hydrochlorothiazide ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
diuretics, chlorothiazide derivatives 1385 58-93-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • hydrochlorothiazide
  • hydrochlorothiazid
  • hydrochlorthiazide
  • hydrochlorzide
A thiazide diuretic often considered the prototypical member of this class. It reduces the reabsorption of electrolytes from the renal tubules. This results in increased excretion of water and electrolytes, including sodium, potassium, chloride, and magnesium. It is used in the treatment of several disorders including edema, hypertension, diabetes insipidus, and hypoparathyroidism.
  • Molecular weight: 297.73
  • Formula: C7H8ClN3O4S2
  • CLOGP: -0.36
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 3
  • TPSA: 118.36
  • ALOGS: -2.12
  • ROTB: 1

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
25 mg O
25 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.60 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 100 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 11.18 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 71 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Feb. 12, 1959 FDA

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
Hyponatraemia 1022.99 9.62 1600 208691 94539 50300294
Hypokalaemia 466.36 9.62 1089 209202 86903 50307930
Pemphigus 435.88 9.62 14 210277 120152 50274681
Maternal exposure during pregnancy 405.04 9.62 85 210206 159693 50235140
Systemic lupus erythematosus 330.35 9.62 88 210203 140534 50254299
Off label use 318.07 9.62 967 209324 473459 49921374
Hand deformity 315.88 9.62 27 210264 100172 50294661
Glossodynia 281.69 9.62 67 210224 115502 50279331
Contraindicated product administered 268.48 9.62 142 210149 148816 50246017
Pericarditis 257.03 9.62 18 210273 78671 50316162
Acute kidney injury 253.72 9.62 1719 208572 226339 50168494
Blood pressure increased 251.49 9.62 1158 209133 131974 50262859
Synovitis 238.48 9.62 108 210183 123757 50271076
Drug ineffective 228.88 9.62 2243 208048 817090 49577743
Blood potassium decreased 227.83 9.62 486 209805 36459 50358374
Treatment failure 225.67 9.62 147 210144 137490 50257343
Exposure during pregnancy 214.17 9.62 118 210173 120897 50273936
Cerebrovascular accident 199.47 9.62 851 209440 93829 50301004
Drug intolerance 189.63 9.62 391 209900 218713 50176120
Myocardial infarction 184.30 9.62 796 209495 88231 50306602
Alopecia 182.55 9.62 474 209817 244573 50150260
Lower respiratory tract infection 181.67 9.62 84 210207 95117 50299716
Angioedema 172.45 9.62 441 209850 37235 50357598
Rheumatoid factor positive 166.97 9.62 10 210281 49849 50344984
Duodenal ulcer perforation 166.44 9.62 5 210286 45606 50349227
Wound 153.92 9.62 128 210163 105666 50289167
Dizziness 152.50 9.62 2148 208143 344221 50050612
Arthropathy 152.18 9.62 264 210027 157642 50237191
Infusion related reaction 147.13 9.62 302 209989 169255 50225578
Coronary artery disease 140.26 9.62 352 209939 29374 50365459
Dehydration 132.79 9.62 1085 209206 151364 50243469
Blood pressure inadequately controlled 130.24 9.62 123 210168 4257 50390576
Syncope 122.49 9.62 790 209501 102212 50292621
Abdominal discomfort 121.00 9.62 523 209768 231118 50163715
Joint swelling 119.06 9.62 569 209722 244717 50150116
Discomfort 117.89 9.62 167 210124 108213 50286620
Product use issue 116.74 9.62 282 210009 149193 50245640
Eosinophilic bronchitis 116.00 9.62 51 210240 432 50394401
Inappropriate antidiuretic hormone secretion 115.57 9.62 201 210090 12942 50381891
Drug abuse 110.79 9.62 55 210236 59791 50335042
Gastrooesophageal reflux disease 110.55 9.62 617 209674 75811 50319022
Asthenia 109.56 9.62 1898 208393 317144 50077689
Therapeutic product effect decreased 104.40 9.62 259 210032 135791 50259042
Sleep disorder due to general medical condition, insomnia type 100.37 9.62 8 210283 31439 50363394
Infection 99.39 9.62 376 209915 172578 50222255
Abortion spontaneous 98.27 9.62 26 210265 41746 50353087
Death 95.99 9.62 877 209414 324502 50070331
Muscle injury 95.48 9.62 19 210272 37092 50357741
Condition aggravated 95.47 9.62 783 209508 296275 50098558
Hypertension 94.41 9.62 1314 208977 209889 50184944
Fall 93.12 9.62 1929 208362 333003 50061830
Swelling 91.11 9.62 477 209814 200395 50194438
Folliculitis 89.32 9.62 26 210265 39199 50355634
Macular degeneration 86.06 9.62 187 210104 14201 50380632
Lactic acidosis 84.75 9.62 318 209973 33037 50361796
Oedema peripheral 84.55 9.62 1016 209275 156945 50237888
Pain 84.47 9.62 1800 208491 577103 49817730
Blood sodium decreased 83.10 9.62 234 210057 20913 50373920
Hypotension 82.59 9.62 1406 208885 234063 50160770
Hypertensive crisis 79.86 9.62 172 210119 12982 50381851
Blood glucose increased 77.49 9.62 535 209756 70789 50324044
Hypochloraemia 77.11 9.62 60 210231 1587 50393246
Transient ischaemic attack 75.23 9.62 299 209992 31911 50362922
Hepatic enzyme increased 74.23 9.62 306 209985 137074 50257759
Toxicity to various agents 71.96 9.62 552 209739 211947 50182886
Intentional self-injury 70.73 9.62 7 210284 23105 50371728
Intentional overdose 69.25 9.62 95 210196 62409 50332424
Helicobacter infection 67.60 9.62 64 210227 49638 50345195
Renal failure 67.06 9.62 708 209583 105925 50288908
Blood urea increased 65.96 9.62 232 210059 23353 50371480
Intentional product use issue 65.80 9.62 138 210153 76780 50318053
Pregnancy 64.83 9.62 21 210270 29556 50365277
Product use in unapproved indication 63.80 9.62 256 210035 115563 50279270
Irritable bowel syndrome 63.46 9.62 72 210219 51369 50343464
Chest pain 63.36 9.62 1060 209231 175822 50219011
Blister 62.88 9.62 166 210125 85252 50309581
Rash 61.71 9.62 1367 208924 436104 49958729
Sprue-like enteropathy 61.68 9.62 34 210257 489 50394344
Hypertensive emergency 60.60 9.62 51 210240 1512 50393321
Hypovolaemia 60.04 9.62 126 210165 9339 50385494
Pancreatitis acute 59.65 9.62 226 210065 23586 50371247
Cardiac failure congestive 57.70 9.62 570 209721 83812 50311021
Angina pectoris 57.11 9.62 238 210053 25950 50368883
Product complaint 56.42 9.62 138 210153 11328 50383505
Live birth 55.82 9.62 3 210288 16405 50378428
Impaired healing 55.76 9.62 130 210161 69656 50325177
Febrile neutropenia 55.62 9.62 213 210078 97454 50297379
Neutropenia 54.08 9.62 376 209915 147589 50247244
Red blood cell sedimentation rate abnormal 52.60 9.62 4 210287 16339 50378494
Blood creatinine increased 51.36 9.62 513 209778 75647 50319186
Polyp 50.12 9.62 86 210205 5476 50389357
Peripheral swelling 49.57 9.62 582 209709 205354 50189479
Sinus bradycardia 49.01 9.62 143 210148 13040 50381793
Cytomegalovirus infection 46.61 9.62 9 210282 17953 50376880
Hip arthroplasty 46.51 9.62 35 210256 30394 50364439
Atrial fibrillation 45.77 9.62 634 209657 101111 50293722
Angina unstable 45.76 9.62 92 210199 6614 50388219
Palpitations 45.44 9.62 596 209695 93910 50300923
Pyrexia 44.58 9.62 1221 209070 378982 50015851
Hyperkalaemia 44.37 9.62 347 209944 47742 50347091
Blood pressure diastolic decreased 44.31 9.62 162 210129 16619 50378214
Stomatitis 42.95 9.62 246 210045 101098 50293735
Hypoglycaemia 42.68 9.62 374 209917 53207 50341626
Recalled product 42.61 9.62 39 210252 1296 50393537
Drug interaction 42.43 9.62 1108 209183 198513 50196320
Hypersensitivity 41.29 9.62 637 209654 214524 50180309
Malignant neoplasm progression 41.13 9.62 145 210146 67979 50326854
Hepatic function abnormal 41.12 9.62 45 210246 32636 50362197
Mobility decreased 40.75 9.62 182 210109 79766 50315067
Rheumatoid arthritis 40.46 9.62 595 209696 201955 50192878
Pemphigoid 40.26 9.62 81 210210 5826 50389007
Blood pressure systolic increased 39.73 9.62 268 210023 35181 50359652
Therapy non-responder 39.20 9.62 97 210194 50925 50343908
Drug resistance 39.02 9.62 15 210276 18974 50375859
Ill-defined disorder 38.87 9.62 108 210183 54546 50340287
Diabetes mellitus 37.89 9.62 340 209951 48693 50346140
Lung diffusion test abnormal 37.88 9.62 17 210274 152 50394681
C-reactive protein abnormal 37.59 9.62 36 210255 27773 50367060
Pancreatitis 37.41 9.62 304 209987 42310 50352523
Loss of employment 36.93 9.62 39 210252 1547 50393286
Milk-alkali syndrome 36.59 9.62 27 210264 658 50394175
Neutrophil count decreased 36.55 9.62 86 210205 45940 50348893
Nausea 36.45 9.62 3402 206889 701996 49692837
Disease progression 35.81 9.62 242 210049 95624 50299209
Disorientation 35.52 9.62 261 210030 35223 50359610
Gastrointestinal disorder 35 9.62 239 210052 94217 50300616
Swollen tongue 34.86 9.62 221 210070 28409 50366424
Large intestine polyp 34.76 9.62 87 210204 7245 50387588
Hospitalisation 34.42 9.62 155 210136 67782 50327051
Arterial occlusive disease 34.05 9.62 67 210224 4741 50390092
Allergic oedema 34.03 9.62 27 210264 735 50394098
Leukopenia 33.65 9.62 155 210136 67373 50327460
Cataract 33.53 9.62 322 209969 46978 50347855
Ventricular hypertrophy 33.40 9.62 53 210238 3162 50391671
Pneumonia aspiration 33.32 9.62 232 210059 30772 50364061
Pneumonia 32.68 9.62 1264 209027 377137 50017696
Conjoined twins 32.46 9.62 18 210273 262 50394571
Premature delivery 31.56 9.62 31 210260 23632 50371201
Nasopharyngitis 31.53 9.62 588 209703 192339 50202494
Systemic infection 31.47 9.62 43 210248 2240 50392593
Mitral valve incompetence 30.74 9.62 149 210142 17322 50377511
Hyperlipidaemia 30.66 9.62 149 210142 17341 50377492
Osteoarthritis 29.83 9.62 425 209866 68181 50326652
Intestinal angioedema 29.73 9.62 23 210268 603 50394230
Bone marrow failure 29.58 9.62 43 210248 27581 50367252
Neutrophilia 29.27 9.62 53 210238 3522 50391311
Acute myeloid leukaemia 29.20 9.62 13 210278 15061 50379772
Blood chloride decreased 29.12 9.62 64 210227 4897 50389936
Depression 28.96 9.62 896 209395 164527 50230306
Myelosuppression 28.92 9.62 10 210281 13507 50381326
Sepsis 28.83 9.62 384 209907 132541 50262292
Arrhythmia 28.35 9.62 235 210056 32897 50361936
Device expulsion 27.89 9.62 48 210243 28774 50366059
Arteriosclerosis 27.75 9.62 92 210199 8985 50385848
Muscle spasms 27.55 9.62 700 209591 124853 50269980
Supraventricular extrasystoles 26.78 9.62 54 210237 3890 50390943
Product substitution issue 26.27 9.62 122 210169 13935 50380898
Weight decreased 26.22 9.62 1147 209144 220098 50174735
Respiratory tract inflammation 25.99 9.62 20 210271 520 50394313
Hypercalcaemia 25.84 9.62 176 210115 23176 50371657
Heart rate irregular 25.81 9.62 153 210138 19207 50375626
Electrolyte imbalance 25.73 9.62 140 210151 17029 50377804
Suicide attempt 25.62 9.62 119 210172 51613 50343220
Carotid artery stenosis 25.50 9.62 59 210232 4672 50390161
Musculoskeletal stiffness 25.43 9.62 378 209913 128103 50266730
Feeling abnormal 25.04 9.62 691 209600 124801 50270032
Ventricular extrasystoles 24.85 9.62 98 210193 10418 50384415
Non-cardiogenic pulmonary oedema 24.70 9.62 20 210271 561 50394272
Myalgia 24.66 9.62 684 209607 123635 50271198
Congenital bladder anomaly 24.60 9.62 13 210278 171 50394662
Drug hypersensitivity 24.46 9.62 826 209465 250184 50144649
Foetal exposure during pregnancy 24.31 9.62 48 210243 27311 50367522
Overdose 24.29 9.62 281 210010 99446 50295387
Urachal abnormality 24.08 9.62 13 210278 179 50394654
Rhabdomyolysis 23.98 9.62 258 210033 38769 50356064
Sinusitis 23.93 9.62 533 209758 170025 50224808
Distributive shock 23.86 9.62 23 210268 817 50394016
Sedation complication 23.59 9.62 4 210287 8762 50386071
Abnormal dreams 23.48 9.62 89 210202 9288 50385545
Device related thrombosis 23.35 9.62 28 210263 1279 50393554
Neutropenic sepsis 23.30 9.62 15 210276 14132 50380701
Persistent cloaca 23.28 9.62 13 210278 192 50394641
Sopor 23.26 9.62 29 210262 19850 50374983
Haemophagocytic lymphohistiocytosis 23.10 9.62 4 210287 8629 50386204
Platelet count decreased 22.93 9.62 288 210003 100438 50294395
Atrioventricular block first degree 22.79 9.62 67 210224 6134 50388699
Nephrocalcinosis 22.77 9.62 24 210267 950 50393883
Oropharyngeal swelling 22.76 9.62 22 210269 784 50394049
Interstitial lung disease 22.56 9.62 129 210162 53047 50341786
Essential hypertension 22.41 9.62 54 210237 4390 50390443
Withdrawal hypertension 22.37 9.62 11 210280 123 50394710
Emotional distress 22.26 9.62 199 210092 28464 50366369
Coma 22.24 9.62 346 209945 56533 50338300
Erythrodermic psoriasis 22.08 9.62 23 210268 898 50393935
Neurosensory hypoacusis 22.05 9.62 13 210278 214 50394619
Cardiac murmur 21.96 9.62 96 210195 10688 50384145
Pancytopenia 21.96 9.62 233 210058 83797 50311036
Cardiac disorder 21.89 9.62 274 210017 42705 50352128
Obstructive airways disorder 21.71 9.62 125 210166 15527 50379306
Cough 21.56 9.62 1217 209074 240047 50154786
Product prescribing error 21.45 9.62 155 210136 20806 50374027
Foetal death 21.44 9.62 4 210287 8176 50386657
Nervousness 20.98 9.62 191 210100 27460 50367373
Orthostatic intolerance 20.93 9.62 23 210268 955 50393878
Visual acuity reduced 20.65 9.62 149 210142 19990 50374843
Intestinal malrotation 20.60 9.62 15 210276 358 50394475
Electrocardiogram abnormal 20.57 9.62 74 210217 7531 50387302
Premature labour 20.56 9.62 11 210280 11465 50383368
Device related infection 20.56 9.62 34 210257 20701 50374132
Septic shock 20.52 9.62 146 210145 57029 50337804
Myocardial ischaemia 20.40 9.62 99 210192 11514 50383319
Anhedonia 20.33 9.62 86 210205 9438 50385395
Coronary artery occlusion 20.29 9.62 73 210218 7430 50387403
Hypoparathyroidism 20.23 9.62 18 210273 576 50394257
Dysgeusia 20.21 9.62 249 210042 38667 50356166
Asthma 20.16 9.62 500 209791 88837 50305996
Sedation 19.95 9.62 63 210228 30547 50364286
Blood creatine phosphokinase increased 19.94 9.62 182 210109 26185 50368648
Procalcitonin increased 19.85 9.62 20 210271 750 50394083
Bundle branch block left 19.82 9.62 64 210227 6166 50388667
Pneumocystis jirovecii pneumonia 19.80 9.62 19 210272 14644 50380189
Diverticulum 19.75 9.62 92 210199 10522 50384311
Somnolence 19.36 9.62 808 209483 154177 50240656
Intervertebral disc protrusion 19.28 9.62 148 210143 20245 50374588
Electrocardiogram ST segment depression 19.15 9.62 37 210254 2583 50392250
Thrombocytopenia 19.06 9.62 395 209896 127278 50267555
Product monitoring error 18.95 9.62 38 210253 2726 50392107
Cardiac stress test abnormal 18.52 9.62 17 210274 567 50394266
Urinary incontinence 18.52 9.62 189 210102 28019 50366814
Poisoning deliberate 18.46 9.62 5 210286 7907 50386926
Gastric disorder 18.46 9.62 196 210095 29352 50365481
Cholelithiasis 18.45 9.62 240 210051 37733 50357100
Hypersensitivity vasculitis 18.36 9.62 47 210244 3968 50390865
Diabetes mellitus inadequate control 18.25 9.62 105 210186 13040 50381793
Gout 18.19 9.62 95 210196 11375 50383458
Cyanopsia 18.09 9.62 5 210286 7 50394826
Tooth erosion 18.07 9.62 15 210276 436 50394397
Neurofibrosarcoma 18.01 9.62 10 210281 146 50394687
Renal artery stenosis 17.97 9.62 28 210263 1644 50393189
Small cell carcinoma 17.95 9.62 10 210281 147 50394686
Osteonecrosis 17.83 9.62 157 210134 22360 50372473
Polymyalgia rheumatica 17.79 9.62 36 210255 2600 50392233
Hypertensive heart disease 17.76 9.62 33 210258 2237 50392596
Therapy partial responder 17.76 9.62 3 210288 6588 50388245
Psoriasis 17.66 9.62 393 209898 68607 50326226
Glycosylated haemoglobin increased 17.63 9.62 89 210202 10517 50384316
Bladder prolapse 17.53 9.62 29 210262 1792 50393041
Transplant rejection 17.52 9.62 9 210282 9600 50385233
Mental status changes 17.52 9.62 229 210062 36043 50358790
Coronary artery stenosis 17.38 9.62 48 210243 4241 50390592
Cutaneous lupus erythematosus 17.37 9.62 34 210257 2397 50392436
Bronchopulmonary aspergillosis 17.34 9.62 5 210286 7587 50387246
Hypocalcaemia 17.28 9.62 179 210112 26637 50368196
Hepatic steatosis 17.28 9.62 166 210125 24218 50370615
Bronchomalacia 17.19 9.62 11 210280 211 50394622
Liver function test increased 17.18 9.62 52 210239 25554 50369279
Epstein-Barr virus infection 17.14 9.62 4 210287 6993 50387840
Deep vein thrombosis 17.06 9.62 412 209879 72892 50321941
Pernicious anaemia 17.02 9.62 17 210274 631 50394202
Device difficult to use 16.95 9.62 10 210281 9876 50384957
Pathological fracture 16.89 9.62 70 210221 7612 50387221
Hypertensive angiopathy 16.88 9.62 8 210283 82 50394751
Neurotoxicity 16.73 9.62 22 210269 14718 50380115
Rheumatoid nodule 16.62 9.62 17 210274 12718 50382115
Gangrene 16.59 9.62 50 210241 4642 50390191
Epilepsy 16.57 9.62 41 210250 21526 50373307
Hypertrophic cardiomyopathy 16.56 9.62 24 210267 1321 50393512
Forced vital capacity decreased 16.55 9.62 20 210271 921 50393912
White blood cell count decreased 16.29 9.62 365 209926 116357 50278476
Anxiety 16.26 9.62 898 209393 176708 50218125
Injection site inflammation 16.22 9.62 39 210252 3166 50391667
Cutaneous T-cell lymphoma 16.22 9.62 23 210268 1241 50393592
Carpal tunnel syndrome 16.19 9.62 123 210168 16770 50378063
Myopathy 16.12 9.62 78 210213 9061 50385772
Lacunar infarction 16.10 9.62 38 210253 3049 50391784
Anti-neutrophil cytoplasmic antibody positive vasculitis 16.01 9.62 32 210259 2290 50392543
Fear of injection 15.96 9.62 3 210288 6100 50388733
Haemodialysis 15.94 9.62 73 210218 8289 50386544
Macular oedema 15.92 9.62 42 210249 3612 50391221
Cytokine release syndrome 15.88 9.62 8 210283 8626 50386207
Therapeutic product effect incomplete 15.85 9.62 276 210015 91239 50303594
Polydipsia 15.80 9.62 38 210253 3086 50391747
Adverse drug reaction 15.72 9.62 150 210141 55072 50339761
Fear 15.71 9.62 109 210182 14440 50380393
Mesenteric panniculitis 15.64 9.62 8 210283 98 50394735
Peripheral vascular disorder 15.48 9.62 54 210237 5413 50389420
Dystonia 15.47 9.62 16 210275 11910 50382923
Panniculitis 15.45 9.62 8 210283 8495 50386338
Meniere's disease 15.44 9.62 10 210281 196 50394637
Carotid bruit 15.41 9.62 16 210275 622 50394211
Glomerulonephritis rapidly progressive 15.39 9.62 18 210273 801 50394032
Mouth ulceration 15.38 9.62 62 210229 27962 50366871
Coronary ostial stenosis 15.28 9.62 7 210284 66 50394767
Hyperglycaemia 15.22 9.62 224 210067 36181 50358652
Hyperhidrosis 15.01 9.62 482 209809 88944 50305889
Body height decreased 14.98 9.62 75 210216 8833 50386000
Extrasystoles 14.97 9.62 48 210243 4607 50390226
Spinal osteoarthritis 14.88 9.62 105 210186 13987 50380846
Tendon rupture 14.85 9.62 64 210227 7080 50387753
Depressed level of consciousness 14.84 9.62 141 210150 51812 50343021
C-reactive protein increased 14.78 9.62 191 210100 66283 50328550
Hypoparathyroidism secondary 14.75 9.62 6 210285 41 50394792
Injection site pain 14.70 9.62 350 209941 110674 50284159
Metabolic alkalosis 14.66 9.62 34 210257 2697 50392136
Acute myocardial infarction 14.64 9.62 186 210105 29087 50365746
Mucosal membrane hyperplasia 14.62 9.62 6 210285 42 50394791
Renal cyst 14.51 9.62 73 210218 8614 50386219
Low density lipoprotein increased 14.48 9.62 54 210237 5592 50389241
Osmotic demyelination syndrome 14.41 9.62 15 210276 585 50394248
Rectal prolapse 14.41 9.62 26 210265 1723 50393110
Micturition disorder 14.39 9.62 27 210264 1844 50392989
Oesophageal discomfort 14.37 9.62 9 210282 166 50394667
Confabulation 14.33 9.62 11 210280 285 50394548
Hyponatraemic encephalopathy 14.28 9.62 10 210281 224 50394609
Eosinophilia 14.23 9.62 129 210162 18523 50376310
Therapeutic response unexpected 14.21 9.62 114 210177 15801 50379032
Cardiac hypertrophy 14.20 9.62 19 210272 970 50393863
Intestinal villi atrophy 14.18 9.62 9 210282 170 50394663
Clostridium difficile infection 14.14 9.62 56 210235 25383 50369450
Breast neoplasm 14.13 9.62 22 210269 1291 50393542
Blood hyposmosis 14.10 9.62 5 210286 22 50394811
Bradycardia 14.06 9.62 359 209932 64067 50330766
Mandibular mass 14.05 9.62 9 210282 173 50394660
Rotator cuff syndrome 13.98 9.62 89 210202 11455 50383378
Choroidal effusion 13.98 9.62 13 210278 441 50394392
Accidental exposure to product 13.96 9.62 49 210242 23008 50371825
Abortion induced 13.96 9.62 11 210280 9333 50385500
Liver disorder 13.87 9.62 94 210197 37128 50357705
Diverticulitis 13.80 9.62 204 210087 32978 50361855
Multiple organ dysfunction syndrome 13.79 9.62 138 210153 50199 50344634
Post-anoxic myoclonus 13.75 9.62 5 210286 24 50394809
Coronavirus test positive 13.69 9.62 15 210276 621 50394212
Bacterial infection 13.67 9.62 115 210176 16166 50378667
Cardiomegaly 13.59 9.62 113 210178 15832 50379001
International normalised ratio decreased 13.55 9.62 43 210248 4105 50390728
Blood pressure decreased 13.54 9.62 316 209975 55593 50339240
Haematotoxicity 13.52 9.62 8 210283 7887 50386946
Pulpitis dental 13.52 9.62 17 210274 816 50394017
Photosensitivity reaction 13.51 9.62 96 210195 12815 50382018
Vertigo 13.51 9.62 296 209995 51536 50343297
Cardiac ventriculogram left 13.46 9.62 3 210288 0 50394833
Renal artery dissection 13.46 9.62 3 210288 0 50394833
Eczema weeping 13.46 9.62 3 210288 0 50394833
Dilatation atrial 13.46 9.62 26 210265 1815 50393018
Renal injury 13.44 9.62 71 210220 8540 50386293
Gastroenteritis clostridial 13.41 9.62 14 210277 548 50394285
Actinic keratosis 13.38 9.62 29 210262 2198 50392635
Dysuria 13.37 9.62 179 210112 28325 50366508
Amaurosis fugax 13.36 9.62 12 210279 389 50394444
Encephalitis 13.33 9.62 7 210284 7373 50387460
Jaw disorder 13.28 9.62 48 210243 4895 50389938
Ventricular fibrillation 13.16 9.62 82 210209 10477 50384356
Allergic hepatitis 13.12 9.62 5 210286 28 50394805
Gait disturbance 13.06 9.62 755 209536 149250 50245583
Eosinophilia myalgia syndrome 12.98 9.62 4 210287 10 50394823
Left ventricular hypertrophy 12.98 9.62 47 210244 4798 50390035
Hypophagia 12.95 9.62 174 210117 27554 50367279
Blood pressure abnormal 12.89 9.62 94 210197 12653 50382180
Anaphylactic reaction 12.89 9.62 153 210138 53902 50340931
Product residue present 12.86 9.62 39 210252 3633 50391200
Microalbuminuria 12.85 9.62 11 210280 334 50394499
Paraesthesia 12.84 9.62 617 209674 119626 50275207
Epileptic encephalopathy 12.80 9.62 10 210281 266 50394567
Heart rate decreased 12.77 9.62 218 210073 36279 50358554
Blood uric acid increased 12.76 9.62 40 210251 3794 50391039
Meniscus injury 12.75 9.62 56 210235 6246 50388587
Chest wall mass 12.70 9.62 6 210285 61 50394772
Renal tubular necrosis 12.69 9.62 79 210212 10089 50384744
Acute respiratory distress syndrome 12.67 9.62 45 210246 21054 50373779
Glomerulonephritis 12.62 9.62 23 210268 1536 50393297
Eosinophil count increased 12.56 9.62 71 210220 8759 50386074
Product commingling 12.52 9.62 8 210283 153 50394680
Ultrasound kidney abnormal 12.43 9.62 5 210286 33 50394800
Endometrial cancer 12.42 9.62 33 210258 2850 50391983
Lipohypertrophy 12.40 9.62 14 210277 599 50394234
Adenocarcinoma 12.35 9.62 30 210261 2451 50392382
Gastritis erosive 12.26 9.62 48 210243 5086 50389747
Maternal drugs affecting foetus 12.25 9.62 3 210288 5074 50389759
Endometrial cancer stage I 12.24 9.62 9 210282 218 50394615
Myelodysplastic syndrome 12.23 9.62 28 210263 15104 50379729
Diarrhoea 12.18 9.62 2692 207599 585784 49809049
Orthostatic hypotension 12.16 9.62 181 210110 29300 50365533
Lymphocyte count decreased 12.16 9.62 62 210229 26245 50368588
Knee arthroplasty 12.16 9.62 93 210198 35753 50359080
Psychotic disorder 12.13 9.62 48 210243 21764 50373069
Pollakiuria 12.12 9.62 152 210139 23699 50371134
Osteomyelitis acute 12.10 9.62 9 210282 222 50394611
Disseminated intravascular coagulation 12.08 9.62 34 210257 17101 50377732
Haematoma muscle 12.04 9.62 15 210276 713 50394120
Complication of device insertion 12.04 9.62 5 210286 6036 50388797
Schizophrenia 11.97 9.62 8 210283 7389 50387444
Macrocytosis 11.96 9.62 27 210264 2103 50392730
Vitiligo 11.96 9.62 19 210272 1135 50393698
Hypomagnesaemia 11.95 9.62 148 210143 23008 50371825
Petechiae 11.93 9.62 91 210200 12421 50382412
Pituitary apoplexy 11.88 9.62 7 210284 115 50394718
Hip fracture 11.81 9.62 162 210129 25769 50369064
Metastases to fallopian tube 11.73 9.62 5 210286 39 50394794
Wound treatment 11.67 9.62 8 210283 173 50394660
Adrenocortical carcinoma 11.62 9.62 5 210286 40 50394793
Insomnia 11.59 9.62 860 209431 174005 50220828
Cutaneous T-cell lymphoma stage I 11.58 9.62 4 210287 16 50394817
Hepatotoxicity 11.57 9.62 66 210225 27160 50367673
Tanning 11.55 9.62 6 210285 76 50394757
Diabetic neuropathy 11.52 9.62 37 210254 3554 50391279
Laryngeal pain 11.48 9.62 41 210250 4158 50390675
Prothrombin time abnormal 11.45 9.62 11 210280 389 50394444
Iliac artery embolism 11.40 9.62 3 210288 3 50394830
Gastric atony 11.40 9.62 3 210288 3 50394830
Early satiety 11.34 9.62 15 210276 757 50394076
Foreign body in reproductive tract 11.34 9.62 12 210279 477 50394356
Subacute cutaneous lupus erythematosus 11.26 9.62 27 210264 2188 50392645
Atrioventricular block 11.22 9.62 55 210236 6423 50388410
Parkinsonism 11.21 9.62 69 210222 8778 50386055
Thrombotic microangiopathy 11.17 9.62 12 210279 8779 50386054
Progressive multifocal leukoencephalopathy 11.16 9.62 19 210272 11438 50383395
Shock haemorrhagic 11.16 9.62 66 210225 8278 50386555
Thyroid neoplasm 11.13 9.62 36 210255 3471 50391362
Cytopenia 11.13 9.62 12 210279 8763 50386070
Blood creatine increased 11.11 9.62 45 210246 4842 50389991
Nodal rhythm 11.10 9.62 22 210269 1565 50393268
Hypercholesterolaemia 11.10 9.62 85 210206 11618 50383215
Blood creatinine abnormal 11.02 9.62 30 210261 2628 50392205
Anaemia postoperative 11.02 9.62 26 210265 2085 50392748
Oesophageal oedema 11.02 9.62 5 210286 46 50394787
Pruritus allergic 11.00 9.62 18 210273 1102 50393731
Hyperammonaemia 11.00 9.62 3 210288 4721 50390112
Hypovitaminosis 10.98 9.62 13 210278 586 50394247
Abdominal panniculectomy 10.94 9.62 3 210288 4 50394829
Non-cardiac chest pain 10.90 9.62 50 210241 5682 50389151
Pathogen resistance 10.87 9.62 5 210286 5684 50389149
Azotaemia 10.84 9.62 39 210252 3969 50390864
Cerebral ischaemia 10.84 9.62 51 210240 5857 50388976
Rhinalgia 10.78 9.62 17 210274 1009 50393824
Lipoedema 10.77 9.62 9 210282 264 50394569
Paradoxical psoriasis 10.77 9.62 7 210284 138 50394695
Diverticulum oesophageal 10.77 9.62 7 210284 138 50394695
Pain in extremity 10.73 9.62 1293 208998 271572 50123261
Respiratory depression 10.73 9.62 21 210270 11989 50382844
Delayed fontanelle closure 10.71 9.62 4 210287 21 50394812
Procedural complication 10.64 9.62 44 210247 4779 50390054
Tricuspid valve incompetence 10.61 9.62 90 210201 12680 50382153
Angle closure glaucoma 10.56 9.62 25 210266 2009 50392824
Herpes zoster 10.56 9.62 219 210072 70567 50324266
Respiratory disorder 10.54 9.62 81 210210 31106 50363727
Vomiting 10.53 9.62 2118 208173 458640 49936193
Tooth abscess 10.36 9.62 90 210201 12770 50382063
Oral fibroma 10.32 9.62 5 210286 54 50394779
Immune reconstitution inflammatory syndrome 10.31 9.62 5 210286 5511 50389322
Hyponatraemic syndrome 10.29 9.62 12 210279 532 50394301
Multiple drug therapy 10.27 9.62 24 210267 1913 50392920
Endometrial hyperplasia 10.27 9.62 14 210277 728 50394105
Vision blurred 10.26 9.62 412 209879 78235 50316598
Varicose vein ruptured 10.24 9.62 5 210286 55 50394778
Retroperitoneal fibrosis 10.22 9.62 9 210282 284 50394549
Product administration error 10.21 9.62 126 210165 19573 50375260
Haemorrhagic fever 10.19 9.62 3 210288 6 50394827
Femoral bruit 10.19 9.62 3 210288 6 50394827
Breast prosthesis user 10.19 9.62 3 210288 6 50394827
Renin increased 10.18 9.62 7 210284 152 50394681
Human herpesvirus 6 encephalitis 10.18 9.62 7 210284 152 50394681
Nocturia 10.17 9.62 55 210236 6675 50388158
Skin haemorrhage 10.09 9.62 56 210235 6862 50387971
Respiratory failure 10.08 9.62 295 209996 90886 50303947
Drug tolerance decreased 10.06 9.62 14 210277 9146 50385687
Neonatal respiratory distress 10.04 9.62 9 210282 291 50394542
Disability 10.04 9.62 24 210267 12751 50382082
Unintended pregnancy 10.01 9.62 4 210287 4942 50389891
Hereditary angioedema 10.00 9.62 47 210244 5395 50389438
Chest discomfort 9.94 9.62 476 209815 92246 50302587
Vascular purpura 9.94 9.62 18 210273 1196 50393637
Serotonin syndrome 9.93 9.62 61 210230 24652 50370181
Neuromyopathy 9.91 9.62 12 210279 554 50394279
Renal scan abnormal 9.88 9.62 3 210288 7 50394826
Antidiuretic hormone abnormality 9.87 9.62 4 210287 27 50394806
Vertebral artery stenosis 9.86 9.62 5 210286 60 50394773
Device dislocation 9.84 9.62 51 210240 21495 50373338
Granuloma skin 9.82 9.62 6 210285 5812 50389021
Premature baby 9.79 9.62 41 210250 18296 50376537
Spondylolysis 9.79 9.62 5 210286 61 50394772
Pseudomonas infection 9.78 9.62 15 210276 9415 50385418
Sleep apnoea syndrome 9.64 9.62 146 210145 23722 50371111
Caesarean section 9.63 9.62 33 210258 15606 50379227
Torsade de pointes 9.62 9.62 83 210208 11752 50383081
Hypertrichosis 9.62 9.62 16 210275 993 50393840

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
Hyponatraemia 439.92 10.45 883 116219 66750 29390675
Angioedema 327.16 10.45 509 116593 31406 29426019
Off label use 254.76 10.45 505 116597 300295 29157130
Hypokalaemia 215.21 10.45 556 116546 49647 29407778
Acute kidney injury 191.72 10.45 1742 115360 263525 29193900
Drug abuse 189.82 10.45 42 117060 79841 29377584
Cerebrovascular accident 152.46 10.45 656 116446 76255 29381170
Dizziness 147.22 10.45 1266 115836 188418 29269007
Syncope 144.71 10.45 672 116430 80699 29376726
Death 135.10 10.45 799 116303 341285 29116140
Pyrexia 112.77 10.45 673 116429 286949 29170476
Coronary artery disease 105.92 10.45 400 116702 43790 29413635
Product use in unapproved indication 103.21 10.45 115 116987 86760 29370665
Pneumonia 97.62 10.45 806 116296 319366 29138059
Neutropenia 93.28 10.45 243 116859 131468 29325957
Milk-alkali syndrome 92.63 10.45 44 117058 478 29456947
Blood pressure increased 90.33 10.45 550 116552 73253 29384172
Blood pressure inadequately controlled 89.85 10.45 75 117027 2311 29455114
Hypotension 86.65 10.45 1161 115941 193193 29264232
Febrile neutropenia 85.79 10.45 199 116903 112041 29345384
Myocardial infarction 79.56 10.45 725 116377 109571 29347854
Blood glucose increased 78.88 10.45 450 116652 58534 29398891
Pancreatitis acute 78.85 10.45 244 116858 24141 29433284
Toxicity to various agents 76.27 10.45 391 116711 173270 29284155
Sepsis 69.18 10.45 310 116792 142372 29315053
Blood potassium decreased 68.10 10.45 175 116927 15559 29441866
Thrombocytopenia 62.93 10.45 297 116805 134526 29322899
Drug ineffective 59.10 10.45 1048 116054 362122 29095303
Dehydration 58.47 10.45 703 116399 114045 29343380
Cytomegalovirus infection 57.60 10.45 11 117091 23204 29434221
Hypertensive crisis 51.53 10.45 103 116999 7745 29449680
Pancreatitis 51.27 10.45 271 116831 34243 29423182
Hypovolaemia 49.75 10.45 103 116999 7942 29449483
Bundle branch block left 48.31 10.45 80 117022 5197 29452228
Treatment failure 47.09 10.45 46 117056 36893 29420532
Hepatic function abnormal 45.46 10.45 53 117049 39206 29418219
Foetal exposure during pregnancy 44.55 10.45 41 117061 33826 29423599
Product use issue 43.60 10.45 86 117016 51358 29406067
Lactic acidosis 42.55 10.45 234 116868 30013 29427412
Interstitial lung disease 40.40 10.45 107 116995 57611 29399814
Blood creatinine increased 39.29 10.45 512 116590 84590 29372835
Injury 38.86 10.45 164 116938 18882 29438543
Blood mercury abnormal 38.43 10.45 18 117084 189 29457236
Cardiomegaly 38.35 10.45 131 116971 13645 29443780
Leukopenia 38.14 10.45 103 116999 55100 29402325
Hospitalisation 38.01 10.45 78 117024 45910 29411515
Metabolic alkalosis 36.80 10.45 34 117068 1202 29456223
5-hydroxyindolacetic acid in urine increased 36.48 10.45 18 117084 214 29457211
Blood pressure systolic increased 35.89 10.45 147 116955 16698 29440727
Cardiac failure congestive 35.45 10.45 461 116641 76120 29381305
Renal artery stenosis 34.99 10.45 41 117061 1920 29455505
Interstitial granulomatous dermatitis 34.75 10.45 16 117086 161 29457264
Hypomagnesaemia 34.54 10.45 149 116953 17319 29440106
Drug intolerance 34.38 10.45 89 117013 48290 29409135
Intentional product use issue 34.35 10.45 73 117029 42425 29415000
Sprue-like enteropathy 33.02 10.45 21 117081 419 29457006
Pancytopenia 32.73 10.45 194 116908 82974 29374451
Blood urea increased 32.15 10.45 206 116896 27906 29429519
Blood cholesterol increased 31.59 10.45 134 116968 15461 29441964
Hypochloraemia 31.31 10.45 22 117080 521 29456904
Hypertension 31.14 10.45 641 116461 115973 29341452
Glycosylated haemoglobin increased 31.09 10.45 95 117007 9331 29448094
Drug resistance 30.87 10.45 24 117078 21516 29435909
Bone marrow failure 30.77 10.45 38 117064 27411 29430014
Infection 30.75 10.45 178 116924 76573 29380852
Carotid artery stenosis 29.75 10.45 59 117043 4410 29453015
Blood chloride decreased 29.30 10.45 51 117051 3450 29453975
Hypertensive emergency 28.86 10.45 25 117077 811 29456614
Bronchopulmonary aspergillosis 28.28 10.45 7 117095 12337 29445088
Granulomatous pneumonitis 28.21 10.45 9 117093 28 29457397
Myelosuppression 27.88 10.45 7 117095 12220 29445205
Inappropriate antidiuretic hormone secretion 27.88 10.45 101 117001 10831 29446594
Vertigo 27.39 10.45 164 116938 21697 29435728
Renal failure 26.93 10.45 637 116465 117962 29339463
Hypercalcaemia 26.91 10.45 111 116991 12648 29444777
Pulmonary valve disease 26.90 10.45 16 117086 282 29457143
Pneumonia aspiration 26.55 10.45 67 117035 36670 29420755
Angina pectoris 26.46 10.45 195 116907 27655 29429770
Transient ischaemic attack 26.29 10.45 170 116932 23100 29434325
Swollen tongue 26.10 10.45 107 116995 12159 29445266
Mitral valve incompetence 25.98 10.45 113 116989 13180 29444245
Pericardial disease 25.64 10.45 17 117085 365 29457060
Liver disorder 25.63 10.45 44 117058 27705 29429720
Cytokine release syndrome 25.48 10.45 10 117092 13109 29444316
Sopor 25.44 10.45 6 117096 10928 29446497
Orthostatic intolerance 25.32 10.45 21 117081 641 29456784
Drug-induced liver injury 25.32 10.45 29 117073 21626 29435799
Oedema peripheral 25.31 10.45 562 116540 102995 29354430
Intentional self-injury 25.03 10.45 9 117093 12452 29444973
Nodular rash 24.96 10.45 11 117091 99 29457326
Lichen planus 24.83 10.45 23 117079 816 29456609
Low density lipoprotein decreased 24.61 10.45 25 117077 995 29456430
Arteriosclerosis coronary artery 24.56 10.45 95 117007 10510 29446915
Platelet count decreased 24.33 10.45 281 116821 104391 29353034
Blood triglycerides increased 24.25 10.45 108 116994 12726 29444699
Aspergillus infection 24.24 10.45 6 117096 10575 29446850
Neutrophil count decreased 23.98 10.45 90 117012 43477 29413948
Lower respiratory tract infection 23.59 10.45 43 117059 26459 29430966
Erectile dysfunction 23.13 10.45 136 116966 17873 29439552
Disseminated intravascular coagulation 23.10 10.45 27 117075 19953 29437472
Pseudolymphoma 22.87 10.45 18 117084 509 29456916
Actinic keratosis 22.86 10.45 48 117054 3738 29453687
Blood sodium decreased 22.64 10.45 117 116985 14650 29442775
Acute myocardial infarction 22.57 10.45 292 116810 48146 29409279
Angina unstable 22.50 10.45 94 117008 10771 29446654
Malaise 22.32 10.45 472 116630 159130 29298295
Peritonitis 21.91 10.45 16 117086 14808 29442617
Contraindicated product administered 21.86 10.45 24 117078 18242 29439183
Renal injury 21.71 10.45 89 117013 10113 29447312
Blood pressure decreased 21.55 10.45 275 116827 45202 29412223
Choroidal effusion 21.50 10.45 11 117091 142 29457283
Choroidal detachment 21.47 10.45 15 117087 352 29457073
Neurotoxicity 21.30 10.45 16 117086 14597 29442828
Bacteraemia 21.18 10.45 20 117082 16303 29441122
Neutropenic sepsis 21.09 10.45 10 117092 11717 29445708
Graft versus host disease 21.03 10.45 6 117096 9622 29447803
Tricuspid valve incompetence 20.94 10.45 77 117025 8317 29449108
Gout 20.63 10.45 126 116976 16785 29440640
Congenital diaphragmatic anomaly 20.59 10.45 7 117095 28 29457397
Atrial fibrillation 20.31 10.45 555 116547 105091 29352334
Ventricular hypertrophy 20.10 10.45 49 117053 4215 29453210
Polydipsia 19.85 10.45 43 117059 3422 29454003
Extrasystoles 19.77 10.45 43 117059 3431 29453994
Intestinal villi atrophy 19.75 10.45 10 117092 126 29457299
Osteoarthritis 19.69 10.45 131 116971 17972 29439453
Arrhythmia 19.64 10.45 200 116902 31113 29426312
Pulmonary valve stenosis congenital 19.55 10.45 10 117092 129 29457296
Respiratory depression 19.46 10.45 15 117087 13508 29443917
Lymphomatoid papulosis 19.37 10.45 11 117091 177 29457248
Acquired acrodermatitis enteropathica 19.23 10.45 5 117097 5 29457420
Microalbuminuria 19.17 10.45 18 117084 650 29456775
Myalgia 19.13 10.45 405 116697 73614 29383811
Alkalosis hypochloraemic 18.87 10.45 13 117089 298 29457127
Haemophagocytic lymphohistiocytosis 18.82 10.45 9 117093 10495 29446930
Drug reaction with eosinophilia and systemic symptoms 18.75 10.45 53 117049 27939 29429486
Immune reconstitution inflammatory syndrome 18.72 10.45 4 117098 7798 29449627
Drug dependence 18.71 10.45 34 117068 20947 29436478
Seizure 18.65 10.45 258 116844 92865 29364560
Gastrointestinal tract mucosal pigmentation 18.63 10.45 14 117088 369 29457056
Hemiparesis 18.35 10.45 109 116993 14377 29443048
Product complaint 18.32 10.45 55 117047 5350 29452075
Lymphocyte count decreased 18.31 10.45 30 117072 19241 29438184
High density lipoprotein decreased 18.25 10.45 38 117064 2941 29454484
Fall 18.25 10.45 867 116235 176311 29281114
Pharyngeal oedema 18.18 10.45 57 117045 5677 29451748
Vascular purpura 18.16 10.45 25 117077 1378 29456047
CD4/CD8 ratio increased 18.14 10.45 4 117098 0 29457425
Renin decreased 18.14 10.45 4 117098 0 29457425
Muscle necrosis 18.03 10.45 19 117083 790 29456635
Pneumocystis jirovecii pneumonia 18.01 10.45 24 117078 16755 29440670
Physical examination abnormal 17.89 10.45 12 117090 263 29457162
Septic shock 17.81 10.45 160 116942 62400 29395025
Spinal cord infarction 17.77 10.45 12 117090 266 29457159
Neoplasm 17.71 10.45 46 117056 4115 29453310
Aortic arteriosclerosis 17.69 10.45 44 117058 3832 29453593
Arteriosclerosis 17.67 10.45 84 117018 10172 29447253
Diastolic dysfunction 17.61 10.45 52 117050 5012 29452413
Precancerous skin lesion 17.55 10.45 16 117086 556 29456869
Toxic epidermal necrolysis 17.49 10.45 28 117074 18125 29439300
Low density lipoprotein increased 17.49 10.45 44 117058 3860 29453565
Vestibular neuronitis 17.44 10.45 10 117092 164 29457261
Hyperlipidaemia 17.43 10.45 97 117005 12493 29444932
Supraventricular extrasystoles 17.42 10.45 37 117065 2904 29454521
Mastitis 17.33 10.45 10 117092 166 29457259
Renal artery angioplasty 17.23 10.45 5 117097 10 29457415
Renal artery stent placement 17.23 10.45 5 117097 10 29457415
Akathisia 17.14 10.45 3 117099 6739 29450686
Shock 17.10 10.45 144 116958 21260 29436165
Polyuria 17.09 10.45 66 117036 7296 29450129
Hepatic neoplasm 17.03 10.45 28 117074 1808 29455617
Pancreatitis necrotising 16.86 10.45 32 117070 2315 29455110
Carcinoid tumour of the gastrointestinal tract 16.81 10.45 7 117095 54 29457371
Stomatitis 16.55 10.45 83 117019 37030 29420395
Dystonia 16.50 10.45 9 117093 9740 29447685
Sinus bradycardia 16.47 10.45 90 117012 11513 29445912
Rales 16.36 10.45 66 117036 7444 29449981
Mitral valve disease 16.33 10.45 22 117080 1188 29456237
Laryngeal cleft 16.33 10.45 5 117097 13 29457412
Expired product administered 16.23 10.45 35 117067 2776 29454649
Malignant neoplasm progression 16.11 10.45 201 116901 73658 29383767
Liver function test increased 16.09 10.45 14 117088 11871 29445554
Kidney transplant rejection 15.99 10.45 4 117098 7001 29450424
C-reactive protein increased 15.98 10.45 106 116996 44157 29413268
Hypoaesthesia 15.97 10.45 299 116803 53168 29404257
Lymphangiectasia intestinal 15.92 10.45 4 117098 3 29457422
Chest pain 15.89 10.45 567 116535 111406 29346019
Exposure during pregnancy 15.84 10.45 7 117095 8547 29448878
Gastrointestinal angiodysplasia 15.83 10.45 15 117087 548 29456877
Aplastic anaemia 15.82 10.45 5 117097 7505 29449920
Dysgeusia 15.77 10.45 148 116954 22526 29434899
Fear 15.77 10.45 77 117025 9427 29447998
Eosinophilic colitis 15.70 10.45 10 117092 200 29457225
Electrolyte imbalance 15.70 10.45 87 117015 11187 29446238
Mucosal inflammation 15.66 10.45 68 117034 31527 29425898
Supraventricular tachycardia 15.63 10.45 79 117023 9805 29447620
Waist circumference increased 15.59 10.45 17 117085 735 29456690
Coronary arterial stent insertion 15.49 10.45 42 117060 3855 29453570
Left ventricular hypertrophy 15.49 10.45 60 117042 6643 29450782
Dilatation atrial 15.48 10.45 27 117075 1830 29455595
Anhedonia 15.47 10.45 63 117039 7137 29450288
Paresis cranial nerve 15.33 10.45 7 117095 69 29457356
Shoshin beriberi 15.33 10.45 7 117095 69 29457356
Therapeutic product effect incomplete 15.28 10.45 92 117010 39213 29418212
Atrioventricular block first degree 15.17 10.45 51 117051 5268 29452157
Bradycardia 15.03 10.45 353 116749 65276 29392149
Coma 15.00 10.45 93 117009 39357 29418068
White blood cell count decreased 14.94 10.45 236 116866 83126 29374299
Intestinal intraepithelial lymphocytes increased 14.92 10.45 4 117098 5 29457420
Psoriasis 14.89 10.45 194 116908 32033 29425392
Transplant rejection 14.88 10.45 9 117093 9203 29448222
Enterocolitis 14.85 10.45 4 117098 6662 29450763
Sedation 14.82 10.45 29 117073 17376 29440049
Coronary artery occlusion 14.80 10.45 79 117023 10015 29447410
Photosensitivity reaction 14.64 10.45 74 117028 9184 29448241
Type 2 diabetes mellitus 14.60 10.45 98 117004 13483 29443942
Premature baby 14.54 10.45 29 117073 17251 29440174
Aortic valve stenosis 14.52 10.45 29 117073 2179 29455246
Acute myeloid leukaemia 14.51 10.45 27 117075 16486 29440939
Acute cutaneous lupus erythematosus 14.50 10.45 7 117095 79 29457346
Blood uric acid increased 14.46 10.45 53 117049 5715 29451710
Colitis 14.45 10.45 69 117033 31179 29426246
Hemiataxia 14.44 10.45 6 117096 46 29457379
Brain stem infarction 14.42 10.45 20 117082 1110 29456315
Atrioventricular block 14.14 10.45 60 117042 6922 29450503
Miosis 14.14 10.45 7 117095 8002 29449423
Electrocardiogram U-wave abnormality 14.11 10.45 6 117096 49 29457376
Torsade de pointes 14.09 10.45 58 117044 6603 29450822
Balance disorder 14.00 10.45 211 116891 35959 29421466
Weight loss poor 13.96 10.45 8 117094 131 29457294
Urine albumin/creatinine ratio increased 13.96 10.45 8 117094 131 29457294
Aggression 13.92 10.45 83 117019 35458 29421967
Osteitis deformans 13.82 10.45 5 117097 25 29457400
Cutaneous T-cell lymphoma 13.76 10.45 21 117081 1272 29456153
Pemphigoid 13.73 10.45 63 117039 7518 29449907
Patent ductus arteriosus 13.73 10.45 35 117067 3096 29454329
Transaminases increased 13.68 10.45 45 117057 22617 29434808
Febrile bone marrow aplasia 13.63 10.45 6 117096 7345 29450080
Renin increased 13.57 10.45 7 117095 92 29457333
Substance abuse 13.47 10.45 5 117097 6782 29450643
Tendon rupture 13.46 10.45 55 117047 6240 29451185
Infective pulmonary exacerbation of cystic fibrosis 13.41 10.45 4 117098 6232 29451193
Synovitis 13.37 10.45 14 117088 10876 29446549
Shock hypoglycaemic 13.37 10.45 7 117095 95 29457330
Intestinal angioedema 13.35 10.45 9 117093 199 29457226
Electrocardiogram T wave amplitude decreased 13.27 10.45 9 117093 201 29457224
Pyelitis 13.24 10.45 7 117095 97 29457328
Fatigue 13.24 10.45 1440 115662 315381 29142044
Preternatural anus 13.18 10.45 7 117095 98 29457327
Carcinogenicity 13.15 10.45 6 117096 59 29457366
Hormone level abnormal 13.12 10.45 11 117091 341 29457084
Bundle branch block right 13.05 10.45 57 117045 6660 29450765
Pathogen resistance 13.01 10.45 8 117094 8108 29449317
Rhabdomyolysis 13.00 10.45 324 116778 60484 29396941
Dissociation 12.96 10.45 19 117083 1110 29456315
Myocardial ischaemia 12.89 10.45 108 116994 15920 29441505
Tumour lysis syndrome 12.83 10.45 22 117080 13862 29443563
Parotitis 12.75 10.45 17 117085 909 29456516
Weaning failure 12.71 10.45 9 117093 216 29457209
Renal artery restenosis 12.65 10.45 4 117098 12 29457413
Gait disturbance 12.61 10.45 380 116722 72969 29384456
Gastrointestinal mucosal necrosis 12.56 10.45 8 117094 160 29457265
Dermatosis 12.52 10.45 10 117092 289 29457136
Forced expiratory flow decreased 12.48 10.45 8 117094 162 29457263
Hypophagia 12.47 10.45 132 116970 20740 29436685
Meningitis streptococcal 12.42 10.45 5 117097 35 29457390
Pleural effusion 12.41 10.45 205 116897 71703 29385722
Peripheral vascular disorder 12.33 10.45 43 117059 4524 29452901
Macular ischaemia 12.33 10.45 6 117096 69 29457356
Accelerated hypertension 12.29 10.45 9 117093 228 29457197
High frequency ablation 12.22 10.45 8 117094 168 29457257
Therapy non-responder 12.20 10.45 72 117030 30839 29426586
Agitation 12.19 10.45 137 116965 51167 29406258
Electrocardiogram QT interval 12.18 10.45 5 117097 37 29457388
Renovascular hypertension 12.18 10.45 4 117098 14 29457411
Basilar artery thrombosis 12.14 10.45 8 117094 170 29457255
Cardiac discomfort 12.10 10.45 12 117090 464 29456961
Troponin I increased 12.10 10.45 25 117077 1925 29455500
Orthostatic hypotension 12.09 10.45 140 116962 22489 29434936
Basal cell carcinoma 12.07 10.45 111 116991 16799 29440626
Occult blood 12.02 10.45 13 117089 557 29456868
Neuroleptic malignant syndrome 12.02 10.45 29 117073 16119 29441306
Echocardiogram abnormal 12.00 10.45 16 117086 855 29456570
Alanine aminotransferase increased 12.00 10.45 203 116899 70741 29386684
Abnormal behaviour 11.94 10.45 49 117053 23078 29434347
Cataract nuclear 11.93 10.45 12 117090 472 29456953
Hypertensive heart disease 11.90 10.45 26 117076 2081 29455344
Cytopenia 11.75 10.45 13 117089 9846 29447579
Infusion related reaction 11.73 10.45 114 116988 43772 29413653
Coronary artery bypass 11.70 10.45 43 117059 4642 29452783
Cardiac disorder 11.69 10.45 210 116892 37053 29420372
Aortic valve incompetence 11.68 10.45 45 117057 4968 29452457
Epilepsy 11.55 10.45 36 117066 18396 29439029
Multiple organ dysfunction syndrome 11.53 10.45 178 116924 62938 29394487
Hyperammonaemia 11.53 10.45 4 117098 5659 29451766
Trigger finger 11.51 10.45 14 117088 682 29456743
Aortic valve sclerosis 11.49 10.45 15 117087 785 29456640
Left ventricle outflow tract obstruction 11.45 10.45 7 117095 130 29457295
Nail discolouration 11.44 10.45 15 117087 789 29456636
Vision blurred 11.42 10.45 223 116879 39953 29417472
Mechanical urticaria 11.36 10.45 6 117096 83 29457342
Myopathy 11.32 10.45 76 117026 10457 29446968
Ventricular arrhythmia 11.29 10.45 42 117060 4562 29452863
Left ventricular dysfunction 11.29 10.45 67 117035 8835 29448590
Inappropriate schedule of product administration 11.27 10.45 117 116985 44355 29413070
Nephropathy 11.27 10.45 46 117056 5217 29452208
Electrocardiogram ST segment abnormal 11.21 10.45 12 117090 508 29456917
Stenosis 11.21 10.45 17 117085 1024 29456401
Ascites 11.16 10.45 92 117010 36527 29420898
Dermatomyositis 11.12 10.45 17 117085 1031 29456394
Indifference 11.12 10.45 7 117095 137 29457288
Asthenia 11.11 10.45 993 116109 214257 29243168
Hypercalciuria 11.10 10.45 9 117093 266 29457159
Chromatopsia 10.98 10.45 8 117094 201 29457224
Swelling face 10.92 10.45 126 116976 20224 29437201
Prothrombin time prolonged 10.89 10.45 66 117036 8766 29448659
Enterococcal infection 10.88 10.45 10 117092 8258 29449167
Hyperkalaemia 10.81 10.45 319 116783 61073 29396352
Abdominal tenderness 10.80 10.45 35 117067 3547 29453878
Post procedural haematoma 10.79 10.45 20 117082 1421 29456004
Incontinence 10.79 10.45 44 117058 4988 29452437
Renal tubular necrosis 10.75 10.45 95 117007 14220 29443205
Multiple drug therapy 10.74 10.45 10 117092 357 29457068
Oxygen saturation decreased 10.68 10.45 120 116982 44817 29412608
Renal artery arteriosclerosis 10.60 10.45 4 117098 23 29457402
Carotid artery occlusion 10.52 10.45 24 117078 1977 29455448

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
Hyponatraemia 1354.31 9.62 2249 254518 146090 64095875
Hypokalaemia 601.32 9.62 1429 255338 120474 64121491
Angioedema 444.17 9.62 845 255922 60976 64180989
Off label use 435.65 9.62 1196 255571 631610 63610355
Acute kidney injury 389.83 9.62 3087 253680 446153 63795812
Drug abuse 314.06 9.62 71 256696 132303 64109662
Cerebrovascular accident 304.03 9.62 1218 255549 136365 64105600
Blood pressure increased 235.82 9.62 1329 255438 171223 64070742
Coronary artery disease 230.02 9.62 643 256124 59790 64182175
Blood potassium decreased 225.92 9.62 498 256269 39901 64202064
Myocardial infarction 224.50 9.62 1274 255493 164547 64077418
Syncope 214.63 9.62 1213 255554 156422 64085543
Maternal exposure during pregnancy 210.89 9.62 60 256707 95824 64146141
Dizziness 204.80 9.62 2612 254155 427551 63814414
Hand deformity 174.53 9.62 22 256745 62749 64179216
Pemphigus 174.43 9.62 19 256748 60682 64181283
Drug ineffective 164.08 9.62 2359 254408 837888 63404077
Pericarditis 153.40 9.62 31 256736 62485 64179480
Synovitis 153.33 9.62 103 256664 98987 64142978
Death 149.24 9.62 1218 255549 481487 63760478
Dehydration 147.82 9.62 1414 255353 215349 64026616
Neutropenia 140.61 9.62 486 256281 239138 64002827
Product use in unapproved indication 139.54 9.62 310 256457 176308 64065657
Systemic lupus erythematosus 136.64 9.62 69 256698 77543 64164422
Lower respiratory tract infection 136.40 9.62 106 256661 94508 64147457
Drug intolerance 134.23 9.62 348 256419 187644 64054321
Hypotension 133.26 9.62 2193 254574 378781 63863184
Febrile neutropenia 130.48 9.62 352 256415 187305 64054660
Blood pressure inadequately controlled 129.41 9.62 132 256635 5252 64236713
Pyrexia 129.15 9.62 1513 255254 557131 63684834
Toxicity to various agents 128.54 9.62 883 255884 362630 63879335
Pneumonia 127.25 9.62 1521 255246 558055 63683910
Treatment failure 127.18 9.62 167 256600 116649 64125316
Inappropriate antidiuretic hormone secretion 126 9.62 276 256491 22013 64219952
Contraindicated product administered 124.89 9.62 147 256620 107682 64134283
Milk-alkali syndrome 117.74 9.62 68 256699 1125 64240840
Exposure during pregnancy 115.85 9.62 84 256683 77591 64164374
Lactic acidosis 114.82 9.62 517 256250 60893 64181072
Pancreatitis acute 112.41 9.62 401 256366 42454 64199511
Blood glucose increased 110.68 9.62 719 256048 97354 64144611
Hypovolaemia 107.85 9.62 209 256558 15277 64226688
Duodenal ulcer perforation 107.10 9.62 8 256759 34617 64207348
Hypertensive crisis 106.62 9.62 229 256538 18019 64223946
Infection 103.73 9.62 382 256385 184498 64057467
Hypertension 100.98 9.62 1520 255247 257741 63984224
Rheumatoid factor positive 100.21 9.62 11 256756 34927 64207038
Hypochloraemia 96.97 9.62 74 256693 1987 64239978
Glossodynia 96.43 9.62 70 256697 64626 64177339
Fall 95.47 9.62 2251 254516 414575 63827390
Cytomegalovirus infection 94.32 9.62 17 256750 37182 64204783
Sepsis 93.46 9.62 536 256231 229805 64012160
Infusion related reaction 93.45 9.62 338 256429 164129 64077836
Sprue-like enteropathy 91.95 9.62 55 256712 974 64240991
Hypertensive emergency 90.48 9.62 74 256693 2202 64239763
Hepatic function abnormal 86.58 9.62 77 256690 64236 64177729
Cardiac failure congestive 84.59 9.62 843 255924 129737 64112228
Asthenia 83.93 9.62 2264 254503 425780 63816185
Gastrooesophageal reflux disease 83.32 9.62 592 256175 82551 64159414
Transient ischaemic attack 78.89 9.62 367 256400 43815 64198150
Product use issue 77.72 9.62 325 256442 151390 64090575
Alopecia 75.86 9.62 370 256397 165320 64076645
Condition aggravated 74.59 9.62 1039 255728 371387 63870578
Intentional self-injury 74.23 9.62 13 256754 29031 64212934
Thrombocytopenia 73.48 9.62 555 256212 223246 64018719
Therapeutic product effect decreased 72.38 9.62 227 256540 115124 64126841
Renal failure 69.81 9.62 1063 255704 180625 64061340
Angina pectoris 69.44 9.62 359 256408 44722 64197243
Sleep disorder due to general medical condition, insomnia type 68.82 9.62 11 256756 26259 64215706
Blood sodium decreased 67.42 9.62 264 256503 29218 64212747
Chest pain 66.63 9.62 1314 255453 234666 64007299
Neutrophil count decreased 66.40 9.62 129 256638 77067 64164898
Bundle branch block left 65.74 9.62 132 256635 9902 64232063
Blood pressure systolic increased 65.52 9.62 378 256389 49075 64192890
Intentional product use issue 65.39 9.62 180 256587 95184 64146781
Angina unstable 64.24 9.62 170 256597 15297 64226668
Joint swelling 62.96 9.62 551 256216 214831 64027134
Blood urea increased 62.81 9.62 344 256423 43809 64198156
Pancreatitis 61.22 9.62 427 256340 59180 64182785
Muscle injury 61.04 9.62 15 256752 26422 64215543
Oedema peripheral 61.02 9.62 1176 255591 209141 64032824
Blood creatinine increased 60.75 9.62 816 255951 134966 64106999
Abortion spontaneous 60.57 9.62 13 256754 25130 64216835
Arthropathy 59.57 9.62 263 256504 120704 64121261
Folliculitis 58.81 9.62 23 256744 30054 64211911
Drug resistance 57.71 9.62 34 256733 35068 64206897
Sinus bradycardia 55.63 9.62 209 256558 22684 64219281
Interstitial lung disease 54.73 9.62 202 256565 97530 64144435
Product complaint 54.41 9.62 136 256631 11818 64230147
Myelosuppression 54.09 9.62 14 256753 23816 64218149
Pancytopenia 53.60 9.62 342 256425 142967 64098998
Leukopenia 53.00 9.62 215 256552 101027 64140938
Hyperlipidaemia 52.74 9.62 206 256561 22770 64219195
Bone marrow failure 52.73 9.62 68 256699 47884 64194081
Blood chloride decreased 49.11 9.62 98 256669 7318 64234647
Irritable bowel syndrome 48.79 9.62 46 256721 37323 64204642
Swollen tongue 48.16 9.62 270 256497 34684 64207281
Pregnancy 47.86 9.62 12 256755 20853 64221112
Bronchopulmonary aspergillosis 47.79 9.62 9 256758 19076 64222889
Mitral valve incompetence 47.71 9.62 215 256552 25323 64216642
Renal artery stenosis 47.68 9.62 59 256708 2910 64239055
Orthostatic intolerance 47.41 9.62 44 256723 1556 64240409
Pemphigoid 47.26 9.62 136 256631 12850 64229115
Red blood cell sedimentation rate abnormal 47.10 9.62 5 256762 16301 64225664
Platelet count decreased 46.83 9.62 434 256333 167277 64074688
Carotid artery stenosis 46.78 9.62 100 256667 7841 64234124
Ventricular hypertrophy 46.67 9.62 89 256678 6427 64235538
Atrial fibrillation 46.36 9.62 947 255820 170142 64071823
Hypercalcaemia 46.19 9.62 247 256520 31169 64210796
Malignant neoplasm progression 46.07 9.62 262 256505 112609 64129356
Sopor 45.64 9.62 31 256736 29630 64212335
Stomatitis 45.51 9.62 253 256514 109352 64132613
Drug interaction 44.97 9.62 1815 254952 360268 63881697
Hypomagnesaemia 43.97 9.62 277 256490 37099 64204866
Intestinal angioedema 43.89 9.62 32 256735 800 64241165
Wound 42.21 9.62 159 256608 76318 64165647
Neutropenic sepsis 41.99 9.62 20 256747 23252 64218713
Supraventricular extrasystoles 41.40 9.62 80 256687 5835 64236130
Hyperkalaemia 41.28 9.62 598 256169 100531 64141434
Intentional overdose 41.05 9.62 201 256566 89743 64152222
Cardiomegaly 41.01 9.62 195 256572 23489 64218476
Glycosylated haemoglobin increased 40.39 9.62 148 256619 15871 64226094
Blood pressure diastolic decreased 40.36 9.62 186 256581 22115 64219850
Arteriosclerosis 40.29 9.62 147 256620 15730 64226235
Septic shock 40.25 9.62 250 256517 105187 64136778
Injury 39.44 9.62 368 256399 55624 64186341
Emotional distress 39.28 9.62 262 256505 35776 64206189
5-hydroxyindolacetic acid in urine increased 39.22 9.62 19 256748 215 64241750
Disease progression 38.96 9.62 368 256399 141312 64100653
Electrolyte imbalance 38.85 9.62 201 256566 25042 64216923
Arrhythmia 38.83 9.62 351 256416 52593 64189372
Blood mercury abnormal 38.34 9.62 18 256749 189 64241776
Peripheral swelling 38.14 9.62 594 256173 208559 64033406
Acute myeloid leukaemia 38.03 9.62 32 256735 27431 64214534
Metabolic alkalosis 37.68 9.62 61 256706 3867 64238098
Sedation 37.67 9.62 67 256700 41395 64200570
Cytokine release syndrome 37.43 9.62 18 256749 20811 64221154
Therapy non-responder 37.02 9.62 136 256631 65763 64176202
Haemophagocytic lymphohistiocytosis 36.93 9.62 12 256755 17597 64224368
Blister 36.92 9.62 181 256586 80786 64161179
Hypoglycaemia 36.86 9.62 532 256235 89360 64152605
Hepatic enzyme increased 36.38 9.62 336 256431 129607 64112358
Arterial occlusive disease 36.29 9.62 84 256683 6949 64235016
Acute myocardial infarction 36.29 9.62 431 256336 69287 64172678
Lung diffusion test abnormal 36.12 9.62 16 256751 145 64241820
Graft versus host disease 35.70 9.62 6 256761 13807 64228158
Myocardial ischaemia 35.69 9.62 185 256582 23066 64218899
Liver disorder 35.60 9.62 102 256665 53249 64188716
Rhabdomyolysis 35.32 9.62 537 256230 91189 64150776
Pneumocystis jirovecii pneumonia 34.94 9.62 35 256732 27599 64214366
Atrioventricular block first degree 34.88 9.62 108 256659 10626 64231339
Anhedonia 34.87 9.62 127 256640 13579 64228386
Discomfort 34.50 9.62 185 256582 80693 64161272
White blood cell count decreased 33.82 9.62 434 256333 157403 64084562
Hospitalisation 33.78 9.62 169 256598 75038 64166927
Cardiac murmur 33.63 9.62 112 256655 11451 64230514
Renal injury 33.54 9.62 136 256631 15293 64226672
Live birth 33.51 9.62 3 256764 11201 64230764
Allergic oedema 33.44 9.62 26 256741 718 64241247
Swelling 33.43 9.62 443 256324 159775 64082190
Choroidal effusion 33.34 9.62 24 256743 588 64241377
Granulomatous pneumonitis 33.26 9.62 12 256755 59 64241906
Infective pulmonary exacerbation of cystic fibrosis 33.11 9.62 4 256763 11792 64230173
Arteriosclerosis coronary artery 33.06 9.62 136 256631 15393 64226572
Dystonia 32.85 9.62 17 256750 18848 64223117
Respiratory depression 32.85 9.62 27 256740 23416 64218549
Palpitations 32.59 9.62 591 256176 103897 64138068
Disseminated intravascular coagulation 32.44 9.62 49 256718 32299 64209666
Helicobacter infection 32.21 9.62 65 256702 38297 64203668
Neurotoxicity 32.10 9.62 37 256730 27367 64214598
Lymphocyte count decreased 31.64 9.62 72 256695 40627 64201338
Actinic keratosis 31.54 9.62 66 256701 5099 64236866
Bronchomalacia 31.22 9.62 16 256751 206 64241759
Multiple organ dysfunction syndrome 31.14 9.62 256 256511 101157 64140808
Loss of employment 30.79 9.62 38 256729 1869 64240096
Fear 30.62 9.62 160 256607 20011 64221954
Abdominal discomfort 30.53 9.62 526 256241 181796 64060169
Haematotoxicity 30.40 9.62 7 256760 12889 64229076
Transplant rejection 29.83 9.62 16 256751 17385 64224580
Large intestine polyp 29.78 9.62 103 256664 10734 64231231
Bacteraemia 29.76 9.62 38 256729 26873 64215092
Aspergillus infection 29.67 9.62 14 256753 16365 64225600
Cardiac disorder 29.46 9.62 346 256421 55470 64186495
Overdose 29.14 9.62 453 256314 159113 64082852
Osteoarthritis 28.87 9.62 382 256385 62954 64179011
Pulmonary valve disease 28.67 9.62 16 256751 247 64241718
Pericardial disease 28.00 9.62 20 256747 484 64241481
Essential hypertension 27.87 9.62 63 256704 5131 64236834
Vascular purpura 27.72 9.62 42 256725 2514 64239451
Hypertensive heart disease 27.30 9.62 52 256715 3752 64238213
Kidney transplant rejection 27.26 9.62 3 256764 9508 64232457
Rash 27.12 9.62 1521 255246 457028 63784937
Immune reconstitution inflammatory syndrome 27.04 9.62 8 256759 12462 64229503
Aggression 26.91 9.62 94 256673 46138 64195827
Photosensitivity reaction 26.79 9.62 143 256624 18030 64223935
Disorientation 26.40 9.62 339 256428 55489 64186476
Vertigo 26.11 9.62 354 256413 58657 64183308
Cutaneous T-cell lymphoma 26.01 9.62 39 256728 2313 64239652
Product prescribing error 25.95 9.62 234 256533 35035 64206930
Eosinophilic bronchitis 25.85 9.62 17 256750 358 64241607
Product monitoring error 25.83 9.62 63 256704 5391 64236574
Pernicious anaemia 25.83 9.62 20 256747 549 64241416
Intestinal villi atrophy 25.72 9.62 17 256750 361 64241604
Nausea 25.57 9.62 3534 253233 782266 63459699
Interstitial granulomatous dermatitis 25.56 9.62 14 256753 208 64241757
Electrocardiogram ST segment depression 25.54 9.62 55 256712 4334 64237631
Extrasystoles 25.47 9.62 71 256696 6587 64235378
C-reactive protein abnormal 25.44 9.62 48 256719 28999 64212966
Gout 25.37 9.62 159 256608 21254 64220711
Myalgia 25.25 9.62 818 255949 157799 64084166
Polydipsia 25.22 9.62 65 256702 5756 64236209
Ventricular extrasystoles 25.21 9.62 137 256630 17392 64224573
Renal artery stent placement 25.01 9.62 8 256759 25 64241940
Mobility decreased 24.87 9.62 220 256547 85620 64156345
Epilepsy 24.73 9.62 61 256706 33470 64208495
Anti-neutrophil cytoplasmic antibody positive vasculitis 24.70 9.62 43 256724 2893 64239072
Myelodysplastic syndrome 24.66 9.62 45 256722 27534 64214431
Myopathy 24.64 9.62 137 256630 17543 64224422
Tricuspid valve incompetence 24.53 9.62 133 256634 16870 64225095
Muscle spasms 24.49 9.62 735 256032 140288 64101677
Venoocclusive liver disease 24.49 9.62 5 256762 10010 64231955
Bradycardia 24.42 9.62 630 256137 117589 64124376
Depression 24.39 9.62 926 255841 182365 64059600
Microalbuminuria 24.12 9.62 23 256744 842 64241123
Left ventricular hypertrophy 24.11 9.62 88 256679 9418 64232547
Hypophagia 23.90 9.62 252 256515 39335 64202630
Systemic infection 23.84 9.62 53 256714 4268 64237697
Atrioventricular block 23.84 9.62 103 256664 11912 64230053
Nasopharyngitis 23.84 9.62 596 256171 195477 64046488
Sedation complication 23.66 9.62 6 256761 10348 64231617
Peripheral vascular disorder 23.54 9.62 73 256694 7188 64234777
Toxic epidermal necrolysis 23.40 9.62 73 256694 37093 64204872
C-reactive protein increased 23.39 9.62 253 256514 94656 64147309
Hypersensitivity 23.39 9.62 599 256168 195853 64046112
Cataract 23.29 9.62 309 256458 50953 64191012
Device related infection 23.15 9.62 55 256712 30571 64211394
Adverse drug reaction 22.88 9.62 98 256669 45366 64196599
Blood cholesterol increased 22.83 9.62 302 256465 49764 64192201
Impaired healing 22.76 9.62 144 256623 60329 64181636
Tendon rupture 22.69 9.62 94 256673 10673 64231292
Respiratory failure 22.67 9.62 479 256288 160704 64081261
Erectile dysfunction 22.62 9.62 105 256662 12522 64229443
Weight decreased 22.58 9.62 1371 255396 284368 63957597
Thrombotic microangiopathy 22.34 9.62 20 256747 16635 64225330
Liver function test increased 22.32 9.62 57 256710 30913 64211052
Mydriasis 22.25 9.62 17 256750 15295 64226670
Dilatation atrial 22.14 9.62 45 256722 3405 64238560
Hyperammonaemia 22.13 9.62 6 256761 9898 64232067
Dysgeusia 21.96 9.62 285 256482 46762 64195203
Premature delivery 21.88 9.62 25 256742 18564 64223401
Polyuria 21.82 9.62 104 256663 12539 64229426
Diverticulum 21.65 9.62 107 256660 13091 64228874
Hypogammaglobulinaemia 21.63 9.62 7 256760 10292 64231673
Cytopenia 21.45 9.62 18 256749 15453 64226512
Low density lipoprotein decreased 21.39 9.62 24 256743 1066 64240899
Lacunar infarction 21.17 9.62 59 256708 5473 64236492
Lymphopenia 21.09 9.62 44 256723 25613 64216352
Physical examination abnormal 21.07 9.62 13 256754 244 64241721
Non-cardiogenic pulmonary oedema 21.02 9.62 26 256741 1282 64240683
Depressed level of consciousness 20.92 9.62 215 256552 81221 64160744
Device related thrombosis 20.85 9.62 33 256734 2052 64239913
Diastolic dysfunction 20.72 9.62 80 256687 8795 64233170
Pancreatitis necrotising 20.69 9.62 42 256725 3175 64238790
Bladder prolapse 20.49 9.62 24 256743 1117 64240848
Pleural effusion 20.26 9.62 368 256399 126191 64115774
Neurosensory hypoacusis 20.09 9.62 12 256755 212 64241753
Osteonecrosis of jaw 19.95 9.62 86 256681 39739 64202226
Low density lipoprotein increased 19.93 9.62 72 256695 7668 64234297
Mental status changes 19.79 9.62 348 256419 60814 64181151
Peritonitis 19.67 9.62 44 256723 24979 64216986
Mucosal inflammation 19.66 9.62 157 256610 62427 64179538
Drug hypersensitivity 19.61 9.62 761 256006 237054 64004911
Bundle branch block right 19.59 9.62 87 256680 10182 64231783
Encephalitis 19.52 9.62 13 256754 12558 64229407
Pathogen resistance 19.44 9.62 13 256754 12530 64229435
Enterocolitis 19.25 9.62 12 256755 12006 64229959
Acquired acrodermatitis enteropathica 19.21 9.62 5 256762 5 64241960
Muscle necrosis 19.16 9.62 24 256743 1199 64240766
Acute respiratory distress syndrome 18.94 9.62 85 256682 38850 64203115
Coronary artery occlusion 18.93 9.62 107 256660 13784 64228181
Renovascular hypertension 18.69 9.62 7 256760 39 64241926
Accidental exposure to product 18.64 9.62 49 256718 26315 64215650
Gait disturbance 18.63 9.62 851 255916 171304 64070661
Blood uric acid increased 18.58 9.62 73 256694 8090 64233875
Blood creatine phosphokinase increased 18.53 9.62 332 256435 58226 64183739
Rotator cuff syndrome 18.35 9.62 96 256671 12011 64229954
Substance abuse 18.34 9.62 7 256760 9285 64232680
Respiratory tract inflammation 18.32 9.62 19 256748 771 64241194
Hypoxia 18.27 9.62 244 256523 87905 64154060
Nervousness 18.25 9.62 189 256578 29367 64212598
Pollakiuria 18.24 9.62 199 256568 31331 64210634
Tooth erosion 18.18 9.62 14 256753 381 64241584
Hip arthroplasty 18.07 9.62 36 256731 21315 64220650
Oropharyngeal swelling 18.06 9.62 23 256744 1168 64240797
Orthostatic hypotension 17.74 9.62 273 256494 46465 64195500
Multiple drug therapy 17.66 9.62 32 256735 2222 64239743
Ill-defined disorder 17.57 9.62 103 256664 43949 64198016
Meniere's disease 17.55 9.62 10 256757 161 64241804
Coronary artery bypass 17.51 9.62 57 256710 5758 64236207
Angle closure glaucoma 17.46 9.62 35 256732 2622 64239343
Blood pressure decreased 17.40 9.62 458 256309 85741 64156224
Uveitis 17.36 9.62 15 256752 12693 64229272
Serotonin syndrome 17.22 9.62 89 256678 39193 64202772
Injection site inflammation 17.21 9.62 39 256728 3182 64238783
Carpal tunnel syndrome 17.20 9.62 115 256652 15713 64226252
Product quality issue 17.20 9.62 188 256579 29611 64212354
Renal artery angioplasty 17.20 9.62 5 256762 10 64241955
Breast neoplasm 17.06 9.62 19 256748 837 64241128
Progressive multifocal leukoencephalopathy 16.98 9.62 29 256738 18203 64223762
Clostridium difficile infection 16.97 9.62 80 256687 36083 64205882
Lichen planus 16.92 9.62 32 256735 2296 64239669
Diverticulitis 16.81 9.62 231 256536 38387 64203578
Heart rate irregular 16.78 9.62 175 256592 27238 64214727
Schizophrenia 16.75 9.62 12 256755 11156 64230809
Therapy partial responder 16.74 9.62 10 256757 10238 64231727
Occult blood 16.59 9.62 24 256743 1378 64240587
Akathisia 16.45 9.62 13 256754 11497 64230468
Blood triglycerides increased 16.44 9.62 130 256637 18736 64223229
Pruritus allergic 16.42 9.62 19 256748 873 64241092
Drug ineffective for unapproved indication 16.36 9.62 66 256701 31067 64210898
Mouth ulceration 16.29 9.62 70 256697 32374 64209591
Cell death 16.27 9.62 44 256723 4010 64237955
Choroidal detachment 16.24 9.62 15 256752 527 64241438
Thalamic infarction 16.12 9.62 21 256746 1091 64240874
Blood creatine increased 16.08 9.62 70 256697 8122 64233843
Sinusitis 16.04 9.62 450 256317 145478 64096487
Nephrocalcinosis 16.02 9.62 23 256744 1311 64240654
Withdrawal hypertension 15.96 9.62 12 256755 315 64241650
Intervertebral disc degeneration 15.91 9.62 98 256669 13022 64228943
Hypertensive angiopathy 15.89 9.62 8 256759 99 64241866
Erythrodermic psoriasis 15.80 9.62 25 256742 1554 64240411
Cystitis haemorrhagic 15.69 9.62 6 256761 7950 64234015
Mandibular mass 15.57 9.62 10 256757 202 64241763
Neurofibrosarcoma 15.52 9.62 10 256757 203 64241762
Rectal prolapse 15.47 9.62 26 256741 1700 64240265
Endometrial cancer stage I 15.47 9.62 9 256758 151 64241814
Spinal osteoarthritis 15.47 9.62 104 256663 14237 64227728
Pain 15.43 9.62 1949 254818 551562 63690403
Hyperhidrosis 15.41 9.62 626 256141 124294 64117671
Gastric disorder 15.41 9.62 181 256586 29016 64212949
Seizure 15.34 9.62 527 256240 166365 64075600
Shoshin beriberi 15.29 9.62 7 256760 69 64241896
Meniscus injury 15.25 9.62 55 256712 5852 64236113
Pharyngeal oedema 15.21 9.62 110 256657 15421 64226544
Distributive shock 15.18 9.62 27 256740 1848 64240117
Paradoxical drug reaction 15.08 9.62 3 256764 6117 64235848
Renin increased 15.06 9.62 10 256757 214 64241751
Polymyalgia rheumatica 15.06 9.62 38 256729 3321 64238644
Intentional product misuse 15.03 9.62 200 256567 72095 64169870
Colitis 15.03 9.62 155 256612 58519 64183446
Cutaneous lupus erythematosus 14.92 9.62 33 256734 2649 64239316
Renal tubular necrosis 14.91 9.62 144 256623 21966 64219999
Erythema 14.90 9.62 601 256166 186469 64055496
Poisoning deliberate 14.88 9.62 19 256748 13439 64228526
Troponin I increased 14.87 9.62 41 256726 3780 64238185
Anxiety 14.83 9.62 966 255801 201683 64040282
Lipohypertrophy 14.80 9.62 17 256750 775 64241190
Fluid intake reduced 14.80 9.62 50 256717 5150 64236815
Psychotic disorder 14.79 9.62 79 256688 34499 64207466
Carcinoid tumour of the gastrointestinal tract 14.78 9.62 7 256760 75 64241890
Mucosal membrane hyperplasia 14.75 9.62 6 256761 43 64241922
Gouty arthritis 14.73 9.62 22 256745 1300 64240665
Blood osmolarity decreased 14.63 9.62 21 256746 1197 64240768
Lymphangiectasia intestinal 14.48 9.62 4 256763 6 64241959
Pseudomonas infection 14.42 9.62 31 256736 17852 64224113
Agranulocytosis 14.40 9.62 91 256676 38138 64203827
Fear of injection 14.36 9.62 3 256764 5909 64236056
Alkalosis hypochloraemic 14.31 9.62 13 256754 447 64241518
Gastrointestinal disorder 14.30 9.62 261 256506 89448 64152517
Suicide attempt 14.20 9.62 198 256569 70809 64171156
Blood hyposmosis 14.13 9.62 5 256762 23 64241942
Gastrointestinal angiodysplasia 14.12 9.62 18 256749 915 64241050
Agitation 14.12 9.62 257 256510 88110 64153855
Allergic cough 14.07 9.62 13 256754 457 64241508
Shock hypoglycaemic 14.07 9.62 10 256757 240 64241725
Panniculitis 14.04 9.62 9 256758 8870 64233095
Nodular rash 13.99 9.62 11 256756 309 64241656
Electrocardiogram U-wave abnormality 13.95 9.62 7 256760 86 64241879
Enterococcal infection 13.91 9.62 21 256746 13845 64228120
Renal function test abnormal 13.87 9.62 41 256726 3933 64238032
Electrocardiogram T wave amplitude decreased 13.85 9.62 14 256753 551 64241414
Rheumatoid nodule 13.85 9.62 18 256749 12633 64229332
Lymphomatoid papulosis 13.81 9.62 11 256756 315 64241650
Post-anoxic myoclonus 13.79 9.62 5 256762 25 64241940
Intestinal intraepithelial lymphocytes increased 13.76 9.62 4 256763 8 64241957
Cholelithiasis 13.70 9.62 256 256511 45250 64196715
Cardiovascular disorder 13.60 9.62 109 256658 15772 64226193
Squamous cell carcinoma 13.45 9.62 98 256669 13771 64228194
Miosis 13.39 9.62 20 256747 13246 64228719
Body temperature decreased 13.36 9.62 160 256607 25768 64216197
Carotid bruit 13.34 9.62 15 256752 668 64241297
Endometrial hyperplasia 13.30 9.62 13 256754 491 64241474
Rhinovirus infection 13.26 9.62 4 256763 6152 64235813
Torsade de pointes 13.18 9.62 116 256651 17247 64224718
Laryngeal pain 13.15 9.62 51 256716 5617 64236348
Eosinophilia myalgia syndrome 13.15 9.62 4 256763 10 64241955
Preternatural anus 13.15 9.62 7 256760 98 64241867
Gangrene 13.13 9.62 61 256706 7277 64234688
Aplastic anaemia 13.09 9.62 22 256745 13898 64228067
Tumour lysis syndrome 13.09 9.62 37 256730 19403 64222562
Polyp 13.08 9.62 57 256710 6616 64235349
Neoplasm 12.99 9.62 59 256708 6972 64234993
Intervertebral disc displacement 12.99 9.62 12 256755 422 64241543
Electrocardiogram abnormal 12.92 9.62 95 256672 13386 64228579
Cardiac arrest 12.91 9.62 492 256275 153572 64088393
Allergic hepatitis 12.90 9.62 5 256762 31 64241934
Pulpitis dental 12.88 9.62 18 256749 1001 64240964
Jaw disorder 12.79 9.62 44 256723 4573 64237392
Trigger finger 12.78 9.62 37 256730 3508 64238457
Herpes zoster 12.75 9.62 230 256537 78957 64163008
Pulmonary alveolar haemorrhage 12.70 9.62 12 256755 9726 64232239
Hepatocellular injury 12.63 9.62 117 256650 45118 64196847
Ventricular fibrillation 12.63 9.62 148 256619 23712 64218253
Renal artery restenosis 12.62 9.62 4 256763 12 64241953
Hip fracture 12.58 9.62 164 256603 26935 64215030
Bacterial sepsis 12.57 9.62 7 256760 7450 64234515
Drug-induced liver injury 12.56 9.62 125 256642 47518 64194447
COVID-19 12.54 9.62 183 256584 64957 64177008
International normalised ratio decreased 12.53 9.62 61 256706 7417 64234548
Foetal death 12.51 9.62 4 256763 5926 64236039
Neuroleptic malignant syndrome 12.50 9.62 54 256713 24942 64217023
Hepatic steatosis 12.50 9.62 183 256584 30824 64211141
Pain in jaw 12.45 9.62 103 256664 40652 64201313
Cerebral ischaemia 12.45 9.62 75 256692 9887 64232078
Basal cell carcinoma 12.43 9.62 182 256585 30656 64211309
Intervertebral disc protrusion 12.41 9.62 129 256638 20062 64221903
Renal artery arteriosclerosis 12.39 9.62 5 256762 35 64241930
Febrile bone marrow aplasia 12.33 9.62 16 256751 11239 64230726
Hyponatraemic encephalopathy 12.33 9.62 10 256757 294 64241671
Device expulsion 12.28 9.62 43 256724 21093 64220872
Echocardiogram abnormal 12.28 9.62 24 256743 1765 64240200
Small cell carcinoma 12.21 9.62 10 256757 298 64241667
Bone erosion 12.18 9.62 17 256750 11578 64230387
CD4/CD8 ratio increased 12.16 9.62 4 256763 14 64241951
Vestibular neuronitis 12.12 9.62 14 256753 642 64241323
Pathological fracture 12.03 9.62 69 256698 8936 64233029
Wrong technique in product usage process 12.00 9.62 184 256583 64790 64177175
Respiratory syncytial virus infection 12.00 9.62 7 256760 7261 64234704
Immunosuppressant drug level increased 11.97 9.62 7 256760 7252 64234713
Ischaemic stroke 11.96 9.62 172 256595 28863 64213102
Hepatic neoplasm 11.95 9.62 33 256734 3044 64238921
Metastases to fallopian tube 11.93 9.62 5 256762 39 64241926
Glomerulonephritis rapidly progressive 11.90 9.62 20 256747 1308 64240657
Hypercholesterolaemia 11.82 9.62 103 256664 15270 64226695
Haemolysis 11.78 9.62 16 256751 11023 64230942
Cyanopsia 11.73 9.62 6 256761 77 64241888
Paresis cranial nerve 11.72 9.62 5 256762 41 64241924
Hypoparathyroidism 11.71 9.62 16 256751 871 64241094
Hypovitaminosis 11.69 9.62 16 256751 872 64241093
Acute coronary syndrome 11.69 9.62 123 256644 19187 64222778
Premature labour 11.67 9.62 8 256759 7612 64234353
Osteitis deformans 11.66 9.62 8 256759 181 64241784
Oxygen saturation decreased 11.65 9.62 331 256436 106845 64135120
Sleep apnoea syndrome 11.61 9.62 175 256592 29657 64212308
Renal artery dissection 11.52 9.62 3 256764 3 64241962
Homans' sign 11.52 9.62 3 256764 3 64241962
Hemiataxia 11.51 9.62 5 256762 43 64241922
Depressed mood 11.49 9.62 106 256661 40906 64201059
Crystal arthropathy 11.48 9.62 8 256759 186 64241779
Carcinogenicity 11.46 9.62 6 256761 81 64241884
Encephalopathy 11.41 9.62 165 256602 58654 64183311
Diabetes mellitus 11.41 9.62 346 256421 66128 64175837
Aortic valve incompetence 11.35 9.62 64 256703 8237 64233728
Pseudolymphoma 11.29 9.62 17 256750 1012 64240953
Device issue 11.29 9.62 49 256718 22599 64219366
Macrocytosis 11.27 9.62 28 256739 2424 64239541
Recalled product 11.27 9.62 16 256751 903 64241062
Non-cardiac chest pain 11.27 9.62 66 256701 8614 64233351
Psoriatic arthropathy 11.22 9.62 114 256653 43167 64198798
Gastrointestinal mucosal necrosis 11.22 9.62 8 256759 193 64241772
Atrophy 11.22 9.62 24 256743 1883 64240082
Electrocardiogram Q waves 11.21 9.62 6 256761 85 64241880
Anaphylactic reaction 11.19 9.62 199 256568 68465 64173500
Accelerated hypertension 11.17 9.62 13 256754 601 64241364
General physical health deterioration 11.16 9.62 952 255815 203473 64038492
Angiopathy 11.15 9.62 52 256715 6213 64235752
Aortic arteriosclerosis 11.14 9.62 59 256708 7417 64234548
Diabetic neuropathy 11.10 9.62 48 256719 5553 64236412
Atrioventricular block second degree 11.07 9.62 53 256714 6401 64235564
Nephropathy 11.04 9.62 64 256703 8322 64233643
Blood growth hormone increased 11.03 9.62 13 256754 609 64241356
Device use error 11.02 9.62 6 256761 6465 64235500
Metabolic syndrome 10.99 9.62 27 256740 2321 64239644
Paradoxical psoriasis 10.96 9.62 7 256760 140 64241825
Hypocalcaemia 10.93 9.62 230 256537 41523 64200442
Ischaemic cardiomyopathy 10.91 9.62 55 256712 6783 64235182
Plasma cell myeloma 10.88 9.62 124 256643 45951 64196014
Coronary artery restenosis 10.87 9.62 19 256748 1283 64240682
Parotitis 10.86 9.62 26 256741 2199 64239766
Hemiparesis 10.86 9.62 173 256594 29654 64212311
Hepatitis B reactivation 10.85 9.62 3 256764 4886 64237079
Cardiac stress test abnormal 10.84 9.62 14 256753 721 64241244
Delirium 10.82 9.62 202 256565 68992 64172973
Nail bed inflammation 10.77 9.62 12 256755 529 64241436
Disability 10.76 9.62 20 256747 12152 64229813
Aspiration 10.74 9.62 33 256734 16852 64225113
Staphylococcal sepsis 10.70 9.62 22 256745 12877 64229088
Rales 10.67 9.62 100 256667 15129 64226836
Device difficult to use 10.66 9.62 14 256753 9784 64232181
Coronary artery stenosis 10.63 9.62 79 256688 11169 64230796
Nodal arrhythmia 10.62 9.62 23 256744 1820 64240145
Aortic valve sclerosis 10.62 9.62 21 256746 1558 64240407
Therapeutic response shortened 10.59 9.62 15 256752 10155 64231810
Pulmonary tuberculosis 10.58 9.62 8 256759 7236 64234729
Confabulation 10.57 9.62 11 256756 448 64241517
Cardiac discomfort 10.57 9.62 17 256750 1072 64240893
Hypervitaminosis D 10.56 9.62 6 256761 96 64241869
Drug reaction with eosinophilia and systemic symptoms 10.55 9.62 152 256615 54065 64187900
Foreign body in reproductive tract 10.53 9.62 11 256756 450 64241515
Staring 10.53 9.62 27 256740 2383 64239582
Diabetic vascular disorder 10.53 9.62 5 256762 54 64241911
Antidiuretic hormone abnormality 10.53 9.62 5 256762 54 64241911
Acute hepatic failure 10.44 9.62 61 256706 26051 64215914
High density lipoprotein decreased 10.41 9.62 37 256730 3909 64238056
Product commingling 10.40 9.62 6 256761 99 64241866
Iatrogenic injury 10.40 9.62 19 256748 1328 64240637
Blood lactate dehydrogenase increased 10.38 9.62 83 256684 32995 64208970
Diverticulum oesophageal 10.34 9.62 7 256760 155 64241810
Supraventricular tachycardia 10.33 9.62 118 256649 18789 64223176
Deep vein thrombosis 10.32 9.62 515 256252 104667 64137298
Iliac artery embolism 10.32 9.62 3 256764 6 64241959
Osmotic demyelination syndrome 10.32 9.62 18 256749 1213 64240752
Tooth abscess 10.31 9.62 92 256675 13734 64228231
Diabetes mellitus inadequate control 10.30 9.62 130 256637 21191 64220774
Muscular dystrophy 10.25 9.62 6 256761 102 64241863
Adenocarcinoma 10.23 9.62 33 256734 3318 64238647
Pneumatosis intestinalis 10.22 9.62 4 256763 5225 64236740
Fine motor skill dysfunction 10.22 9.62 3 256764 4696 64237269
Spinal cord infarction 10.19 9.62 12 256755 562 64241403
Body height decreased 10.17 9.62 58 256709 7496 64234469
Swelling face 10.16 9.62 308 256459 58858 64183107
Paraesthesia 10.15 9.62 643 256124 133879 64108086
Pneumothorax 10.13 9.62 56 256711 24242 64217723
Renal cyst 10.08 9.62 85 256682 12485 64229480
Asphyxia 10.07 9.62 14 256753 9552 64232413
Exposure to toxic agent 10.07 9.62 6 256761 6153 64235812
Labyrinthitis 10.06 9.62 28 256739 2595 64239370
Hyperparathyroidism primary 10.05 9.62 10 256757 386 64241579
Haemorrhagic stroke 10.04 9.62 71 256696 9880 64232085
Ventricular arrhythmia 10.03 9.62 57 256710 7358 64234607
Forced vital capacity decreased 10.00 9.62 20 256747 1496 64240469
Product residue present 9.96 9.62 32 256735 3210 64238755
Neutrophil count increased 9.96 9.62 59 256708 25115 64216850
Mitral valve disease 9.96 9.62 28 256739 2610 64239355
Forced expiratory flow decreased 9.96 9.62 8 256759 232 64241733
Aortic valve calcification 9.96 9.62 13 256754 677 64241288
White blood cell count abnormal 9.93 9.62 42 256725 4812 64237153
Bladder irrigation 9.92 9.62 5 256762 62 64241903
Klebsiella infection 9.92 9.62 24 256743 13257 64228708
Renin decreased 9.85 9.62 6 256761 110 64241855
Amaurosis fugax 9.82 9.62 14 256753 793 64241172
Granuloma skin 9.82 9.62 6 256761 6068 64235897
Pituitary apoplexy 9.78 9.62 7 256760 170 64241795
Epileptic encephalopathy 9.76 9.62 10 256757 400 64241565
Mesenteric panniculitis 9.75 9.62 8 256759 239 64241726
Aplasia 9.75 9.62 8 256759 6945 64235020
Haemarthrosis 9.75 9.62 44 256723 5185 64236780
Asymptomatic bacteriuria 9.73 9.62 9 256758 317 64241648
Gastrointestinal tract mucosal pigmentation 9.73 9.62 15 256752 912 64241053
Injection site hypersensitivity 9.73 9.62 21 256746 1658 64240307
Wound treatment 9.71 9.62 7 256760 172 64241793
Electrocardiogram ST-T change 9.70 9.62 20 256747 1529 64240436
Activated partial thromboplastin time 9.68 9.62 4 256763 30 64241935
Cardio-respiratory arrest 9.67 9.62 308 256459 98085 64143880
Brain stem infarction 9.66 9.62 22 256745 1801 64240164
Coma scale abnormal 9.65 9.62 10 256757 7764 64234201

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C03AA03 CARDIOVASCULAR SYSTEM
DIURETICS
LOW-CEILING DIURETICS, THIAZIDES
Thiazides, plain
ATC C03AB03 CARDIOVASCULAR SYSTEM
DIURETICS
LOW-CEILING DIURETICS, THIAZIDES
Thiazides and potassium in combination
ATC C03AX01 CARDIOVASCULAR SYSTEM
DIURETICS
LOW-CEILING DIURETICS, THIAZIDES
Thiazides, combinations with other drugs
ATC C03EA01 CARDIOVASCULAR SYSTEM
DIURETICS
DIURETICS AND POTASSIUM-SPARING AGENTS IN COMBINATION
Low-ceiling diuretics and potassium-sparing agents
ATC C09BX03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
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 C09DX03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX07 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09XA52 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Renin-inhibitors
ATC C09XA54 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Renin-inhibitors
FDA CS M0471776 Thiazides
FDA PE N0000175359 Increased Diuresis
FDA EPC N0000175419 Thiazide Diuretic
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D004232 Diuretics
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D045283 Natriuretic Agents
MeSH PA D049993 Sodium Chloride Symporter Inhibitors
CHEBI has role CHEBI:35498 diuretics
CHEBI has role CHEBI:35674 antihypertensive drugs
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Chronic heart failure indication 48447003
Edema indication 267038008
Hypertensive urgency indication 443482000
Edema due to Hepatic Cirrhosis indication
Edema due to Nephrotic Syndrome indication
Pulmonary Edema due to Chronic Heart Failure indication
Hypertension with Left Ventricular Hypertrophy indication
Peripheral Edema due to Chronic Heart Failure indication
Nephrogenic diabetes insipidus off-label use 111395007 DOID:12387
Calcium renal calculus off-label use 427649000
Anuria contraindication 2472002 DOID:2983
Bronchospasm contraindication 4386001
Suicidal thoughts contraindication 6471006
Psoriasis contraindication 9014002 DOID:8893
Peptic ulcer contraindication 13200003 DOID:750
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Chronic disease of respiratory system contraindication 17097001
Metabolic acidosis, normal anion gap, acidifying salts contraindication 18104000
Jaundice contraindication 18165001
Cirrhosis of liver contraindication 19943007 DOID:5082
Secondary angle-closure glaucoma contraindication 21571006
Electroconvulsive therapy contraindication 23835007
Acute vomiting contraindication 23971007
Complete atrioventricular block contraindication 27885002
Hypovolemia contraindication 28560003
Acute cerebrovascular insufficiency contraindication 29322000
Obstruction of bile duct contraindication 30144000
Parkinsonism contraindication 32798002
Dehydration contraindication 34095006
Depressive disorder contraindication 35489007
Hyperuricemia contraindication 35885006 DOID:1920
Sick sinus syndrome contraindication 36083008 DOID:13884
Acute hepatitis contraindication 37871000
Immunosuppression contraindication 38013005
Anaphylaxis contraindication 39579001
Angioedema contraindication 41291007 DOID:1558
Hypokalemia contraindication 43339004
Diabetes mellitus type 2 contraindication 44054006 DOID:9352
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Diabetes mellitus type 1 contraindication 46635009 DOID:9744
Sinus bradycardia contraindication 49710005
Cough contraindication 49727002
Acidosis contraindication 51387008
Syndrome of inappropriate vasopressin secretion contraindication 55004003 DOID:3401
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Aortic valve stenosis contraindication 60573004 DOID:1712
Chronic bronchitis contraindication 63480004 DOID:6132
Ulcerative colitis contraindication 64766004 DOID:8577
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Benign intracranial hypertension contraindication 68267002 DOID:11459
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Wolff-Parkinson-White pattern contraindication 74390002 DOID:384
Transplantation contraindication 77465005
Chronic idiopathic constipation contraindication 82934008
Hereditary angioneurotic edema contraindication 82966003 DOID:14735
Oliguria contraindication 83128009
Epilepsy contraindication 84757009 DOID:1826
Megaloblastic anemia due to folate deficiency contraindication 85649008 DOID:14026
Pulmonary emphysema contraindication 87433001
Cardiogenic shock contraindication 89138009
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Kidney stone contraindication 95570007
Disorder of connective tissue contraindication 105969002 DOID:65
Diabetic renal disease contraindication 127013003
Disorder of muscle contraindication 129565002 DOID:423
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Angina pectoris contraindication 194828000
Partial atrioventricular block contraindication 195039008
Second degree atrioventricular block contraindication 195042002
Decompensated cardiac failure contraindication 195111005
Asthma contraindication 195967001 DOID:2841
Acute hepatic failure contraindication 197270009
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007
Hypertrophic cardiomyopathy contraindication 233873004 DOID:11984
Disease of liver contraindication 235856003 DOID:409
Hypoglycemic disorder contraindication 237630007
Disorder of electrolytes contraindication 237840007
Lupus erythematosus and erythema multiforme-like syndrome contraindication 238926009
Rhabdomyolysis contraindication 240131006
Raynaud's phenomenon contraindication 266261006
Calculus in biliary tract contraindication 266474003
Anemia contraindication 271737000 DOID:2355
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Pheochromocytoma contraindication 302835009
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Severe chronic obstructive pulmonary disease contraindication 313299006
Right ventricular failure contraindication 367363000
Surgical procedure contraindication 387713003
Peripheral arterial occlusive disease contraindication 399957001
Peripheral vascular disease contraindication 400047006
Severe diarrhea contraindication 409587002
Autoimmune hemolytic anemia contraindication 413603009 DOID:718
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Myocardial infarction in recovery phase contraindication 418044006
Porphyria contraindication 418470004
Intraoperative floppy iris syndrome contraindication 418801006
Poor metabolizer due to cytochrome p450 CYP2D6 variant contraindication 423629005
Slow acetylator due to N-acetyltransferase enzyme variant contraindication 425079005
Azotemia contraindication 445009001
Smokes tobacco daily contraindication 449868002
Acute exacerbation of asthma contraindication 708038006
Head and Neck Angioedema contraindication
Severe Aortic Valve Stenosis contraindication
Intestinal Angioedema contraindication
Severe Cerebrovascular Disease contraindication
First Degree Atrioventricular Heart Block contraindication
Hemodialysis with High-Flux Membrane contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Cattle Postparturient udder edema Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Hydrozide Injection Boehringer lngelheim Animal Health USA Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.89 acidic
pKa2 11.02 acidic
pKa3 0.71 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Solute carrier family 12 member 3 Transporter INHIBITOR A2 7.01 WOMBAT-PK CHEMBL
Carbonic anhydrase 1 Enzyme Ki 6.48 CHEMBL
Carbonic anhydrase 4 Enzyme WOMBAT-PK
Calcium-activated potassium channel subunit alpha-1 Ion channel WOMBAT-PK
Carbonic anhydrase 2 Enzyme Ki 5.90 WOMBAT-PK
Astrosclerin-3 Enzyme Ki 6.40 CHEMBL
Delta carbonic anhydrase Unclassified Ki 5.37 CHEMBL
Carbonic anhydrase Enzyme Ki 7.50 CHEMBL
Carbonic anhydrase, alpha family Unclassified Ki 6.53 CHEMBL
Carbonate dehydratase Enzyme Ki 8.14 CHEMBL

External reference:

IDSource
4017615 VUID
N0000145995 NUI
D00340 KEGG_DRUG
4017615 VANDF
C0020261 UMLSCUI
CHEBI:5778 CHEBI
HCZ PDB_CHEM_ID
CHEMBL435 ChEMBL_ID
CHEMBL43686 ChEMBL_ID
CHEMBL15605 ChEMBL_ID
DB00999 DRUGBANK_ID
D006852 MESH_DESCRIPTOR_UI
3639 PUBCHEM_CID
4836 IUPHAR_LIGAND_ID
841 INN_ID
0J48LPH2TH UNII
5487 RXNORM
4834 MMSL
924 MMSL
d00253 MMSL
002294 NDDF
387525002 SNOMEDCT_US
91667005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Avalide HUMAN PRESCRIPTION DRUG LABEL 2 0024-5855 TABLET, FILM COATED 12.50 mg ORAL NDA 30 sections
Avalide HUMAN PRESCRIPTION DRUG LABEL 2 0024-5856 TABLET, FILM COATED 12.50 mg ORAL NDA 30 sections
ALDACTAZIDE HUMAN PRESCRIPTION DRUG LABEL 2 0025-1011 TABLET, FILM COATED 25 mg ORAL NDA 24 sections
ALDACTAZIDE HUMAN PRESCRIPTION DRUG LABEL 2 0025-1021 TABLET, FILM COATED 50 mg ORAL NDA 24 sections
Irbesartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0254 TABLET 12.50 mg ORAL ANDA 28 sections
Irbesartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0255 TABLET 12.50 mg ORAL ANDA 28 sections
telmisartan and hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0545 TABLET 12.50 mg ORAL NDA authorized generic 27 sections
telmisartan and hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0546 TABLET 12.50 mg ORAL NDA authorized generic 27 sections
telmisartan and hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0547 TABLET 25 mg ORAL NDA authorized generic 27 sections
ACCURETIC HUMAN PRESCRIPTION DRUG LABEL 2 0071-0220 TABLET, FILM COATED 12.50 mg ORAL NDA 22 sections
ACCURETIC HUMAN PRESCRIPTION DRUG LABEL 2 0071-0222 TABLET, FILM COATED 12.50 mg ORAL NDA 22 sections
ACCURETIC HUMAN PRESCRIPTION DRUG LABEL 2 0071-0223 TABLET, FILM COATED 25 mg ORAL NDA 22 sections
ACCURETIC HUMAN PRESCRIPTION DRUG LABEL 2 0071-3112 TABLET, FILM COATED 12.50 mg ORAL NDA 22 sections
ACCURETIC HUMAN PRESCRIPTION DRUG LABEL 2 0071-5212 TABLET, FILM COATED 12.50 mg ORAL NDA 22 sections
ACCURETIC HUMAN PRESCRIPTION DRUG LABEL 2 0071-7225 TABLET, FILM COATED 25 mg ORAL NDA 22 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0314 TABLET, FILM COATED 12.50 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0314 TABLET, FILM COATED 12.50 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0315 TABLET, FILM COATED 12.50 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0315 TABLET, FILM COATED 12.50 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0383 TABLET, FILM COATED 25 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0383 TABLET, FILM COATED 25 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0471 TABLET, FILM COATED 12.50 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0471 TABLET, FILM COATED 12.50 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0472 TABLET, FILM COATED 25 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0472 TABLET, FILM COATED 25 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0559 TABLET, FILM COATED 12.50 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0559 TABLET, FILM COATED 12.50 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0560 TABLET, FILM COATED 25 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0560 TABLET, FILM COATED 25 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0561 TABLET, FILM COATED 12.50 mg ORAL NDA 31 sections