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

Stem definitionDrug idCAS RN
aldosterone antagonists, spironolactone derivates 2475 52-01-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • spironolactone
  • abbolactone
  • aldactone
  • aldopur
  • berlactone
  • euteberol
  • quimolactona
  • spirolactone
A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827)
  • Molecular weight: 416.58
  • Formula: C24H32O4S
  • CLOGP: 2.84
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 60.44
  • ALOGS: -5.32
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
75 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.02 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 13.72 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 25 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Jan. 21, 1960 FDA GD SEARLE LLC

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
Hyperkalaemia 2010.45 9.83 1437 151022 46652 50406013
Acute kidney injury 1124.98 9.83 2259 150200 225799 50226866
Cardiac failure 885.94 9.83 1118 151341 74922 50377743
Hyponatraemia 674.46 9.83 1111 151348 95028 50357637
Drug ineffective 669.57 9.83 899 151560 818434 49634231
Pulmonary arterial hypertension 551.82 9.83 471 151988 19848 50432817
Right ventricular failure 486.79 9.83 395 152064 15498 50437167
Hepatic encephalopathy 392.94 9.83 284 152175 9352 50443313
Pulmonary hypertension 361.50 9.83 474 151985 32943 50419722
Ascites 356.33 9.83 488 151971 35373 50417292
Synovitis 334.87 9.83 8 152451 123857 50328808
Renal impairment 328.81 9.83 713 151746 74948 50377717
Pemphigus 323.94 9.83 8 152451 120158 50332507
Drug interaction 307.45 9.83 1303 151156 198318 50254347
Joint swelling 294.64 9.83 188 152271 245098 50207567
Hypotension 291.36 9.83 1441 151018 234028 50218637
Cardiac failure congestive 281.37 9.83 717 151742 83665 50369000
Arthropathy 279.92 9.83 66 152393 157840 50294825
Hand deformity 276.66 9.83 5 152454 100194 50352471
Systemic lupus erythematosus 267.27 9.83 50 152409 140572 50312093
Bradycardia 267.27 9.83 596 151863 63830 50388835
Rheumatoid arthritis 263.38 9.83 141 152318 202409 50250256
Maternal exposure during pregnancy 261.95 9.83 78 152381 159700 50292965
Oedema peripheral 261.89 9.83 1055 151404 156906 50295759
Dyspnoea 259.94 9.83 2652 149807 544956 49907709
Renal failure 258.35 9.83 807 151652 105826 50346839
Fluid retention 253.58 9.83 506 151953 50143 50402522
Glossodynia 252.48 9.83 27 152432 115542 50337123
Drug intolerance 246.96 9.83 180 152279 218924 50233741
Treatment failure 242.99 9.83 58 152401 137579 50315086
Contraindicated product administered 240.05 9.83 75 152384 148883 50303782
Infusion related reaction 238.67 9.83 106 152353 169451 50283214
Therapeutic product effect decreased 231.18 9.83 62 152397 135988 50316677
Pain 224.58 9.83 941 151518 577962 49874703
International normalised ratio increased 213.48 9.83 429 152030 42723 50409942
Alopecia 210.83 9.83 257 152202 244790 50207875
Dehydration 210.11 9.83 963 151496 151486 50301179
Blood creatinine increased 205.69 9.83 599 151860 75561 50377104
Hypervolaemia 199.48 9.83 310 152149 25189 50427476
Atrial fibrillation 199.36 9.83 717 151742 101028 50351637
Wound 183.93 9.83 46 152413 105748 50346917
Hepatic cirrhosis 178.79 9.83 242 152217 17335 50435330
Hypersensitivity 174.33 9.83 236 152223 214925 50237740
Discomfort 172.02 9.83 56 152403 108324 50344341
Abdominal discomfort 167.36 9.83 275 152184 231366 50221299
Pericarditis 165.32 9.83 21 152438 78668 50373997
Arthralgia 163.11 9.83 724 151735 437978 50014687
Blood potassium increased 159.59 9.83 221 152238 16177 50436488
Rash 159.02 9.83 728 151731 436743 50015922
Oedema 154.32 9.83 514 151945 69667 50382998
Completed suicide 146.34 9.83 110 152349 131779 50320886
Blood urea increased 143.29 9.83 256 152203 23329 50429336
Musculoskeletal stiffness 140.20 9.83 109 152350 128372 50324293
Exposure during pregnancy 139.39 9.83 97 152362 120918 50331747
Cardiac failure chronic 131.71 9.83 99 152360 3464 50449201
Off label use 131.45 9.83 864 151595 473562 49979103
Anaemia 127.43 9.83 1240 151219 251216 50201449
Dyspnoea exertional 126.03 9.83 390 152069 50843 50401822
Hepatic enzyme increased 121.30 9.83 141 152318 137239 50315426
Helicobacter infection 118.37 9.83 8 152451 49694 50402971
Drug hypersensitivity 113.81 9.83 382 152077 250628 50202037
Melaena 112.99 9.83 250 152209 26614 50426051
Drug abuse 112.10 9.83 22 152437 59824 50392841
Duodenal ulcer perforation 109.63 9.83 7 152452 45604 50407061
Lower respiratory tract infection 103.54 9.83 81 152378 95120 50357545
Syncope 100.31 9.83 591 151868 102411 50350254
Hepatic failure 99.99 9.83 267 152192 32016 50420649
Gastrointestinal haemorrhage 97.04 9.83 458 152001 72863 50379802
Folliculitis 94.33 9.83 6 152453 39219 50413446
Product use issue 94.02 9.83 193 152266 149282 50303383
Swelling 92.86 9.83 303 152156 200569 50252096
N-terminal prohormone brain natriuretic peptide increased 92.46 9.83 60 152399 1650 50451015
Cardioactive drug level increased 89.02 9.83 62 152397 1922 50450743
Cardiac failure acute 87.58 9.83 116 152343 8134 50444531
Blood bilirubin increased 87.40 9.83 253 152206 31785 50420880
Product prescribing error 86.94 9.83 194 152265 20767 50431898
Transfusion 84.78 9.83 145 152314 12760 50439905
Toxicity to various agents 84.07 9.83 342 152117 212157 50240508
General physical health deterioration 83.06 9.83 722 151737 141712 50310953
Impaired healing 80.24 9.83 56 152403 69730 50382935
Brain natriuretic peptide increased 78.75 9.83 82 152377 4445 50448220
Stomatitis 77.18 9.83 116 152343 101228 50351437
Orthopnoea 76.42 9.83 90 152369 5599 50447066
Hepatocellular carcinoma 74.90 9.83 56 152403 1943 50450722
Atrioventricular block 74.88 9.83 95 152364 6383 50446282
Sensitisation 74.66 9.83 51 152408 1531 50451134
Febrile neutropenia 74.17 9.83 112 152347 97555 50355110
Blood pressure decreased 73.79 9.83 349 152110 55560 50397105
Hypokalaemia 73.22 9.83 485 151974 87507 50365158
Sinusitis 72.25 9.83 267 152192 170291 50282374
Pulmonary oedema 70.16 9.83 313 152146 48625 50404040
Pain in jaw 69.47 9.83 264 152195 38164 50414501
Irritable bowel syndrome 69.45 9.83 34 152425 51407 50401258
Atrial flutter 69.16 9.83 107 152352 8656 50444009
Glomerular filtration rate decreased 68.88 9.83 125 152334 11527 50441138
Hepatic function abnormal 67.96 9.83 235 152224 32446 50420219
Congestive cardiomyopathy 67.10 9.83 83 152376 5435 50447230
Ill-defined disorder 65.33 9.83 42 152417 54612 50398053
Chronic kidney disease 65.23 9.83 265 152194 39506 50413159
Product monitoring error 64.86 9.83 59 152400 2705 50449960
Ejection fraction 64.63 9.83 42 152417 1158 50451507
Polycystic ovaries 64.20 9.83 56 152403 2428 50450237
Ventricular tachycardia 64.02 9.83 145 152314 15676 50436989
Injection site pain 63.50 9.83 151 152308 110873 50341792
Infection 63.08 9.83 287 152172 172667 50279998
Pulmonary arterial pressure increased 62.51 9.83 63 152396 3285 50449380
Pleural effusion 62.44 9.83 440 152019 81014 50371651
Sleep disorder due to general medical condition, insomnia type 62.28 9.83 10 152449 31437 50421228
Abdominal distension 61.35 9.83 403 152056 72500 50380165
Renal disorder 60.91 9.83 202 152257 27303 50425362
Nasopharyngitis 60.74 9.83 337 152122 192590 50260075
Cardiomegaly 59.97 9.83 142 152317 15803 50436862
Injection site erythema 59.78 9.83 83 152376 74853 50377812
Catheter management 59.50 9.83 56 152403 2683 50449982
Left ventricular failure 59.16 9.83 73 152386 4768 50447897
Injection site reaction 59.05 9.83 39 152420 49993 50402672
Abortion spontaneous 58.88 9.83 26 152433 41746 50410919
Intentional overdose 58.60 9.83 61 152398 62443 50390222
Arthritis 57.94 9.83 108 152351 86613 50366052
Atrioventricular block complete 57.84 9.83 89 152370 7166 50445499
Urticaria 56.05 9.83 201 152258 129360 50323305
Concomitant disease aggravated 55.92 9.83 93 152366 7998 50444667
Fall 55.38 9.83 1360 151099 333572 50119093
Arrhythmia 55.32 9.83 222 152237 32910 50419755
Catheter site infection 54.60 9.83 66 152393 4220 50448445
Electrolyte imbalance 54.17 9.83 143 152316 17026 50435639
Paracentesis 54.15 9.83 34 152425 882 50451783
Generalised oedema 52.42 9.83 123 152336 13608 50439057
Haematemesis 52.21 9.83 193 152266 27532 50425133
Anaphylactic reaction 51.53 9.83 52 152407 54003 50398662
Mobility decreased 51.28 9.83 102 152357 79846 50372819
Fatigue 51.15 9.83 1685 150774 705916 49746749
Gastrointestinal disorder 50.48 9.83 133 152326 94323 50358342
Epistaxis 48.73 9.83 345 152114 63609 50389056
Prothrombin time prolonged 48.71 9.83 92 152367 8746 50443919
Oxygen saturation decreased 48.38 9.83 382 152077 72866 50379799
Cardiogenic shock 48.28 9.83 129 152330 15470 50437195
Oesophageal varices haemorrhage 48.12 9.83 33 152426 997 50451668
Paraesthesia 47.83 9.83 193 152266 120050 50332615
Cor pulmonale 47.68 9.83 42 152417 1845 50450820
Congestive hepatopathy 46.69 9.83 47 152412 2447 50450218
Device related infection 46.55 9.83 153 152306 20582 50432083
Blood sodium decreased 46.55 9.83 155 152304 20992 50431673
Tricuspid valve incompetence 46.17 9.83 112 152347 12658 50440007
Hip arthroplasty 46.05 9.83 17 152442 30412 50422253
Pericardial effusion 44.77 9.83 174 152285 25415 50427250
Respiratory failure 44.46 9.83 445 152014 90736 50361929
Cardiac disorder 44.01 9.83 250 152209 42729 50409936
Sinoatrial block 43.90 9.83 28 152431 747 50451918
Intentional product use issue 43.67 9.83 105 152354 76813 50375852
Blister 43.60 9.83 123 152336 85295 50367370
Knee arthroplasty 43.59 9.83 27 152432 35819 50416846
Palpitations 43.59 9.83 456 152003 94050 50358615
Psoriatic arthropathy 42.86 9.83 47 152412 46985 50405680
Body tinea 42.78 9.83 34 152425 1293 50451372
Hypoxia 42.64 9.83 282 152177 50841 50401824
Varices oesophageal 42.32 9.83 47 152412 2742 50449923
Hypertrichosis 41.72 9.83 30 152429 979 50451686
Therapeutic product effect incomplete 41.57 9.83 139 152320 91376 50361289
Neutropenia 41.51 9.83 268 152191 147697 50304968
Haematoma 41.38 9.83 192 152267 30318 50422347
Shock haemorrhagic 41.29 9.83 83 152376 8261 50444404
Inhibitory drug interaction 39.83 9.83 41 152418 2192 50450473
Labelled drug-drug interaction medication error 39.07 9.83 93 152366 10384 50442281
Hypovolaemic shock 39.07 9.83 62 152397 5126 50447539
Electrocardiogram QRS complex prolonged 39.06 9.83 63 152396 5281 50447384
Sputum culture positive 38.82 9.83 33 152426 1381 50451284
Aspartate aminotransferase increased 38.67 9.83 382 152077 77616 50375049
Osteoarthritis 38.67 9.83 94 152365 68512 50384153
Vital capacity decreased 38.56 9.83 28 152431 928 50451737
Blood cholesterol increased 38.45 9.83 67 152392 55148 50397517
Upper gastrointestinal haemorrhage 38.43 9.83 121 152338 15914 50436751
Injection site pruritus 38.37 9.83 39 152420 40372 50412293
Blood alkaline phosphatase increased 38.23 9.83 218 152241 37308 50415357
Ammonia increased 38.07 9.83 55 152404 4186 50448479
Metabolic alkalosis 38.01 9.83 44 152415 2687 50449978
Foetal exposure during pregnancy 37.05 9.83 18 152441 27341 50425324
Cardiomyopathy 36.79 9.83 117 152342 15469 50437196
Portal hypertension 36.48 9.83 48 152411 3344 50449321
Blood aldosterone increased 36.26 9.83 15 152444 154 50452511
Subdural haematoma 36.03 9.83 103 152356 12844 50439821
Multiple sclerosis relapse 35.87 9.83 46 152413 42918 50409747
Therapeutic response decreased 35.04 9.83 55 152404 47176 50405489
Product use in unapproved indication 34.97 9.83 205 152254 115614 50337051
Reversible airways obstruction 34.75 9.83 27 152432 993 50451672
Red blood cell sedimentation rate increased 34.61 9.83 23 152436 29393 50423272
Ejection fraction abnormal 34.61 9.83 25 152434 822 50451843
Orthostatic hypotension 34.59 9.83 178 152281 29303 50423362
Ventricular fibrillation 34.39 9.83 89 152370 10470 50442195
Injection site bruising 34.33 9.83 36 152423 36732 50415933
Sleep disorder 34.28 9.83 76 152383 57207 50395458
Atrial tachycardia 34.21 9.83 37 152422 2095 50450570
Catheter placement 34.02 9.83 36 152423 1988 50450677
Chest pain 33.72 9.83 733 151726 176149 50276516
Pregnancy 33.64 9.83 24 152435 29553 50423112
Lung transplant 33.56 9.83 42 152417 2783 50449882
Hepatorenal syndrome 32.91 9.83 33 152426 1710 50450955
Gamma-glutamyltransferase increased 32.79 9.83 176 152283 29447 50423218
Ischaemic stroke 32.56 9.83 114 152345 15834 50436831
Haemoptysis 32.54 9.83 158 152301 25415 50427250
Bundle branch block left 32.06 9.83 63 152396 6167 50446498
Multiple organ dysfunction syndrome 31.86 9.83 260 152199 50077 50402588
Anuria 31.83 9.83 90 152369 11154 50441511
Neuropathy peripheral 31.53 9.83 167 152292 96590 50356075
Pulmonary congestion 31.14 9.83 109 152350 15138 50437527
Live birth 30.79 9.83 6 152453 16402 50436263
Oliguria 30.71 9.83 73 152386 8143 50444522
Rhinitis allergic 30.26 9.83 67 152392 7133 50445532
Hypertrophic cardiomyopathy 30.18 9.83 28 152431 1317 50451348
Hypovolaemia 30.03 9.83 79 152380 9386 50443279
Cardioversion 29.97 9.83 26 152433 1119 50451546
Acute respiratory failure 29.84 9.83 168 152291 28614 50424051
Adverse drug reaction 29.31 9.83 78 152381 55144 50397521
Therapeutic drug monitoring analysis not performed 29.24 9.83 21 152438 684 50451981
Cardiac output decreased 28.89 9.83 23 152436 877 50451788
Hepatic cancer 28.71 9.83 42 152417 3233 50449432
N-terminal prohormone brain natriuretic peptide abnormal 28.70 9.83 9 152450 37 50452628
Waist circumference increased 28.69 9.83 21 152438 705 50451960
Catheterisation cardiac 28.68 9.83 47 152412 3993 50448672
Concomitant disease progression 28.55 9.83 33 152426 2012 50450653
Ejection fraction decreased 28.48 9.83 121 152338 18399 50434266
Jugular vein distension 28.20 9.83 22 152437 814 50451851
Sinus node dysfunction 28.06 9.83 46 152413 3909 50448756
Jaundice 27.89 9.83 155 152304 26274 50426391
Diffuse large B-cell lymphoma refractory 27.88 9.83 24 152435 1022 50451643
Purpura 27.73 9.83 79 152380 9832 50442833
Bundle branch block right 27.67 9.83 50 152409 4595 50448070
Hypochloraemia 27.16 9.83 29 152430 1618 50451047
Vascular resistance pulmonary decreased 27.14 9.83 10 152449 73 50452592
Renin increased 27.13 9.83 12 152447 147 50452518
Hypoaesthesia 26.98 9.83 249 152210 127008 50325657
Sight disability 26.76 9.83 11 152448 111 50452554
Thermohypoaesthesia 26.67 9.83 11 152448 112 50452553
Dyspnoea paroxysmal nocturnal 26.62 9.83 21 152438 790 50451875
Sleep apnoea syndrome 26.55 9.83 142 152317 23726 50428939
Urine output decreased 26.23 9.83 80 152379 10341 50442324
Nephrectomy 26.08 9.83 21 152438 814 50451851
Shock 25.86 9.83 127 152332 20523 50432142
Dizziness 25.78 9.83 1283 151176 345086 50107579
Joint stiffness 25.77 9.83 32 152427 30276 50422389
Cardiorenal syndrome 25.76 9.83 18 152441 561 50452104
Left-to-right cardiac shunt 25.68 9.83 11 152448 124 50452541
Bronchial secretion retention 25.59 9.83 27 152432 1486 50451179
Sudden death 25.48 9.83 72 152387 8919 50443746
Infection susceptibility increased 25.40 9.83 35 152424 2549 50450116
Catheter site erythema 25.34 9.83 44 152415 3918 50448747
Joint range of motion decreased 25.34 9.83 12 152447 18500 50434165
Muscle spasticity 25.33 9.83 10 152449 17174 50435491
Device stimulation issue 25.25 9.83 9 152450 59 50452606
Drug resistance 24.95 9.83 13 152446 18976 50433689
Pemphigoid 24.86 9.83 55 152404 5852 50446813
Lactic acidosis 24.85 9.83 179 152280 33176 50419489
Cyanosis 24.75 9.83 101 152358 15083 50437582
Atrial enlargement 24.59 9.83 14 152445 302 50452363
Haemoglobin decreased 24.49 9.83 528 151931 126688 50325977
Abdominal cavity drainage 24.45 9.83 15 152444 373 50452292
Acute pulmonary oedema 24.44 9.83 62 152397 7205 50445460
Female sexual arousal disorder 24.23 9.83 6 152453 7 50452658
Hypothyroidism 24.21 9.83 181 152278 33944 50418721
Renal function test abnormal 24.20 9.83 36 152423 2813 50449852
Catheter site discharge 24.18 9.83 29 152430 1839 50450826
Hyperthyroidism 23.97 9.83 86 152373 12089 50440576
Bursitis 23.84 9.83 19 152440 22116 50430549
Calcium deficiency 23.72 9.83 21 152438 929 50451736
Fear of eating 23.64 9.83 14 152445 326 50452339
Exercise tolerance decreased 23.54 9.83 48 152411 4826 50447839
Accidental exposure to product 23.35 9.83 21 152438 23036 50429629
Viral diarrhoea 23.17 9.83 10 152449 115 50452550
Back pain 23.13 9.83 496 151963 219534 50233131
Cortisol increased 22.90 9.83 14 152445 346 50452319
Iron deficiency anaemia 22.87 9.83 106 152353 16728 50435937
Haemorrhage subcutaneous 22.76 9.83 34 152425 2667 50449998
Hyperbilirubinaemia 22.73 9.83 72 152387 9498 50443167
Mucosal inflammation 22.62 9.83 55 152404 40087 50412578
Sinus bradycardia 22.54 9.83 89 152370 13094 50439571
Multimorbidity 22.50 9.83 16 152443 513 50452152
Blood potassium decreased 22.40 9.83 189 152270 36756 50415909
Platelet count decreased 22.35 9.83 427 152032 100299 50352366
Seizure 22.32 9.83 237 152222 117637 50335028
Bradyarrhythmia 22.29 9.83 28 152431 1862 50450803
Intentional self-injury 22.29 9.83 22 152437 23090 50429575
Mitral valve incompetence 22.27 9.83 108 152351 17363 50435302
Oxygen consumption increased 22.27 9.83 39 152420 3497 50449168
Brain stem stroke 22.16 9.83 12 152447 234 50452431
Pulmonary arterial pressure abnormal 22.14 9.83 15 152444 444 50452221
Intra-abdominal fluid collection 22.03 9.83 29 152430 2021 50450644
Premature labour 21.95 9.83 4 152455 11472 50441193
Suicidal ideation 21.94 9.83 89 152370 55296 50397369
Inappropriate antidiuretic hormone secretion 21.88 9.83 88 152371 13055 50439610
Inability to afford medication 21.88 9.83 25 152434 1505 50451160
Anxiety 21.80 9.83 390 152069 177216 50275449
Neonatal respiratory failure 21.76 9.83 11 152448 185 50452480
Right ventricular dilatation 21.64 9.83 20 152439 936 50451729
Decreased appetite 21.43 9.83 773 151686 200150 50252515
Injection site swelling 21.42 9.83 60 152399 41713 50410952
Haemorrhagic disorder 21.26 9.83 18 152441 749 50451916
Vascular access site infection 21.22 9.83 7 152452 35 50452630
Cytomegalovirus infection 21.19 9.83 14 152445 17948 50434717
Cardiac murmur 21.08 9.83 76 152383 10708 50441957
Vascular access site thrombosis 21.06 9.83 7 152452 36 50452629
Bilirubin conjugated increased 21.04 9.83 31 152428 2401 50450264
Bile acid malabsorption 20.81 9.83 10 152449 150 50452515
Blood test abnormal 20.64 9.83 78 152381 11241 50441424
Portopulmonary hypertension 20.59 9.83 9 152450 107 50452558
Suicide attempt 20.58 9.83 83 152376 51649 50401016
Cirrhosis alcoholic 20.47 9.83 11 152448 211 50452454
Bone erosion 20.45 9.83 5 152454 11682 50440983
Catheter removal 20.37 9.83 13 152446 347 50452318
Vessel puncture site haemorrhage 20.37 9.83 9 152450 110 50452555
Portal vein thrombosis 20.31 9.83 29 152430 2183 50450482
Liver disorder 20.27 9.83 186 152273 37036 50415629
Dyspnoea at rest 20.14 9.83 38 152421 3609 50449056
Pulmonary arterial wedge pressure increased 19.94 9.83 12 152447 288 50452377
Transplant evaluation 19.89 9.83 20 152439 1040 50451625
Intentional product misuse 19.86 9.83 73 152386 46661 50406004
Vascular device infection 19.80 9.83 42 152417 4342 50448323
Stress 19.74 9.83 89 152370 53704 50398961
Right ventricular dysfunction 19.74 9.83 24 152435 1544 50451121
Night sweats 19.71 9.83 45 152414 33529 50419136
Sedation 19.67 9.83 39 152420 30571 50422094
Liver transplant 19.65 9.83 28 152431 2104 50450561
Psychotic disorder 19.65 9.83 22 152437 21790 50430875
Systemic infection 19.61 9.83 29 152430 2254 50450411
Tenosynovitis 19.54 9.83 4 152455 10561 50442104
Metastases to central nervous system 19.41 9.83 5 152454 11277 50441388
Hepatomegaly 19.37 9.83 74 152385 10719 50441946
Ischaemic cardiomyopathy 19.33 9.83 29 152430 2283 50450382
Catheter site pain 19.31 9.83 38 152421 3724 50448941
Peripartum cardiomyopathy 19.22 9.83 9 152450 127 50452538
Chronic hepatic failure 19.20 9.83 14 152445 467 50452198
Dystonia 19.19 9.83 6 152453 11920 50440745
Polyuria 19.19 9.83 56 152403 7065 50445600
Cardiac hypertrophy 19.18 9.83 19 152440 970 50451695
Peritonitis bacterial 19.17 9.83 43 152416 4618 50448047
Blood loss anaemia 19.12 9.83 61 152398 8078 50444587
Occult blood positive 19.06 9.83 35 152424 3256 50449409
Red cell distribution width abnormal 18.97 9.83 9 152450 131 50452534
Device alarm issue 18.71 9.83 22 152437 1366 50451299
Multiple drug therapy 18.68 9.83 26 152433 1911 50450754
Multiple allergies 18.59 9.83 62 152397 8401 50444264
Asthenia 18.47 9.83 1155 151304 317887 50134778
Poor peripheral circulation 18.43 9.83 34 152425 3174 50449491
Product quality issue 18.41 9.83 41 152418 30817 50421848
Brain natriuretic peptide abnormal 18.40 9.83 12 152447 333 50452332
Diet noncompliance 18.31 9.83 11 152448 263 50452402
Immunodeficiency 18.26 9.83 11 152448 14817 50437848
Oesophageal variceal ligation 18.26 9.83 5 152454 11 50452654
Right atrial dilatation 18.22 9.83 15 152444 600 50452065
Cardiac dysfunction 18.18 9.83 24 152435 1677 50450988
Progressive multifocal leukoencephalopathy 18.02 9.83 6 152453 11451 50441214
Marasmus 18.01 9.83 13 152446 427 50452238
Grip strength decreased 17.96 9.83 7 152452 12114 50440551
Hyperuricaemia 17.95 9.83 42 152417 4638 50448027
Oropharyngeal pain 17.91 9.83 149 152310 77652 50375013
Nodal rhythm 17.91 9.83 23 152436 1564 50451101
Electrocardiogram abnormal 17.87 9.83 57 152402 7548 50445117
Walking distance test abnormal 17.81 9.83 14 152445 524 50452141
Foot deformity 17.72 9.83 19 152440 19191 50433474
Haemorrhoidal haemorrhage 17.58 9.83 36 152423 3631 50449034
Hospitalisation 17.54 9.83 295 152164 67642 50385023
Condition aggravated 17.30 9.83 1076 151383 295982 50156683
Incision site impaired healing 17.26 9.83 9 152450 162 50452503
Left ventricular dysfunction 17.22 9.83 70 152389 10436 50442229
Type 2 diabetes mellitus 17.16 9.83 50 152409 34325 50418340
Central venous catheterisation 16.80 9.83 26 152433 2104 50450561
Alanine aminotransferase increased 16.76 9.83 366 152093 87993 50364672
Sinus arrest 16.69 9.83 23 152436 1675 50450990
Urine output increased 16.61 9.83 19 152440 1145 50451520
Glucose tolerance impaired 16.52 9.83 43 152416 5075 50447590
Blood catecholamines decreased 16.47 9.83 4 152455 4 50452661
Rhabdomyolysis 16.45 9.83 185 152274 38842 50413823
Nasal congestion 16.27 9.83 230 152229 50890 50401775
Hypertension 16.07 9.83 499 151960 210704 50241961
Leukaemic infiltration renal 16.05 9.83 5 152454 20 50452645
Catheter site swelling 16.00 9.83 20 152439 1324 50451341
Premature baby 15.97 9.83 19 152440 18318 50434347
Prerenal failure 15.86 9.83 21 152438 1472 50451193
Pulmonary veno-occlusive disease 15.79 9.83 17 152442 958 50451707
Amaurosis 15.65 9.83 13 152446 527 50452138
Joint effusion 15.56 9.83 10 152449 13011 50439654
Splenomegaly 15.54 9.83 64 152395 9596 50443069
Vasodilatation 15.49 9.83 26 152433 2253 50450412
Ulcer 15.48 9.83 23 152436 20177 50432488
Akathisia 15.46 9.83 3 152456 8226 50444439
Nodal arrhythmia 15.46 9.83 18 152441 1106 50451559
Pneumonia 15.45 9.83 1332 151127 377069 50075596
Gout 15.42 9.83 72 152387 11398 50441267
Aspiration pleural cavity 15.40 9.83 15 152444 750 50451915
Gamma-glutamyltransferase abnormal 15.37 9.83 9 152450 205 50452460
Primary biliary cholangitis 15.36 9.83 18 152441 1114 50451551
Blood uric acid increased 15.35 9.83 35 152424 3799 50448866
Ventricular failure 15.35 9.83 11 152448 357 50452308
Renin decreased 15.25 9.83 7 152452 94 50452571
Migraine 15.22 9.83 149 152310 75131 50377534
Musculoskeletal disorder 15.08 9.83 18 152441 17331 50435334
Peripheral swelling 15.08 9.83 489 151970 205447 50247218
Activated partial thromboplastin time prolonged 15.05 9.83 48 152411 6354 50446311
Malignant neoplasm progression 15.00 9.83 132 152327 67992 50384673
Torsade de pointes 14.97 9.83 73 152386 11762 50440903
Mixed hepatocellular cholangiocarcinoma 14.86 9.83 4 152455 8 50452657
Drug monitoring procedure not performed 14.86 9.83 12 152447 467 50452198
Sedation complication 14.86 9.83 4 152455 8762 50443903
Altered state of consciousness 14.86 9.83 115 152344 21795 50430870
Left ventricular enlargement 14.82 9.83 6 152453 58 50452607
Therapeutic embolisation 14.63 9.83 8 152451 159 50452506
Asterixis 14.62 9.83 18 152441 1173 50451492
Electrocardiogram T wave amplitude increased 14.40 9.83 5 152454 30 50452635
Hepatorenal failure 14.40 9.83 13 152446 590 50452075
Blood pressure systolic decreased 14.39 9.83 44 152415 5695 50446970
Coagulopathy 14.36 9.83 98 152361 17846 50434819
Osteonecrosis of jaw 14.36 9.83 50 152409 32476 50420189
Herpes zoster 14.36 9.83 140 152319 70646 50382019
Inferior vena cava dilatation 14.30 9.83 6 152453 64 50452601
Metastases to bone 14.27 9.83 20 152439 17975 50434690
Blood albumin decreased 14.21 9.83 78 152381 13158 50439507
Multiple sclerosis 14.14 9.83 25 152434 20468 50432197
Chronic respiratory failure 14.12 9.83 21 152438 1641 50451024
Pain in extremity 14.09 9.83 675 151784 272190 50180475
Hypercapnia 14.05 9.83 38 152421 4589 50448076
Malignant ascites 14.03 9.83 15 152444 838 50451827
Inflammation 14.02 9.83 107 152352 56805 50395860
Gouty arthritis 14.00 9.83 12 152447 508 50452157
Disseminated intravascular coagulation 13.97 9.83 94 152365 17041 50435624
Injection site mass 13.92 9.83 16 152443 15664 50437001
No adverse event 13.91 9.83 53 152406 33525 50419140
Alcoholic liver disease 13.89 9.83 7 152452 117 50452548
Depression 13.79 9.83 386 152073 165037 50287628
Brain natriuretic peptide 13.75 9.83 5 152454 35 50452630
Pulmonary aplasia 13.72 9.83 4 152455 12 50452653
Blood creatine increased 13.72 9.83 39 152420 4848 50447817
Premature delivery 13.66 9.83 32 152427 23631 50429034
Cortisol free urine increased 13.63 9.83 5 152454 36 50452629
Electrocardiogram QT shortened 13.63 9.83 7 152452 122 50452543
Subchorionic haematoma 13.63 9.83 7 152452 122 50452543
Hypernatraemia 13.61 9.83 46 152413 6275 50446390
Glomerular filtration rate abnormal 13.59 9.83 12 152447 529 50452136
Haptoglobin decreased 13.48 9.83 13 152446 642 50452023
Left atrial dilatation 13.46 9.83 21 152438 1711 50450954
Photophobia 13.42 9.83 15 152444 14872 50437793
Chronic obstructive pulmonary disease 13.42 9.83 231 152228 53204 50399461
Blood potassium abnormal 13.42 9.83 24 152435 2188 50450477
Pericarditis constrictive 13.40 9.83 10 152449 346 50452319
Blood cholesterol decreased 13.40 9.83 14 152445 762 50451903
Colitis 13.39 9.83 65 152394 38464 50414201
Poor quality sleep 13.38 9.83 91 152368 16555 50436110
Foetal death 13.37 9.83 4 152455 8176 50444489
Vascular stenosis 13.36 9.83 9 152450 264 50452401
Cardiac failure high output 13.36 9.83 9 152450 264 50452401
Generalised tonic-clonic seizure 13.33 9.83 38 152421 26272 50426393
Upper respiratory tract inflammation 13.33 9.83 25 152434 2364 50450301
Metabolic acidosis 13.30 9.83 177 152282 38648 50414017
Erysipelas 13.29 9.83 47 152412 6561 50446104
Azotaemia 13.27 9.83 34 152425 3974 50448691
Schizophrenia 13.27 9.83 3 152456 7394 50445271
Postpericardiotomy syndrome 13.26 9.83 4 152455 14 50452651
Dementia 13.18 9.83 88 152371 15909 50436756
Tachypnoea 13.13 9.83 82 152377 14495 50438170
Mucocutaneous haemorrhage 13.11 9.83 6 152453 80 50452585
Blood culture negative 13.09 9.83 7 152452 133 50452532
Embolic stroke 13.07 9.83 31 152428 3453 50449212
Ventricular arrhythmia 13.02 9.83 30 152429 3279 50449386
Ballismus 12.98 9.83 6 152453 82 50452583
Pyrexia 12.98 9.83 978 151481 379225 50073440
Blood urea abnormal 12.96 9.83 12 152447 563 50452102
Device expulsion 12.93 9.83 44 152415 28778 50423887
Hyperglycaemia 12.90 9.83 167 152292 36238 50416427
White blood cell count decreased 12.87 9.83 261 152198 116461 50336204
Urine potassium increased 12.84 9.83 4 152455 16 50452649
Tendonitis 12.82 9.83 19 152440 16686 50435979
Haemodynamic instability 12.78 9.83 53 152406 7971 50444694
Hidradenitis 12.72 9.83 22 152437 1953 50450712
Visual acuity reduced transiently 12.68 9.83 7 152452 142 50452523
Incorrect route of product administration 12.68 9.83 23 152436 18643 50434022
Device difficult to use 12.65 9.83 7 152452 9879 50442786
Catheter site pruritus 12.62 9.83 22 152437 1965 50450700
Cardiac flutter 12.54 9.83 30 152429 3360 50449305
Bone marrow failure 12.51 9.83 42 152417 27582 50425083
Upper-airway cough syndrome 12.48 9.83 55 152404 8495 50444170
Injection site warmth 12.47 9.83 14 152445 13852 50438813
Drug therapeutic incompatibility 12.47 9.83 5 152454 47 50452618
Posterior reversible encephalopathy syndrome 12.44 9.83 16 152443 14912 50437753
Macular degeneration 12.43 9.83 15 152444 14373 50438292
Atrial septal defect repair 12.42 9.83 8 152451 217 50452448
Basal cell carcinoma 12.38 9.83 33 152426 23323 50429342
Cerebral infarction 12.30 9.83 109 152350 21495 50431170
Pruritus 12.28 9.83 714 151745 282854 50169811
Coma hepatic 12.26 9.83 12 152447 604 50452061
Injection site haemorrhage 12.22 9.83 29 152430 21317 50431348
Blood bilirubin abnormal 12.21 9.83 13 152446 723 50451942
Throat tightness 12.19 9.83 28 152431 20819 50431846
Right ventricular systolic pressure increased 12.15 9.83 11 152448 501 50452164
Blood bilirubin unconjugated increased 12.14 9.83 9 152450 308 50452357
Ear pain 12.13 9.83 44 152415 28239 50424426
Cardiac pacemaker insertion 12.11 9.83 31 152428 3622 50449043
Cellulitis 12.10 9.83 289 152170 70509 50382156
Bleeding varicose vein 12.05 9.83 8 152451 229 50452436
Neonatal hyponatraemia 11.94 9.83 5 152454 53 50452612
Cardiac ablation 11.93 9.83 17 152442 1277 50451388
Aortic valve incompetence 11.93 9.83 40 152419 5436 50447229
Platelet dysfunction 11.92 9.83 6 152453 100 50452565
Extensor plantar response 11.90 9.83 16 152443 1138 50451527
Blood antidiuretic hormone increased 11.89 9.83 3 152456 4 50452661
Glaucoma 11.89 9.83 18 152441 15668 50436997
Psoriasis 11.77 9.83 142 152317 68858 50383807
Presyncope 11.73 9.83 118 152341 24080 50428585
Gastric varices haemorrhage 11.71 9.83 6 152453 104 50452561
Catastrophic reaction 11.66 9.83 4 152455 23 50452642
Erythema 11.60 9.83 344 152115 146070 50306595
Hypertonic bladder 11.59 9.83 27 152432 2973 50449692
Dependence on oxygen therapy 11.54 9.83 9 152450 333 50452332
Renal injury 11.53 9.83 54 152405 8557 50444108
Supraventricular tachycardia 11.52 9.83 72 152387 12729 50439936
Venous pressure jugular increased 11.50 9.83 11 152448 538 50452127
Toxic epidermal necrolysis 11.48 9.83 105 152354 20887 50431778
Gait inability 11.45 9.83 65 152394 36962 50415703
Drug withdrawal syndrome 11.45 9.83 38 152421 25043 50427622
Hypophosphataemia 11.44 9.83 53 152406 8361 50444304
International normalised ratio abnormal 11.44 9.83 26 152433 2817 50449848
Human metapneumovirus test positive 11.40 9.83 5 152454 60 50452605
Chronic right ventricular failure 11.38 9.83 4 152455 25 50452640
Ventricular assist device insertion 11.38 9.83 4 152455 25 50452640
Gastrointestinal arteriovenous malformation 11.38 9.83 11 152448 545 50452120
Gastrointestinal angiectasia 11.32 9.83 5 152454 61 50452604
Diarrhoea infectious 11.30 9.83 14 152445 918 50451747
Scleroderma 11.29 9.83 36 152423 4765 50447900
Cardiac arrest 11.28 9.83 331 152128 83320 50369345
Renal artery stenosis 11.26 9.83 19 152440 1653 50451012
Palliative care 11.22 9.83 9 152450 347 50452318
Blood calcium decreased 11.17 9.83 29 152430 20677 50431988
Fibrinous bronchitis 11.15 9.83 3 152456 6 50452659
Thyroxine increased 11.11 9.83 11 152448 561 50452104
Deformity 11.10 9.83 5 152454 7935 50444730
Liver injury 11.04 9.83 38 152421 24768 50427897
Localised oedema 11 9.83 36 152423 4831 50447834
Duodenal ulcer 10.99 9.83 45 152414 6730 50445935
Neuromyelitis optica spectrum disorder 10.98 9.83 13 152446 813 50451852
Right-to-left cardiac shunt 10.97 9.83 7 152452 187 50452478
CREST syndrome 10.93 9.83 10 152449 462 50452203
Injection site rash 10.93 9.83 20 152439 16157 50436508
Circulatory collapse 10.92 9.83 100 152359 19900 50432765
Loss of personal independence in daily activities 10.90 9.83 147 152312 69903 50382762
Haemodialysis 10.88 9.83 52 152407 8310 50444355
Low cardiac output syndrome 10.87 9.83 8 152451 271 50452394
Respiratory distress 10.86 9.83 140 152319 30349 50422316
Endocarditis 10.85 9.83 37 152422 5070 50447595
Nephrocalcinosis 10.81 9.83 14 152445 960 50451705
Hepatitis C 10.78 9.83 36 152423 4881 50447784
QRS axis abnormal 10.77 9.83 14 152445 964 50451701
Gastritis erosive 10.74 9.83 37 152422 5097 50447568
Malaise 10.71 9.83 1161 151298 334371 50118294
Atrioventricular block first degree 10.71 9.83 42 152417 6159 50446506
Toxic neuropathy 10.66 9.83 9 152450 373 50452292
Vertebrobasilar insufficiency 10.65 9.83 5 152454 71 50452594
Lower gastrointestinal haemorrhage 10.62 9.83 45 152414 6834 50445831
Product availability issue 10.61 9.83 21 152438 2067 50450598
Electrocardiogram T wave peaked 10.58 9.83 7 152452 199 50452466
Systemic scleroderma 10.57 9.83 13 152446 846 50451819
Blood pressure systolic abnormal 10.54 9.83 5 152454 7701 50444964
Walking disability 10.47 9.83 16 152443 1280 50451385
Listeraemia 10.46 9.83 5 152454 74 50452591
Encephalopathy 10.46 9.83 151 152308 33560 50419105
Bone density decreased 10.41 9.83 63 152396 11012 50441653
Cardiac cirrhosis 10.39 9.83 6 152453 133 50452532
Colitis ulcerative 10.38 9.83 22 152437 16832 50435833
Hyperglycaemic hyperosmolar nonketotic syndrome 10.37 9.83 11 152448 609 50452056
Conduction disorder 10.36 9.83 16 152443 1292 50451373
Ectopic ACTH syndrome 10.35 9.83 6 152453 134 50452531
Injury 10.24 9.83 96 152363 48829 50403836
Catheter site rash 10.23 9.83 12 152447 743 50451922
Ventricular dyssynchrony 10.23 9.83 4 152455 35 50452630
Diabetic metabolic decompensation 10.21 9.83 17 152442 1463 50451202
Dilatation ventricular 10.18 9.83 22 152437 2303 50450362
Hypoglycaemia 10.18 9.83 222 152237 53359 50399306
Aortic valve calcification 10.17 9.83 9 152450 398 50452267
C-reactive protein increased 10.16 9.83 140 152319 66334 50386331
Stress fracture 10.14 9.83 4 152455 6871 50445794
Hepatitis fulminant 10.13 9.83 26 152433 3042 50449623
Dizziness postural 10.11 9.83 41 152418 6104 50446561
Parkinsonism 10.09 9.83 53 152406 8794 50443871
Food allergy 10.07 9.83 6 152453 8131 50444534
Balloon atrial septostomy 10.06 9.83 5 152454 81 50452584
Breast discomfort 10.05 9.83 9 152450 404 50452261
Strabismus 10.02 9.83 19 152440 1811 50450854
Device related sepsis 10.02 9.83 28 152431 3447 50449218
Caesarean section 9.98 9.83 20 152439 15619 50437046
Labelled drug-disease interaction medication error 9.97 9.83 6 152453 144 50452521
Respiratory depression 9.88 9.83 13 152446 11997 50440668
Haematocrit abnormal 9.87 9.83 12 152447 772 50451893
Electrocardiogram QT prolonged 9.86 9.83 215 152244 51671 50400994
Pharyngitis 9.84 9.83 24 152435 17479 50435186
Acute myocardial infarction 9.84 9.83 133 152326 29140 50423525

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
Hyperkalaemia 2123.44 10.49 1813 112385 59579 29400750
Acute kidney injury 768.30 10.49 2504 111694 262763 29197566
Hepatic encephalopathy 600.00 10.49 456 113742 12579 29447750
Cardiac failure 595.34 10.49 1084 113114 78203 29382126
Ascites 416.80 10.49 605 113593 36014 29424315
Hyponatraemia 278.39 10.49 726 113472 66907 29393422
Drug ineffective 276.55 10.49 623 113575 362547 29097782
Cardiac failure chronic 262.29 10.49 210 113988 6257 29454072
Hepatic cirrhosis 254.07 10.49 296 113902 14148 29446181
Cardiac failure congestive 242.78 10.49 748 113450 75833 29384496
Hypotension 230.33 10.49 1408 112790 192946 29267383
Hepatic failure 223.64 10.49 421 113777 31091 29429238
Gynaecomastia 220.64 10.49 211 113987 8006 29452323
Oedema peripheral 205.58 10.49 868 113330 102689 29357640
Drug abuse 204.29 10.49 32 114166 79851 29380478
Completed suicide 192.31 10.49 55 114143 90191 29370138
Right ventricular failure 182.88 10.49 187 114011 7703 29452626
Pulmonary hypertension 178.37 10.49 284 113914 18324 29442005
Blood potassium increased 160.66 10.49 238 113960 14413 29445916
Dyspnoea 160.61 10.49 1945 112253 324787 29135542
Dehydration 156.18 10.49 863 113335 113885 29346444
Renal impairment 153.04 10.49 671 113527 80662 29379667
Off label use 138.87 10.49 644 113554 300156 29160173
Oesophageal varices haemorrhage 127.52 10.49 96 114102 2606 29457723
Renal failure 126.95 10.49 838 113360 117761 29342568
Ejection fraction decreased 125.35 10.49 223 113975 15755 29444574
Pulmonary arterial hypertension 124.91 10.49 149 114049 7300 29453029
Febrile neutropenia 124.60 10.49 150 114048 112090 29348239
Hepatorenal syndrome 120.24 10.49 87 114111 2219 29458110
Toxicity to various agents 118.13 10.49 315 113883 173346 29286983
Hepatic cancer 118.03 10.49 135 114063 6321 29454008
Ventricular tachycardia 115.85 10.49 264 113934 22310 29438019
Blood creatinine increased 114.32 10.49 638 113560 84464 29375865
Neutropenia 114.12 10.49 209 113989 131502 29328827
International normalised ratio increased 109.01 10.49 398 113800 43974 29416355
Bradycardia 108.95 10.49 522 113676 65107 29395222
Brain natriuretic peptide increased 108.61 10.49 106 114092 4124 29456205
Congestive cardiomyopathy 106.89 10.49 130 114068 6500 29453829
Hepatocellular carcinoma 100.70 10.49 130 114068 6908 29453421
Oedema 100.18 10.49 364 113834 40119 29420210
N-terminal prohormone brain natriuretic peptide increased 98.71 10.49 72 114126 1860 29458469
General physical health deterioration 98.30 10.49 707 113491 102150 29358179
Arthralgia 98.14 10.49 249 113949 139368 29320961
Orthopnoea 96.58 10.49 103 114095 4457 29455872
Mitral valve incompetence 87.38 10.49 172 114026 13121 29447208
Intentional overdose 84.79 10.49 22 114176 38506 29421823
Blood urea increased 84.69 10.49 270 113928 27842 29432487
Drug interaction 82.18 10.49 1141 113057 196244 29264085
Foetal exposure during pregnancy 81.22 10.49 16 114182 33851 29426478
Atrioventricular block complete 75.01 10.49 121 114077 7890 29452439
Varices oesophageal 73.69 10.49 75 114123 3071 29457258
Fluid retention 71.62 10.49 227 113971 23333 29436996
Ischaemic cardiomyopathy 71.23 10.49 98 114100 5540 29454789
Therapeutic product effect incomplete 70.02 10.49 32 114166 39273 29421056
Syncope 69.59 10.49 545 113653 80826 29379503
Infusion related reaction 66.20 10.49 44 114154 43842 29416487
Rheumatoid arthritis 65.88 10.49 21 114177 32131 29428198
Orthostatic hypotension 65.13 10.49 214 113984 22415 29437914
Suicide attempt 61.97 10.49 27 114171 34083 29426246
Tricuspid valve incompetence 60.56 10.49 113 114085 8281 29452048
Cardiac failure acute 60.49 10.49 119 114079 9073 29451256
Breast tenderness 58.98 10.49 36 114162 684 29459645
Blood bilirubin increased 58.68 10.49 273 113925 33620 29426709
Ammonia increased 58.52 10.49 75 114123 3956 29456373
Urticaria 57.51 10.49 76 114122 54584 29405745
Dyspnoea exertional 57.46 10.49 286 113912 36204 29424125
Pyrexia 56.18 10.49 778 113420 286844 29173485
Blood pressure decreased 55.80 10.49 333 113865 45144 29415185
Chronic kidney disease 54.94 10.49 282 113916 36134 29424195
Atrial fibrillation 54.60 10.49 636 113562 105010 29355319
Depression 54.40 10.49 159 114039 84988 29375341
Arrhythmia 54.05 10.49 252 113946 31061 29429268
Rash 53.53 10.49 472 113726 189347 29270982
Neuropathy peripheral 52.73 10.49 123 114075 70904 29389425
Bundle branch block left 52.57 10.49 82 114116 5195 29455134
Suicidal ideation 52.09 10.49 35 114163 34681 29425648
Intentional product misuse 51.94 10.49 35 114163 34626 29425703
Concomitant disease aggravated 51.90 10.49 79 114119 4899 29455430
Nipple pain 51.78 10.49 31 114167 568 29459761
Brain natriuretic peptide abnormal 51.27 10.49 25 114173 297 29460032
Product dose omission issue 50.62 10.49 196 114002 96187 29364142
Gastrointestinal haemorrhage 49.52 10.49 497 113701 79036 29381293
Treatment failure 49.33 10.49 42 114156 36897 29423432
Pain 48.88 10.49 425 113773 171007 29289322
Cardiogenic shock 48.68 10.49 174 114024 19016 29441313
Electrocardiogram T wave peaked 48.56 10.49 28 114170 477 29459852
Melaena 48.13 10.49 243 113955 30933 29429396
Anaemia 47.59 10.49 1062 113136 199889 29260440
Leukopenia 46.49 10.49 89 114109 55114 29405215
Glomerular filtration rate decreased 46.31 10.49 121 114077 11145 29449184
Bradyarrhythmia 45.91 10.49 47 114151 1938 29458391
Product use in unapproved indication 44.77 10.49 178 114020 86697 29373632
Hypokalaemia 44.41 10.49 339 113859 49864 29410465
Anxiety 43.93 10.49 175 114023 85190 29375139
Blood cholesterol 43.76 10.49 19 114179 169 29460160
Hypervolaemia 43.58 10.49 158 114040 17387 29442942
Cytomegalovirus infection 42.77 10.49 18 114180 23197 29437132
Therapeutic drug monitoring analysis not performed 41.43 10.49 25 114173 465 29459864
Left ventricular dilatation 41.28 10.49 28 114170 642 29459687
Abdominal distension 41.16 10.49 311 113887 45600 29414729
Hypersensitivity 40.57 10.49 90 114108 52813 29407516
Chronic hepatic failure 40.31 10.49 24 114174 435 29459894
Anaphylactic reaction 39.78 10.49 29 114169 27544 29432785
Drug dependence 39.08 10.49 16 114182 20965 29439364
Portal hypertension 38.74 10.49 57 114141 3429 29456900
Congestive hepatopathy 38.58 10.49 40 114158 1674 29458655
Intentional product use issue 38.03 10.49 66 114132 42432 29417897
Ventricular fibrillation 37.99 10.49 141 114057 15692 29444637
Seizure 37.82 10.49 208 113990 92915 29367414
Intentional self-injury 36.80 10.49 3 114195 12458 29447871
Joint swelling 36.78 10.49 86 114112 49544 29410785
Polyuria 36.54 10.49 85 114113 7277 29453052
Breast pain 36.36 10.49 34 114164 1253 29459076
Injection site pain 36.33 10.49 43 114155 32403 29427926
Headache 36.31 10.49 464 113734 173543 29286786
Cardioactive drug level increased 36.18 10.49 38 114160 1615 29458714
Cardiomegaly 35.87 10.49 126 114072 13650 29446679
Therapeutic product effect decreased 35.20 10.49 37 114161 29414 29430915
Liver transplant 35.06 10.49 44 114154 2272 29458057
Sinusitis 34.87 10.49 49 114149 34301 29426028
Death 34.81 10.49 1031 113167 341053 29119276
Musculoskeletal stiffness 34.60 10.49 57 114141 37401 29422928
White blood cell count decreased 34.51 10.49 185 114013 83177 29377152
Overdose 34.24 10.49 175 114023 79644 29380685
Electrolyte imbalance 33.68 10.49 108 114090 11166 29449163
Cardiomyopathy 33.26 10.49 129 114069 14658 29445671
Abdominal cavity drainage 32.83 10.49 19 114179 326 29460003
Pulmonary arterial pressure abnormal 32.82 10.49 16 114182 190 29460139
Electrocardiogram abnormal 32.54 10.49 81 114117 7241 29453088
Premature baby 32.47 10.49 13 114185 17267 29443062
Neuroleptic malignant syndrome 32.28 10.49 11 114187 16137 29444192
Fall 32.27 10.49 904 113294 176274 29284055
Mucosal inflammation 32.15 10.49 45 114153 31550 29428779
Quadriparesis 32.14 10.49 31 114167 1188 29459141
Paraesthesia 31.92 10.49 104 114094 53741 29406588
Hypovolaemia 31.64 10.49 85 114113 7960 29452369
Hepatic function abnormal 31.37 10.49 259 113939 39000 29421329
Faecal volume decreased 31.34 10.49 13 114185 102 29460227
Accidental exposure to product 30.65 10.49 3 114195 10750 29449579
Product monitoring error 30.48 10.49 44 114154 2601 29457728
Nodal rhythm 30.07 10.49 31 114167 1289 29459040
Left ventricular dysfunction 30.06 10.49 89 114109 8813 29451516
Pulmonary oedema 29.50 10.49 273 113925 42462 29417867
Pneumonitis 29.48 10.49 39 114159 28005 29432324
Chronic obstructive pulmonary disease 29.48 10.49 264 113934 40691 29419638
Insomnia 29.46 10.49 211 113987 88550 29371779
Arthropathy 29.40 10.49 24 114174 21530 29438799
Blood sodium decreased 29.37 10.49 124 114074 14643 29445686
Low cardiac output syndrome 28.65 10.49 20 114178 481 29459848
Jaundice 28.28 10.49 202 113996 29094 29431235
Tremor 27.84 10.49 168 114030 73370 29386959
Pulmonary congestion 27.57 10.49 108 114090 12328 29448001
Scrotal oedema 27.41 10.49 31 114167 1433 29458896
Hyperhidrosis 27.39 10.49 142 114056 64398 29395931
Neutrophil count decreased 27.34 10.49 82 114116 43485 29416844
Ejection fraction 27.23 10.49 11 114187 80 29460249
Amyloidosis 27.09 10.49 36 114162 1968 29458361
Peritonitis bacterial 26.99 10.49 65 114133 5691 29454638
Subarachnoid haemorrhage 26.41 10.49 90 114108 9602 29450727
Pleural effusion 26.38 10.49 407 113791 71501 29388828
Diaphragmatic spasm 26.34 10.49 11 114187 88 29460241
Sudden death 26.16 10.49 116 114082 13994 29446335
Multiple sclerosis relapse 26.13 10.49 6 114192 11413 29448916
Blood loss anaemia 25.83 10.49 74 114124 7192 29453137
Torsade de pointes 25.81 10.49 70 114128 6591 29453738
Inability to afford medication 25.73 10.49 25 114173 967 29459362
Adverse drug reaction 25.66 10.49 33 114165 23987 29436342
Generalised oedema 25.60 10.49 98 114100 11067 29449262
Cirrhosis alcoholic 25.18 10.49 22 114176 741 29459588
Nasopharyngitis 24.91 10.49 132 114066 59533 29400796
Drug ineffective for unapproved indication 24.65 10.49 12 114186 14202 29446127
Sopor 24.52 10.49 6 114192 10928 29449401
Left ventricular failure 24.51 10.49 55 114143 4598 29455731
Osteonecrosis of jaw 24.29 10.49 17 114181 16493 29443836
Protein-losing gastroenteropathy 24.26 10.49 15 114183 292 29460037
Ventricular hypokinesia 24.09 10.49 54 114144 4511 29455818
Hallucination 24.05 10.49 90 114108 44622 29415707
Blood aldosterone increased 23.97 10.49 7 114191 15 29460314
Aggression 23.68 10.49 65 114133 35476 29424853
Glomerular filtration rate abnormal 23.65 10.49 21 114177 723 29459606
Hepatitis C 23.63 10.49 82 114116 8828 29451501
Dyspnoea paroxysmal nocturnal 23.56 10.49 28 114170 1366 29458963
Iron deficiency anaemia 23.46 10.49 82 114116 8860 29451469
Waist circumference increased 23.45 10.49 21 114177 731 29459598
Localised oedema 23.41 10.49 43 114155 3113 29457216
Lactic acidosis 23.34 10.49 198 114000 30049 29430280
Back pain 23.10 10.49 268 113930 102016 29358313
Basal cell carcinoma 22.85 10.49 19 114179 16891 29443438
Atrioventricular block 22.81 10.49 69 114129 6913 29453416
Urine output decreased 22.77 10.49 83 114115 9155 29451174
Sudden cardiac death 22.77 10.49 43 114155 3179 29457150
Pneumonia 22.74 10.49 1008 113190 319164 29141165
Oxygen saturation increased 22.66 10.49 14 114184 272 29460057
Jugular vein distension 22.62 10.49 19 114179 606 29459723
Drug intolerance 22.52 10.49 103 114095 48276 29412053
Ventricular internal diameter abnormal 22.46 10.49 10 114188 95 29460234
Therapeutic response decreased 22.45 10.49 38 114160 24673 29435656
Pancreatitis 22.35 10.49 64 114134 34450 29425879
Platelet count normal 22.30 10.49 7 114191 21 29460308
Liver disorder 22.13 10.49 183 114015 27566 29432763
Anuria 22.08 10.49 84 114114 9457 29450872
Portal vein thrombosis 21.96 10.49 43 114155 3266 29457063
Gastrointestinal disorder 21.86 10.49 49 114149 28657 29431672
N-terminal prohormone brain natriuretic peptide abnormal 21.75 10.49 12 114186 187 29460142
Pain in extremity 21.71 10.49 298 113900 110135 29350194
Electrocardiogram QRS complex abnormal 21.71 10.49 14 114184 294 29460035
Bundle branch block right 21.59 10.49 66 114132 6651 29453678
Coma hepatic 21.52 10.49 16 114182 426 29459903
Infection 21.50 10.49 191 114007 76560 29383769
Loss of personal independence in daily activities 21.42 10.49 41 114157 25399 29434930
Oesophageal variceal ligation 21.34 10.49 9 114189 74 29460255
Oliguria 21.23 10.49 70 114128 7342 29452987
Adrenal adenoma 21.14 10.49 14 114184 308 29460021
Gastric varices 21.06 10.49 15 114183 373 29459956
Drug withdrawal syndrome 21.04 10.49 23 114175 17961 29442368
Fractured coccyx 21.04 10.49 11 114187 153 29460176
COVID-19 21.03 10.49 70 114128 35944 29424385
Bone marrow failure 20.79 10.49 47 114151 27402 29432927
Neutrophil count increased 20.63 10.49 16 114182 14726 29445603
Malignant neoplasm progression 20.61 10.49 184 114014 73675 29386654
Memory impairment 20.54 10.49 72 114126 36398 29423931
Paracentesis 20.45 10.49 15 114183 391 29459938
Spur cell anaemia 20.31 10.49 8 114190 54 29460275
Hypoaesthesia 20.31 10.49 122 114076 53345 29406984
Feeling abnormal 20.28 10.49 125 114073 54320 29406009
Vision blurred 20.25 10.49 83 114115 40093 29420236
Graft versus host disease 20.24 10.49 6 114192 9622 29450707
Condition aggravated 20.17 10.49 722 113476 145573 29314756
Prothrombin time prolonged 19.82 10.49 77 114121 8755 29451574
Azotaemia 19.82 10.49 50 114148 4507 29455822
Apparent mineralocorticoid excess 19.68 10.49 7 114191 34 29460295
Metabolic alkalosis 19.54 10.49 24 114174 1212 29459117
Pancytopenia 19.52 10.49 216 113982 82952 29377377
Pulmonary embolism 19.50 10.49 195 114003 76339 29383990
Neck pain 19.46 10.49 33 114165 21414 29438915
Blood potassium abnormal 19.37 10.49 22 114176 1022 29459307
Thrombosis 19.23 10.49 93 114105 42952 29417377
Hydrothorax 19.13 10.49 15 114183 433 29459896
Cardiac disorder 19.06 10.49 224 113974 37039 29423290
Dyskinesia 19.02 10.49 30 114168 20031 29440298
Blood ketone body increased 18.98 10.49 14 114184 368 29459961
Cardiac arrest 18.84 10.49 448 113750 85143 29375186
Weight increased 18.65 10.49 407 113791 76260 29384069
Blood thyroid stimulating hormone abnormal 18.53 10.49 12 114186 254 29460075
Transfusion 18.36 10.49 66 114132 7232 29453097
Tuberculosis 18.11 10.49 3 114195 7193 29453136
Cardioversion 17.85 10.49 19 114179 820 29459509
Sedation 17.49 10.49 25 114173 17380 29442949
Encephalopathy 17.41 10.49 190 114008 30853 29429476
Acute myeloid leukaemia 17.32 10.49 23 114175 16490 29443839
Electrolyte depletion 17.31 10.49 10 114188 171 29460158
Portal hypertensive gastropathy 17.30 10.49 15 114183 500 29459829
Rales 17.28 10.49 66 114132 7444 29452885
Injection site erythema 17.28 10.49 17 114181 13939 29446390
Transplant rejection 17.20 10.49 7 114191 9205 29451124
Oropharyngeal pain 17.05 10.49 57 114141 29228 29431101
Metabolic acidosis 16.94 10.49 221 113977 37441 29422888
Hyperthyroidism 16.90 10.49 72 114126 8536 29451793
Generalised tonic-clonic seizure 16.87 10.49 30 114168 19109 29441220
Resting tremor 16.86 10.49 16 114182 601 29459728
Exposure during pregnancy 16.80 10.49 6 114192 8548 29451781
Renin increased 16.71 10.49 8 114190 91 29460238
Akathisia 16.55 10.49 3 114195 6739 29453590
Haematotoxicity 16.41 10.49 3 114195 6696 29453633
Haematemesis 16.33 10.49 156 114042 24470 29435859
Conjunctival scar 16.25 10.49 7 114191 61 29460268
Primary hyperaldosteronism 16.25 10.49 7 114191 61 29460268
Diabetic ketoacidosis 16.24 10.49 23 114175 16050 29444279
Influenza 16.20 10.49 95 114103 41786 29418543
Epstein-Barr virus infection 16.17 10.49 3 114195 6626 29453703
Subdural haematoma 16.16 10.49 123 114075 18070 29442259
Xanthopsia 16.16 10.49 9 114189 143 29460186
Respiratory depression 16.15 10.49 17 114181 13506 29446823
Upper gastrointestinal haemorrhage 16.14 10.49 142 114056 21772 29438557
Diplopia 16.13 10.49 17 114181 13501 29446828
Stomatitis 16.11 10.49 81 114117 37032 29423297
Myasthenic syndrome 16.04 10.49 13 114185 394 29459935
Agitation 16.03 10.49 124 114074 51180 29409149
Endometriosis male 15.93 10.49 5 114193 15 29460314
Blood urea abnormal 15.93 10.49 17 114181 736 29459593
Irritability 15.92 10.49 39 114159 22113 29438216
Circulatory collapse 15.89 10.49 125 114073 18548 29441781
Disease recurrence 15.85 10.49 23 114175 15891 29444438
Injection site reaction 15.83 10.49 12 114186 11176 29449153
Arthritis 15.75 10.49 47 114151 24972 29435357
Bladder irrigation 15.68 10.49 7 114191 67 29460262
Base excess decreased 15.59 10.49 10 114188 208 29460121
Aspergillus infection 15.43 10.49 11 114187 10570 29449759
Bronchopulmonary aspergillosis 15.33 10.49 15 114183 12329 29448000
Respiratory arrest 15.23 10.49 50 114148 25783 29434546
Herpes zoster 15.19 10.49 62 114136 29990 29430339
Oral lichen planus 15.17 10.49 9 114189 162 29460167
Cytokine release syndrome 15.10 10.49 17 114181 13102 29447227
Poisoning 15.09 10.49 10 114188 9983 29450346
Left atrial dilatation 15.07 10.49 25 114173 1668 29458661
Cardiac amyloidosis 15.03 10.49 18 114180 885 29459444
Somnolence 14.92 10.49 264 113934 93691 29366638
Labelled drug-drug interaction medication error 14.88 10.49 89 114109 12070 29448259
Scrotal swelling 14.88 10.49 21 114177 1216 29459113
Drug level decreased 14.87 10.49 3 114195 6244 29454085
Psoriatic arthropathy 14.86 10.49 21 114177 14670 29445659
Colitis 14.85 10.49 66 114132 31182 29429147
Product quality issue 14.85 10.49 24 114174 15871 29444458
Child-Pugh-Turcotte score increased 14.83 10.49 5 114193 20 29460309
Enteritis 14.70 10.49 4 114194 6787 29453542
Nephrogenic anaemia 14.67 10.49 27 114171 1958 29458371
Potentiating drug interaction 14.63 10.49 44 114154 4394 29455935
Double hit lymphoma 14.60 10.49 4 114194 6 29460323
Burning feet syndrome 14.52 10.49 7 114191 81 29460248
Angina pectoris 14.50 10.49 168 114030 27682 29432647
Electrocardiogram T wave amplitude increased 14.47 10.49 6 114192 47 29460282
International normalised ratio abnormal 14.47 10.49 34 114164 2929 29457400
Haematoma 14.40 10.49 145 114053 23067 29437262
Acquired haemophilia 14.36 10.49 17 114181 826 29459503
Oxygen consumption decreased 14.34 10.49 9 114189 180 29460149
Hypoparathyroidism secondary 14.31 10.49 8 114190 128 29460201
Angina unstable 14.25 10.49 81 114117 10784 29449545
Atrioventricular block first degree 14.15 10.49 49 114149 5270 29455059
Transplant evaluation 14.06 10.49 13 114185 472 29459857
Dizziness 14.05 10.49 880 113318 188804 29271525
Erysipelas 14.03 10.49 42 114156 4183 29456146
Breast mass 13.98 10.49 14 114184 562 29459767
Coordination abnormal 13.95 10.49 5 114193 7109 29453220
Type 2 diabetes mellitus 13.90 10.49 95 114103 13486 29446843
Middle insomnia 13.83 10.49 51 114147 5657 29454672
Diastolic dysfunction 13.78 10.49 47 114151 5017 29455312
Tooth disorder 13.77 10.49 10 114188 9519 29450810
Hypertensive cardiomyopathy 13.73 10.49 8 114190 139 29460190
Dyspnoea at rest 13.70 10.49 35 114163 3179 29457150
Pacemaker generated arrhythmia 13.68 10.49 3 114195 0 29460329
Secondary sexual characteristics absence 13.68 10.49 3 114195 0 29460329
Concomitant disease progression 13.68 10.49 29 114169 2332 29457997
Periarthritis calcarea 13.66 10.49 6 114192 55 29460274
Creatinine renal clearance decreased 13.65 10.49 34 114164 3040 29457289
Electrocardiogram change 13.41 10.49 14 114184 591 29459738
Articular calcification 13.39 10.49 6 114192 58 29460271
Preternatural anus 13.35 10.49 7 114191 98 29460231
International normalised ratio decreased 13.31 10.49 41 114157 4149 29456180
Serotonin syndrome 13.25 10.49 30 114168 17482 29442847
Colitis ulcerative 13.17 10.49 18 114180 12751 29447578
Blood chloride increased 13.14 10.49 31 114167 2678 29457651
Left ventricular hypertrophy 13.11 10.49 56 114142 6647 29453682
Stress 13.08 10.49 41 114157 21449 29438880
Exercise tolerance decreased 13.07 10.49 41 114157 4190 29456139
Hyperuricaemia 13.05 10.49 57 114141 6832 29453497
Product prescribing error 12.99 10.49 116 114082 17860 29442469
Thrombocytopenia 12.98 10.49 409 113789 134414 29325915
Lichenoid keratosis 12.97 10.49 27 114171 2143 29458186
Pulmonary veno-occlusive disease 12.93 10.49 12 114186 438 29459891
Withdrawal syndrome 12.92 10.49 14 114184 10978 29449351
Parkinsonism 12.84 10.49 6 114192 7272 29453057
Pulmonary hypertensive crisis 12.84 10.49 8 114190 158 29460171
Prerenal failure 12.81 10.49 24 114174 1764 29458565
Prothrombin level decreased 12.78 10.49 18 114180 1040 29459289
Performance enhancing product use 12.71 10.49 6 114192 66 29460263
Influenza like illness 12.67 10.49 50 114148 24420 29435909
Myocardial fibrosis 12.65 10.49 18 114180 1050 29459279
Tachycardia 12.62 10.49 200 113998 72210 29388119
Hepatomegaly 12.58 10.49 70 114128 9247 29451082
Left ventricular enlargement 12.54 10.49 14 114184 638 29459691
Rash erythematous 12.53 10.49 42 114156 21520 29438809
Portal shunt procedure 12.51 10.49 4 114194 13 29460316
Pulmonary renal syndrome 12.49 10.49 8 114190 166 29460163
Pneumocystis jirovecii pneumonia 12.48 10.49 29 114169 16750 29443579
Erythema 12.46 10.49 211 113987 75395 29384934
Epistaxis 12.41 10.49 274 113924 51430 29408899
Plasma cell myeloma 12.41 10.49 88 114110 37027 29423302
Dependence on oxygen therapy 12.41 10.49 8 114190 168 29460161
Squamous cell carcinoma of skin 12.40 10.49 11 114187 9475 29450854
Low birth weight baby 12.37 10.49 5 114193 6603 29453726
Gouty arthritis 12.37 10.49 17 114181 960 29459369
Hypochromic anaemia 12.34 10.49 15 114183 749 29459580
Conduction disorder 12.32 10.49 24 114174 1816 29458513
Eye pain 12.31 10.49 16 114182 11579 29448750
Haemodynamic test abnormal 12.31 10.49 5 114193 37 29460292
Hepatic pain 12.15 10.49 19 114179 1206 29459123
Abnormal behaviour 12.14 10.49 47 114151 23080 29437249
Diffuse vasculitis 12.11 10.49 6 114192 74 29460255
Chills 12.07 10.49 198 114000 71102 29389227
Urogenital haemorrhage 12.06 10.49 12 114186 478 29459851
Pulmonary vein stenosis 11.97 10.49 5 114193 40 29460289
Clostridium difficile infection 11.93 10.49 28 114170 16113 29444216
Dilatation ventricular 11.92 10.49 28 114170 2412 29457917
Immature granulocyte count increased 11.90 10.49 6 114192 77 29460252
Crepitations 11.86 10.49 30 114168 2709 29457620
Ejection fraction abnormal 11.82 10.49 15 114183 783 29459546
Acute respiratory distress syndrome 11.79 10.49 47 114151 22888 29437441
Appendicitis 11.69 10.49 10 114188 8769 29451560
Haemophagocytic lymphohistiocytosis 11.67 10.49 14 114184 10490 29449839
Enteropathy-associated T-cell lymphoma 11.61 10.49 3 114195 3 29460326
Postrenal failure 11.57 10.49 11 114187 414 29459915
Adrenal cyst 11.57 10.49 6 114192 82 29460247
Product use issue 11.52 10.49 135 114063 51309 29409020
Hepatic calcification 11.52 10.49 10 114188 334 29459995
Road traffic accident 11.49 10.49 27 114171 15534 29444795
Mental impairment 11.47 10.49 11 114187 9130 29451199
Substance abuse 11.36 10.49 6 114192 6781 29453548
Acute pulmonary oedema 11.28 10.49 54 114144 6725 29453604
Systemic infection 11.25 10.49 25 114173 2076 29458253
Cholangiocarcinoma 11.24 10.49 16 114182 934 29459395
Embolic stroke 11.19 10.49 35 114163 3571 29456758
Nephrolithiasis 11.16 10.49 55 114143 25279 29435050
Apheresis related complication 11.15 10.49 4 114194 20 29460309
Injection site swelling 11.06 10.49 12 114186 9405 29450924
Muscle rigidity 11.05 10.49 12 114186 9399 29450930
Tricuspid valve replacement 10.99 10.49 4 114194 21 29460308
Psychotic disorder 10.92 10.49 41 114157 20313 29440016
Goitre 10.90 10.49 20 114178 1447 29458882
Respiratory syncytial virus infection 10.88 10.49 35 114163 3624 29456705
Breath odour 10.85 10.49 14 114184 743 29459586
Acute myocardial infarction 10.79 10.49 254 113944 48184 29412145
Hypoglycaemic coma 10.76 10.49 25 114173 2138 29458191
Cardiac asthma 10.73 10.49 8 114190 214 29460115
Fungal infection 10.72 10.49 23 114175 13662 29446667
Fluid intake reduced 10.62 10.49 30 114168 2892 29457437
Therapeutic embolisation 10.53 10.49 9 114189 294 29460035
Restless legs syndrome 10.53 10.49 7 114191 6977 29453352
Metamyelocyte count increased 10.53 10.49 10 114188 376 29459953
Blood pressure abnormal 10.52 10.49 53 114145 6737 29453592

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
Hyperkalaemia 3894.50 10.05 3088 229075 98041 64168528
Acute kidney injury 1777.21 10.05 4535 227628 444705 63821864
Cardiac failure 1186.76 10.05 1884 230279 130489 64136080
Hepatic encephalopathy 919.18 10.05 694 231469 20372 64246197
Hyponatraemia 827.84 10.05 1719 230444 146620 64119949
Drug ineffective 686.68 10.05 1239 230924 839008 63427561
Ascites 650.40 10.05 950 231213 61051 64205518
Pulmonary arterial hypertension 573.04 10.05 574 231589 24793 64241776
Right ventricular failure 537.59 10.05 514 231649 20957 64245612
Pulmonary hypertension 445.08 10.05 656 231507 42483 64224086
Cardiac failure congestive 437.13 10.05 1243 230920 129337 64137232
Renal impairment 432.45 10.05 1265 230898 133752 64132817
Hypotension 430.85 10.05 2589 229574 378385 63888184
Oedema peripheral 428.54 10.05 1693 230470 208624 64057945
Completed suicide 384.79 10.05 163 232000 224251 64042318
Renal failure 361.50 10.05 1452 230711 180236 64086333
Dehydration 355.65 10.05 1634 230529 215129 64051440
Cardiac failure chronic 353.15 10.05 279 231884 8762 64257807
Dyspnoea 351.59 10.05 4038 228125 714636 63551933
Hepatic cirrhosis 330.97 10.05 440 231723 25858 64240711
Bradycardia 321.13 10.05 1046 231117 117173 64149396
Drug interaction 318.76 10.05 2312 229851 359771 63906798
Synovitis 318.56 10.05 8 232155 99082 64167487
Drug abuse 316.42 10.05 49 232114 132325 64134244
Joint swelling 280.09 10.05 219 231944 215163 64051406
Hepatic failure 276.35 10.05 614 231549 54780 64211789
Blood creatinine increased 276.22 10.05 1093 231070 134689 64131880
Rheumatoid arthritis 274.14 10.05 124 232039 164170 64102399
Infusion related reaction 273.07 10.05 125 232038 164342 64102227
Off label use 263.97 10.05 1277 230886 631529 63635040
International normalised ratio increased 262.19 10.05 751 231412 78416 64188153
Fluid retention 254.96 10.05 622 231541 58984 64207585
Arthropathy 250.93 10.05 63 232100 120904 64145665
Blood potassium increased 243.67 10.05 378 231785 25602 64240967
Arthralgia 239.37 10.05 805 231358 441455 63825114
Gynaecomastia 237.87 10.05 187 231976 5829 64260740
Toxicity to various agents 235.53 10.05 608 231555 362905 63903664
Pain 212.46 10.05 1149 231014 552362 63714207
Atrial fibrillation 212.42 10.05 1193 230970 169896 64096673
Therapeutic product effect decreased 210.40 10.05 76 232087 115275 64151294
Hand deformity 205.91 10.05 4 232159 62767 64203802
Oedema 205.72 10.05 763 231400 91172 64175397
Drug intolerance 196.76 10.05 232 231931 187760 64078809
Treatment failure 196.65 10.05 87 232076 116729 64149840
Blood urea increased 193.35 10.05 465 231698 43688 64222881
Maternal exposure during pregnancy 189.30 10.05 55 232108 95829 64170740
Febrile neutropenia 187.54 10.05 240 231923 187417 64079152
Pemphigus 184.13 10.05 8 232155 60693 64205876
Hypersensitivity 182.46 10.05 265 231898 196187 64070382
Hypervolaemia 178.28 10.05 413 231750 37872 64228697
General physical health deterioration 176.38 10.05 1300 230863 203125 64063444
Rash 170.24 10.05 962 231201 457587 63808982
Musculoskeletal stiffness 169.48 10.05 118 232045 123088 64143481
Syncope 161.08 10.05 1045 231118 156590 64109979
Hepatocellular carcinoma 160.73 10.05 174 231989 8229 64258340
Orthopnoea 157.26 10.05 179 231984 8955 64257614
Ventricular tachycardia 156.66 10.05 367 231796 33898 64232671
Dyspnoea exertional 155.07 10.05 600 231563 73130 64193439
Oesophageal varices haemorrhage 152.60 10.05 117 232046 3512 64263057
N-terminal prohormone brain natriuretic peptide increased 152.42 10.05 116 232047 3443 64263126
Glossodynia 152.18 10.05 25 232138 64671 64201898
Brain natriuretic peptide increased 149.42 10.05 160 232003 7473 64259096
Anaemia 145.81 10.05 2038 230125 376642 63889927
Alopecia 143.76 10.05 234 231929 165456 64101113
Systemic lupus erythematosus 141.74 10.05 51 232112 77561 64189008
Pericarditis 138.76 10.05 28 232135 62488 64204081
Hepatorenal syndrome 138.61 10.05 112 232051 3634 64262935
Neutropenia 135.02 10.05 428 231735 239196 64027373
Intentional overdose 133.45 10.05 79 232084 89865 64176704
Cardiac failure acute 130.38 10.05 221 231942 16123 64250446
Congestive cardiomyopathy 130.02 10.05 173 231990 10171 64256398
Atrioventricular block complete 129.94 10.05 206 231957 14212 64252357
Melaena 128.71 10.05 455 231708 53093 64213476
Blood bilirubin increased 124.82 10.05 473 231690 57080 64209489
Hepatic cancer 123.24 10.05 143 232020 7305 64259264
Contraindicated product administered 119.40 10.05 127 232036 107702 64158867
Chronic kidney disease 115.84 10.05 464 231699 57455 64209114
Gastrointestinal haemorrhage 113.20 10.05 840 231323 131472 64135097
Cardioactive drug level increased 112.41 10.05 96 232067 3369 64263200
Exposure during pregnancy 111.37 10.05 71 232092 77604 64188965
Ejection fraction decreased 109.59 10.05 287 231876 28420 64238149
Sinusitis 108.86 10.05 226 231937 145702 64120867
Drug hypersensitivity 103.95 10.05 471 231692 237344 64029225
Abdominal discomfort 103.82 10.05 324 231839 181998 64084571
Hepatic enzyme increased 102.29 10.05 195 231968 129748 64136821
Injection site pain 101.69 10.05 152 232011 111256 64155313
Wound 100.27 10.05 77 232086 76400 64190169
Arrhythmia 100.22 10.05 417 231746 52527 64214042
Tricuspid valve incompetence 99.26 10.05 201 231962 16802 64249767
Blood pressure decreased 98.97 10.05 589 231574 85610 64180959
Urticaria 97.83 10.05 243 231920 147074 64119495
Varices oesophageal 95.98 10.05 105 232058 5025 64261544
Glomerular filtration rate decreased 94.27 10.05 214 231949 19358 64247211
Atrioventricular block 93.91 10.05 161 232002 11854 64254715
Concomitant disease aggravated 93.30 10.05 157 232006 11385 64255184
Hypokalaemia 92.66 10.05 753 231410 121150 64145419
Mitral valve incompetence 92.10 10.05 250 231913 25288 64241281
Orthostatic hypotension 91.52 10.05 372 231791 46366 64220203
Discomfort 90.94 10.05 94 232069 80784 64185785
Helicobacter infection 89.82 10.05 15 232148 38347 64228222
Lower respiratory tract infection 88.39 10.05 127 232036 94487 64172082
Injection site erythema 88.18 10.05 75 232088 70725 64195844
Product monitoring error 87.38 10.05 103 232060 5351 64261218
Duodenal ulcer perforation 86.96 10.05 11 232152 34614 64231955
Anaphylactic reaction 86.42 10.05 72 232091 68592 64197977
Stomatitis 85.80 10.05 165 231998 109440 64157129
Product use in unapproved indication 85.67 10.05 336 231827 176282 64090287
Ischaemic cardiomyopathy 85.38 10.05 114 232049 6724 64259845
Transfusion 84.73 10.05 195 231968 17799 64248770
Abdominal distension 84.68 10.05 614 231549 95380 64171189
Cardiomegaly 83.57 10.05 230 231933 23454 64243115
Nasopharyngitis 83.47 10.05 392 231771 195681 64070888
Therapeutic product effect incomplete 83.46 10.05 153 232010 103329 64163240
Cardiogenic shock 82.66 10.05 281 231882 32146 64234423
Bundle branch block left 81.79 10.05 137 232026 9897 64256672
Intentional product use issue 80.52 10.05 137 232026 95227 64171342
Arthritis 78.79 10.05 112 232051 83702 64182867
Muscle injury 78.50 10.05 4 232159 26433 64240136
Product prescribing error 78.23 10.05 292 231871 34977 64231592
Electrolyte imbalance 77.32 10.05 233 231930 25010 64241559
Folliculitis 76.90 10.05 9 232154 30068 64236501
Impaired healing 76.61 10.05 63 232100 60410 64206159
Infection 76.14 10.05 374 231789 184506 64082063
Ammonia increased 74.67 10.05 108 232055 6869 64259700
Intentional product misuse 73.68 10.05 91 232072 72204 64194365
Ejection fraction 73.62 10.05 50 232113 1236 64265333
Fall 73.20 10.05 1991 230172 414835 63851734
Paraesthesia 72.43 10.05 245 231918 134277 64132292
Hepatic function abnormal 72.25 10.05 437 231726 63876 64202693
Pulmonary oedema 72.16 10.05 508 231655 78166 64188403
Blood sodium decreased 72.11 10.05 252 231911 29230 64237339
Cardiac disorder 71.00 10.05 392 231771 55424 64211145
Pyrexia 70.60 10.05 1504 230659 557140 63709429
Injection site reaction 69.18 10.05 41 232122 46623 64219946
Product use issue 68.95 10.05 296 231867 151419 64115150
Pleural effusion 67.59 10.05 725 231438 125834 64140735
Therapeutic drug monitoring analysis not performed 66.72 10.05 46 232117 1166 64265403
Suicide attempt 65.64 10.05 96 232067 70911 64195658
Suicidal ideation 64.46 10.05 87 232076 66455 64200114
Gastrointestinal disorder 63.50 10.05 143 232020 89566 64177003
Generalised oedema 62.48 10.05 191 231972 20662 64245907
Sensitisation 62.45 10.05 51 232112 1680 64264889
Sleep disorder due to general medical condition, insomnia type 62.11 10.05 10 232153 26260 64240309
Congestive hepatopathy 61.95 10.05 74 232089 3899 64262670
Psoriatic arthropathy 61.43 10.05 40 232123 43241 64223328
Cytomegalovirus infection 60.56 10.05 29 232134 37170 64229399
Paracentesis 60.55 10.05 44 232119 1215 64265354
Brain natriuretic peptide abnormal 60.08 10.05 35 232128 655 64265914
Left ventricular failure 59.59 10.05 108 232055 8309 64258260
Cardiomyopathy 58.82 10.05 213 231950 25143 64241426
Neuropathy peripheral 58.63 10.05 221 231942 117304 64149265
Polycystic ovaries 58.54 10.05 54 232109 2101 64264468
C-reactive protein abnormal 58.54 10.05 16 232147 29031 64237538
Mucosal inflammation 58.45 10.05 84 232079 62500 64204069
Irritable bowel syndrome 58.04 10.05 31 232132 37338 64229231
Portal hypertension 57.62 10.05 90 232073 6129 64260440
Ventricular fibrillation 57.54 10.05 203 231960 23657 64242912
Mobility decreased 57.42 10.05 141 232022 85699 64180870
Prothrombin time prolonged 56.66 10.05 154 232009 15587 64250982
Swelling 56.65 10.05 341 231822 159877 64106692
Hypovolaemia 56.24 10.05 152 232011 15334 64251235
Electrocardiogram T wave peaked 56.08 10.05 36 232127 807 64265762
Haematemesis 54.47 10.05 322 231841 46677 64219892
Anxiety 54.33 10.05 467 231696 202182 64064387
Atrial flutter 53.91 10.05 173 231990 19207 64247362
Bradyarrhythmia 53.73 10.05 67 232096 3691 64262878
Pain in jaw 53.70 10.05 289 231874 40466 64226103
Pulmonary arterial pressure increased 53.52 10.05 70 232093 4046 64262523
Polyuria 53.03 10.05 131 232032 12512 64254057
Metabolic alkalosis 51.38 10.05 67 232096 3861 64262708
Intentional self-injury 49.85 10.05 21 232142 29023 64237546
Blood aldosterone increased 48.81 10.05 21 232142 197 64266372
Inability to afford medication 48.81 10.05 46 232117 1840 64264729
Injection site pruritus 48.42 10.05 39 232124 37787 64228782
Multiple sclerosis relapse 48.31 10.05 46 232117 41089 64225480
Pulmonary congestion 48.28 10.05 192 231971 23688 64242881
Catheter management 48.27 10.05 60 232103 3295 64263274
Epistaxis 48.20 10.05 553 231610 97578 64168991
Nipple pain 48.11 10.05 28 232135 523 64266046
Pulmonary arterial pressure abnormal 48.00 10.05 30 232133 641 64265928
Subdural haematoma 47.73 10.05 214 231949 27840 64238729
Liver transplant 47.72 10.05 66 232097 4026 64262543
Ill-defined disorder 47.51 10.05 53 232110 43999 64222570
Jaundice 47.29 10.05 318 231845 48194 64218375
Electrocardiogram abnormal 46.65 10.05 130 232033 13351 64253218
Depression 46.22 10.05 429 231734 182862 64083707
Cor pulmonale 46.04 10.05 46 232117 1979 64264590
Sudden death 45.92 10.05 168 231995 19928 64246641
Labelled drug-drug interaction medication error 45.91 10.05 179 231984 21883 64244686
Therapeutic response decreased 45.88 10.05 73 232090 52115 64214454
Accidental exposure to product 45.35 10.05 19 232144 26345 64240224
Renin increased 45.03 10.05 20 232143 204 64266365
Bundle branch block right 44.77 10.05 108 232055 10161 64256408
Seizure 44.10 10.05 386 231777 166506 64100063
Peritonitis bacterial 43.68 10.05 99 232064 8944 64257625
Cardiac murmur 43.51 10.05 115 232048 11448 64255121
Abortion spontaneous 43.44 10.05 18 232145 25125 64241444
Abdominal cavity drainage 43.23 10.05 29 232134 702 64265867
Blood cholesterol increased 43.11 10.05 71 232092 49995 64216574
White blood cell count decreased 43.07 10.05 362 231801 157475 64109094
Progressive multifocal leukoencephalopathy 42.97 10.05 7 232156 18225 64248344
Anuria 42.88 10.05 158 232005 18806 64247763
Dyspnoea paroxysmal nocturnal 42.78 10.05 44 232119 1960 64264609
Lactic acidosis 42.73 10.05 372 231791 61038 64205531
N-terminal prohormone brain natriuretic peptide abnormal 42.62 10.05 20 232143 234 64266335
Osteoarthritis 42.39 10.05 104 232059 63232 64203337
Hypoaesthesia 42.16 10.05 310 231853 138798 64127771
Catheter site infection 41.52 10.05 74 232089 5619 64260950
Haematoma 41.44 10.05 297 231866 45953 64220616
Renal disorder 41.44 10.05 243 231920 35122 64231447
Oliguria 41.35 10.05 131 232032 14445 64252124
Chronic hepatic failure 41.27 10.05 30 232133 829 64265740
Upper gastrointestinal haemorrhage 41.26 10.05 242 231921 34978 64231591
Urine output decreased 41.22 10.05 142 232021 16350 64250219
Oropharyngeal pain 40.59 10.05 173 231990 88694 64177875
Iron deficiency anaemia 40.31 10.05 171 231992 21718 64244851
Chronic obstructive pulmonary disease 40.26 10.05 412 231751 70636 64195933
Electrocardiogram QRS complex prolonged 40.07 10.05 97 232066 9147 64257422
Overdose 40 10.05 374 231789 159192 64107377
Adverse drug reaction 39.58 10.05 64 232099 45400 64221169
Cardioversion 39.54 10.05 41 232122 1844 64264725
Sinoatrial block 39.25 10.05 33 232130 1133 64265436
Injection site bruising 38.96 10.05 44 232119 36329 64230240
Generalised tonic-clonic seizure 38.71 10.05 52 232111 39805 64226764
Osteonecrosis of jaw 38.64 10.05 52 232111 39773 64226796
Blood loss anaemia 38.63 10.05 124 232039 13768 64252801
Neuroleptic malignant syndrome 38.43 10.05 21 232142 24975 64241594
Sedation 38.37 10.05 56 232107 41406 64225163
Pain in extremity 38.16 10.05 816 231347 302269 63964300
Injection site swelling 38.12 10.05 56 232107 41297 64225272
Back pain 38.10 10.05 652 231511 249519 64017050
Shock haemorrhagic 37.22 10.05 139 232024 16652 64249917
Leukopenia 37.09 10.05 213 231950 101029 64165540
Left ventricular dilatation 36.91 10.05 29 232134 903 64265666
Joint range of motion decreased 36.53 10.05 12 232151 19331 64247238
Azotaemia 36.09 10.05 82 232081 7420 64259149
Nodal rhythm 36.01 10.05 48 232115 2826 64263743
Bone marrow failure 35.95 10.05 74 232089 47878 64218691
Stress 35.54 10.05 106 232057 60428 64206141
Haematotoxicity 35.21 10.05 3 232160 12893 64253676
Hepatitis C 34.99 10.05 103 232060 10912 64255657
Waist circumference increased 34.64 10.05 33 232130 1338 64265231
Oesophageal variceal ligation 34.36 10.05 14 232149 113 64266456
Body tinea 34.35 10.05 32 232131 1261 64265308
Knee arthroplasty 34.35 10.05 28 232135 26971 64239598
Scrotal oedema 34.26 10.05 31 232132 1176 64265393
Low cardiac output syndrome 34.24 10.05 26 232137 769 64265800
Left ventricular dysfunction 34.02 10.05 136 232027 16818 64249751
Pericardial effusion 33.97 10.05 250 231913 39004 64227565
Muscle spasticity 33.93 10.05 9 232154 16660 64249909
Epstein-Barr virus infection 33.83 10.05 3 232160 12485 64254084
Torsade de pointes 33.82 10.05 138 232025 17225 64249344
Cirrhosis alcoholic 33.79 10.05 28 232135 942 64265627
Blister 33.76 10.05 163 232000 80804 64185765
Jugular vein distension 33.75 10.05 32 232131 1290 64265279
Atrial tachycardia 33.66 10.05 52 232111 3507 64263062
Blood cholesterol 33.03 10.05 19 232144 347 64266222
Portal vein thrombosis 32.77 10.05 62 232101 4929 64261640
Concomitant disease progression 32.67 10.05 49 232114 3220 64263349
Basal cell carcinoma 32.28 10.05 38 232125 30800 64235769
Red blood cell sedimentation rate increased 32.15 10.05 39 232124 31196 64235373
Condition aggravated 32.01 10.05 1643 230520 370783 63895786
Ejection fraction abnormal 31.94 10.05 32 232131 1381 64265188
Dizziness 31.91 10.05 1872 230291 428291 63838278
Hypovolaemic shock 31.66 10.05 95 232068 10171 64256398
Exercise tolerance decreased 31.40 10.05 79 232084 7631 64258938
Electrocardiogram T wave amplitude increased 31.26 10.05 11 232152 56 64266513
Glomerular filtration rate abnormal 31.24 10.05 30 232133 1229 64265340
Hyperhidrosis 30.78 10.05 294 231869 124626 64141943
Fatigue 30.50 10.05 2302 229861 746428 63520141
Hyperbilirubinaemia 30.44 10.05 154 232009 21051 64245518
Hyperthyroidism 30.42 10.05 138 232025 18041 64248528
Cardiac output decreased 30.36 10.05 34 232129 1670 64264899
Bursitis 30.29 10.05 20 232143 21465 64245104
Drug resistance 30.01 10.05 50 232113 35052 64231517
Pneumonitis 29.71 10.05 88 232075 50277 64216292
Erythema 29.62 10.05 484 231679 186586 64079983
Blood pressure fluctuation 29.61 10.05 92 232071 51779 64214790
Sopor 29.52 10.05 38 232125 29623 64236946
Transplant evaluation 29.36 10.05 32 232131 1525 64265044
Herpes zoster 29.32 10.05 166 231997 79021 64187548
Sleep disorder 29.30 10.05 113 232050 59596 64206973
Joint stiffness 29.19 10.05 40 232123 30364 64236205
Musculoskeletal disorder 29.08 10.05 14 232149 17892 64248677
Neutrophil count decreased 29.03 10.05 161 232002 77035 64189534
Catheter placement 29.01 10.05 41 232122 2552 64264017
Respiratory depression 28.98 10.05 25 232138 23418 64243151
Grip strength decreased 28.78 10.05 4 232159 11720 64254849
Hip arthroplasty 28.62 10.05 21 232142 21330 64245239
Blood alkaline phosphatase increased 28.46 10.05 319 231844 55960 64210609
Adrenal adenoma 28.37 10.05 26 232137 1003 64265566
Bone erosion 28.36 10.05 4 232159 11591 64254978
Faecal volume decreased 28.25 10.05 13 232150 145 64266424
Device related infection 28.21 10.05 198 231965 30428 64236141
Akathisia 28.08 10.05 4 232159 11506 64255063
Poisoning deliberate 27.91 10.05 7 232156 13451 64253118
Drug ineffective for unapproved indication 27.89 10.05 43 232120 31090 64235479
Hypertrichosis 27.81 10.05 27 232136 1121 64265448
Tremor 27.81 10.05 371 231792 147859 64118710
Malignant neoplasm progression 27.66 10.05 266 231897 112605 64153964
Prerenal failure 27.61 10.05 45 232118 3177 64263392
Neoplasm progression 27.61 10.05 67 232096 40897 64225672
Inhibitory drug interaction 27.55 10.05 48 232115 3579 64262990
Pemphigoid 27.54 10.05 106 232057 12880 64253689
Systemic infection 27.54 10.05 53 232110 4268 64262301
Vital capacity decreased 27.46 10.05 26 232137 1046 64265523
Poisoning 27.45 10.05 23 232140 21856 64244713
Pregnancy 27.35 10.05 21 232142 20844 64245725
Asthenia 27.18 10.05 1838 230325 426206 63840363
Live birth 27.09 10.05 4 232159 11200 64255369
Schizophrenia 26.97 10.05 4 232159 11164 64255405
Palpitations 26.93 10.05 527 231636 103961 64162608
Breast tenderness 26.88 10.05 35 232128 2014 64264555
Diaphragmatic spasm 26.87 10.05 11 232152 90 64266479
Platelet count normal 26.82 10.05 8 232155 21 64266548
Hypertension 26.82 10.05 719 231444 258542 64008027
Purpura 26.71 10.05 128 232035 17118 64249451
Acute pulmonary oedema 26.71 10.05 104 232059 12705 64253864
Catheterisation cardiac 26.55 10.05 56 232107 4817 64261752
Localised oedema 26.53 10.05 71 232092 7120 64259449
Acute myeloid leukaemia 26.50 10.05 36 232127 27427 64239142
Circulatory collapse 26.49 10.05 210 231953 33522 64233047
Gouty arthritis 26.38 10.05 28 232135 1294 64265275
Chest pain 26.32 10.05 1069 231094 234911 64031658
Protein-losing gastroenteropathy 26.23 10.05 19 232144 522 64266047
Blood potassium decreased 26.19 10.05 241 231922 40158 64226411
Metabolic acidosis 26.02 10.05 379 231784 70579 64195990
Insomnia 25.94 10.05 529 231634 197307 64069262
Dyspnoea at rest 25.93 10.05 65 232098 6264 64260305
Tendonitis 25.85 10.05 21 232142 20261 64246308
Fear of eating 25.84 10.05 17 232146 398 64266171
Blood pressure increased 25.83 10.05 451 231712 172101 64094468
Left-to-right cardiac shunt 25.77 10.05 11 232152 101 64266468
Walking distance test abnormal 25.58 10.05 21 232142 697 64265872
Calcium deficiency 25.08 10.05 21 232142 717 64265852
Vascular resistance pulmonary decreased 25.06 10.05 10 232153 76 64266493
Atrial enlargement 24.99 10.05 20 232143 640 64265929
COVID-19 24.97 10.05 135 232028 65005 64201564
Respiratory arrest 24.90 10.05 102 232061 52883 64213686
Hyperuricaemia 24.82 10.05 87 232076 10104 64256465
Haemorrhage subcutaneous 24.80 10.05 51 232112 4310 64262259
Sinus node dysfunction 24.77 10.05 67 232096 6761 64259808
Sinus bradycardia 24.72 10.05 154 232009 22739 64243830
Ischaemic stroke 24.60 10.05 184 231979 28851 64237718
Psoriasis 24.60 10.05 154 232009 71549 64195020
Drug withdrawal syndrome 24.56 10.05 47 232116 31244 64235325
Hepatomegaly 24.51 10.05 123 232040 16759 64249810
Lung transplant 24.50 10.05 49 232114 4059 64262510
Reversible airways obstruction 24.32 10.05 25 232138 1113 64265456
Oxygen consumption increased 24.22 10.05 52 232111 4529 64262040
Bronchopulmonary aspergillosis 24.02 10.05 20 232143 19065 64247504
Therapy partial responder 24.00 10.05 4 232159 10244 64256325
Colitis 23.95 10.05 119 232044 58555 64208014
Blood pressure systolic decreased 23.87 10.05 78 232085 8742 64257827
Graft versus host disease 23.69 10.05 10 232153 13803 64252766
Hypochloraemia 23.67 10.05 33 232130 2028 64264541
Migraine 23.42 10.05 131 232032 62546 64204023
Erysipelas 23.41 10.05 79 232084 9002 64257567
Apparent mineralocorticoid excess 23.36 10.05 8 232155 37 64266532
Female sexual arousal disorder 23.17 10.05 6 232157 7 64266562
Blood urea abnormal 23.08 10.05 25 232138 1183 64265386
Coma hepatic 23.03 10.05 23 232140 989 64265580
Asterixis 23.02 10.05 35 232128 2328 64264241
Aortic valve incompetence 22.99 10.05 74 232089 8227 64258342
Sputum culture positive 22.93 10.05 40 232123 2986 64263583
Dilatation ventricular 22.88 10.05 46 232117 3824 64262745
Left atrial dilatation 22.86 10.05 38 232125 2728 64263841
Endocarditis 22.79 10.05 80 232083 9298 64257271
Blood pressure systolic increased 22.74 10.05 96 232067 49357 64217212
Night sweats 22.72 10.05 61 232102 35985 64230584
Throat tightness 22.71 10.05 30 232133 23130 64243439
Embolic stroke 22.52 10.05 64 232099 6647 64259922
Thermohypoaesthesia 22.51 10.05 10 232153 102 64266467
Disease recurrence 22.48 10.05 50 232113 31460 64235109
Foot deformity 22.42 10.05 16 232147 16488 64250081
Cardiorenal syndrome 22.37 10.05 25 232138 1225 64265344
Aggression 22.36 10.05 88 232075 46144 64220425
Ventricular internal diameter abnormal 22.35 10.05 11 232152 144 64266425
Myelosuppression 22.23 10.05 32 232131 23798 64242771
Sedation complication 22.23 10.05 5 232158 10349 64256220
Gastric varices 22.09 10.05 17 232146 513 64266056
Haemoglobin decreased 22.05 10.05 885 231278 194178 64072391
Glaucoma 22.01 10.05 16 232147 16332 64250237
Sudden cardiac death 21.91 10.05 50 232113 4537 64262032
Gamma-glutamyltransferase increased 21.88 10.05 269 231894 48241 64218328
Cytomegalovirus viraemia 21.75 10.05 6 232157 10822 64255747
Sight disability 21.70 10.05 10 232153 112 64266457
Dyskinesia 21.69 10.05 71 232092 39317 64227252
Liver disorder 21.59 10.05 290 231873 53061 64213508
Urine potassium increased 21.57 10.05 6 232157 11 64266558
Inflammation 21.50 10.05 142 232021 65158 64201411
Psychotic disorder 21.43 10.05 59 232104 34519 64232050
Decreased appetite 21.37 10.05 1227 230936 280062 63986507
Device alarm issue 21.32 10.05 30 232133 1860 64264709
Pulmonary veno-occlusive disease 21.29 10.05 26 232137 1402 64265167
International normalised ratio abnormal 21.25 10.05 52 232111 4936 64261633
Tenosynovitis 21.22 10.05 8 232155 11825 64254744
Catheter removal 21.11 10.05 17 232146 549 64266020
Pericarditis constrictive 21.05 10.05 17 232146 551 64266018
Conduction disorder 20.90 10.05 38 232125 2930 64263639
Electrocardiogram change 20.82 10.05 23 232140 1113 64265456
Hypophagia 20.75 10.05 226 231937 39361 64227208
Rales 20.74 10.05 109 232054 15120 64251449
Intra-abdominal fluid collection 20.70 10.05 36 232127 2681 64263888
Right ventricular dysfunction 20.58 10.05 32 232131 2171 64264398
Acute graft versus host disease 20.30 10.05 4 232159 9080 64257489
Portal hypertensive gastropathy 20.23 10.05 23 232140 1149 64265420
Serotonin syndrome 20.15 10.05 73 232090 39209 64227360
Catheter site erythema 20.08 10.05 50 232113 4799 64261770
Acute respiratory failure 20.03 10.05 271 231892 49663 64216906
Neutropenic sepsis 20.03 10.05 33 232130 23239 64243330
Blood creatine increased 20.01 10.05 70 232093 8122 64258447
Vision blurred 20.00 10.05 218 231945 90098 64176471
Product quality issue 19.88 10.05 49 232114 29750 64236819
Hypothyroidism 19.86 10.05 228 231935 40229 64226340
Rhabdomyolysis 19.85 10.05 451 231712 91275 64175294
Vascular access site thrombosis 19.84 10.05 7 232156 36 64266533
Transplant rejection 19.81 10.05 20 232143 17381 64249188
Portopulmonary hypertension 19.79 10.05 10 232153 139 64266430
Haemorrhoidal haemorrhage 19.64 10.05 55 232108 5664 64260905
Pulmonary hypertensive crisis 19.62 10.05 13 232150 308 64266261
Shock 19.44 10.05 217 231946 38023 64228546
Influenza like illness 19.41 10.05 136 232027 61566 64205003
Cytokine release syndrome 19.40 10.05 28 232135 20801 64245768
Therapeutic embolisation 19.40 10.05 15 232148 456 64266113
Pruritus 19.13 10.05 924 231239 311476 63955093
Cardiac hypertrophy 19.10 10.05 25 232138 1446 64265123
Multiple allergies 19.08 10.05 55 232108 5759 64260810
Cystitis haemorrhagic 18.87 10.05 3 232160 7953 64258616
Rash pruritic 18.82 10.05 125 232038 57279 64209290
Catheter site discharge 18.80 10.05 31 232132 2210 64264359
Encephalitis 18.70 10.05 11 232152 12560 64254009
Diplopia 18.66 10.05 43 232120 26722 64239847
Ventricular hypokinesia 18.64 10.05 66 232097 7703 64258866
Renal function test abnormal 18.63 10.05 43 232120 3931 64262638
Sinus arrest 18.60 10.05 37 232126 3053 64263516
Diffuse large B-cell lymphoma 18.59 10.05 7 232156 10354 64256215
Oxygen saturation increased 18.53 10.05 15 232148 488 64266081
Bulbospinal muscular atrophy congenital 18.52 10.05 4 232159 0 64266569
Ulcer 18.52 10.05 34 232129 22956 64243613
Ear infection 18.51 10.05 35 232128 23369 64243200
Hypertrophic cardiomyopathy 18.46 10.05 28 232135 1858 64264711
Cardiac dysfunction 18.46 10.05 37 232126 3069 64263500
Urogenital haemorrhage 18.40 10.05 17 232146 663 64265906
Injection site warmth 18.36 10.05 13 232150 13449 64253120
Injury 18.32 10.05 122 232041 55870 64210699
ECG signs of myocardial ischaemia 18.30 10.05 13 232150 346 64266223
Nephrectomy 18.20 10.05 24 232139 1398 64265171
Quadriparesis 18.15 10.05 35 232128 2822 64263747
Infection susceptibility increased 18.07 10.05 34 232129 2692 64263877
Aspiration pleural cavity 18.03 10.05 24 232139 1411 64265158
Coma 18.02 10.05 215 231948 87400 64179169
Rhinitis allergic 18.01 10.05 67 232096 8011 64258558
Fungal infection 18.00 10.05 63 232100 34188 64232381
Somnolence 17.98 10.05 577 231586 203068 64063501
Dystonia 17.93 10.05 25 232138 18840 64247729
Right ventricular dilatation 17.90 10.05 24 232139 1421 64265148
Withdrawal syndrome 17.82 10.05 36 232127 23456 64243113
Upper respiratory tract inflammation 17.82 10.05 41 232122 3741 64262828
Spur cell anaemia 17.81 10.05 8 232155 84 64266485
Ventricular arrhythmia 17.80 10.05 63 232100 7352 64259217
Premature labour 17.79 10.05 3 232160 7617 64258952
Injection site haemorrhage 17.75 10.05 38 232125 24240 64242329
Colitis ulcerative 17.72 10.05 35 232128 22993 64243576
Uveitis 17.69 10.05 12 232151 12696 64253873
Amyloidosis 17.65 10.05 32 232131 2462 64264107
Primary hyperaldosteronism 17.63 10.05 9 232154 128 64266441
Osteonecrosis 17.62 10.05 48 232115 28181 64238388
Atrioventricular block first degree 17.60 10.05 81 232082 10653 64255916
Haemoptysis 17.60 10.05 261 231902 48787 64217782
Activated partial thromboplastin time prolonged 17.59 10.05 92 232071 12739 64253830
Neurotoxicity 17.56 10.05 46 232117 27358 64239211
Hyperaldosteronism 17.46 10.05 13 232150 373 64266196
Intervertebral disc degeneration 17.46 10.05 13 232150 13107 64253462
Cyanosis 17.43 10.05 138 232025 22017 64244552
Photophobia 17.37 10.05 22 232141 17271 64249298
Injection site mass 17.32 10.05 22 232141 17248 64249321
Neck pain 17.28 10.05 140 232023 61393 64205176
Electrocardiogram QRS complex abnormal 17.26 10.05 15 232148 539 64266030
Tuberculosis 17.24 10.05 13 232150 13025 64253544
Drug level decreased 17.20 10.05 10 232153 11493 64255076
Ventricular extrasystoles 17.13 10.05 115 232048 17414 64249155
Catheter site swelling 17.11 10.05 25 232138 1605 64264964
Joint effusion 17.11 10.05 14 232149 13459 64253110
Drug dependence 17.02 10.05 62 232101 33250 64233319
Device difficult to use 16.95 10.05 7 232156 9791 64256778
Hepatorenal failure 16.93 10.05 21 232142 1151 64265418
Thrombotic microangiopathy 16.92 10.05 21 232142 16634 64249935
Hypoparathyroidism secondary 16.89 10.05 10 232153 193 64266376
Loss of personal independence in daily activities 16.81 10.05 173 231990 72281 64194288
Bleeding varicose vein 16.74 10.05 14 232149 477 64266092
Immunodeficiency 16.73 10.05 20 232143 16104 64250465
Marasmus 16.65 10.05 18 232145 850 64265719
Gout 16.64 10.05 133 232030 21280 64245289
Influenza 16.40 10.05 277 231886 106254 64160315
Ectopic ACTH syndrome 16.37 10.05 9 232154 150 64266419
Diet noncompliance 16.35 10.05 13 232150 412 64266157
Brain stem stroke 16.29 10.05 13 232150 414 64266155
Diabetic ketoacidosis 16.29 10.05 54 232109 29791 64236778
Endometriosis male 16.28 10.05 5 232158 15 64266554
Multiple sclerosis 16.17 10.05 27 232136 18914 64247655
Nodal arrhythmia 16.15 10.05 26 232137 1817 64264752
Aspartate aminotransferase increased 16.07 10.05 554 231609 119234 64147335
Cardiac arrest 16.04 10.05 693 231470 153371 64113198
Product dose omission issue 15.97 10.05 557 231606 194190 64072379
Encephalopathy 15.95 10.05 299 231864 58520 64208049
Cortisol increased 15.93 10.05 13 232150 428 64266141
Posterior reversible encephalopathy syndrome 15.89 10.05 37 232126 22909 64243660
Metastases to central nervous system 15.82 10.05 16 232147 13896 64252673
Drug tolerance decreased 15.81 10.05 3 232160 6995 64259574
Mass 15.80 10.05 19 232144 15257 64251312
Pancytopenia 15.71 10.05 394 231769 142915 64123654
Scrotal swelling 15.69 10.05 18 232145 908 64265661
Dizziness postural 15.56 10.05 73 232090 9679 64256890
Toxic epidermal necrolysis 15.44 10.05 203 231960 36963 64229606
Second primary malignancy 15.44 10.05 13 232150 12324 64254245
Angina unstable 15.44 10.05 102 232061 15365 64251204
Caesarean section 15.22 10.05 11 232152 11263 64255306
Peripartum cardiomyopathy 15.12 10.05 8 232155 123 64266446
Hospitalisation 15.11 10.05 366 231797 74841 64191728
Hypernatraemia 15.09 10.05 85 232078 12104 64254465
International normalised ratio decreased 15.01 10.05 60 232103 7418 64259151
Vessel puncture site haemorrhage 15.01 10.05 9 232154 178 64266391
Atrial septal defect repair 14.99 10.05 12 232151 384 64266185
Bronchial secretion retention 14.90 10.05 30 232133 2497 64264072
Bone pain 14.89 10.05 105 232058 47467 64219102
Transplant dysfunction 14.89 10.05 3 232160 6705 64259864
Injection site rash 14.82 10.05 21 232142 15721 64250848
Leukaemic infiltration renal 14.80 10.05 5 232158 22 64266547
Multiple drug therapy 14.80 10.05 28 232135 2226 64264343
Ventricular dyssynchrony 14.77 10.05 6 232157 48 64266521
Hypoaesthesia oral 14.74 10.05 12 232151 11568 64255001
Lymphocyte count decreased 14.70 10.05 86 232077 40613 64225956
Viral diarrhoea 14.66 10.05 10 232153 249 64266320
Lymphadenopathy 14.64 10.05 103 232060 46583 64219986
Blood culture negative 14.62 10.05 9 232154 187 64266382
Gender dysphoria 14.56 10.05 6 232157 50 64266519
Vasodilatation 14.53 10.05 33 232130 2985 64263584
Acute myocardial infarction 14.53 10.05 341 231822 69377 64197192
Premature delivery 14.52 10.05 28 232135 18561 64248008
Agitation 14.52 10.05 227 231936 88140 64178429
Hallucination 14.45 10.05 180 231983 72608 64193961
Catheter site pain 14.44 10.05 42 232121 4420 64262149
Conjunctival scar 14.41 10.05 7 232156 89 64266480
Blood albumin decreased 14.31 10.05 127 232036 20946 64245623
Squamous cell carcinoma of skin 14.28 10.05 13 232150 11863 64254706
Vascular access site infection 14.20 10.05 7 232156 92 64266477
Brain oedema 14.18 10.05 37 232126 22038 64244531
Eye pain 14.17 10.05 62 232101 31563 64235006
Pulmonary capillary haemangiomatosis 14.16 10.05 6 232157 54 64266515
Electrolyte depletion 14.12 10.05 11 232152 338 64266231
Hepatic neoplasm 14.11 10.05 33 232130 3044 64263525
Eye irritation 14.10 10.05 22 232141 15834 64250735
Periarthritis calcarea 14.07 10.05 6 232157 55 64266514
Ankylosing spondylitis 14.06 10.05 6 232157 8228 64258341
Movement disorder 14.04 10.05 37 232126 21963 64244606
Substance abuse 14.00 10.05 8 232155 9284 64257285
Incision site impaired healing 13.99 10.05 10 232153 269 64266300
Inappropriate antidiuretic hormone secretion 13.96 10.05 132 232031 22157 64244412
Cystitis 13.95 10.05 93 232070 42582 64223987
Muscle haemorrhage 13.91 10.05 49 232114 5704 64260865
Secondary sexual characteristics absence 13.89 10.05 3 232160 0 64266569
Disability 13.84 10.05 14 232149 12158 64254411
Cardiac amyloidosis 13.84 10.05 21 232142 1394 64265175
Gastric polyps 13.81 10.05 32 232131 2933 64263636
Preternatural anus 13.81 10.05 7 232156 98 64266471
Emotional disorder 13.78 10.05 15 232148 12592 64253977
Injection site urticaria 13.73 10.05 12 232151 11169 64255400
Red cell distribution width abnormal 13.70 10.05 9 232154 210 64266359
Mouth ulceration 13.70 10.05 65 232098 32379 64234190
Sleep apnoea syndrome 13.70 10.05 166 231997 29666 64236903
Blood uric acid increased 13.68 10.05 62 232101 8101 64258468
Osteomyelitis 13.67 10.05 52 232111 27535 64239034
Pulmonary vein stenosis 13.63 10.05 8 232155 152 64266417
Lymphopenia 13.61 10.05 47 232116 25610 64240959
Chills 13.57 10.05 383 231780 136881 64129688
Device occlusion 13.54 10.05 71 232092 9842 64256727
Bladder irrigation 13.53 10.05 6 232157 61 64266508
Blood creatinine abnormal 13.50 10.05 39 232124 4088 64262481
Bilirubin conjugated increased 13.50 10.05 44 232119 4924 64261645
Blood thyroid stimulating hormone abnormal 13.49 10.05 15 232148 731 64265838
Oxygen saturation decreased 13.46 10.05 492 231671 106684 64159885
Ataxia 13.45 10.05 38 232125 22046 64244523
Memory impairment 13.44 10.05 222 231941 85460 64181109
Blood calcium decreased 13.43 10.05 47 232116 25507 64241062
Nephrolithiasis 13.39 10.05 97 232066 43586 64222983
Ear pain 13.36 10.05 46 232117 25090 64241479
Pulmonary arterial wedge pressure increased 13.33 10.05 12 232151 452 64266117
Urine output increased 13.33 10.05 24 232139 1837 64264732
Subchorionic haematoma 13.33 10.05 7 232156 106 64266463
Visual impairment 13.31 10.05 187 231976 73890 64192679
Gastritis erosive 13.29 10.05 69 232094 9526 64257043
Labelled drug-disease interaction medication error 13.28 10.05 10 232153 292 64266277
Renin decreased 13.15 10.05 7 232156 109 64266460
Liver carcinoma ruptured 13.09 10.05 8 232155 164 64266405
Prothrombin level decreased 13.07 10.05 21 232142 1465 64265104
Mood swings 13.06 10.05 27 232136 17441 64249128
Oxygen consumption decreased 13.05 10.05 11 232152 379 64266190
Eosinophilia 13.03 10.05 201 231962 37875 64228694
Renal dysplasia 13.02 10.05 4 232159 12 64266557
Partial seizures 13.00 10.05 5 232158 7302 64259267
Tricuspid valve disease 13.00 10.05 11 232152 381 64266188
Postrenal failure 12.98 10.05 13 232150 561 64266008
Xanthopsia 12.96 10.05 10 232153 303 64266266
Drug tolerance 12.94 10.05 3 232160 6082 64260487
Left ventricular hypertrophy 12.92 10.05 68 232095 9438 64257131
Dysarthria 12.91 10.05 144 232019 59262 64207307
Hypoglycaemia 12.88 10.05 419 231744 89473 64177096
Panniculitis 12.88 10.05 8 232155 8871 64257698
Left ventricular enlargement 12.80 10.05 14 232149 670 64265899
Hydrothorax 12.79 10.05 19 232144 1238 64265331
Aortic stenosis 12.72 10.05 51 232112 6314 64260255
Bile acid malabsorption 12.72 10.05 8 232155 173 64266396
Prostatomegaly 12.72 10.05 31 232132 2936 64263633
Primary biliary cholangitis 12.71 10.05 17 232146 1004 64265565
Cerebral infarction 12.67 10.05 213 231950 40831 64225738
Hypoglycaemic coma 12.66 10.05 39 232124 4235 64262334
Therapeutic response increased 12.65 10.05 12 232151 484 64266085
Fibrinous bronchitis 12.65 10.05 5 232158 37 64266532
Affective disorder 12.57 10.05 4 232159 6576 64259993
Blood catecholamines decreased 12.56 10.05 4 232159 14 64266555
Aspergillus infection 12.51 10.05 25 232138 16354 64250215
Subarachnoid haemorrhage 12.46 10.05 111 232052 18327 64248242
Resting tremor 12.46 10.05 20 232143 1394 64265175
Foetal death 12.46 10.05 3 232160 5927 64260642
Nephrogenic anaemia 12.44 10.05 33 232130 3292 64263277
Right atrial dilatation 12.43 10.05 14 232149 692 64265877
Child-Pugh-Turcotte score increased 12.42 10.05 5 232158 39 64266530
Burning feet syndrome 12.41 10.05 7 232156 123 64266446
Haematuria 12.36 10.05 295 231868 60176 64206393
Restlessness 12.36 10.05 88 232075 39697 64226872
C-reactive protein increased 12.36 10.05 254 231909 94655 64171914
Product storage error 12.31 10.05 18 232145 13300 64253269
Device use error 12.25 10.05 4 232159 6467 64260102
Secretion discharge 12.25 10.05 15 232148 11949 64254620
Bundle branch block 12.19 10.05 20 232143 1420 64265149
Coordination abnormal 12.17 10.05 22 232141 14942 64251627
Ovarian cyst 12.16 10.05 13 232150 11005 64255564
Craniotomy 12.15 10.05 10 232153 333 64266236
Gastric varices haemorrhage 12.15 10.05 10 232153 333 64266236
Tricuspid valve replacement 12.14 10.05 4 232159 16 64266553
Full blood count abnormal 12.14 10.05 162 232001 29595 64236974
Portal shunt procedure 12.14 10.05 4 232159 16 64266553
Drug abuser 12.08 10.05 3 232160 5805 64260764
Renal injury 12.08 10.05 96 232067 15333 64251236
Exostosis 12.07 10.05 14 232149 11424 64255145
Chronic respiratory failure 12.00 10.05 28 232135 2578 64263991
Vascular device infection 11.94 10.05 49 232114 6131 64260438
Blood ketone body increased 11.93 10.05 13 232150 619 64265950
Tooth disorder 11.91 10.05 41 232122 22361 64244208
Performance enhancing product use 11.90 10.05 6 232157 83 64266486
Intestinal obstruction 11.90 10.05 79 232084 36207 64230362
Alpha 1 foetoprotein increased 11.90 10.05 14 232149 726 64265843
Pneumocystis jirovecii pneumonia 11.89 10.05 55 232108 27579 64238990
Infective pulmonary exacerbation of cystic fibrosis 11.85 10.05 15 232148 11781 64254788
Meningitis aseptic 11.84 10.05 3 232160 5727 64260842
Macroangiopathy 11.83 10.05 7 232156 135 64266434
Persistent foetal circulation 11.82 10.05 3 232160 3 64266566
Thrombosis 11.76 10.05 181 231982 70461 64196108
BK virus infection 11.73 10.05 6 232157 7406 64259163
Myasthenic syndrome 11.72 10.05 13 232150 632 64265937
Puncture site pain 11.71 10.05 5 232158 46 64266523
Multiple organ dysfunction syndrome 11.65 10.05 461 231702 100952 64165617
Adrenal cyst 11.65 10.05 6 232157 87 64266482
Cataract 11.64 10.05 123 232040 51139 64215430
Hepatic calcification 11.63 10.05 10 232153 354 64266215
Demyelination 11.63 10.05 5 232158 6829 64259740
Cardiac ablation 11.62 10.05 22 232141 1750 64264819
Cortisol free urine increased 11.61 10.05 5 232158 47 64266522
Hypomania 11.61 10.05 3 232160 5651 64260918
Infected skin ulcer 11.58 10.05 30 232133 2950 64263619
Insurance issue 11.55 10.05 29 232134 2797 64263772
Hepatitis fulminant 11.54 10.05 49 232114 6225 64260344
Brain natriuretic peptide 11.52 10.05 5 232158 48 64266521
Base excess decreased 11.52 10.05 10 232153 359 64266210
Tongue disorder 11.49 10.05 16 232147 12064 64254505
Alkalosis hypochloraemic 11.49 10.05 11 232152 449 64266120
Fluid intake reduced 11.48 10.05 43 232120 5157 64261412
Graft versus host disease in gastrointestinal tract 11.48 10.05 3 232160 5609 64260960
Device inappropriate shock delivery 11.43 10.05 5 232158 49 64266520
Aspiration bone marrow 11.43 10.05 5 232158 49 64266520
Inappropriate schedule of product administration 11.43 10.05 249 231914 92037 64174532
Apheresis related complication 11.43 10.05 4 232159 20 64266549
Pulmonary artery dilatation 11.42 10.05 10 232153 363 64266206
Acute left ventricular failure 11.39 10.05 19 232144 1368 64265201
Fistula 11.36 10.05 11 232152 9750 64256819
Unintentional medical device removal 11.35 10.05 5 232158 6729 64259840
Rash erythematous 11.33 10.05 116 232047 48517 64218052
Venous pressure jugular increased 11.32 10.05 18 232145 1245 64265324
Small intestinal obstruction 11.31 10.05 45 232118 23528 64243041
Blood potassium abnormal 11.30 10.05 27 232136 2525 64264044
Adenovirus infection 11.29 10.05 6 232157 7249 64259320
Adrenomegaly 11.28 10.05 10 232153 369 64266200
Haemorrhagic disorder 11.27 10.05 19 232144 1380 64265189
Poor venous access 11.26 10.05 17 232146 12400 64254169
Respiratory failure 11.26 10.05 698 231465 160485 64106084
Articular calcification 11.24 10.05 6 232157 94 64266475
Foot fracture 11.24 10.05 31 232132 18126 64248443
Internal haemorrhage 11.23 10.05 56 232107 7611 64258958
Therapeutic response shortened 11.22 10.05 12 232151 10158 64256411
Dry eye 11.19 10.05 60 232103 28959 64237610
Atrial thrombosis 11.19 10.05 30 232133 3012 64263557
Ventricular assist device insertion 11.17 10.05 5 232158 52 64266517
QRS axis abnormal 11.14 10.05 22 232141 1805 64264764
Gamma-glutamyltransferase abnormal 11.11 10.05 11 232152 468 64266101
Synovial cyst 11.10 10.05 7 232156 7700 64258869
Central venous catheterisation 11.07 10.05 28 232135 2713 64263856
Stevens-Johnson syndrome 11.04 10.05 179 231984 34070 64232499
Tenderness 11.02 10.05 35 232128 19567 64247002
Pulmonary embolism 11.00 10.05 423 231740 145933 64120636
Catastrophic reaction 10.97 10.05 4 232159 23 64266546
Heart sounds abnormal 10.95 10.05 17 232146 1152 64265417
Amaurosis 10.94 10.05 16 232147 1028 64265541
Extrapyramidal disorder 10.93 10.05 35 232128 19517 64247052
Hypocoagulable state 10.93 10.05 22 232141 1831 64264738
Incorrect route of product administration 10.85 10.05 45 232118 23253 64243316
Paranoia 10.82 10.05 27 232136 16325 64250244
Blood bilirubin abnormal 10.81 10.05 16 232147 1039 64265530
Haemorrhagic infarction 10.78 10.05 13 232150 692 64265877
Spinal pain 10.77 10.05 18 232145 12603 64253966
Altered state of consciousness 10.74 10.05 194 231969 37708 64228861
Dilatation atrial 10.71 10.05 32 232131 3418 64263151
Subcutaneous haematoma 10.70 10.05 26 232137 2457 64264112
Congenital arterial malformation 10.69 10.05 4 232159 25 64266544
Blood pressure systolic abnormal 10.68 10.05 12 232151 9930 64256639
Haemothorax 10.66 10.05 40 232123 4802 64261767
Catheter site inflammation 10.66 10.05 15 232148 930 64265639
Cognitive disorder 10.64 10.05 137 232026 54950 64211619
Cryoglobulins present 10.62 10.05 3 232160 6 64266563
Fear of injection 10.60 10.05 4 232159 5908 64260661
Peroneal nerve palsy 10.59 10.05 3 232160 5318 64261251
Nephrocalcinosis 10.59 10.05 18 232145 1316 64265253
Dependence on oxygen therapy 10.57 10.05 10 232153 402 64266167
Diffuse vasculitis 10.56 10.05 6 232157 107 64266462
Enteritis 10.51 10.05 17 232146 12060 64254509
Angina pectoris 10.49 10.05 224 231939 44857 64221712
Systemic scleroderma 10.44 10.05 15 232148 948 64265621
Swelling face 10.40 10.05 150 232013 59016 64207553
Headache 10.40 10.05 1711 230452 527756 63738813
Haematocrit abnormal 10.39 10.05 18 232145 1336 64265233
Right-to-left cardiac shunt 10.34 10.05 7 232156 172 64266397
Breast discomfort 10.34 10.05 9 232154 324 64266245
Depressed mood 10.32 10.05 96 232067 40916 64225653
Anxiety disorder due to a general medical condition 10.31 10.05 3 232160 7 64266562
Enteropathy-associated T-cell lymphoma 10.31 10.05 3 232160 7 64266562
Hyperandrogenism 10.31 10.05 3 232160 7 64266562
Neutrophil count increased 10.30 10.05 51 232112 25123 64241446
Blood albumin abnormal 10.29 10.05 12 232151 616 64265953
Joint injury 10.27 10.05 45 232118 22902 64243667
Costal cartilage fracture 10.24 10.05 8 232155 247 64266322
Balance disorder 10.23 10.05 227 231936 83699 64182870
Forced expiratory volume decreased 10.22 10.05 6 232157 6861 64259708
Alcoholic liver disease 10.21 10.05 11 232152 517 64266052
Time perception altered 10.20 10.05 7 232156 176 64266393
Alkalosis 10.19 10.05 10 232153 421 64266148
Prolactin-producing pituitary tumour 10.17 10.05 6 232157 115 64266454
Blood pressure diastolic abnormal 10.16 10.05 17 232146 11900 64254669
Bradypnoea 10.10 10.05 3 232160 5156 64261413
Feeling abnormal 10.07 10.05 386 231777 133216 64133353
Toxic skin eruption 10.06 10.05 110 232053 19174 64247395

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C03DA01 CARDIOVASCULAR SYSTEM
DIURETICS
ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS
Aldosterone antagonists
FDA MoA N0000011310 Aldosterone Antagonists
FDA EPC N0000175557 Aldosterone Antagonist
MeSH PA D004232 Diuretics
MeSH PA D006727 Hormone Antagonists
MeSH PA D000451 Mineralocorticoid Receptor Antagonists
MeSH PA D045283 Natriuretic Agents
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 | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Chronic heart failure indication 48447003
Aldosteronism indication 88213004 DOID:446
Edema indication 267038008
Ascites indication 389026000
Diagnostic Test for Primary Aldosteronism indication
Hypokalemia Prevention indication
Peripheral Edema due to Chronic Heart Failure indication
Edema due to Hepatic Cirrhosis indication
Edema due to Nephrotic Syndrome indication
Pulmonary Edema due to Chronic Heart Failure indication
Acne off-label use 11381005 DOID:6543
Polycystic ovaries off-label use 69878008
Anuria contraindication 2472002 DOID:2983
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Metabolic acidosis, normal anion gap, acidifying salts contraindication 18104000
Secondary angle-closure glaucoma contraindication 21571006
Hypovolemia contraindication 28560003
Dehydration contraindication 34095006
Hyperuricemia contraindication 35885006 DOID:1920
Hypokalemia contraindication 43339004
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Acute nephropathy contraindication 58574008
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Neonatal hyperbilirubinemia contraindication 281610001
Azotemia contraindication 445009001




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

ProductApplicantIngredients
Cardalis Ceva Sante Animale 2

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
25MG/5ML CAROSPIR CMP DEV LLC N209478 Aug. 4, 2017 RX SUSPENSION ORAL 9757394 Oct. 28, 2036 CAROSPIR IS INDICATED FOR TREATMENT OF NYHA CLASS III-IV HEART FAILURE AND REDUCED EJECTION FRACTION TO INCREASE SURVIVAL, MANAGE EDEMA, AND TO REDUCE THE NEED FOR HOSPITALIZATION FOR HEART FAILURE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Mineralocorticoid receptor Nuclear hormone receptor ANTAGONIST IC50 9.88 WOMBAT-PK CHEMBL
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor WOMBAT-PK
Androgen receptor Nuclear hormone receptor Ki 7.40 CHEMBL
Progesterone receptor Nuclear hormone receptor EC50 6.03 WOMBAT-PK
Estrogen receptor beta Nuclear hormone receptor EC50 5.48 CHEMBL
Cytochrome P450 2C19 Enzyme IC50 5.52 DRUG MATRIX
Glucocorticoid receptor Nuclear hormone receptor IC50 6.23 WOMBAT-PK
Multidrug and toxin extrusion protein 1 Transporter IC50 4.73 CHEMBL
Androgen receptor Transcription factor IC50 6.17 CHEMBL
Progesterone receptor Transcription factor Ki 6.66 DRUG MATRIX

External reference:

IDSource
4017881 VUID
N0000146234 NUI
D00443 KEGG_DRUG
4017881 VANDF
C0037982 UMLSCUI
CHEBI:9241 CHEBI
SNL PDB_CHEM_ID
CHEMBL1393 ChEMBL_ID
D013148 MESH_DESCRIPTOR_UI
DB00421 DRUGBANK_ID
5833 PUBCHEM_CID
2875 IUPHAR_LIGAND_ID
987 INN_ID
27O7W4T232 UNII
151317 RXNORM
1558 MMSL
1587 MMSL
5506 MMSL
d00373 MMSL
002211 NDDF
13929005 SNOMEDCT_US
387078006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Aldactone HUMAN PRESCRIPTION DRUG LABEL 1 0025-1001 TABLET, FILM COATED 25 mg ORAL NDA 26 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
Aldactone HUMAN PRESCRIPTION DRUG LABEL 1 0025-1031 TABLET, FILM COATED 100 mg ORAL NDA 26 sections
Aldactone HUMAN PRESCRIPTION DRUG LABEL 1 0025-1041 TABLET, FILM COATED 50 mg ORAL NDA 26 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 0378-0243 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Spironolactone and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0378-0403 TABLET 25 mg ORAL ANDA 25 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 0378-0437 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 0378-2146 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8178 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8221 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6927 TABLET 25 mg ORAL ANDA 24 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 10544-499 TABLET 25 mg ORAL ANDA 16 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 10544-523 TABLET 25 mg ORAL ANDA 16 sections
SPIRONOLACTONE HUMAN PRESCRIPTION DRUG LABEL 1 16714-084 TABLET 25 mg ORAL ANDA 25 sections
SPIRONOLACTONE HUMAN PRESCRIPTION DRUG LABEL 1 16714-085 TABLET, FILM COATED 50 mg ORAL ANDA 25 sections
SPIRONOLACTONE HUMAN PRESCRIPTION DRUG LABEL 1 16714-086 TABLET, FILM COATED 100 mg ORAL ANDA 25 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 16729-225 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 16729-226 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 16729-227 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
CaroSpir HUMAN PRESCRIPTION DRUG LABEL 1 17856-0120 Suspension 25 mg ORAL NDA 25 sections
CaroSpir HUMAN PRESCRIPTION DRUG LABEL 1 17856-0120 Suspension 25 mg ORAL NDA 25 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 21695-766 TABLET 25 mg ORAL ANDA 26 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 21695-960 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 33261-764 TABLET, FILM COATED 100 mg ORAL ANDA 27 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 33261-869 TABLET, FILM COATED 25 mg ORAL ANDA 27 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 33261-895 TABLET, FILM COATED 50 mg ORAL ANDA 27 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 42254-183 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections
Spironolactone and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 42292-017 TABLET 25 mg ORAL ANDA 25 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 42708-101 TABLET, FILM COATED 25 mg ORAL ANDA 23 sections