sinus arrest 12.64 9.66 17 120369 1932 63366704
Carpal tunnel syndrome 12.62 9.66 75 120311 20742 63347894
Bradycardia neonatal 12.54 9.66 12 120374 940 63367696
Lymphostasis 12.53 9.66 3 120383 6 63368630
Airway remodelling 12.45 9.66 5 120381 78 63368558
Ligament injury 12.42 9.66 13 120373 1134 63367502
Polyuria 12.36 9.66 40 120346 8502 63360134
Erysipelas 12.34 9.66 38 120348 7867 63360769
Hypertensive encephalopathy 12.33 9.66 10 120376 628 63368008
Metastases to bone 12.30 9.66 13 120373 21006 63347630
Bone marrow failure 12.27 9.66 23 120363 29267 63339369
Carotid artery stenosis 12.26 9.66 29 120357 5141 63363495
Prosthesis implantation 12.22 9.66 5 120381 82 63368554
Catheterisation cardiac 12.22 9.66 27 120359 4576 63364060
Haemorrhage subcutaneous 12.20 9.66 21 120365 2962 63365674
Blood sodium increased 12.20 9.66 20 120366 2712 63365924
Atrioventricular block 12.16 9.66 37 120349 7610 63361026
Facet joint syndrome 12.02 9.66 4 120382 12134 63356502
Cutaneous lymphoma 12.00 9.66 6 120380 160 63368476
Joint stiffness 11.98 9.66 40 120346 41829 63326807
Urticaria chronic 11.97 9.66 10 120376 655 63367981
Coronary artery restenosis 11.90 9.66 8 120378 376 63368260
Gastrointestinal cancer metastatic 11.90 9.66 5 120381 88 63368548
Malnutrition 11.90 9.66 59 120327 15239 63353397
Duodenal ulcer 11.85 9.66 37 120349 7719 63360917
Marasmus 11.81 9.66 9 120377 516 63368120
Parkinson's disease 11.76 9.66 13 120373 1206 63367430
Gastric cancer 11.75 9.66 27 120359 4696 63363940
Mydriasis 11.73 9.66 4 120382 11952 63356684
Atrial flutter 11.73 9.66 43 120343 9729 63358907
Swollen tongue 11.70 9.66 109 120277 34691 63333945
Functional residual capacity increased 11.70 9.66 5 120381 92 63368544
Microangiopathy 11.69 9.66 13 120373 1215 63367421
Perihepatic discomfort 11.67 9.66 3 120383 9 63368627
Cell marker increased 11.65 9.66 7 120379 270 63368366
Large intestine polyp 11.63 9.66 38 120348 8119 63360517
Urticaria 11.61 9.66 233 120153 165569 63203067
Orthopnoea 11.60 9.66 32 120354 6229 63362407
Dysaesthesia 11.59 9.66 26 120360 4452 63364184
Hepatotoxicity 11.57 9.66 34 120352 37007 63331629
Merycism 11.56 9.66 7 120379 274 63368362
Glomerulosclerosis 11.52 9.66 8 120378 397 63368239
Peritoneal haematoma 11.50 9.66 5 120381 96 63368540
Microalbuminuria 11.50 9.66 8 120378 398 63368238
Renal disorder 11.45 9.66 104 120282 32870 63335766
Myelosuppression 11.42 9.66 17 120369 23686 63344950
Diverticulum 11.36 9.66 49 120337 11942 63356694
Gastritis erosive 11.33 9.66 31 120355 6008 63362628
Heliotrope rash 11.33 9.66 6 120380 181 63368455
Renal atrophy 11.29 9.66 14 120372 1468 63367168
Haemodialysis 11.28 9.66 40 120346 8907 63359729
Weight increased 11.26 9.66 393 119993 260399 63108237
International normalised ratio increased 11.20 9.66 136 120250 46289 63322347
Cytomegalovirus infection 11.13 9.66 14 120372 20938 63347698
Disability 11.13 9.66 11 120375 18336 63350300
Joint contracture 11.12 9.66 15 120371 1709 63366927
Haematemesis 11.12 9.66 97 120289 30315 63338321
Exercise tolerance decreased 11.10 9.66 29 120357 5468 63363168
Suicidal ideation 11.09 9.66 71 120315 62350 63306286
Wound dehiscence 11.08 9.66 27 120359 4876 63363760
C-reactive protein increased 11.02 9.66 246 120140 94461 63274175
Neutropenic sepsis 10.99 9.66 9 120377 16429 63352207
Blood chloride decreased 10.95 9.66 29 120357 5513 63363123
Injection site vesicles 10.95 9.66 20 120366 2957 63365679
Cutaneous listeriosis 10.91 9.66 4 120382 48 63368588
Hepatic cytolysis 10.85 9.66 8 120378 15399 63353237
Large intestinal ulcer haemorrhage 10.84 9.66 5 120381 111 63368525
Gastric mucosa erythema 10.81 9.66 7 120379 309 63368327
Nocturia 10.78 9.66 37 120349 8104 63360532
Adverse reaction 10.76 9.66 3 120383 10200 63358436
Brain stem haemorrhage 10.75 9.66 10 120376 756 63367880
Injection site swelling 10.71 9.66 50 120336 47522 63321114
Cognitive disorder 10.69 9.66 62 120324 55753 63312883
Periodontitis 10.67 9.66 21 120365 3282 63365354
Vascular calcification 10.67 9.66 10 120376 763 63367873
Status epilepticus 10.62 9.66 8 120378 15225 63353411
Heat illness 10.59 9.66 6 120380 207 63368429
Meniere's disease 10.59 9.66 6 120380 207 63368429
Bronchiectasis 10.59 9.66 9 120377 16133 63352503
Fixed eruption 10.53 9.66 12 120374 1152 63367484
Peritonitis 10.53 9.66 62 120324 17092 63351544
Azotaemia 10.52 9.66 25 120361 4446 63364190
Mouth ulceration 10.51 9.66 30 120356 32954 63335682
Face oedema 10.50 9.66 70 120316 20142 63348494
Affect lability 10.49 9.66 4 120382 11147 63357489
Blood alkaline phosphatase increased 10.42 9.66 126 120260 42841 63325795
Iron binding capacity total decreased 10.38 9.66 7 120379 331 63368305
Peripheral vascular disorder 10.36 9.66 30 120356 6005 63362631
Subarachnoid haemorrhage 10.35 9.66 54 120332 14229 63354407
Chronic gastritis 10.34 9.66 19 120367 2822 63365814
Tremor 10.33 9.66 326 120060 131913 63236723
Carcinogenicity 10.30 9.66 3 120383 16 63368620
Mesothelioma malignant 10.29 9.66 4 120382 57 63368579
Sinus tachycardia 10.26 9.66 80 120306 24188 63344448
Intervertebral disc disorder 10.24 9.66 26 120360 4817 63363819
Therapy cessation 10.23 9.66 27 120359 30430 63338206
Liver iron concentration abnormal 10.23 9.66 4 120382 58 63368578
Stool analysis abnormal 10.23 9.66 4 120382 58 63368578
Inappropriate antidiuretic hormone secretion 10.22 9.66 57 120329 15405 63353231
Illness 10.22 9.66 53 120333 49006 63319630
Sleep disorder 10.21 9.66 102 120284 81464 63287172
Nail disorder 10.20 9.66 6 120380 13009 63355627
Poikiloderma 10.19 9.66 6 120380 223 63368413
Faeces discoloured 10.16 9.66 65 120321 18444 63350192
Postural tremor 10.14 9.66 7 120379 344 63368292
Epistaxis 10.13 9.66 194 120192 72531 63296105
Product administration error 10.13 9.66 75 120311 22322 63346314
Periodontal disease 10.12 9.66 14 120372 1634 63367002
Blood parathyroid hormone decreased 10.10 9.66 3 120383 9788 63358848
Movement disorder 10.06 9.66 73 120313 21588 63347048
Haemorrhagic tumour necrosis 10.01 9.66 3 120383 18 63368618
Intracranial aneurysm 10.00 9.66 22 120364 3717 63364919
Diastolic dysfunction 10.00 9.66 31 120355 6440 63362196
Intervertebral disc protrusion 9.94 9.66 78 120308 23631 63345005
Hypothyroidism 9.90 9.66 124 120262 42508 63326128
Mood swings 9.90 9.66 12 120374 18236 63350400
Oedema mouth 9.89 9.66 17 120369 2396 63366240
Decreased appetite 9.87 9.66 576 119810 250476 63118160
Pancreatitis 9.86 9.66 139 120247 48916 63319720
Psychogenic seizure 9.84 9.66 14 120372 1678 63366958
Skin ulcer 9.83 9.66 45 120341 43000 63325636
Adenocarcinoma 9.83 9.66 19 120367 2931 63365705
Thrombotic cerebral infarction 9.81 9.66 5 120381 139 63368497
Transferrin decreased 9.79 9.66 6 120380 240 63368396
Infective exacerbation of chronic obstructive airways disease 9.78 9.66 12 120374 1245 63367391
Calcium metabolism disorder 9.68 9.66 5 120381 143 63368493

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 293.56 10.19 357 84982 419167 34452425
Blood pressure inadequately controlled 214.29 10.19 112 85227 2528 34869064
Drug abuse 188.33 10.19 14 85325 99082 34772510
Blood pressure increased 174.66 10.19 542 84797 87560 34784032
Drug ineffective 137.40 10.19 612 84727 456139 34415453
Blood creatinine increased 132.35 10.19 520 84819 94456 34777136
Death 124.06 10.19 526 84813 397523 34474069
Cerebral infarction 119.54 10.19 229 85110 27226 34844366
Toxicity to various agents 116.24 10.19 194 85145 200168 34671424
Myocardial infarction 98.35 10.19 567 84772 120518 34751074
Hyperkalaemia 96.67 10.19 380 84959 69009 34802583
Blood urea increased 93.58 10.19 220 85119 30144 34841448
Completed suicide 92.67 10.19 63 85276 98105 34773487
Cardiac failure 85.98 10.19 445 84894 90803 34780789
Hypertensive crisis 82.01 10.19 104 85235 8647 34862945
Renal failure 81.62 10.19 572 84767 129985 34741607
Product use in unapproved indication 72.56 10.19 109 85230 117390 34754202
Febrile neutropenia 71.67 10.19 141 85198 136708 34734884
Cerebrovascular accident 70.02 10.19 399 84940 84412 34787180
Syncope 68.26 10.19 419 84920 91032 34780560
Fear of disease 67.04 10.19 26 85313 280 34871312
Cardiac failure chronic 66.60 10.19 89 85250 7790 34863802
Dizziness 66.48 10.19 820 84519 217701 34653891
Cardiac failure congestive 61.81 10.19 381 84958 82889 34788703
Neutropenia 60.60 10.19 189 85150 156589 34715003
Interstitial lung disease 58.45 10.19 314 85025 64968 34806624
Angina pectoris 58.42 10.19 189 85150 31174 34840418
Renal impairment 57.79 10.19 412 84927 94101 34777491
Acute kidney injury 56.40 10.19 1051 84288 303937 34567655
Product dose omission issue 55.48 10.19 132 85207 119579 34752013
Acute myocardial infarction 53.37 10.19 266 85073 53453 34818139
Treatment failure 49.61 10.19 26 85313 46671 34824921
Mitral valve incompetence 46.82 10.19 109 85230 14834 34856758
Disease progression 46.33 10.19 124 85215 107953 34763639
Blood creatine phosphokinase increased 44.47 10.19 222 85117 44635 34826957
Hospitalisation 44.38 10.19 44 85295 56858 34814734
Coronary artery disease 44.36 10.19 234 85105 48071 34823521
Angioedema 43.65 10.19 194 85145 37180 34834412
Blood pressure decreased 41.59 10.19 241 85098 51274 34820318
Blood lactic acid 41.00 10.19 19 85320 327 34871265
Product use issue 39.62 10.19 58 85281 63158 34808434
Sprue-like enteropathy 39.46 10.19 21 85318 492 34871100
Hypotension 38.21 10.19 756 84583 220893 34650699
Lymphocyte stimulation test positive 37.90 10.19 23 85316 697 34870895
Eosinophilic colitis 37.70 10.19 16 85323 221 34871371
Oxygen saturation increased 37.36 10.19 17 85322 280 34871312
Glomerular filtration rate decreased 36.79 10.19 91 85248 12870 34858722
Aortic aneurysm 36.45 10.19 62 85277 6717 34864875
Sepsis 36.14 10.19 248 85091 166313 34705279
Infusion related reaction 35.95 10.19 46 85293 53011 34818581
Atrial fibrillation 34.45 10.19 453 84886 121940 34749652
Product impurity 34.38 10.19 10 85329 39 34871553
Condition aggravated 34.30 10.19 302 85037 191894 34679698
Drug ineffective for unapproved indication 34.08 10.19 8 85331 23707 34847885
Cerebral haemorrhage 33.98 10.19 172 85167 34765 34836827
Arrhythmia 33.93 10.19 175 85164 35633 34835959
Bundle branch block left 33.90 10.19 56 85283 5923 34865669
Gamma-glutamyltransferase increased 33.58 10.19 151 85188 29080 34842512
Intentional product use issue 32.70 10.19 60 85279 59756 34811836
Hemiplegia 32.63 10.19 60 85279 6912 34864680
Blood pressure diastolic decreased 32.60 10.19 70 85269 9024 34862568
Fractured coccyx 32.12 10.19 13 85326 158 34871434
Adrenal adenoma 32.07 10.19 18 85321 470 34871122
Hyponatraemia 31.72 10.19 325 85014 82366 34789226
Drug dependence 31.36 10.19 10 85329 24207 34847385
Cell marker increased 31.17 10.19 17 85322 419 34871173
Blood glucose increased 30.95 10.19 273 85066 66445 34805147
Brain natriuretic peptide abnormal 30.89 10.19 16 85323 354 34871238
Chronic kidney disease 30.82 10.19 189 85150 41021 34830571
Pancreatic neoplasm 30.71 10.19 22 85317 886 34870706
Oedema peripheral 30.27 10.19 435 84904 119377 34752215
Shock 30.13 10.19 128 85211 24051 34847541
N-terminal prohormone brain natriuretic peptide abnormal 29.60 10.19 13 85326 196 34871396
Blood potassium increased 29.45 10.19 98 85241 16397 34855195
Pulmonary arterial pressure abnormal 29.13 10.19 13 85326 204 34871388
Sinus arrest 29.05 10.19 28 85311 1712 34869880
Type 2 diabetes mellitus 28.40 10.19 95 85244 15937 34855655
COVID-19 28.18 10.19 96 85243 77454 34794138
Clostridium difficile infection 27.91 10.19 6 85333 18892 34852700
Blood triglycerides increased 27.89 10.19 87 85252 14072 34857520
Arteriosclerosis 27.82 10.19 78 85261 11890 34859702
Mucosal inflammation 27.73 10.19 32 85307 38590 34833002
Pulmonary valve stenosis congenital 27.38 10.19 11 85328 131 34871461
Suicidal ideation 27.37 10.19 35 85304 40353 34831239
Diabetes mellitus 27.27 10.19 202 85137 46671 34824921
Left ventricular dilatation 26.90 10.19 19 85320 748 34870844
Painful respiration 26.74 10.19 23 85316 1213 34870379
Ventricular extrasystoles 26.69 10.19 77 85262 11931 34859661
Sedation 26.63 10.19 9 85330 20997 34850595
Conduction disorder 26.27 10.19 29 85310 2081 34869511
Aggression 26.16 10.19 34 85305 38930 34832662
Orthostatic intolerance 25.70 10.19 19 85320 804 34870788
Cardiac failure acute 25.67 10.19 70 85269 10500 34861092
Ejection fraction abnormal 25.28 10.19 20 85319 937 34870655
Gastritis erosive 25.22 10.19 49 85290 5883 34865709
Chronic pigmented purpura 25.20 10.19 10 85329 115 34871477
Dyslipidaemia 24.98 10.19 56 85283 7432 34864160
Colon cancer 24.97 10.19 61 85278 8560 34863032
Cerebellar ischaemia 24.60 10.19 10 85329 123 34871469
Periarthritis calcarea 24.54 10.19 9 85330 82 34871510
Agitation 24.47 10.19 66 85273 57333 34814259
Drug intolerance 24.28 10.19 70 85269 59500 34812092
Articular calcification 24.25 10.19 9 85330 85 34871507
Breast discomfort 24.25 10.19 6 85333 10 34871582
Bradycardia 24.14 10.19 286 85053 75132 34796460
Microalbuminuria 23.72 10.19 17 85322 685 34870907
Intentional self-injury 23.38 10.19 3 85336 13768 34857824
Lymphocyte count abnormal 23.33 10.19 21 85318 1177 34870415
Foetal exposure during pregnancy 22.86 10.19 36 85303 38065 34833527
Goitre 22.53 10.19 24 85315 1654 34869938
Electrocardiogram QRS complex abnormal 22.51 10.19 13 85326 359 34871233
Myocardial ischaemia 22.35 10.19 93 85246 17315 34854277
Atrioventricular block 22.24 10.19 56 85283 8007 34863585
Malignant neoplasm progression 22.23 10.19 125 85214 87921 34783671
Quality of life decreased 22.05 10.19 37 85302 3964 34867628
Blood thyroid stimulating hormone abnormal 21.94 10.19 13 85326 377 34871215
Aortic valve incompetence 21.80 10.19 46 85293 5858 34865734
Chest injury 21.79 10.19 23 85316 1568 34870024
Synovitis 21.74 10.19 4 85335 14062 34857530
Merycism 21.70 10.19 8 85331 74 34871518
Pemphigoid 21.66 10.19 58 85281 8608 34862984
Haemophagocytic lymphohistiocytosis 21.61 10.19 3 85336 12970 34858622
Pancytopenia 21.46 10.19 140 85199 95017 34776575
Melaena 21.46 10.19 154 85185 35226 34836366
Drug resistance 21.44 10.19 19 85320 25908 34845684
Ventricular hypokinesia 21.37 10.19 44 85295 5508 34866084
Psychotic disorder 21.35 10.19 17 85322 24435 34847157
Idiopathic pulmonary fibrosis 21.26 10.19 34 85305 3500 34868092
Gastric cancer 21.16 10.19 48 85291 6421 34865171
Status epilepticus 20.81 10.19 3 85336 12611 34858981
Immature granulocyte count increased 20.78 10.19 9 85330 131 34871461
Hepatitis E antibody positive 20.74 10.19 11 85328 256 34871336
Lung diffusion disorder 20.36 10.19 9 85330 138 34871454
Thrombotic stroke 20.36 10.19 11 85328 266 34871326
Osteoarthritis 20.33 10.19 102 85237 20540 34851052
Nephrogenic anaemia 20.28 10.19 26 85313 2185 34869407
Lateropulsion 20.07 10.19 4 85335 0 34871592
Thrombocytopenia 20 10.19 265 85074 155982 34715610
Coronary arterial stent insertion 19.91 10.19 36 85303 4093 34867499
Coronary artery restenosis 19.89 10.19 18 85321 1016 34870576
Walking aid user 19.85 10.19 24 85315 1900 34869692
Renal artery stenosis 19.82 10.19 26 85313 2235 34869357
Patent ductus arteriosus 19.81 10.19 32 85307 3322 34868270
Subacute hepatic failure 19.78 10.19 8 85331 97 34871495
Vertigo 19.65 10.19 118 85221 25418 34846174
Hyperglycaemia 19.58 10.19 164 85175 39316 34832276
Hepatitis E virus test positive 19.57 10.19 11 85328 288 34871304
Bundle branch block right 19.49 10.19 51 85288 7465 34864127
Adrenal cyst 19.47 10.19 9 85330 154 34871438
Hallucination, auditory 19.28 10.19 3 85336 11914 34859678
Hyperuricaemia 19.27 10.19 53 85286 7990 34863602
Gouty arthritis 19.13 10.19 18 85321 1068 34870524
Pyonephrosis 19.06 10.19 7 85332 64 34871528
Chest pain 19.06 10.19 424 84915 126338 34745254
Pulmonary hypoplasia 19.05 10.19 13 85326 484 34871108
Pneumonia 19.03 10.19 709 84630 361918 34509674
Neuropathy peripheral 19.03 10.19 122 85217 83141 34788451
Renal failure neonatal 18.88 10.19 8 85331 110 34871482
Coronary artery stenosis 18.86 10.19 59 85280 9557 34862035
Rhythm idioventricular 18.75 10.19 11 85328 313 34871279
Myelosuppression 18.65 10.19 12 85327 19253 34852339
Fear 18.49 10.19 62 85277 10414 34861178
Bursitis 18.41 10.19 41 85298 5417 34866175
Ejection fraction decreased 18.41 10.19 94 85245 19060 34852532
Post streptococcal glomerulonephritis 18.31 10.19 8 85331 119 34871473
Angioplasty 18.29 10.19 17 85322 993 34870599
Urine albumin/creatinine ratio increased 18.24 10.19 10 85329 249 34871343
Vomiting 18.15 10.19 463 84876 247158 34624434
BRASH syndrome 17.94 10.19 13 85326 533 34871059
Hypertrophic osteoarthropathy 17.84 10.19 7 85332 78 34871514
Blood pressure systolic decreased 17.70 10.19 36 85303 4467 34867125
Lacunar infarction 17.60 10.19 29 85310 3061 34868531
Blood lactate dehydrogenase increased 17.54 10.19 106 85233 22884 34848708
Tricuspid valve incompetence 17.43 10.19 58 85281 9702 34861890
Deep vein thrombosis 17.37 10.19 91 85248 65157 34806435
Blood cholesterol increased 17.15 10.19 97 85242 20446 34851146
Renal cyst 17.11 10.19 55 85284 9038 34862554
Oscillopsia 17.04 10.19 6 85333 48 34871544
Dyspnoea exertional 17.01 10.19 171 85168 43108 34828484
Urticaria chronic 17.01 10.19 7 85332 89 34871503
Rhabdomyolysis 17 10.19 247 85092 67916 34803676
Hypoparathyroidism 16.75 10.19 13 85326 592 34871000
Loss of personal independence in daily activities 16.64 10.19 35 85304 33144 34838448
Brain stem infarction 16.62 10.19 18 85321 1264 34870328
Leukopenia 16.54 10.19 88 85251 62768 34808824
Cardiovascular disorder 16.42 10.19 58 85281 9998 34861594
Peripheral arterial occlusive disease 16.42 10.19 41 85298 5833 34865759
Neurotoxicity 16.39 10.19 12 85327 17998 34853594
Angina unstable 16.35 10.19 64 85275 11589 34860003
Erectile dysfunction 16.29 10.19 96 85243 20541 34851051
Dyspnoea 16.25 10.19 1097 84242 375685 34495907
Intentional product misuse 16.20 10.19 57 85282 45554 34826038
Cardiac vein perforation 16.19 10.19 5 85334 25 34871567
Appendicitis 16.09 10.19 8 85331 14799 34856793
Transient ischaemic attack 16.06 10.19 119 85220 27494 34844098
Surfactant protein increased 16.04 10.19 4 85335 7 34871585
Pericardial haemorrhage 15.83 10.19 28 85311 3130 34868462
Atrial thrombosis 15.72 10.19 23 85316 2191 34869401
Liver function test increased 15.63 10.19 8 85331 14557 34857035
Glycosylated haemoglobin increased 15.62 10.19 62 85277 11298 34860294
Loss of consciousness 15.57 10.19 286 85053 82381 34789211
Retinopathy 15.47 10.19 22 85317 2042 34869550
Product substitution issue 15.45 10.19 57 85282 10038 34861554
Bile duct cancer 15.33 10.19 13 85326 672 34870920
Therapy non-responder 15.23 10.19 47 85292 39099 34832493
Blood pressure abnormal 15.22 10.19 49 85290 8057 34863535
Protein urine present 15.15 10.19 37 85302 5191 34866401
Osteochondrosis 15.12 10.19 16 85323 1094 34870498
Carotid artery stenosis 15.06 10.19 36 85303 4983 34866609
Blepharochalasis 15.05 10.19 3 85336 0 34871592
Diabetic nephropathy 14.95 10.19 22 85317 2106 34869486
Cardiac pacemaker insertion 14.92 10.19 26 85313 2872 34868720
Seizure 14.85 10.19 174 85165 104683 34766909
Rheumatoid arthritis 14.81 10.19 46 85293 38192 34833400
Myosclerosis 14.77 10.19 9 85330 275 34871317
Generalised tonic-clonic seizure 14.71 10.19 18 85321 21156 34850436
Primary hyperaldosteronism 14.60 10.19 6 85333 76 34871516
Respiratory depression 14.56 10.19 11 85328 16234 34855358
Ischaemic stroke 14.47 10.19 85 85254 18165 34853427
Acquired C1 inhibitor deficiency 14.32 10.19 4 85335 13 34871579
Hypertensive heart disease 14.26 10.19 23 85316 2385 34869207
Bronchitis 14.25 10.19 161 85178 41802 34829790
Colitis 14.21 10.19 46 85293 37704 34833888
Lip oedema 14.18 10.19 24 85315 2589 34869003
Lymphocyte count 14.06 10.19 6 85333 84 34871508
Renal dysplasia 14.01 10.19 8 85331 216 34871376
Extrapyramidal disorder 13.93 10.19 7 85332 12873 34858719
Nephrocalcinosis 13.90 10.19 12 85327 636 34870956
Pyrexia 13.90 10.19 668 84671 332345 34539247
Renal cell carcinoma 13.86 10.19 35 85304 5013 34866579
Adverse drug reaction 13.86 10.19 32 85307 29310 34842282
Therapeutic product effect incomplete 13.72 10.19 70 85269 50471 34821121
Abnormal behaviour 13.68 10.19 25 85314 24944 34846648
Injection site pain 13.68 10.19 49 85290 38956 34832636
Eyelid ptosis congenital 13.63 10.19 6 85333 91 34871501
Carcinoid tumour 13.56 10.19 8 85331 230 34871362
Atrioventricular block first degree 13.47 10.19 39 85300 6053 34865539
Bacteraemia 13.45 10.19 17 85322 19700 34851892
Sacroiliac joint dysfunction 13.40 10.19 5 85334 48 34871544
Cytokine release syndrome 13.36 10.19 22 85317 22855 34848737
Dyslalia 13.31 10.19 11 85328 549 34871043
Inguinal hernia 13.29 10.19 45 85294 7596 34863996
Nodal rhythm 13.28 10.19 17 85322 1426 34870166
Ischaemic cardiomyopathy 13.27 10.19 40 85299 6349 34865243
Arteriosclerosis coronary artery 13.23 10.19 63 85276 12422 34859170
Extrasystoles 13.21 10.19 29 85310 3794 34867798
Abdominal tenderness 13.18 10.19 30 85309 4021 34867571
Dystonia 13.14 10.19 5 85334 10840 34860752
Hepatic calcification 13.12 10.19 9 85330 338 34871254
Costal cartilage fracture 13.08 10.19 8 85331 246 34871346
Diabetic retinopathy 13.08 10.19 19 85320 1798 34869794
Lower respiratory tract infection 13.01 10.19 37 85302 31600 34839992
Hypocapnia 13.00 10.19 7 85332 168 34871424
Nausea 12.99 10.19 688 84651 339220 34532372
Atrioventricular block complete 12.93 10.19 51 85288 9268 34862324
Lipid metabolism disorder 12.91 10.19 9 85330 347 34871245
Coronary artery occlusion 12.86 10.19 57 85282 10905 34860687
Blood uric acid increased 12.81 10.19 52 85287 9572 34862020
Influenza 12.81 10.19 70 85269 49596 34821996
Chronic coronary syndrome 12.78 10.19 7 85332 174 34871418
Neutropenic sepsis 12.75 10.19 9 85330 13758 34857834
Intentional overdose 12.72 10.19 59 85280 43615 34827977
Ventricular hypertrophy 12.71 10.19 32 85307 4575 34867017
Papillary renal cell carcinoma 12.68 10.19 8 85331 260 34871332
Tachycardia 12.66 10.19 139 85200 84633 34786959
Malignant melanoma 12.65 10.19 46 85293 8044 34863548
Adrenomegaly 12.62 10.19 9 85330 360 34871232
Graft versus host disease 12.60 10.19 5 85334 10564 34861028
Erythema multiforme 12.54 10.19 48 85291 8601 34862991
Haematocrit decreased 12.52 10.19 127 85212 32089 34839503
Electrocardiogram ST segment depression 12.52 10.19 22 85317 2446 34869146
Hallucination 12.52 10.19 74 85265 51424 34820168
Paranoia 12.40 10.19 7 85332 12061 34859531
Activated partial thromboplastin time shortened 12.38 10.19 10 85329 483 34871109
Oedema neonatal 12.35 10.19 4 85335 24 34871568
Septic shock 12.29 10.19 114 85225 71720 34799872
Metamyelocyte count increased 12.25 10.19 9 85330 377 34871215
Chest discomfort 12.20 10.19 194 85145 54336 34817256
Concomitant disease progression 12.20 10.19 22 85317 2496 34869096
Kounis syndrome 12.20 10.19 22 85317 2496 34869096
Hypercholesterolaemia 12.19 10.19 48 85291 8714 34862878
Small intestine carcinoma 12.06 10.19 11 85328 627 34870965
Acute coronary syndrome 12.00 10.19 65 85274 13480 34858112
Cytomegalovirus infection 11.94 10.19 29 85310 26106 34845486
Emotional distress 11.92 10.19 70 85269 14956 34856636
Chest wall haematoma 11.87 10.19 7 85332 201 34871391
Malabsorption 11.85 10.19 21 85318 2351 34869241
Benign prostatic hyperplasia 11.81 10.19 68 85271 14427 34857165
Miscarriage of partner 11.77 10.19 3 85336 6 34871586
Abdominal compartment syndrome 11.70 10.19 13 85326 940 34870652
Palpitations 11.64 10.19 149 85190 39837 34831755
pH body fluid increased 11.59 10.19 5 85334 72 34871520
Genital candidiasis 11.59 10.19 5 85334 72 34871520
Coronary angioplasty 11.58 10.19 9 85330 411 34871181
Choroidal detachment 11.54 10.19 9 85330 413 34871179
Osteitis deformans 11.47 10.19 4 85335 31 34871561
Pancreatitis chronic 11.40 10.19 20 85319 2220 34869372
Anaemia 11.23 10.19 686 84653 232649 34638943
Blood pressure systolic increased 11.20 10.19 95 85244 22857 34848735
Cardiac valve sclerosis 11.18 10.19 5 85334 79 34871513
Adverse event 11.17 10.19 18 85321 18859 34852733
Diastolic dysfunction 11.12 10.19 37 85302 6190 34865402
Haemangioma 11.07 10.19 18 85321 1879 34869713
Intermittent claudication 11.06 10.19 20 85319 2274 34869318
Small intestinal haemorrhage 10.98 10.19 19 85320 2087 34869505
Aneurysm 10.96 10.19 18 85321 1894 34869698
Anhedonia 10.92 10.19 42 85297 7543 34864049
Legionella test positive 10.92 10.19 3 85336 9 34871583
Constipation 10.87 10.19 253 85086 136729 34734863
Product residue present 10.85 10.19 22 85317 2724 34868868
Venoocclusive liver disease 10.84 10.19 3 85336 7963 34863629
Neuromyopathy 10.83 10.19 13 85326 1021 34870571
Aortic aneurysm rupture 10.77 10.19 13 85326 1027 34870565
Hepatic function abnormal 10.76 10.19 160 85179 44203 34827389
Paralysis 10.74 10.19 36 85303 6046 34865546
Psoriatic arthropathy 10.69 10.19 20 85319 19778 34851814
Orthopnoea 10.65 10.19 32 85307 5071 34866521
Hypoglycaemia 10.62 10.19 190 85149 54450 34817142
Miosis 10.59 10.19 5 85334 9530 34862062
Transplant rejection 10.57 10.19 6 85333 10305 34861287
Blood cholesterol decreased 10.53 10.19 13 85326 1051 34870541
Pathogen resistance 10.49 10.19 5 85334 9477 34862115
Myelocyte count increased 10.41 10.19 8 85331 359 34871233
Hypogammaglobulinaemia 10.38 10.19 3 85336 7737 34863855
Blood phosphorus increased 10.34 10.19 3 85336 7718 34863874
Costovertebral angle tenderness 10.29 10.19 5 85334 96 34871496
Glare 10.29 10.19 5 85334 96 34871496
Joint stiffness 10.22 10.19 7 85332 10866 34860726

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 347.99 9.45 800 156405 906415 78680768
Blood pressure inadequately controlled 319.78 9.45 181 157024 5996 79581187
Cardiac failure congestive 272.40 9.45 754 156451 141648 79445535
Blood pressure increased 258.03 9.45 959 156246 210401 79376782
Hyperkalaemia 255.72 9.45 642 156563 113756 79473427
Myocardial infarction 247.32 9.45 862 156343 183267 79403916
Hyponatraemia 240.08 9.45 834 156371 177014 79410169
Completed suicide 213.34 9.45 109 157096 245658 79341525
Acute kidney injury 211.40 9.45 1746 155459 517658 79069525
Cerebral infarction 194.06 9.45 334 156871 45342 79541841
Coronary artery disease 174.99 9.45 394 156811 65080 79522103
Hand deformity 174.35 9.45 7 157198 103912 79483271
Hypertensive crisis 166.24 9.45 205 157000 20565 79566618
Renal failure 166.01 9.45 810 156395 200158 79387025
Drug ineffective 157.58 9.45 1370 155835 1079543 78507640
Drug abuse 152.18 9.45 65 157140 162626 79424557
Syncope 150.87 9.45 727 156478 178722 79408461
Blood creatinine increased 149.49 9.45 654 156551 154403 79432780
Anti-cyclic citrullinated peptide antibody positive 148.99 9.45 3 157202 83140 79504043
Toxicity to various agents 145.84 9.45 391 156814 421149 79166034
Glossodynia 137.40 9.45 20 157185 103317 79483866
Pemphigus 135.41 9.45 18 157187 99564 79487619
Systemic lupus erythematosus 134.84 9.45 36 157169 121113 79466070
Product use issue 123.29 9.45 139 157066 209683 79377500
Product use in unapproved indication 121.52 9.45 191 157014 250168 79337015
Cardiac failure 118.56 9.45 611 156594 154231 79432952
Oedema peripheral 118.26 9.45 877 156328 251411 79335772
Pericarditis 114.07 9.45 32 157173 104204 79482979
Hypotension 111.89 9.45 1343 155862 438974 79148209
Alopecia 111.80 9.45 177 157028 231178 79356005
Renal impairment 111.50 9.45 609 156596 157174 79430009
Death 109.27 9.45 662 156543 565852 79021331
Duodenal ulcer perforation 106.10 9.45 6 157199 66205 79520978
Infusion related reaction 104.89 9.45 183 157022 230054 79357129
Atrial fibrillation 104.42 9.45 708 156497 197178 79390005
Cerebrovascular accident 102.18 9.45 588 156617 154704 79432479
Acute myocardial infarction 101.00 9.45 358 156847 76678 79510505
Arthropathy 97.99 9.45 123 157082 176988 79410195
Blood urea increased 97.82 9.45 263 156942 48527 79538656
Febrile neutropenia 96.06 9.45 194 157011 230805 79356378
Cardiac failure chronic 94.14 9.45 113 157092 11022 79576161
Dizziness 93.64 9.45 1507 155698 524934 79062249
Oligohydramnios 91.46 9.45 66 157139 3346 79583837
Maternal exposure during pregnancy 89.81 9.45 82 157123 136456 79450727
Treatment failure 89.60 9.45 123 157082 170363 79416820
Joint swelling 87.92 9.45 284 156921 288362 79298821
Condition aggravated 87.20 9.45 604 156601 500520 79086663
Angina pectoris 86.33 9.45 261 156944 51471 79535712
Drug intolerance 84.58 9.45 254 156951 263865 79323318
Mitral valve incompetence 84.37 9.45 179 157026 28386 79558797
Therapeutic product effect decreased 84.33 9.45 120 157085 163743 79423440
Wound 83.52 9.45 64 157141 116115 79471068
Helicobacter infection 82.87 9.45 18 157187 69686 79517497
Blood glucose increased 82.70 9.45 446 156759 114529 79472654
Synovitis 77.95 9.45 110 157095 150624 79436559
Intentional product use issue 77.68 9.45 112 157093 152000 79435183
Bradycardia 73.87 9.45 489 156716 135068 79452115
Folliculitis 72.96 9.45 11 157194 55369 79531814
Interstitial lung disease 72.50 9.45 424 156781 112176 79475007
Colitis microscopic 71.63 9.45 97 157108 10671 79576512
Psoriatic arthropathy 71.58 9.45 32 157173 77967 79509216
Blood creatine phosphokinase increased 70.02 9.45 287 156918 65803 79521380
Sleep disorder due to general medical condition, insomnia type 69.62 9.45 4 157201 43552 79543631
Bronchial neoplasm 69.61 9.45 29 157176 479 79586704
Anaemia 68.54 9.45 1245 155960 443770 79143413
Bundle branch block left 65.16 9.45 96 157109 11417 79575766
Thyroid disorder 63.82 9.45 106 157099 13973 79573210
Contraindicated product administered 63.19 9.45 135 157070 157403 79429780
Nasal turbinate hypertrophy 63.15 9.45 30 157175 685 79586498
Chronic kidney disease 62.90 9.45 278 156927 65876 79521307
Muscle injury 58.83 9.45 12 157193 48549 79538634
Angioedema 58.82 9.45 301 156904 75734 79511449
Pain 57.53 9.45 1009 156196 702793 78884390
Rheumatoid factor positive 57.39 9.45 23 157182 59816 79527367
Exposure during pregnancy 57.21 9.45 69 157136 101063 79486120
COVID-19 56.90 9.45 143 157062 157531 79429652
Swelling 56.80 9.45 227 156978 216484 79370699
Chest pain 56.54 9.45 825 156380 281479 79305704
Blood pressure decreased 56.12 9.45 362 156843 99104 79488079
Neutropenia 54.91 9.45 337 156868 287373 79299810
Labile hypertension 54.58 9.45 25 157180 524 79586659
Endometrial ablation 54.01 9.45 29 157176 864 79586319
Glaucoma 53.98 9.45 120 157085 19641 79567542
Product prescribing error 53.45 9.45 202 157003 44611 79542572
Product dose omission issue 53.14 9.45 279 156926 247258 79339925
Infection 52.70 9.45 271 156934 241441 79345742
Discomfort 52.61 9.45 105 157100 125512 79461671
Rheumatoid arthritis 52.37 9.45 222 156983 208248 79378935
Bronchial haemorrhage 50.91 9.45 32 157173 1288 79585895
Rhabdomyolysis 50.81 9.45 363 156842 102768 79484415
Product impurity 50.63 9.45 15 157190 82 79587101
Angina unstable 50.47 9.45 105 157100 16422 79570761
Blister 49.92 9.45 100 157105 119376 79467807
Rash 48.88 9.45 824 156381 577534 79009649
Arthralgia 48.87 9.45 813 156392 570990 79016193
Melaena 48.46 9.45 243 156962 60647 79526536
Diverticulitis 48.27 9.45 199 157006 45737 79541446
Disease progression 47.75 9.45 194 157011 184168 79403015
Diabetes mellitus inadequate control 46.83 9.45 129 157076 24135 79563048
Musculoskeletal stiffness 46.69 9.45 182 157023 174826 79412357
Cerebral haemorrhage 46.50 9.45 231 156974 57442 79529741
Asthenia 46.23 9.45 1328 155877 510361 79076822
Drug ineffective for unapproved indication 45.50 9.45 22 157183 51216 79535967
Tricuspid valve incompetence 45.43 9.45 112 157093 19600 79567583
Hospitalisation 44.63 9.45 73 157132 94163 79493020
Macular degeneration 44.59 9.45 80 157125 11216 79575967
Hip arthroplasty 42.98 9.45 9 157196 35747 79551436
Cardiac failure acute 42.00 9.45 106 157099 18823 79568360
Transient ischaemic attack 41.73 9.45 210 156995 52485 79534698
Thrombotic stroke 41.57 9.45 23 157182 728 79586455
Arrhythmia 41.57 9.45 234 156971 61038 79526145
Arteriosclerosis 41.42 9.45 103 157102 18124 79569059
Blood lactate dehydrogenase increased 41.40 9.45 170 157035 39000 79548183
Sinus arrest 41.35 9.45 43 157162 3579 79583604
Gamma-glutamyltransferase increased 41.27 9.45 215 156990 54465 79532718
Coronary arterial stent insertion 41.05 9.45 55 157150 5989 79581194
Hypoglycaemia 40.81 9.45 341 156864 101253 79485930
Dehydration 40.13 9.45 700 156505 247487 79339696
Blood potassium increased 40.04 9.45 138 157067 29137 79558046
Blood lactic acid 39.59 9.45 19 157186 444 79586739
Lower respiratory tract infection 39.39 9.45 127 157078 129093 79458090
Drug hypersensitivity 39.26 9.45 388 156817 298528 79288655
Intentional overdose 39.08 9.45 95 157110 105865 79481318
Irritable bowel syndrome 39.02 9.45 39 157166 62202 79524981
Adverse drug reaction 38.94 9.45 44 157161 66348 79520835
Stomatitis 38.90 9.45 153 157052 146604 79440579
Ischaemic stroke 38.40 9.45 148 157057 32983 79554200
Forced expiratory volume decreased 38.36 9.45 61 157144 7753 79579430
Lymphocyte stimulation test positive 37.62 9.45 25 157180 1108 79586075
Foetal disorder 37.54 9.45 13 157192 125 79587058
Aortic aneurysm 37.49 9.45 63 157142 8383 79578800
Lymphatic fistula 37.48 9.45 22 157183 781 79586402
Myocardial ischaemia 37.29 9.45 123 157082 25396 79561787
Dyspnoea 36.99 9.45 2053 155152 854972 78732211
Bronchial disorder 36.73 9.45 34 157171 2455 79584728
Fall 36.72 9.45 1238 155967 486391 79100792
Femoral hernia incarcerated 36.52 9.45 22 157183 820 79586363
Sinusitis 36.24 9.45 231 156974 195270 79391913
Rhonchi 35.84 9.45 42 157163 3994 79583189
Atrioventricular block complete 35.80 9.45 92 157113 16518 79570665
N-terminal prohormone brain natriuretic peptide abnormal 35.35 9.45 15 157190 260 79586923
Renal cyst 35.33 9.45 85 157120 14647 79572536
Tachyarrhythmia 35.08 9.45 55 157150 6907 79580276
Cardiovascular disorder 34.96 9.45 96 157109 17929 79569254
Injection site pain 34.64 9.45 135 157070 129703 79457480
Intentional product misuse 34.56 9.45 86 157119 95079 79492104
Abortion spontaneous 34.31 9.45 8 157197 29499 79557684
Fibromyalgia 34.20 9.45 46 157159 64294 79522889
Diverticulum intestinal 34.04 9.45 61 157144 8544 79578639
Renal artery stenosis 33.90 9.45 38 157167 3444 79583739
Pancreatic neoplasm 33.85 9.45 26 157179 1450 79585733
Bronchitis 33.28 9.45 399 156806 130245 79456938
Hyperglycaemia 33.16 9.45 245 156960 70090 79517093
Obstructive airways disorder 32.83 9.45 136 157069 31323 79555860
Pancreatic steatosis 32.65 9.45 23 157182 1122 79586061
Fear of disease 32.38 9.45 24 157181 1268 79585915
Dyslipidaemia 32.18 9.45 71 157134 11562 79575621
Coronary artery stenosis 32.08 9.45 74 157131 12410 79574773
Sedation 31.98 9.45 33 157172 51862 79535321
Glomerular filtration rate decreased 31.91 9.45 108 157097 22594 79564589
Pregnancy 31.78 9.45 7 157198 26844 79560339
Hypokalaemia 31.63 9.45 428 156777 143612 79443571
Ventricular extrasystoles 31.55 9.45 98 157107 19606 79567577
Shock 31.34 9.45 169 157036 43379 79543804
Liver function test increased 31.09 9.45 20 157185 39753 79547430
Migraine 31.05 9.45 80 157125 87413 79499770
Ischaemic cardiomyopathy 31.02 9.45 55 157150 7640 79579543
Vascular resistance pulmonary decreased 30.83 9.45 10 157195 77 79587106
Cell marker increased 30.82 9.45 18 157187 633 79586550
Cardiomegaly 30.77 9.45 118 157087 26234 79560949
Abdominal discomfort 30.64 9.45 331 156874 250396 79336787
Diabetic retinopathy 30.41 9.45 34 157171 3072 79584111
Pemphigoid 30.13 9.45 82 157123 15233 79571950
Haematoma 30.07 9.45 191 157014 52004 79535179
Hepatic enzyme increased 29.78 9.45 224 156981 182386 79404797
Eosinophilic colitis 29.76 9.45 16 157189 478 79586705
Sprue-like enteropathy 29.76 9.45 23 157182 1295 79585888
Impaired healing 29.70 9.45 82 157123 87573 79499610
Coronary artery restenosis 29.59 9.45 23 157182 1306 79585877
Atrioventricular block 29.47 9.45 77 157128 13964 79573219
Drug resistance 29.39 9.45 24 157181 42189 79544994
Coronary artery occlusion 29.14 9.45 81 157124 15234 79571949
Loss of personal independence in daily activities 29.10 9.45 104 157101 102476 79484707
Blood sodium decreased 28.82 9.45 136 157069 33119 79554064
Gastritis erosive 28.66 9.45 65 157140 10782 79576401
Hemiplegia 28.41 9.45 79 157126 14860 79572323
Adrenal adenoma 28.36 9.45 22 157183 1245 79585938
Gastrointestinal disorder 28.34 9.45 134 157071 122071 79465112
Left-to-right cardiac shunt 28.27 9.45 10 157195 103 79587080
Blood pressure systolic increased 28.06 9.45 227 156978 66759 79520424
Diabetes mellitus 27.79 9.45 256 156949 78134 79509049
Oxygen saturation increased 27.70 9.45 16 157189 551 79586632
Wound infection pseudomonas 27.59 9.45 24 157181 1597 79585586
Hepatic function abnormal 27.58 9.45 242 156963 72865 79514318
Drug interaction 27.51 9.45 1039 156166 414144 79173039
Drug dependence 27.37 9.45 24 157181 40745 79546438
Venous pressure jugular increased 27.28 9.45 22 157183 1318 79585865
Ventricular hypertrophy 27.21 9.45 49 157156 6889 79580294
Lacunar infarction 27.20 9.45 45 157160 5912 79581271
Suicidal ideation 26.94 9.45 70 157135 76270 79510913
Status epilepticus 26.81 9.45 8 157197 25033 79562150
Arterial haemorrhage 26.75 9.45 29 157176 2532 79584651
Left ventricular dilatation 26.59 9.45 20 157185 1081 79586102
Haematochezia 26.56 9.45 277 156928 87368 79499815
Device dislocation 26.56 9.45 9 157196 25961 79561222
Hepatic cyst 26.47 9.45 45 157160 6044 79581139
Injection site reaction 26.35 9.45 42 157163 54743 79532440
Periarthritis calcarea 26.04 9.45 9 157196 86 79587097
Psychotic disorder 25.89 9.45 26 157179 41376 79545807
Colon cancer 25.86 9.45 75 157130 14448 79572735
Pulmonary oedema 25.38 9.45 276 156929 87978 79499205
Myalgia 25.29 9.45 510 156695 185131 79402052
Renal cell carcinoma 25.22 9.45 46 157159 6532 79580651
Gastrointestinal haemorrhage 25.07 9.45 420 156785 147299 79439884
Brain natriuretic peptide abnormal 25.06 9.45 17 157188 780 79586403
Hypochromic anaemia 25.05 9.45 29 157176 2722 79584461
Idiopathic pulmonary fibrosis 25.01 9.45 36 157169 4192 79582991
Dyspnoea exertional 24.89 9.45 272 156933 86801 79500382
Multi-organ disorder 24.78 9.45 28 157177 2560 79584623
Loss of consciousness 24.77 9.45 467 156738 167476 79419707
Hypocalvaria 24.66 9.45 7 157198 32 79587151
Fatigue 24.50 9.45 1543 155662 928184 78658999
Myelosuppression 24.41 9.45 26 157179 40270 79546913
Intentional self-injury 24.40 9.45 17 157188 32402 79554781
Inguinal hernia 24.40 9.45 45 157160 6443 79580740
Chronic pigmented purpura 24.00 9.45 11 157194 231 79586952
Decreased appetite 23.90 9.45 862 156343 341556 79245627
Coronary angioplasty 23.83 9.45 13 157192 400 79586783
Hypertension 23.78 9.45 836 156369 330156 79257027
Monoplegia 23.76 9.45 34 157171 3937 79583246
Angiotensin converting enzyme inhibitor foetopathy 23.67 9.45 7 157198 38 79587145
Nodal rhythm 23.58 9.45 30 157175 3105 79584078
Impaired work ability 23.56 9.45 5 157200 19676 79567507
Therapy non-responder 23.34 9.45 98 157107 92207 79494976
Hypersensitivity 23.28 9.45 370 156835 261869 79325314
Clostridium difficile infection 23.22 9.45 30 157175 42655 79544528
Product substitution issue 23.08 9.45 90 157115 20166 79567017
Hyperuricaemia 23.04 9.45 63 157142 11736 79575447
Hepatitis E antibody positive 22.92 9.45 11 157194 257 79586926
Bundle branch block right 22.90 9.45 61 157144 11190 79575993
Cytopenia 22.78 9.45 6 157199 20377 79566806
Carotid artery stenosis 22.60 9.45 52 157153 8706 79578477
Hypertensive heart disease 22.27 9.45 34 157171 4172 79583011
Orthostatic intolerance 22.25 9.45 23 157182 1901 79585282
Total lung capacity increased 22.23 9.45 25 157180 2273 79584910
Vertigo 22.20 9.45 221 156984 68861 79518322
Adverse event 22.18 9.45 54 157151 60160 79527023
Fear 22.12 9.45 94 157111 21892 79565291
Eye haemorrhage 22.02 9.45 55 157150 9702 79577481
Blood triglycerides increased 21.99 9.45 91 157114 20949 79566234
Live birth 21.95 9.45 5 157200 18739 79568444
Therapeutic drug monitoring analysis incorrectly performed 21.86 9.45 15 157190 701 79586482
Hepatitis E virus test positive 21.85 9.45 11 157194 286 79586897
Ventricular hypokinesia 21.68 9.45 53 157152 9226 79577957
Grip strength decreased 21.64 9.45 8 157197 21861 79565322
Therapy interrupted 21.59 9.45 18 157187 31323 79555860
Blood aldosterone increased 21.47 9.45 10 157195 218 79586965
Atrial thrombosis 21.44 9.45 31 157174 3625 79583558
Chest injury 21.22 9.45 27 157178 2794 79584389
Concomitant disease progression 21.17 9.45 30 157175 3443 79583740
Adrenomegaly 21.16 9.45 12 157193 399 79586784
Electrocardiogram QRS complex abnormal 21.08 9.45 14 157191 620 79586563
Eructation 21.05 9.45 58 157147 10851 79576332
Disease recurrence 21.04 9.45 34 157171 44075 79543108
Lateropulsion 20.92 9.45 4 157201 0 79587183
Aortic arteriosclerosis 20.90 9.45 51 157154 8867 79578316
Adrenal cyst 20.90 9.45 9 157196 162 79587021
Carotid artery disease 20.84 9.45 24 157181 2240 79584943
Iron deficiency anaemia 20.81 9.45 103 157102 25569 79561614
Brain contusion 20.73 9.45 19 157186 1354 79585829
Hiatus hernia 20.68 9.45 96 157109 23216 79563967
Incorrect route of product administration 20.64 9.45 23 157182 34906 79552277
Gastric ulcer haemorrhage 20.50 9.45 51 157154 8976 79578207
Skin reaction 20.47 9.45 74 157131 15994 79571189
Forced vital capacity decreased 20.45 9.45 21 157184 1722 79585461
Cytomegalovirus infection 20.22 9.45 33 157172 42611 79544572
Paraesthesia oral 20.19 9.45 87 157118 20384 79566799
Basal ganglion degeneration 20.19 9.45 12 157193 436 79586747
Renin decreased 20.03 9.45 8 157197 118 79587065
Tissue infiltration 19.98 9.45 14 157191 677 79586506
Hypertensive emergency 19.93 9.45 26 157179 2759 79584424
Glycosylated haemoglobin increased 19.89 9.45 83 157122 19177 79568006
Low density lipoprotein increased 19.88 9.45 49 157156 8573 79578610
Graft versus host disease 19.75 9.45 3 157202 15023 79572160
Prerenal failure 19.73 9.45 30 157175 3668 79583515
Post streptococcal glomerulonephritis 19.73 9.45 8 157197 123 79587060
Lung diffusion disorder 19.72 9.45 9 157196 187 79586996
Therapy partial responder 19.67 9.45 5 157200 17392 79569791
Brain stem stroke 19.48 9.45 14 157191 705 79586478
Device issue 19.39 9.45 15 157190 27093 79560090
Neoplasm progression 19.32 9.45 46 157159 51636 79535547
Retrograde amnesia 19.25 9.45 13 157192 592 79586591
Blood uric acid increased 19.17 9.45 64 157141 13296 79573887
Liver injury 19.15 9.45 53 157152 56561 79530622
Pulmonary arterial pressure abnormal 19.09 9.45 14 157191 728 79586455
Coronary artery bypass 19.08 9.45 39 157166 6023 79581160
Malabsorption 19.05 9.45 35 157170 4997 79582186
Seroma 18.88 9.45 23 157182 2277 79584906
Rhythm idioventricular 18.88 9.45 13 157192 611 79586572
Conduction disorder 18.87 9.45 28 157177 3351 79583832
Articular calcification 18.73 9.45 9 157196 211 79586972
Blood alkaline phosphatase increased 18.72 9.45 200 157005 63464 79523719
Uterine enlargement 18.68 9.45 15 157190 893 79586290
Altered state of consciousness 18.62 9.45 149 157056 43673 79543510
Urticaria 18.62 9.45 255 156950 184946 79402237
Hyperlipidaemia 18.59 9.45 101 157104 25992 79561191
Neurotoxicity 18.58 9.45 22 157183 32496 79554687
Erectile dysfunction 18.23 9.45 67 157138 14597 79572586
Neutropenic sepsis 18.09 9.45 16 157189 27048 79560135
Sinus node dysfunction 18.01 9.45 44 157161 7657 79579526
Ophthalmic vein thrombosis 17.98 9.45 9 157196 231 79586952
Pericardial haemorrhage 17.95 9.45 32 157173 4463 79582720
Pyonephrosis 17.92 9.45 7 157198 97 79587086
Nasopharyngitis 17.88 9.45 373 156832 253508 79333675
Peak expiratory flow rate decreased 17.82 9.45 13 157192 670 79586513
Aortic valve stenosis 17.79 9.45 35 157170 5259 79581924
Gout 17.77 9.45 96 157109 24653 79562530
Haemorrhage subcutaneous 17.64 9.45 33 157172 4776 79582407
Neutrophil function disorder 17.59 9.45 5 157200 23 79587160
Chronic sinusitis 17.46 9.45 61 157144 12965 79574218
Lipid metabolism disorder 17.45 9.45 10 157195 339 79586844
Mucosal inflammation 17.45 9.45 83 157122 75497 79511686
Hypochloraemia 17.25 9.45 23 157182 2492 79584691
Product odour abnormal 17.25 9.45 17 157188 1327 79585856
Cardiac vein perforation 17.25 9.45 5 157200 25 79587158
Chronic coronary syndrome 17.24 9.45 7 157198 108 79587075
Malignant melanoma 17.20 9.45 66 157139 14675 79572508
Joint stiffness 17.20 9.45 34 157171 40796 79546387
Dementia Alzheimer's type 17.17 9.45 15 157190 1004 79586179
Pneumothorax traumatic 17.05 9.45 9 157196 259 79586924
Peripheral swelling 17.02 9.45 403 156802 269214 79317969
Renal injury 16.74 9.45 72 157133 16855 79570328
Goitre 16.69 9.45 35 157170 5504 79581679
Left ventricular dysfunction 16.64 9.45 79 157126 19282 79567901
Rectal prolapse 16.63 9.45 21 157184 2157 79585026
Respiratory arrest 16.55 9.45 58 157147 57492 79529691
Anaphylactic reaction 16.52 9.45 97 157108 83646 79503537
Hypertrophic osteoarthropathy 16.51 9.45 7 157198 121 79587062
Microalbuminuria 16.45 9.45 14 157191 904 79586279
Bone marrow failure 16.44 9.45 49 157156 51058 79536125
Haematocrit decreased 16.38 9.45 189 157016 61123 79526060
Toxic skin eruption 16.37 9.45 87 157118 22206 79564977
Pigmentation disorder 16.35 9.45 35 157170 5583 79581600
Arrhythmogenic right ventricular dysplasia 16.35 9.45 5 157200 31 79587152
Sleep disorder due to a general medical condition 16.34 9.45 4 157201 14273 79572910
Abdominal tenderness 16.32 9.45 52 157153 10542 79576641
Transplant rejection 16.28 9.45 9 157196 19428 79567755
Arteriosclerosis coronary artery 16.28 9.45 74 157131 17742 79569441
Mobility decreased 16.26 9.45 158 157047 122017 79465166
Blood pressure abnormal 16.20 9.45 72 157133 17097 79570086
Hypogammaglobulinaemia 16.11 9.45 3 157202 12948 79574235
Gouty arthritis 16.06 9.45 17 157188 1444 79585739
Ill-defined disorder 16.00 9.45 71 157134 65804 79521379
Emotional distress 15.96 9.45 134 157071 39835 79547348
Infective pulmonary exacerbation of cystic fibrosis 15.94 9.45 3 157202 12848 79574335
Blood thyroid stimulating hormone abnormal 15.91 9.45 14 157191 946 79586237
Extrasystoles 15.89 9.45 41 157164 7378 79579805
Erythema multiforme 15.89 9.45 73 157132 17578 79569605
Nephrogenic anaemia 15.87 9.45 28 157177 3874 79583309
Cardiac myxoma 15.86 9.45 7 157198 134 79587049
Aortic valve incompetence 15.82 9.45 48 157157 9482 79577701
Gastric cancer 15.72 9.45 50 157155 10129 79577054
Pyometra 15.71 9.45 6 157199 78 79587105
Diastolic dysfunction 15.70 9.45 52 157153 10759 79576424
Immune reconstitution inflammatory syndrome 15.61 9.45 4 157201 13837 79573346
Procedural pain 15.55 9.45 88 157117 22996 79564187
Acute hepatic failure 15.53 9.45 22 157183 30091 79557092
Diverticulum intestinal haemorrhagic 15.31 9.45 28 157177 3983 79583200
Acute phosphate nephropathy 15.25 9.45 5 157200 40 79587143
Anhedonia 15.23 9.45 64 157141 14834 79572349
Subacute hepatic failure 15.19 9.45 8 157197 229 79586954
Gastritis 15.16 9.45 153 157052 47840 79539343
Fractured coccyx 15.16 9.45 14 157191 1008 79586175
Panniculitis 15.10 9.45 3 157202 12368 79574815
General physical health deterioration 15.04 9.45 675 156530 274563 79312620
Post-anoxic myoclonus 15.03 9.45 5 157200 42 79587141
Azotaemia 14.99 9.45 43 157162 8233 79578950
Product monitoring error 14.91 9.45 45 157160 8861 79578322
Cognitive disorder 14.88 9.45 79 157126 69847 79517336
Malignant neoplasm progression 14.86 9.45 184 157021 135806 79451377
Anuria 14.84 9.45 81 157124 20882 79566301
Nephrotic syndrome 14.70 9.45 52 157153 11122 79576061
Illness 14.67 9.45 45 157160 46466 79540717
Myoglobin blood increased 14.65 9.45 24 157181 3127 79584056
Left ventricular hypertrophy 14.65 9.45 52 157153 11139 79576044
Acquired C1 inhibitor deficiency 14.52 9.45 4 157201 16 79587167
Activated partial thromboplastin time prolonged 14.45 9.45 61 157144 14167 79573016
Merycism 14.38 9.45 8 157197 256 79586927
Premature delivery 14.37 9.45 15 157190 23452 79563731
Acral lentiginous melanoma 14.35 9.45 5 157200 49 79587134
Painful respiration 14.33 9.45 25 157180 3428 79583755
Surfactant protein increased 14.33 9.45 4 157201 17 79587166
Metastatic bronchial carcinoma 14.32 9.45 8 157197 258 79586925
Hepatic calcification 14.30 9.45 9 157196 363 79586820
Tessellated fundus 14.26 9.45 5 157200 50 79587133
Costal cartilage fracture 14.24 9.45 8 157197 261 79586922
Haemoglobin decreased 14.24 9.45 554 156651 221565 79365618
Orthopnoea 14.23 9.45 48 157157 10025 79577158
Duodenal ulcer 14.22 9.45 67 157138 16302 79570881
Hypersensitivity pneumonitis 14.15 9.45 26 157179 3713 79583470
Multiple injuries 14.11 9.45 25 157180 3470 79583713
Peripheral arterial occlusive disease 14.09 9.45 42 157163 8216 79578967
Venoocclusive liver disease 14.07 9.45 3 157202 11768 79575415
Progressive multifocal leukoencephalopathy 13.98 9.45 12 157193 20588 79566595
Lung diffusion test decreased 13.97 9.45 15 157190 1295 79585888
Cerebral arteriosclerosis 13.94 9.45 12 157193 787 79586396
C-reactive protein increased 13.94 9.45 343 156862 128684 79458499
Prescribed overdose 13.93 9.45 34 157171 37849 79549334
Acute coronary syndrome 13.86 9.45 80 157125 21053 79566130
Septic shock 13.85 9.45 165 157040 122636 79464547
Peripheral vascular disorder 13.85 9.45 41 157164 7989 79579194
Hepatic cytolysis 13.84 9.45 20 157185 27131 79560052
Pleural disorder 13.80 9.45 13 157192 960 79586223
Cardio-respiratory arrest 13.75 9.45 142 157063 108368 79478815
Neuropathy peripheral 13.69 9.45 196 157009 141109 79446074
Anaesthesia 13.68 9.45 10 157195 517 79586666
Faecaloma 13.68 9.45 52 157153 11512 79575671
Injection site erythema 13.67 9.45 94 157111 78103 79509080
Aspartate aminotransferase increased 13.64 9.45 364 156841 138277 79448906
Miscarriage of partner 13.62 9.45 3 157202 3 79587180
Mydriasis 13.62 9.45 9 157196 17634 79569549
Aggression 13.57 9.45 53 157152 50905 79536278
Proteinuria 13.53 9.45 110 157095 32392 79554791
Sudden cardiac death 13.46 9.45 31 157174 5194 79581989
Stenosis 13.42 9.45 20 157185 2402 79584781
Ear infection 13.39 9.45 30 157175 34402 79552781
Recalled product administered 13.34 9.45 12 157193 835 79586348
Haemophagocytic lymphohistiocytosis 13.33 9.45 14 157191 21823 79565360
Multiple sclerosis relapse 13.31 9.45 47 157158 46486 79540697
BRASH syndrome 13.31 9.45 13 157192 1004 79586179
Somnolence 13.26 9.45 364 156841 238617 79348566
Protein urine present 13.25 9.45 47 157158 10065 79577118
Distributive shock 13.22 9.45 21 157184 2666 79584517
Kyphosis 13.20 9.45 21 157184 2670 79584513
Bezold-Jarisch reflex 13.19 9.45 4 157201 24 79587159
Rhinitis 13.15 9.45 61 157144 14746 79572437
Epistaxis 13.13 9.45 300 156905 111215 79475968
Body height decreased 13.12 9.45 42 157163 8538 79578645
C-reactive protein abnormal 13.08 9.45 50 157155 48317 79538866
Joint range of motion decreased 12.94 9.45 29 157176 33253 79553930
Hypercreatininaemia 12.93 9.45 13 157192 1040 79586143
Dry eye 12.92 9.45 34 157171 36897 79550286
Ventricular tachycardia 12.92 9.45 133 157072 41802 79545381
Transitional cell cancer of the renal pelvis and ureter 12.88 9.45 5 157200 68 79587115
Pyrexia 12.79 9.45 1158 156047 677551 78909632
Chronic obstructive pulmonary disease 12.75 9.45 238 156967 85181 79502002
Dystonia 12.75 9.45 14 157191 21385 79565798
Haemodialysis 12.73 9.45 70 157135 18098 79569085
Cytokine release syndrome 12.70 9.45 33 157172 35965 79551218
Haemangioma 12.68 9.45 20 157185 2525 79584658
Lactic acidosis 12.65 9.45 202 157003 70157 79517026
Electrocardiogram ST segment depression 12.63 9.45 29 157176 4849 79582334
Weight decreased 12.63 9.45 837 156368 354361 79232822
Large intestine polyp 12.53 9.45 54 157151 12654 79574529
Skin texture abnormal 12.35 9.45 9 157196 463 79586720
Nail disorder 12.31 9.45 4 157201 11848 79575335
Seizure 12.26 9.45 281 156924 188553 79398630
Lower respiratory tract inflammation 12.24 9.45 6 157199 147 79587036
Glomerulosclerosis 12.24 9.45 13 157192 1109 79586074
Mouth ulceration 12.21 9.45 37 157168 38357 79548826
Hyponatraemic syndrome 12.18 9.45 11 157194 769 79586414
Cytomegalovirus viraemia 12.17 9.45 5 157200 12816 79574367
Immunodeficiency 12.15 9.45 15 157190 21753 79565430
Primary hyperaldosteronism 12.13 9.45 6 157199 150 79587033
Hepatotoxicity 12.08 9.45 56 157149 51296 79535887
Suspected suicide 12.03 9.45 3 157202 10573 79576610
Foot deformity 12.01 9.45 18 157187 24056 79563127
Metamyelocyte count increased 11.96 9.45 10 157195 630 79586553
Gastrointestinal stromal tumour 11.91 9.45 16 157189 1747 79585436
Subdural haematoma 11.82 9.45 104 157101 31330 79555853
Aortic valve sclerosis 11.79 9.45 16 157189 1764 79585419
Brain stem infarction 11.78 9.45 17 157188 1984 79585199
Schizophrenia 11.75 9.45 8 157197 15432 79571751
Asthmatic crisis 11.75 9.45 17 157188 1989 79585194
Lip dry 11.72 9.45 8 157197 15410 79571773
Blood pressure systolic decreased 11.65 9.45 48 157157 11028 79576155
Hypoventilation 11.63 9.45 36 157169 7188 79579995
Putamen haemorrhage 11.62 9.45 9 157196 508 79586675
Withdrawal hypertension 11.62 9.45 8 157197 376 79586807
Cutaneous lymphoma 11.62 9.45 7 157198 261 79586922
Accidental exposure to product 11.61 9.45 28 157177 31294 79555889
Blood chloride decreased 11.58 9.45 39 157166 8138 79579045
Thrombocytopenia 11.57 9.45 417 156788 264842 79322341
Perihepatic discomfort 11.55 9.45 3 157202 9 79587174
Actinic keratosis 11.54 9.45 32 157173 6010 79581173
Knee arthroplasty 11.51 9.45 45 157160 43203 79543980
Metastases to bone 11.49 9.45 19 157186 24408 79562775
Complex regional pain syndrome 11.48 9.45 17 157188 2031 79585152
Papillary renal cell carcinoma 11.45 9.45 7 157198 268 79586915
Stress cardiomyopathy 11.44 9.45 48 157157 11118 79576065
Eczema 11.43 9.45 127 157078 40691 79546492
Oesophageal food impaction 11.42 9.45 8 157197 387 79586796
Facet joint syndrome 11.41 9.45 4 157201 11298 79575885
Circulatory collapse 11.38 9.45 119 157086 37549 79549634
Iron binding capacity total decreased 11.34 9.45 8 157197 391 79586792
Low density lipoprotein decreased 11.33 9.45 13 157192 1208 79585975
Functional residual capacity increased 11.32 9.45 5 157200 96 79587087
Haemarthrosis 11.31 9.45 31 157174 5781 79581402
Cardiac pacemaker insertion 11.28 9.45 31 157174 5791 79581392
Nervousness 11.27 9.45 108 157097 33307 79553876
Lipase increased 11.24 9.45 63 157142 16403 79570780
Angioplasty 11.22 9.45 16 157189 1847 79585336
Benign prostatic hyperplasia 11.19 9.45 49 157156 11563 79575620
Brain stem haemorrhage 11.18 9.45 15 157190 1635 79585548
Atrial flutter 11.16 9.45 77 157128 21548 79565635
Nephrogenic systemic fibrosis 11.15 9.45 32 157173 6128 79581055
Thyroxine decreased 11.13 9.45 11 157194 862 79586321
Bradyarrhythmia 11.12 9.45 25 157180 4121 79583062
Chronic leukaemia 11.09 9.45 3 157202 11 79587172
Neutrophil count decreased 11.08 9.45 125 157080 93834 79493349
Basal ganglia haemorrhage 11.03 9.45 15 157190 1656 79585527
No adverse event 11.02 9.45 37 157168 37155 79550028
Aortic dissection 11.01 9.45 25 157180 4150 79583033
Blood phosphorus abnormal 11.00 9.45 7 157198 288 79586895
Ear pain 10.95 9.45 31 157174 32838 79554345
Device related infection 10.94 9.45 33 157172 34261 79552922
Gait disturbance 10.92 9.45 507 156698 206999 79380184
Aspergillus infection 10.91 9.45 13 157192 19148 79568035
Exercise tolerance decreased 10.90 9.45 41 157164 9030 79578153
Respiration abnormal 10.90 9.45 37 157168 7751 79579432
Hepatobiliary cancer 10.89 9.45 3 157202 12 79587171
Red blood cell sedimentation rate increased 10.87 9.45 50 157155 45892 79541291
Activated partial thromboplastin time shortened 10.86 9.45 11 157194 888 79586295
Periodontitis 10.85 9.45 26 157179 4470 79582713
Speech disorder 10.82 9.45 159 157046 54286 79532897
Hallucination, auditory 10.79 9.45 15 157190 20678 79566505
Mood swings 10.78 9.45 14 157191 19866 79567317
Body mass index increased 10.77 9.45 16 157189 1917 79585266
Faeces discoloured 10.77 9.45 96 157109 29031 79558152
Cutaneous listeriosis 10.76 9.45 4 157201 48 79587135
Cough 10.76 9.45 851 156354 365938 79221245
Monoclonal gammopathy 10.72 9.45 11 157194 901 79586282
Nephrocalcinosis 10.71 9.45 14 157191 1488 79585695
Therapy cessation 10.70 9.45 38 157167 37524 79549659
Device leakage 10.69 9.45 4 157201 10852 79576331
Cerebrovascular disorder 10.69 9.45 23 157182 3682 79583501
Heliotrope rash 10.67 9.45 6 157199 196 79586987
Polyuria 10.62 9.45 58 157147 14956 79572227
Amoebic colitis 10.61 9.45 5 157200 112 79587071
Cardiac valve sclerosis 10.61 9.45 5 157200 112 79587071
Hepatic cancer 10.58 9.45 45 157160 10484 79576699
Ejection fraction abnormal 10.56 9.45 18 157187 2422 79584761
Diabetic nephropathy 10.54 9.45 20 157185 2927 79584256
Deep vein thrombosis postoperative 10.53 9.45 4 157201 10748 79576435
Infarction 10.52 9.45 26 157179 4556 79582627
Oscillopsia 10.51 9.45 6 157199 202 79586981
Chest wall haematoma 10.50 9.45 8 157197 441 79586742
Pharyngitis streptococcal 10.47 9.45 4 157201 10710 79576473
Night sweats 10.46 9.45 60 157145 52035 79535148
Peritoneal haematoma 10.43 9.45 6 157199 205 79586978
Product complaint 10.43 9.45 53 157152 13296 79573887
Hypoxia 10.42 9.45 142 157063 103101 79484082
Disability 10.42 9.45 11 157194 17109 79570074
Hemiparesis 10.40 9.45 107 157098 33626 79553557
Osteochondrosis 10.38 9.45 16 157189 1980 79585203
Pancytopenia 10.38 9.45 248 156957 165497 79421686
Incision site oedema 10.35 9.45 3 157202 15 79587168
Breast cancer 10.34 9.45 107 157098 33674 79553509
Renal neoplasm 10.31 9.45 16 157189 1992 79585191
Sinus bradycardia 10.27 9.45 85 157120 25162 79562021
Laryngeal haemorrhage 10.27 9.45 4 157201 55 79587128
Immature granulocyte count increased 10.24 9.45 9 157196 607 79586576
Staphylococcal infection 10.23 9.45 70 157135 58225 79528958
Chondrocalcinosis pyrophosphate 10.20 9.45 15 157190 1781 79585402
Normochromic normocytic anaemia 10.20 9.45 36 157169 7691 79579492
Blood parathyroid hormone decreased 10.18 9.45 4 157201 10532 79576651
Ulcer 10.18 9.45 28 157177 29944 79557239
Labelled drug-drug interaction medication error 10.15 9.45 91 157114 27559 79559624
Palpitations 10.15 9.45 324 156881 126286 79460897
Lipoedema 10.15 9.45 6 157199 216 79586967
Oesophageal achalasia 10.11 9.45 10 157195 784 79586399
Eosinophil count increased 10.10 9.45 63 157142 17042 79570141
Gastrointestinal submucosal tumour 10.08 9.45 5 157200 126 79587057
Liver iron concentration abnormal 10.08 9.45 4 157201 58 79587125
Respiratory syncytial virus infection 10.07 9.45 3 157202 9399 79577784
Hypercholesterolaemia 10.07 9.45 79 157126 23016 79564167
Face oedema 10.02 9.45 92 157113 28044 79559139
Rash maculo-papular 10.00 9.45 67 157138 56011 79531172
Choroidal detachment 9.99 9.45 9 157196 627 79586556
Infusion site pain 9.94 9.45 8 157197 14168 79573015
Frustration tolerance decreased 9.94 9.45 35 157170 7467 79579716
Gravitational oedema 9.93 9.45 15 157190 1824 79585359
Sepsis 9.92 9.45 432 156773 268996 79318187
Lymphostasis 9.89 9.45 3 157202 18 79587165
Left atrial enlargement 9.83 9.45 12 157193 1191 79585992
Visual acuity reduced 9.82 9.45 95 157110 29374 79557809
Urine output decreased 9.80 9.45 65 157140 17957 79569226
Cerebellar ischaemia 9.76 9.45 6 157199 232 79586951
Intestinal polyp 9.75 9.45 16 157189 2088 79585095
Staphylococcal bacteraemia 9.75 9.45 6 157199 12212 79574971
Periodontal disease 9.74 9.45 15 157190 1855 79585328
Blood loss anaemia 9.73 9.45 58 157147 15440 79571743
Ankylosing spondylitis 9.73 9.45 6 157199 12199 79574984
Injection site swelling 9.61 9.45 54 157151 47078 79540105
Small intestine carcinoma 9.56 9.45 11 157194 1025 79586158
Electrocardiogram T wave amplitude increased 9.55 9.45 4 157201 67 79587116
Right ventricular failure 9.53 9.45 20 157185 23477 79563706
Shock haemorrhagic 9.52 9.45 70 157135 19990 79567193
Affective disorder 9.51 9.45 37 157168 8282 79578901
Pollakiuria 9.51 9.45 114 157091 37203 79549980
Spondylolisthesis 9.49 9.45 20 157185 3155 79584028
Bladder transitional cell carcinoma 9.49 9.45 18 157187 2632 79584551
Bacteraemia 9.49 9.45 33 157172 32791 79554392

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 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 ABBVIE 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 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 0078-0314 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 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 0078-0358 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 0078-0359 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 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 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 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 0078-0471 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
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 0078-0488 TABLET, FILM COATED 160 mg ORAL NDA 31 sections