spironolactone 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 ┬ÁM/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 2050.93 9.56 1500 152578 52756 53142232
Acute kidney injury 1095.02 9.56 2321 151757 251547 52943441
Cardiac failure 994.30 9.56 1232 152846 84612 53110376
Hyponatraemia 635.37 9.56 1131 152947 107476 53087512
Drug ineffective 620.26 9.56 879 153199 816366 52378622
Rheumatoid arthritis 502.93 9.56 143 153935 314388 52880600
Right ventricular failure 489.71 9.56 399 153679 16444 53178544
Pulmonary arterial hypertension 470.84 9.56 481 153597 26641 53168347
Ascites 414.77 9.56 542 153536 39193 53155795
Pulmonary hypertension 385.32 9.56 506 153572 36764 53158224
Hepatic encephalopathy 377.75 9.56 286 153792 10573 53184415
Renal impairment 302.83 9.56 713 153365 82605 53112383
Drug interaction 281.93 9.56 1317 152761 218012 52976976
Bradycardia 281.32 9.56 629 153449 70427 53124561
Cardiac failure congestive 279.49 9.56 739 153339 92018 53102970
Oedema peripheral 277.51 9.56 1101 152977 169686 53025302
Hypotension 272.36 9.56 1449 152629 252627 52942361
Pemphigus 263.72 9.56 8 154070 104023 53090965
Synovitis 260.82 9.56 12 154066 107881 53087107
Fluid retention 252.74 9.56 514 153564 53887 53141101
Joint swelling 251.97 9.56 186 153892 234452 52960536
Maternal exposure during pregnancy 249.80 9.56 70 154008 155569 53039419
Renal failure 241.44 9.56 822 153256 117630 53077358
Dyspnoea 241.08 9.56 2667 151411 583565 52611423
Arthropathy 220.78 9.56 67 154011 141386 53053602
Systemic lupus erythematosus 213.52 9.56 50 154028 125364 53069624
Hand deformity 209.86 9.56 8 154070 84841 53110147
Pain 208.86 9.56 933 153145 587465 52607523
Treatment failure 207.42 9.56 57 154021 128346 53066642
Contraindicated product administered 204.98 9.56 68 154010 135561 53059427
Infusion related reaction 204.89 9.56 97 153981 155860 53039128
Drug intolerance 198.10 9.56 181 153897 205312 52989676
Glossodynia 196.45 9.56 28 154050 100263 53094725
Therapeutic product effect decreased 191.65 9.56 62 154016 125593 53069395
Dehydration 190.21 9.56 975 153103 167435 53027553
Blood creatinine increased 189.34 9.56 597 153481 82065 53112923
International normalised ratio increased 189.20 9.56 423 153655 47338 53147650
Hepatic cirrhosis 188.24 9.56 246 153832 17776 53177212
Atrial fibrillation 169.40 9.56 705 153373 110947 53084041
Fluid overload 166.50 9.56 293 153785 27538 53167450
Oedema 162.11 9.56 528 153550 73818 53121170
Alopecia 158.72 9.56 271 153807 234312 52960676
Exposure during pregnancy 147.32 9.56 89 153989 124771 53070217
Completed suicide 146.35 9.56 111 153967 138090 53056898
Rash 145.38 9.56 729 153349 445462 52749526
Hypersensitivity 142.83 9.56 243 153835 210422 52984566
Arthralgia 142.44 9.56 720 153358 439063 52755925
Wound 138.13 9.56 46 154032 91511 53103477
Blood potassium increased 138.07 9.56 211 153867 17630 53177358
Cardiac failure chronic 128.90 9.56 101 153977 3929 53191059
Musculoskeletal stiffness 125.68 9.56 103 153975 123265 53071723
Discomfort 122.86 9.56 61 154017 95411 53099577
Anaemia 121.90 9.56 1278 152800 275440 52919548
Drug hypersensitivity 120.13 9.56 380 153698 264862 52930126
Dyspnoea exertional 119.32 9.56 390 153688 54610 53140378
Pericarditis 119.29 9.56 21 154057 64385 53130603
Off label use 116.64 9.56 842 153236 471370 52723618
Blood urea increased 114.91 9.56 242 153836 25989 53168999
Abdominal discomfort 114.53 9.56 297 153781 220765 52974223
General physical health deterioration 110.53 9.56 765 153313 146177 53048811
Drug abuse 107.83 9.56 28 154050 65498 53129490
Gastrointestinal haemorrhage 104.11 9.56 484 153594 79846 53115142
Syncope 98.81 9.56 607 153471 111386 53083602
Melaena 96.85 9.56 241 153837 28888 53166100
Lower respiratory tract infection 91.36 9.56 77 154001 90904 53104084
Cardiac failure acute 90.15 9.56 121 153957 8971 53186017
Cardioactive drug level increased 89.75 9.56 63 154015 2066 53192922
Hepatic enzyme increased 89.72 9.56 141 153937 126054 53068934
Hepatic failure 88.81 9.56 266 153812 35540 53159448
N-terminal prohormone brain natriuretic peptide increased 86.51 9.56 59 154019 1845 53193143
Helicobacter infection 86.41 9.56 7 154071 39062 53155926
Hypokalaemia 81.92 9.56 518 153560 95999 53098989
Transfusion 80.43 9.56 143 153935 13544 53181444
Product prescribing error 79.16 9.56 193 153885 22838 53172150
Febrile neutropenia 78.70 9.56 113 153965 104823 53090165
Blood bilirubin increased 77.16 9.56 253 153825 35477 53159511
Toxicity to various agents 77.02 9.56 349 153729 219249 52975739
Atrioventricular block 76.95 9.56 99 153979 7041 53187947
Orthopnoea 76.01 9.56 91 153987 6013 53188975
Duodenal ulcer perforation 75.92 9.56 7 154071 35176 53159812
Product use issue 73.41 9.56 186 153892 139398 53055590
Brain natriuretic peptide increased 70.69 9.56 79 153999 4846 53190142
Abortion spontaneous 69.33 9.56 24 154054 46611 53148377
Folliculitis 69.25 9.56 6 154072 31703 53163285
Atrial flutter 66.68 9.56 108 153970 9483 53185505
Stomatitis 65.73 9.56 114 153964 98044 53096944
Injection site erythema 65.33 9.56 76 154002 77173 53117815
Injection site pain 65.28 9.56 144 153934 113247 53081741
Cardiogenic shock 64.94 9.56 151 153927 17331 53177657
Pain in jaw 64.92 9.56 261 153817 40408 53154580
Intentional overdose 64.90 9.56 59 154019 67146 53127842
Sinusitis 64.55 9.56 259 153819 168305 53026683
Pulmonary oedema 63.30 9.56 315 153763 53408 53141580
Congestive cardiomyopathy 62.87 9.56 83 153995 6055 53188933
Swelling 62.72 9.56 311 153767 190794 53004194
Catheter management 61.51 9.56 57 154021 2795 53192193
Tricuspid valve incompetence 60.95 9.56 131 153947 14265 53180723
Pulmonary arterial pressure increased 60.39 9.56 62 154016 3450 53191538
Pleural effusion 59.52 9.56 449 153629 88130 53106858
Ventricular tachycardia 59.09 9.56 147 153931 17615 53177373
Glomerular filtration rate decreased 58.50 9.56 120 153958 12647 53182341
Chronic kidney disease 58.15 9.56 264 153814 43106 53151882
Sleep disorder due to general medical condition, insomnia type 57.87 9.56 3 154075 24346 53170642
Left ventricular failure 57.56 9.56 74 154004 5259 53189729
Mobility decreased 57.31 9.56 82 153996 76189 53118799
Injection site reaction 56.86 9.56 39 154039 51127 53143861
Blood pressure decreased 56.86 9.56 339 153739 61530 53133458
Hepatic function abnormal 56.67 9.56 234 153844 36665 53158323
Therapeutic product effect incomplete 56.67 9.56 112 153966 91672 53103316
Urticaria 56.41 9.56 202 153876 135683 53059305
Concomitant disease aggravated 56.18 9.56 95 153983 8643 53186345
Arthritis 56.10 9.56 104 153974 87194 53107794
Abdominal distension 55.62 9.56 408 153670 79382 53115606
Sensitisation 54.85 9.56 39 154039 1306 53193682
Cardiomegaly 54.73 9.56 143 153935 17657 53177331
Anaphylactic reaction 54.21 9.56 53 154025 58273 53136715
Hepatocellular carcinoma 54.10 9.56 55 154023 3025 53191963
Atrioventricular block complete 54.02 9.56 89 153989 7926 53187062
Paracentesis 53.87 9.56 34 154044 930 53194058
Nasopharyngitis 53.76 9.56 330 153748 191965 53003023
Product monitoring error 52.91 9.56 53 154025 2864 53192124
Fall 51.45 9.56 1377 152701 357063 52837925
Electrolyte imbalance 51.35 9.56 145 153933 18739 53176249
Paraesthesia 51.32 9.56 192 153886 127323 53067665
Cor pulmonale 51.31 9.56 44 154034 1946 53193042
Ill-defined disorder 50.67 9.56 41 154037 49403 53145585
Catheter site infection 50.36 9.56 67 154011 4925 53190063
Anuria 50.16 9.56 111 153967 12329 53182659
Arrhythmia 50.15 9.56 225 153853 36554 53158434
Renal disorder 49.74 9.56 191 153887 28948 53166040
Generalised oedema 49.22 9.56 124 153954 14975 53180013
Irritable bowel syndrome 48.83 9.56 33 154045 43599 53151389
Infection 48.40 9.56 295 153783 171910 53023078
Epistaxis 48.26 9.56 352 153726 68358 53126630
Neutropenia 47.77 9.56 267 153811 158918 53036070
Polycystic ovaries 46.23 9.56 44 154034 2232 53192756
Fatigue 46.10 9.56 1687 152391 728819 52466169
Congestive hepatopathy 45.87 9.56 47 154031 2609 53192379
Haematemesis 44.52 9.56 192 153886 30665 53164323
Oesophageal varices haemorrhage 43.56 9.56 33 154045 1220 53193768
Psoriatic arthropathy 43.40 9.56 45 154033 48145 53146843
Blood sodium decreased 43.19 9.56 156 153922 22960 53172028
Ejection fraction 42.76 9.56 30 154048 983 53194005
Sinoatrial block 42.70 9.56 28 154050 819 53194169
Impaired healing 42.58 9.56 75 154003 64130 53130858
Palpitations 41.36 9.56 465 153613 101883 53093105
Oxygen saturation decreased 41.35 9.56 370 153708 76355 53118633
Orthostatic hypotension 41.30 9.56 183 153895 29570 53165418
Prothrombin time prolonged 41.14 9.56 89 153989 9733 53185255
Device related infection 41.08 9.56 152 153926 22634 53172354
Pericardial effusion 40.33 9.56 171 153907 27107 53167881
Foetal exposure during pregnancy 39.19 9.56 26 154052 34689 53160299
Haematoma 38.84 9.56 197 153881 33647 53161341
Sputum culture positive 38.40 9.56 33 154045 1464 53193524
Hypoxia 38.39 9.56 284 153794 55396 53139592
Electrocardiogram QRS complex prolonged 37.68 9.56 63 154015 5679 53189309
Respiratory failure 37.64 9.56 450 153628 100062 53094926
Vital capacity decreased 37.54 9.56 28 154050 1011 53193977
Injection site pruritus 37.27 9.56 39 154039 41550 53153438
Upper gastrointestinal haemorrhage 37.24 9.56 123 153955 17307 53177681
Ammonia increased 36.67 9.56 55 154023 4518 53190470
Gastrointestinal disorder 36.54 9.56 135 153943 89869 53105119
Pregnancy 36.24 9.56 23 154055 31418 53163570
Body tinea 36.05 9.56 29 154049 1172 53193816
Shock haemorrhagic 35.97 9.56 81 153997 9102 53185886
Multiple sclerosis relapse 35.94 9.56 46 154032 44807 53150181
Subdural haematoma 35.56 9.56 104 153974 13709 53181279
Hip arthroplasty 35.53 9.56 18 154060 27844 53167144
Blood aldosterone increased 35.48 9.56 15 154063 171 53194817
Osteoarthritis 35.45 9.56 96 153982 70390 53124598
Aspartate aminotransferase increased 35.42 9.56 385 153693 83644 53111344
Atrial tachycardia 35.14 9.56 38 154040 2246 53192742
Hypovolaemic shock 34.86 9.56 60 154018 5537 53189451
Lactic acidosis 34.78 9.56 205 153873 37048 53157940
Portal hypertension 34.52 9.56 48 154030 3680 53191308
Varices oesophageal 34.42 9.56 43 154035 2969 53192019
Catheter placement 34.40 9.56 36 154042 2049 53192939
Cardiac disorder 34.36 9.56 243 153835 46723 53148265
Left ventricular dysfunction 34.26 9.56 90 153988 11147 53183841
Knee arthroplasty 34.19 9.56 28 154050 33541 53161447
Labelled drug-drug interaction medication error 33.96 9.56 88 153990 10811 53184177
Cardiomyopathy 33.36 9.56 117 153961 16971 53178017
Blood alkaline phosphatase increased 33.23 9.56 219 153859 41143 53153845
Reversible airways obstruction 33.03 9.56 27 154051 1117 53193871
Therapeutic response decreased 32.98 9.56 54 154024 47515 53147473
Sleep disorder 32.86 9.56 76 154002 58794 53136194
Metabolic alkalosis 32.75 9.56 42 154036 2977 53192011
Neuropathy peripheral 32.64 9.56 170 153908 103017 53091971
Mitral valve incompetence 32.42 9.56 127 153951 19424 53175564
Inhibitory drug interaction 31.61 9.56 36 154042 2254 53192734
Blood cholesterol increased 31.56 9.56 66 154012 52923 53142065
Lung transplant 31.03 9.56 41 154037 2993 53191995
Injection site bruising 30.80 9.56 38 154040 37608 53157380
Intentional product use issue 30.58 9.56 107 153971 72387 53122601
Chest pain 30.55 9.56 742 153336 189443 53005545
Gamma-glutamyltransferase increased 30.27 9.56 183 153895 33372 53161616
Ejection fraction abnormal 30.18 9.56 24 154054 954 53194034
Tachyarrhythmia 29.96 9.56 51 154027 4665 53190323
Hypertrophic cardiomyopathy 29.71 9.56 28 154050 1403 53193585
Hepatorenal syndrome 29.69 9.56 33 154045 2012 53192976
Cardioversion 29.62 9.56 26 154052 1187 53193801
Hypoaesthesia 29.45 9.56 244 153834 132751 53062237
Hepatic cancer 29.36 9.56 43 154035 3458 53191530
Anxiety 29.29 9.56 396 153682 196308 52998680
Oliguria 29.21 9.56 75 154003 9163 53185825
Seizure 28.96 9.56 237 153841 129272 53065716
Psoriasis 28.96 9.56 141 153937 86948 53108040
Multiple organ dysfunction syndrome 28.72 9.56 266 153812 55411 53139577
Catheterisation cardiac 28.68 9.56 47 154031 4167 53190821
Haemoptysis 28.61 9.56 158 153920 27881 53167107
Blister 28.26 9.56 124 153954 78629 53116359
Diffuse large B-cell lymphoma refractory 28.17 9.56 24 154054 1052 53193936
Ventricular fibrillation 28.07 9.56 87 153991 11838 53183150
Vascular resistance pulmonary decreased 27.91 9.56 10 154068 70 53194918
Acute respiratory failure 27.89 9.56 170 153908 31088 53163900
Red blood cell sedimentation rate increased 27.84 9.56 24 154054 28033 53166955
Cardiac output decreased 27.71 9.56 23 154055 972 53194016
Sinus bradycardia 27.67 9.56 99 153979 14502 53180486
Jugular vein distension 27.65 9.56 22 154056 875 53194113
Bundle branch block left 27.62 9.56 62 154016 6951 53188037
Ischaemic stroke 27.54 9.56 114 153964 17879 53177109
Concomitant disease progression 27.51 9.56 33 154045 2185 53192803
Waist circumference increased 27.25 9.56 21 154057 797 53194191
Sight disability 27.20 9.56 11 154067 111 53194877
Thermohypoaesthesia 27.12 9.56 11 154067 112 53194876
N-terminal prohormone brain natriuretic peptide abnormal 27.02 9.56 9 154069 49 53194939
Product quality issue 26.64 9.56 41 154037 36982 53158006
Jaundice 26.51 9.56 164 153914 30149 53164839
Hypovolaemia 26.47 9.56 78 154000 10324 53184664
Left-to-right cardiac shunt 26.45 9.56 11 154067 120 53194868
Depression 26.36 9.56 371 153707 182681 53012307
Sinus node dysfunction 26.18 9.56 46 154032 4315 53190673
Dyspnoea paroxysmal nocturnal 26.08 9.56 21 154057 850 53194138
Pulmonary congestion 26.03 9.56 104 153974 16052 53178936
Multiple sclerosis 26.01 9.56 24 154054 27129 53167859
Ejection fraction decreased 25.99 9.56 120 153958 19728 53175260
Bundle branch block right 25.62 9.56 50 154028 5083 53189905
Live birth 25.61 9.56 6 154072 15053 53179935
Lymphatic fistula 25.52 9.56 21 154057 877 53194111
Adverse drug reaction 25.51 9.56 75 154003 53550 53141438
Renin increased 25.51 9.56 12 154066 179 53194809
Wound infection pseudomonas 25.41 9.56 26 154052 1441 53193547
Product use in unapproved indication 25.32 9.56 205 153873 112084 53082904
Femoral hernia incarcerated 25.23 9.56 21 154057 891 53194097
Muscle spasticity 25.13 9.56 10 154068 17828 53177160
Hyperthyroidism 25.08 9.56 89 153989 12984 53182004
Suicidal ideation 25.06 9.56 90 153988 60421 53134567
Catheter site discharge 25.03 9.56 30 154048 1984 53193004
Catheter site erythema 24.96 9.56 44 154034 4138 53190850
Arterial haemorrhage 24.65 9.56 28 154050 1748 53193240
Bronchial secretion retention 24.65 9.56 27 154051 1619 53193369
Oxygen consumption increased 24.49 9.56 41 154037 3700 53191288
Cardiorenal syndrome 24.35 9.56 18 154060 641 53194347
Joint stiffness 24.32 9.56 31 154047 30252 53164736
Back pain 24.25 9.56 504 153574 233743 52961245
Cortisol increased 24.24 9.56 15 154063 396 53194592
Hypochloraemia 24.21 9.56 29 154049 1917 53193071
Hepatic cyst 24.13 9.56 48 154030 4948 53190040
Asthma 24.09 9.56 200 153878 108772 53086216
Abdominal cavity drainage 24.07 9.56 15 154063 401 53194587
Drug resistance 23.84 9.56 14 154064 19948 53175040
Suicide attempt 23.77 9.56 87 153991 58081 53136907
Device stimulation issue 23.56 9.56 9 154069 77 53194911
Pemphigoid 23.21 9.56 55 154023 6389 53188599
Urine output decreased 23.05 9.56 80 153998 11543 53183445
Premature labour 22.95 9.56 4 154074 12358 53182630
Female sexual arousal disorder 22.88 9.56 6 154072 11 53194977
Psychotic disorder 22.84 9.56 22 154056 24363 53170625
Aortic valve stenosis 22.82 9.56 37 154041 3251 53191737
Atrial enlargement 22.68 9.56 13 154065 297 53194691
Condition aggravated 22.63 9.56 1062 153016 296072 52898916
Bursitis 22.61 9.56 19 154059 22473 53172515
Sudden death 22.51 9.56 73 154005 10175 53184813
Inappropriate antidiuretic hormone secretion 22.31 9.56 94 153984 14857 53180131
Fear of eating 22.31 9.56 14 154064 379 53194609
Joint range of motion decreased 22.30 9.56 12 154066 17944 53177044
Decreased appetite 22.26 9.56 794 153284 214180 52980808
Nodal arrhythmia 22.24 9.56 23 154055 1291 53193697
Exercise tolerance decreased 22.20 9.56 48 154030 5247 53189741
Sedation 22.19 9.56 32 154046 29643 53165345
Intentional product misuse 22.13 9.56 71 154007 49321 53145667
Acute pulmonary oedema 22.06 9.56 63 154015 8192 53186796
Shock 22.03 9.56 128 153950 23011 53171977
Systemic infection 21.96 9.56 29 154049 2116 53192872
Pancreatic steatosis 21.86 9.56 21 154057 1078 53193910
Right ventricular dilatation 21.85 9.56 20 154058 965 53194023
Pulmonary arterial pressure abnormal 21.83 9.56 15 154063 475 53194513
Mucosal inflammation 21.71 9.56 58 154020 42726 53152262
Calcium deficiency 21.68 9.56 20 154058 975 53194013
Cytomegalovirus infection 21.56 9.56 15 154063 19524 53175464
Bradyarrhythmia 21.50 9.56 28 154050 2015 53192973
Injection site swelling 21.47 9.56 58 154020 42570 53152418
Accidental exposure to product 21.43 9.56 22 154056 23652 53171336
Cyanosis 21.35 9.56 100 153978 16539 53178449
Intentional self-injury 21.23 9.56 25 154053 25259 53169729
Brain stem stroke 21.14 9.56 12 154066 269 53194719
Neonatal respiratory failure 21.10 9.56 11 154067 207 53194781
Purpura 20.92 9.56 74 154004 10779 53184209
Haemorrhagic disorder 20.84 9.56 18 154060 804 53194184
Premature delivery 20.67 9.56 27 154051 26077 53168911
Haemoglobin decreased 20.64 9.56 531 153547 136776 53058212
Hepatomegaly 20.56 9.56 78 154000 11753 53183235
Nephrectomy 20.53 9.56 17 154061 716 53194272
Vessel puncture site haemorrhage 20.52 9.56 9 154069 113 53194875
Haemorrhage subcutaneous 20.40 9.56 34 154044 3057 53191931
Blood potassium decreased 20.21 9.56 192 153886 40268 53154720
Cirrhosis alcoholic 20.15 9.56 11 154067 228 53194760
Peripartum cardiomyopathy 20.14 9.56 10 154068 169 53194819
Transplant evaluation 20.13 9.56 20 154058 1070 53193918
Metastases to central nervous system 20.12 9.56 5 154073 12052 53182936
Viral diarrhoea 20.03 9.56 9 154069 120 53194868
Right ventricular dysfunction 19.93 9.56 24 154054 1595 53193393
Migraine 19.93 9.56 143 153935 80274 53114714
Catheter removal 19.92 9.56 13 154065 377 53194611
Oropharyngeal pain 19.90 9.56 145 153933 81123 53113865
Pulmonary arterial wedge pressure increased 19.86 9.56 12 154066 303 53194685
Rhabdomyolysis 19.79 9.56 204 153874 43719 53151269
Renal function test abnormal 19.71 9.56 34 154044 3143 53191845
Infection susceptibility increased 19.62 9.56 30 154048 2507 53192481
Portopulmonary hypertension 19.58 9.56 9 154069 127 53194861
Dyspnoea at rest 19.43 9.56 38 154040 3869 53191119
Bilirubin conjugated increased 19.15 9.56 31 154047 2720 53192268
Multiple allergies 19.10 9.56 61 154017 8434 53186554
Haemarthrosis 19.00 9.56 34 154044 3236 53191752
Intra-abdominal fluid collection 18.99 9.56 28 154050 2265 53192723
Bile acid malabsorption 18.91 9.56 10 154068 194 53194794
Cardiac hypertrophy 18.88 9.56 19 154059 1032 53193956
Dystonia 18.84 9.56 7 154071 13014 53181974
Catheter site pain 18.79 9.56 38 154040 3963 53191025
Night sweats 18.79 9.56 46 154032 34901 53160087
Seroma 18.75 9.56 27 154051 2138 53192850
Sleep apnoea syndrome 18.70 9.56 134 153944 25868 53169120
Platelet count decreased 18.64 9.56 426 153652 107673 53087315
Blood loss anaemia 18.62 9.56 62 154016 8761 53186227
Liver transplant 18.60 9.56 29 154049 2465 53192523
Diverticulum intestinal 18.47 9.56 51 154027 6506 53188482
Oesophageal variceal ligation 18.47 9.56 5 154073 11 53194977
Progressive multifocal leukoencephalopathy 18.45 9.56 6 154072 12123 53182865
Asthenia 18.44 9.56 1189 152889 342401 52852587
Vascular access site infection 18.44 9.56 6 154072 30 53194958
Dizziness 18.35 9.56 1279 152799 370980 52824008
Right atrial dilatation 18.32 9.56 15 154063 622 53194366
Vascular access site thrombosis 18.28 9.56 6 154072 31 53194957
Therapeutic drug monitoring analysis not performed 18.25 9.56 16 154062 729 53194259
Red cell distribution width abnormal 18.03 9.56 9 154069 154 53194834
Walking distance test abnormal 17.99 9.56 14 154064 539 53194449
Electrocardiogram U wave present 17.99 9.56 8 154070 104 53194884
Polyuria 17.96 9.56 57 154021 7854 53187134
Brain natriuretic peptide abnormal 17.95 9.56 12 154066 363 53194625
No adverse event 17.90 9.56 56 154022 39209 53155779
Bone erosion 17.90 9.56 5 154073 11147 53183841
Electrocardiogram T wave amplitude increased 17.88 9.56 5 154073 13 53194975
Device difficult to use 17.87 9.56 4 154074 10355 53184633
Cardiac murmur 17.86 9.56 75 154003 11838 53183150
Electrocardiogram abnormal 17.84 9.56 58 154020 8095 53186893
Iron deficiency anaemia 17.83 9.56 103 153975 18477 53176511
Diet noncompliance 17.75 9.56 11 154067 291 53194697
Herpes zoster 17.68 9.56 133 153945 73886 53121102
Occult blood positive 17.60 9.56 35 154043 3607 53191381
Device alarm issue 17.53 9.56 22 154056 1526 53193462
Hypertrichosis 17.53 9.56 18 154060 1002 53193986
Colitis ulcerative 17.50 9.56 21 154057 21040 53173948
Incision site impaired healing 17.47 9.56 9 154069 165 53194823
Volume blood decreased 17.42 9.56 9 154069 166 53194822
Liver disorder 17.38 9.56 185 153893 39970 53155018
Vascular device infection 17.32 9.56 39 154039 4382 53190606
Premature baby 17.26 9.56 19 154059 19782 53175206
Immunodeficiency 17.18 9.56 11 154067 14956 53180032
Inability to afford medication 17.13 9.56 21 154057 1422 53193566
Stress 16.97 9.56 96 153982 56988 53138000
Packed red blood cell transfusion 16.96 9.56 26 154052 2177 53192811
White blood cell count decreased 16.96 9.56 255 153823 124220 53070768
Hypothyroidism 16.89 9.56 169 153909 35938 53159050
Hyperbilirubinaemia 16.84 9.56 70 154008 10999 53183989
Tenosynovitis 16.82 9.56 4 154074 9935 53185053
Nodal rhythm 16.80 9.56 23 154055 1737 53193251
Rhinitis allergic 16.74 9.56 55 154023 7718 53187270
Aortic arteriosclerosis 16.66 9.56 46 154032 5868 53189120
Chronic hepatic failure 16.65 9.56 13 154065 503 53194485
Blood catecholamines decreased 16.64 9.56 4 154074 4 53194984
Tachypnoea 16.62 9.56 90 153988 15764 53179224
Haemorrhoidal haemorrhage 16.61 9.56 36 154042 3942 53191046
Prerenal failure 16.59 9.56 22 154056 1612 53193376
Multimorbidity 16.31 9.56 15 154063 728 53194260
Ischaemic cardiomyopathy 16.30 9.56 28 154050 2580 53192408
Central venous catheterisation 16.29 9.56 25 154053 2096 53192892
Leukaemic infiltration renal 16.26 9.56 5 154073 20 53194968
Portal vein thrombosis 16.21 9.56 28 154050 2591 53192397
Sinus arrest 15.98 9.56 23 154055 1821 53193167
Cardiac dysfunction 15.97 9.56 23 154055 1822 53193166
Amaurosis 15.96 9.56 13 154065 535 53194453
Marasmus 15.88 9.56 13 154065 539 53194449
Hypervolaemia 15.83 9.56 25 154053 2148 53192840
Catheter site swelling 15.66 9.56 20 154058 1412 53193576
Prothrombin consumption time prolonged 15.64 9.56 6 154072 52 53194936
Pulmonary veno-occlusive disease 15.64 9.56 17 154061 1011 53193977
Urine output increased 15.63 9.56 19 154059 1275 53193713
Plasma cell myeloma 15.63 9.56 78 154000 47796 53147192
Left ventricular enlargement 15.44 9.56 6 154072 54 53194934
Akathisia 15.42 9.56 3 154075 8568 53186420
Blood culture negative 15.42 9.56 8 154070 149 53194839
Poor peripheral circulation 15.39 9.56 32 154046 3405 53191583
Walking disability 15.38 9.56 20 154058 1437 53193551
Foetal death 15.36 9.56 4 154074 9343 53185645
Generalised tonic-clonic seizure 15.35 9.56 38 154040 28720 53166268
Type 2 diabetes mellitus 15.28 9.56 44 154034 31626 53163362
Cognitive disorder 15.17 9.56 72 154006 44706 53150282
Nasal congestion 15.14 9.56 227 153851 53060 53141928
Erysipelas 15.13 9.56 51 154027 7250 53187738
Aspiration pleural cavity 15.09 9.56 15 154063 803 53194185
Therapeutic embolisation 15.04 9.56 8 154070 157 53194831
Chronic respiratory failure 14.98 9.56 22 154056 1774 53193214
Hyperuricaemia 14.92 9.56 41 154037 5215 53189773
Drug therapeutic incompatibility 14.89 9.56 6 154072 60 53194928
Photophobia 14.84 9.56 15 154063 16243 53178745
Inferior vena cava dilatation 14.71 9.56 6 154072 62 53194926
Blood pressure systolic decreased 14.67 9.56 44 154034 5880 53189108
Hospitalisation 14.55 9.56 287 153791 70725 53124263
Abnormal precordial movement 14.55 9.56 3 154075 0 53194988
Hepatorenal failure 14.44 9.56 13 154065 614 53194374
Torsade de pointes 14.43 9.56 75 154003 12930 53182058
Vasodilatation 14.41 9.56 26 154052 2491 53192497
Grip strength decreased 14.38 9.56 8 154070 11741 53183247
Primary biliary cholangitis 14.36 9.56 18 154060 1247 53193741
Renin decreased 14.33 9.56 7 154071 114 53194874
Bleeding varicose vein 14.33 9.56 9 154069 244 53194744
Splenomegaly 14.33 9.56 64 154014 10375 53184613
Loss of personal independence in daily activities 14.16 9.56 131 153947 69684 53125304
Injection site warmth 14.12 9.56 12 154066 14116 53180872
Schizophrenia 14.10 9.56 6 154072 10273 53184715
Glaucoma 14.08 9.56 17 154061 16986 53178002
Drug monitoring procedure not performed 14.07 9.56 12 154066 527 53194461
Metabolic acidosis 14.04 9.56 185 153893 42057 53152931
Gamma-glutamyltransferase abnormal 14.01 9.56 9 154069 254 53194734
Alcoholic liver disease 14.01 9.56 7 154071 120 53194868
Mucocutaneous haemorrhage 13.99 9.56 6 154072 71 53194917
Ventricular failure 13.99 9.56 11 154067 430 53194558
Colitis 13.97 9.56 67 154011 41485 53153503
Device expulsion 13.96 9.56 42 154036 29771 53165217
Mixed hepatocellular cholangiocarcinoma 13.89 9.56 4 154074 12 53194976
Pulmonary aplasia 13.89 9.56 4 154074 12 53194976
Pyrexia 13.88 9.56 990 153088 402203 52792785
Electrocardiogram QT shortened 13.85 9.56 7 154071 123 53194865
Blood potassium abnormal 13.80 9.56 25 154053 2402 53192586
Joint effusion 13.77 9.56 11 154067 13341 53181647
Malignant neoplasm progression 13.76 9.56 136 153942 71405 53123583
Ulcer 13.74 9.56 24 154054 20595 53174393
Haptoglobin decreased 13.72 9.56 13 154065 656 53194332
Asterixis 13.71 9.56 18 154060 1306 53193682
Bone marrow failure 13.69 9.56 43 154035 30072 53164916
Myocarditis infectious 13.65 9.56 4 154074 13 53194975
Cardiac failure high output 13.61 9.56 9 154069 267 53194721
Gouty arthritis 13.59 9.56 12 154066 552 53194436
Blood uric acid increased 13.56 9.56 35 154043 4289 53190699
Posterior reversible encephalopathy syndrome 13.55 9.56 16 154062 16144 53178844
Pruritus 13.54 9.56 702 153376 293130 52901858
Inflammatory marker increased 13.51 9.56 44 154034 6146 53188842
Drug withdrawal syndrome 13.47 9.56 39 154039 27983 53167005
Hypocoagulable state 13.41 9.56 16 154062 1053 53193935
Cortisol free urine increased 13.38 9.56 5 154073 40 53194948
Pericarditis constrictive 13.34 9.56 10 154068 364 53194624
Pain in extremity 13.32 9.56 680 153398 284370 52910618
Coagulopathy 13.30 9.56 100 153978 19598 53175390
Brain natriuretic peptide 13.27 9.56 5 154073 41 53194947
Vascular stenosis 13.18 9.56 9 154069 282 53194706
Breast cancer 13.10 9.56 86 153992 49272 53145716
Gastrointestinal arteriovenous malformation 13.06 9.56 12 154066 582 53194406
Electrocardiogram T wave inversion 13.04 9.56 31 154047 3608 53191380
Catheter site pruritus 13.00 9.56 22 154056 2002 53192986
Throat tightness 12.95 9.56 28 154050 22188 53172800
Ventricular arrhythmia 12.93 9.56 31 154047 3629 53191359
Alanine aminotransferase increased 12.92 9.56 363 153715 94732 53100256
Osteonecrosis of jaw 12.91 9.56 57 154021 36089 53158899
Hypernatraemia 12.88 9.56 47 154031 6950 53188038
Glomerular filtration rate abnormal 12.87 9.56 12 154066 593 53194395
Malignant ascites 12.87 9.56 15 154063 963 53194025
Neutropenic sepsis 12.83 9.56 14 154064 14635 53180353
Gait inability 12.74 9.56 62 154016 38249 53156739
Blood urea abnormal 12.67 9.56 12 154066 605 53194383
Activated partial thromboplastin time prolonged 12.65 9.56 47 154031 7012 53187976
Ballismus 12.61 9.56 6 154072 92 53194896
Epstein-Barr virus infection 12.53 9.56 3 154075 7415 53187573
Blood bilirubin abnormal 12.52 9.56 13 154065 733 53194255
Presyncope 12.44 9.56 123 153955 26071 53168917
Ear pain 12.37 9.56 44 154034 29629 53165359
Blood test abnormal 12.32 9.56 66 154012 11511 53183477
Left atrial dilatation 12.31 9.56 21 154057 1924 53193064
Blood albumin decreased 12.29 9.56 78 154000 14464 53180524
Incorrect route of product administration 12.29 9.56 23 154055 19221 53175767
Atrial septal defect repair 12.20 9.56 8 154070 234 53194754
Cardiac ablation 12.19 9.56 17 154061 1307 53193681
Embolic stroke 12.17 9.56 31 154047 3768 53191220
Neonatal hyponatraemia 12.15 9.56 5 154073 53 53194935
Hypercapnia 12.13 9.56 37 154041 4990 53189998
Platelet dysfunction 12.11 9.56 6 154072 101 53194887
Hypophosphataemia 12.10 9.56 54 154024 8751 53186237
Gout 12.07 9.56 69 154009 12330 53182658
Cardiac flutter 12.07 9.56 30 154048 3592 53191396
Erythema 12.06 9.56 353 153725 156616 53038372
Haemodynamic instability 12.03 9.56 53 154025 8541 53186447
Coma hepatic 12 9.56 12 154066 647 53194341
Urine potassium increased 11.98 9.56 4 154074 22 53194966
Cardiac pacemaker insertion 11.97 9.56 31 154047 3806 53191182
Insomnia 11.92 9.56 431 153647 186641 53008347
Electrocardiogram QT prolonged 11.91 9.56 229 153849 56174 53138814
CREST syndrome 11.86 9.56 10 154068 432 53194556
Gastric varices haemorrhage 11.85 9.56 6 154072 106 53194882
Catastrophic reaction 11.83 9.56 4 154074 23 53194965
Osteoporosis 11.81 9.56 82 153996 46378 53148610
Glucose tolerance impaired 11.78 9.56 38 154040 5282 53189706
Visual acuity reduced transiently 11.72 9.56 7 154071 173 53194815
Caesarean section 11.69 9.56 20 154058 17300 53177688
Postpericardiotomy syndrome 11.69 9.56 4 154074 24 53194964
Right ventricular systolic pressure increased 11.67 9.56 11 154067 551 53194437
Chronic right ventricular failure 11.55 9.56 4 154074 25 53194963
Ventricular assist device insertion 11.55 9.56 4 154074 25 53194963
Gastritis erosive 11.48 9.56 39 154039 5567 53189421
Low density lipoprotein abnormal 11.34 9.56 7 154071 184 53194804
Urinary retention 11.34 9.56 129 153949 28337 53166651
Injection site rash 11.32 9.56 19 154059 16560 53178428
Aphasia 11.32 9.56 48 154030 30730 53164258
Fibrinous bronchitis 11.27 9.56 3 154075 6 53194982
Dependence on oxygen therapy 11.27 9.56 9 154069 360 53194628
Inflammation 11.24 9.56 108 153970 57028 53137960
Gastrointestinal angiectasia 11.24 9.56 5 154073 65 53194923
Foot deformity 11.16 9.56 23 154055 18545 53176443
Tendonitis 11.15 9.56 20 154058 16986 53178002
Injection site haemorrhage 11.11 9.56 30 154048 22021 53172967
Musculoskeletal disorder 11.10 9.56 21 154057 17478 53177510
Hyperglycaemia 11.09 9.56 170 153908 39914 53155074
Extensor plantar response 11.09 9.56 16 154062 1269 53193719
Eosinophil count increased 11.06 9.56 56 154022 9556 53185432
Altered state of consciousness 11.02 9.56 115 153963 24721 53170267
Scleroderma 11.01 9.56 36 154042 5039 53189949
Pharyngitis 11.00 9.56 24 154054 18956 53176032
Congenital musculoskeletal anomaly 10.95 9.56 10 154068 481 53194507
Dermatitis contact 10.90 9.56 53 154025 8899 53186089
Hypertonic bladder 10.89 9.56 27 154051 3228 53191760
Right-to-left cardiac shunt 10.79 9.56 7 154071 201 53194787
Nephrocalcinosis 10.78 9.56 14 154064 1005 53193983
Injection site mass 10.69 9.56 19 154059 16195 53178793
Azotaemia 10.69 9.56 33 154045 4480 53190508
International normalised ratio abnormal 10.69 9.56 26 154052 3071 53191917
Listeraemia 10.66 9.56 5 154073 74 53194914
Stress fracture 10.64 9.56 4 154074 7383 53187605
Hepatic hydrothorax 10.60 9.56 4 154074 33 53194955
Diffuse large B-cell lymphoma 10.58 9.56 3 154075 6622 53188366
Toxic neuropathy 10.57 9.56 9 154069 394 53194594
Confusional state 10.56 9.56 673 153405 193548 53001440
Aortic valve calcification 10.50 9.56 9 154069 398 53194590
Venous pressure jugular increased 10.47 9.56 11 154067 629 53194359
Subchorionic haematoma 10.43 9.56 6 154072 138 53194850
Respiratory depression 10.40 9.56 13 154065 12793 53182195
Catheter culture positive 10.39 9.56 6 154072 139 53194849
Tremor 10.36 9.56 280 153798 125456 53069532
Deformity 10.35 9.56 5 154073 7949 53187039
Poisoning 10.29 9.56 15 154063 13835 53181153
Nephrolithiasis 10.28 9.56 63 154015 36684 53158304
Renal artery stenosis 10.26 9.56 19 154059 1857 53193131
Endocarditis 10.23 9.56 37 154041 5447 53189541
Electrocardiogram T wave peaked 10.23 9.56 7 154071 220 53194768
QRS axis abnormal 10.21 9.56 14 154064 1059 53193929
Blood creatinine abnormal 10.17 9.56 24 154054 2780 53192208
Cardiac cirrhosis 10.17 9.56 6 154072 145 53194843
Cardiovascular disorder 10.13 9.56 66 154012 12347 53182641
Sedation complication 10.12 9.56 4 154074 7162 53187826
Blood bilirubin unconjugated increased 10.10 9.56 9 154069 419 53194569
Balloon atrial septostomy 10.10 9.56 5 154073 84 53194904
Ectopic ACTH syndrome 10.10 9.56 5 154073 84 53194904
Poor quality sleep 10.09 9.56 85 153993 17238 53177750
Impaired quality of life 10.07 9.56 34 154044 4837 53190151
Localised oedema 10.06 9.56 36 154042 5273 53189715
Visual impairment 10.05 9.56 149 153929 72763 53122225
Thyroxine increased 10.05 9.56 10 154068 536 53194452
Catheter site rash 10.03 9.56 12 154066 792 53194196
Optic ischaemic neuropathy 9.98 9.56 14 154064 1082 53193906
Influenza like illness 9.98 9.56 120 153958 60739 53134249
Cheilosis 9.96 9.56 3 154075 11 53194977
Cardiac valve thickening 9.92 9.56 4 154074 40 53194948
Cardiac operation 9.90 9.56 24 154054 2829 53192159
Supraventricular tachycardia 9.83 9.56 73 154005 14252 53180736
Malignant melanoma 9.82 9.56 10 154068 10792 53184196
Upper respiratory tract inflammation 9.78 9.56 24 154054 2850 53192138
Hyperhidrosis 9.78 9.56 209 153869 96584 53098404
Right atrial pressure increased 9.78 9.56 6 154072 156 53194832
Hepatojugular reflux 9.76 9.56 3 154075 12 53194976
Heart transplant 9.75 9.56 9 154069 439 53194549
Percutaneous coronary intervention 9.74 9.56 6 154072 157 53194831
Labelled drug-disease interaction medication error 9.67 9.56 6 154072 159 53194829
Human metapneumovirus test positive 9.67 9.56 4 154074 43 53194945
Left ventricular dilatation 9.61 9.56 9 154069 447 53194541
Vertebrobasilar insufficiency 9.59 9.56 5 154073 94 53194894
Acidosis 9.56 9.56 61 154017 11331 53183657
Disseminated intravascular coagulation 9.56 9.56 93 153985 19626 53175362

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 2114.85 10.69 1833 112165 67917 32331611
Acute kidney injury 776.96 10.69 2521 111477 290947 32108581
Cardiac failure 768.81 10.69 1247 112751 90426 32309102
Hepatic encephalopathy 578.57 10.69 453 113545 14442 32385086
Ascites 502.74 10.69 661 113337 39530 32359998
Cardiac failure congestive 293.95 10.69 804 113194 84048 32315480
Hyponatraemia 273.10 10.69 721 113277 73792 32325736
Cardiac failure chronic 267.75 10.69 214 113784 7026 32392502
Drug ineffective 244.59 10.69 623 113375 382854 32016674
Hepatic cirrhosis 240.90 10.69 296 113702 16513 32383015
Hypotension 226.51 10.69 1412 112586 214698 32184830
Oedema peripheral 220.41 10.69 887 113111 113204 32286324
Gynaecomastia 217.62 10.69 207 113791 8612 32390916
Hepatic failure 214.16 10.69 420 113578 35260 32364268
Right ventricular failure 194.44 10.69 191 113807 8272 32391256
Completed suicide 177.51 10.69 52 113946 92465 32307063
Drug abuse 167.53 10.69 38 113960 80205 32319323
Pulmonary hypertension 164.78 10.69 274 113724 20220 32379308
Dehydration 156.29 10.69 876 113122 128082 32271446
Dyspnoea 153.38 10.69 1938 112060 360107 32039421
Blood potassium increased 146.40 10.69 233 113765 16571 32382957
Ejection fraction decreased 132.57 10.69 229 113769 17429 32382099
Renal impairment 131.40 10.69 654 113344 91318 32308210
Febrile neutropenia 124.92 10.69 141 113857 119425 32280103
Hepatorenal syndrome 119.31 10.69 88 113910 2557 32396971
Oesophageal varices haemorrhage 117.60 10.69 94 113904 3085 32396443
Bradycardia 116.83 10.69 529 113469 71033 32328495
Renal failure 116.60 10.69 839 113159 133639 32265889
Hepatic cancer 114.37 10.69 134 113864 7106 32392422
International normalised ratio increased 112.47 10.69 403 113595 48632 32350896
Brain natriuretic peptide increased 111.96 10.69 104 113894 4196 32395332
Oedema 110.41 10.69 379 113619 44768 32354760
Pulmonary arterial hypertension 109.68 10.69 153 113845 9668 32389860
Ventricular tachycardia 107.77 10.69 261 113737 25295 32374233
Neutropenia 107.32 10.69 210 113788 141965 32257563
Off label use 105.62 10.69 636 113362 305684 32093844
Blood creatinine increased 104.64 10.69 635 113363 95497 32304031
Rheumatoid arthritis 97.24 10.69 19 113979 44525 32355003
Toxicity to various agents 95.59 10.69 313 113685 177728 32221800
Congestive cardiomyopathy 95.46 10.69 122 113876 7080 32392448
Orthopnoea 90.26 10.69 100 113898 4987 32394541
Drug interaction 85.68 10.69 1153 112845 217032 32182496
Arthralgia 85.29 10.69 253 113745 148195 32251333
Foetal exposure during pregnancy 85.28 10.69 20 113978 41281 32358247
General physical health deterioration 85.24 10.69 693 113305 114566 32284962
Mitral valve incompetence 81.94 10.69 169 113829 14702 32384826
Atrioventricular block complete 80.64 10.69 126 113872 8818 32390710
Blood urea increased 79.82 10.69 272 113726 32001 32367527
Hepatocellular carcinoma 78.14 10.69 134 113864 10136 32389392
N-terminal prohormone brain natriuretic peptide increased 77.12 10.69 61 113937 1971 32397557
Fluid retention 76.72 10.69 236 113762 26314 32373214
Intentional overdose 75.09 10.69 26 113972 41575 32357953
Syncope 69.39 10.69 547 113451 89577 32309951
Ischaemic cardiomyopathy 65.61 10.69 96 113902 6338 32393190
Varices oesophageal 65.01 10.69 72 113926 3589 32395939
Therapeutic product effect incomplete 63.17 10.69 33 113965 41308 32358220
Orthostatic hypotension 60.65 10.69 213 113785 25437 32374091
Infusion related reaction 60.47 10.69 43 113955 45556 32353972
Tricuspid valve incompetence 60.19 10.69 113 113885 9174 32390354
Depression 59.70 10.69 160 113838 96900 32302628
Breast tenderness 59.66 10.69 36 113962 741 32398787
Pyrexia 59.26 10.69 779 113219 319189 32080339
Ammonia increased 58.19 10.69 75 113923 4389 32395139
Rash 55.68 10.69 468 113530 208865 32190663
Cardiac failure acute 54.07 10.69 114 113884 10070 32389458
Melaena 53.37 10.69 252 113746 34413 32365115
Blood bilirubin increased 53.33 10.69 273 113725 38511 32361017
Urticaria 53.23 10.69 79 113919 59535 32339993
Neuropathy peripheral 52.74 10.69 120 113878 76862 32322666
Gastrointestinal haemorrhage 52.06 10.69 499 113499 86383 32313145
Dyspnoea exertional 51.33 10.69 271 113727 38690 32360838
Arrhythmia 51.01 10.69 252 113746 35051 32364477
Brain natriuretic peptide abnormal 50.98 10.69 25 113973 334 32399194
Cardiogenic shock 50.96 10.69 174 113824 20488 32379040
Blood pressure decreased 50.88 10.69 330 113668 50750 32348778
Intentional product misuse 50.48 10.69 32 113966 36019 32363509
Suicidal ideation 50.38 10.69 36 113962 38047 32361481
Pain 50.00 10.69 419 113579 187137 32212391
Anxiety 49.92 10.69 171 113827 95834 32303694
Product dose omission issue 49.18 10.69 189 113809 102386 32297142
Atrial fibrillation 48.71 10.69 624 113374 116080 32283448
Electrocardiogram T wave peaked 48.70 10.69 28 113970 525 32399003
Chronic kidney disease 48.58 10.69 272 113726 39703 32359825
Suicide attempt 48.22 10.69 38 113960 38206 32361322
Nipple pain 47.54 10.69 29 113969 609 32398919
Bundle branch block left 47.42 10.69 78 113920 5701 32393827
Concomitant disease aggravated 45.98 10.69 76 113922 5577 32393951
Leukopenia 44.26 10.69 90 113908 60032 32339496
Anaemia 44.03 10.69 1060 112938 222564 32176964
Hypokalaemia 43.81 10.69 337 113661 54757 32344771
Treatment failure 43.28 10.69 44 113954 39119 32360409
Death 43.25 10.69 1017 112981 381500 32018028
Cytomegalovirus infection 42.48 10.69 18 113980 25446 32374082
Headache 42.21 10.69 462 113536 195735 32203793
Abdominal distension 41.47 10.69 315 113683 50980 32348548
Bradyarrhythmia 41.10 10.69 44 113954 2110 32397418
Drug dependence 40.15 10.69 16 113982 23468 32376060
Plasma cell myeloma 40.11 10.69 89 113909 57525 32342003
Left ventricular dilatation 39.82 10.69 27 113971 684 32398844
Hypersensitivity 39.58 10.69 90 113908 57668 32341860
Anaphylactic reaction 39.28 10.69 29 113969 30143 32369385
Chronic hepatic failure 38.97 10.69 24 113974 513 32399015
Congestive hepatopathy 37.67 10.69 40 113958 1900 32397628
Therapeutic drug monitoring analysis not performed 37.67 10.69 23 113975 484 32399044
Cardioactive drug level increased 37.32 10.69 38 113960 1718 32397810
Product use in unapproved indication 37.24 10.69 168 113830 87036 32312492
Pulmonary arterial pressure abnormal 37.18 10.69 17 113981 192 32399336
Breast pain 37.16 10.69 34 113964 1345 32398183
Electrolyte imbalance 37.14 10.69 112 113886 12350 32387178
Glomerular filtration rate decreased 37.12 10.69 114 113884 12697 32386831
Portal hypertension 36.28 10.69 57 113941 4007 32395521
Lactic acidosis 36.09 10.69 221 113777 33315 32366213
Ventricular fibrillation 36.08 10.69 138 113860 17172 32382356
Seizure 35.42 10.69 216 113782 103638 32295890
Polyuria 35.21 10.69 83 113915 7902 32391626
Insomnia 35.13 10.69 207 113791 100141 32299387
Cardiomyopathy 34.48 10.69 129 113869 15884 32383644
Quadriparesis 34.10 10.69 31 113967 1216 32398312
Abdominal cavity drainage 33.69 10.69 19 113979 343 32399185
Therapeutic product effect decreased 32.98 10.69 36 113962 30981 32368547
Blood cholesterol 32.92 10.69 15 113983 168 32399360
Premature baby 32.68 10.69 12 113986 18506 32381022
Injection site pain 32.32 10.69 41 113957 33017 32366511
Mucosal inflammation 32.14 10.69 42 113956 33392 32366136
Cardiomegaly 32.11 10.69 121 113877 14950 32384578
Sinusitis 32.09 10.69 49 113949 36511 32363017
Pneumonitis 32.01 10.69 35 113963 30099 32369429
Joint swelling 32.00 10.69 85 113913 51650 32347878
Paraesthesia 31.99 10.69 103 113895 58841 32340687
White blood cell count decreased 31.98 10.69 188 113810 91010 32308518
Pulmonary oedema 31.38 10.69 273 113725 45994 32353534
Musculoskeletal stiffness 31.33 10.69 56 113942 39208 32360320
Electrocardiogram abnormal 30.91 10.69 78 113920 7752 32391776
Blood sodium decreased 30.84 10.69 127 113871 16347 32383181
Left ventricular dysfunction 30.67 10.69 89 113909 9606 32389922
Hallucination 30.65 10.69 89 113909 52530 32346998
Hypovolaemia 30.53 10.69 84 113914 8793 32390735
Product monitoring error 30.09 10.69 41 113957 2533 32396995
Faecal volume decreased 30.07 10.69 12 113986 94 32399434
Neuroleptic malignant syndrome 29.77 10.69 12 113986 17483 32382045
Intentional product use issue 29.55 10.69 65 113933 42146 32357382
Nodal rhythm 29 10.69 31 113967 1484 32398044
Subarachnoid haemorrhage 28.64 10.69 91 113907 10320 32389208
Hepatic function abnormal 28.56 10.69 261 113737 44579 32354949
Liver transplant 28.41 10.69 42 113956 2798 32396730
Tremor 28.26 10.69 168 113830 81109 32318419
Overdose 28.20 10.69 184 113814 86893 32312635
Intentional self-injury 28.16 10.69 7 113991 13893 32385635
Cirrhosis alcoholic 27.88 10.69 23 113975 790 32398738
Fall 27.84 10.69 892 113106 195309 32204219
Low cardiac output syndrome 27.73 10.69 18 113980 423 32399105
Hyperhidrosis 27.53 10.69 142 113856 71026 32328502
Arthropathy 27.53 10.69 23 113975 22466 32377062
Scrotal oedema 27.53 10.69 31 113967 1574 32397954
Condition aggravated 27.37 10.69 727 113271 154934 32244594
Pulmonary congestion 27.36 10.69 105 113893 13086 32386442
Protein-losing gastroenteropathy 26.70 10.69 16 113982 325 32399203
Neutrophil count decreased 26.54 10.69 81 113917 47058 32352470
Anuria 26.49 10.69 91 113907 10746 32388782
Pleural effusion 26.32 10.69 406 113592 78586 32320942
Ventricular hypokinesia 26.18 10.69 55 113943 4845 32394683
Accidental exposure to product 26.14 10.69 4 113994 11198 32388330
Generalised oedema 25.59 10.69 99 113899 12384 32387144
Pneumonia 25.58 10.69 1003 112995 354249 32045279
Osteonecrosis of jaw 25.50 10.69 18 113980 19148 32380380
Blood loss anaemia 25.10 10.69 73 113925 7889 32391639
Ejection fraction 24.98 10.69 10 113988 79 32399449
Diaphragmatic spasm 24.66 10.69 10 113988 82 32399446
Blood aldosterone increased 24.63 10.69 7 113991 15 32399513
Oxygen saturation increased 24.61 10.69 14 113984 257 32399271
Torsade de pointes 24.36 10.69 69 113929 7346 32392182
Adverse drug reaction 24.33 10.69 33 113965 25828 32373700
Nasopharyngitis 24.26 10.69 128 113870 63659 32335869
Fluid overload 24.15 10.69 134 113864 19487 32380041
Aggression 24.14 10.69 65 113933 39324 32360204
Urine output decreased 24.10 10.69 86 113912 10348 32389180
Multiple sclerosis relapse 23.74 10.69 6 113992 11775 32387753
Back pain 23.25 10.69 263 113735 110790 32288738
Left ventricular failure 23.06 10.69 54 113944 5119 32394409
Jugular vein distension 23.01 10.69 18 113980 572 32398956
Atrioventricular block 23.00 10.69 69 113929 7586 32391942
Platelet count normal 22.97 10.69 7 113991 21 32399507
Jaundice 22.87 10.69 201 113797 33957 32365571
Localised oedema 22.83 10.69 42 113956 3357 32396171
Inability to afford medication 22.66 10.69 23 113975 1036 32398492
Transfusion 22.38 10.69 69 113929 7699 32391829
Electrocardiogram QRS complex abnormal 22.22 10.69 14 113984 312 32399216
Dyspnoea paroxysmal nocturnal 22.19 10.69 27 113971 1490 32398038
Sudden death 22.12 10.69 114 113884 16118 32383410
Oesophageal variceal ligation 22.07 10.69 9 113989 75 32399453
Drug withdrawal syndrome 22.04 10.69 23 113975 20208 32379320
N-terminal prohormone brain natriuretic peptide abnormal 22.02 10.69 12 113986 202 32399326
Bone marrow failure 21.96 10.69 46 113952 30358 32369170
Sudden cardiac death 21.94 10.69 44 113954 3750 32395778
Fractured coccyx 21.85 10.69 11 113987 156 32399372
Nonalcoholic fatty liver disease 21.72 10.69 14 113984 325 32399203
Thrombosis 21.46 10.69 85 113913 45669 32353859
Coma hepatic 21.42 10.69 16 113982 474 32399054
Drug ineffective for unapproved indication 21.40 10.69 11 113987 13901 32385627
Infection 21.30 10.69 192 113806 84523 32315005
Chronic obstructive pulmonary disease 21.29 10.69 263 113735 48490 32351038
Portal vein thrombosis 21.22 10.69 43 113955 3692 32395836
Spur cell anaemia 21.19 10.69 8 113990 53 32399475
Bundle branch block right 20.89 10.69 66 113932 7462 32392066
Oliguria 20.88 10.69 70 113928 8164 32391364
Graft versus host disease 20.84 10.69 6 113992 10800 32388728
Loss of personal independence in daily activities 20.75 10.69 39 113959 26794 32372734
Tuberculosis 20.64 10.69 3 113995 8726 32390802
Feeling abnormal 20.42 10.69 126 113872 60297 32339231
Rales 20.39 10.69 67 113931 7734 32391794
Apparent mineralocorticoid excess 20.34 10.69 7 113991 34 32399494
Neutrophil count increased 20.32 10.69 16 113982 16098 32383430
Pain in extremity 20.28 10.69 294 113704 118607 32280921
Gastric varices 20.21 10.69 15 113983 440 32399088
Psoriasis 20.19 10.69 88 113910 46035 32353493
Hypoaesthesia 20.07 10.69 121 113877 58232 32341296
Adrenal adenoma 19.93 10.69 14 113984 376 32399152
Blood thyroid stimulating hormone abnormal 19.88 10.69 12 113986 247 32399281
Therapeutic response decreased 19.76 10.69 38 113960 25882 32373646
Memory impairment 19.76 10.69 74 113924 40405 32359123
Gastrointestinal disorder 19.75 10.69 50 113948 30881 32368647
Product quality issue 19.70 10.69 23 113975 19210 32380318
Labelled drug-drug interaction medication error 19.65 10.69 91 113907 12322 32387206
Acute myeloid leukaemia 19.57 10.69 23 113975 19151 32380377
Liver disorder 19.53 10.69 183 113815 31471 32368057
Paracentesis 19.46 10.69 14 113984 391 32399137
Dyskinesia 19.43 10.69 33 113965 23570 32375958
Ventricular internal diameter abnormal 19.28 10.69 9 113989 107 32399421
Resting tremor 19.22 10.69 17 113981 643 32398885
Amyloidosis 19.15 10.69 31 113967 2235 32397293
Pancytopenia 19.11 10.69 216 113782 91019 32308509
Prothrombin time prolonged 18.89 10.69 76 113922 9679 32389849
Pulmonary embolism 18.75 10.69 195 113803 83464 32316064
Cardiac arrest 18.75 10.69 458 113540 96318 32303210
Haematemesis 18.70 10.69 163 113835 27472 32372056
Psoriatic arthropathy 18.68 10.69 21 113977 17839 32381689
Blood ketone body increased 18.68 10.69 14 113984 417 32399111
Azotaemia 18.63 10.69 51 113947 5323 32394205
Schizophrenia 18.43 10.69 6 113992 9978 32389550
Iron deficiency anaemia 18.33 10.69 75 113923 9626 32389902
Metabolic alkalosis 18.28 10.69 24 113974 1430 32398098
Blood potassium abnormal 18.24 10.69 22 113976 1203 32398325
Cardiac disorder 17.91 10.69 225 113773 41641 32357887
Colitis ulcerative 17.89 10.69 20 113978 17031 32382497
Diabetic ketoacidosis 17.78 10.69 22 113976 17910 32381618
Weight increased 17.76 10.69 401 113597 83262 32316266
Vision blurred 17.74 10.69 87 113911 44099 32355429
Agitation 17.49 10.69 123 113875 57113 32342415
Myocardial fibrosis 17.47 10.69 17 113981 727 32398801
COVID-19 17.32 10.69 56 113942 31959 32367569
Colitis 17.27 10.69 61 113937 33890 32365638
Waist circumference increased 17.17 10.69 17 113981 743 32398785
Metabolic acidosis 17.10 10.69 218 113780 40481 32359047
Tooth disorder 17.09 10.69 7 113991 10100 32389428
Sopor 17.04 10.69 10 113988 11739 32387789
Basal cell carcinoma 16.95 10.69 22 113976 17546 32381982
Conjunctival scar 16.90 10.69 7 113991 61 32399467
Neck pain 16.86 10.69 34 113964 22753 32376775
Oropharyngeal pain 16.85 10.69 55 113943 31297 32368231
Myasthenic syndrome 16.81 10.69 13 113985 406 32399122
Encephalopathy 16.81 10.69 189 113809 34068 32365460
Bronchopulmonary aspergillosis 16.75 10.69 14 113984 13673 32385855
Cardiac amyloidosis 16.71 10.69 19 113979 975 32398553
Primary hyperaldosteronism 16.70 10.69 7 113991 63 32399465
Infective pulmonary exacerbation of cystic fibrosis 16.70 10.69 5 113993 8774 32390754
Aspergillus infection 16.58 10.69 10 113988 11564 32387964
Irritability 16.41 10.69 39 113959 24615 32374913
Endometriosis male 16.41 10.69 5 113993 15 32399513
Malignant neoplasm progression 16.38 10.69 186 113812 78310 32321218
Renin increased 16.37 10.69 8 113990 106 32399422
Drug intolerance 16.33 10.69 106 113892 50129 32349399
Bladder irrigation 16.33 10.69 7 113991 67 32399461
Electrolyte depletion 16.31 10.69 10 113988 212 32399316
Cardioversion 16.25 10.69 18 113980 897 32398631
Exposure during pregnancy 16.25 10.69 6 113992 9223 32390305
Hyperuricaemia 16.23 10.69 64 113934 8077 32391451
Blood urea abnormal 16.14 10.69 17 113981 800 32398728
Sedation 16.09 10.69 25 113973 18501 32381027
Respiratory arrest 16.04 10.69 50 113948 28858 32370670
Base excess decreased 16.02 10.69 10 113988 219 32399309
Pancreatitis 15.97 10.69 74 113924 38077 32361451
Packed red blood cell transfusion 15.89 10.69 24 113974 1630 32397898
Pneumocystis jirovecii pneumonia 15.88 10.69 26 113972 18844 32380684
Hyperthyroidism 15.84 10.69 70 113928 9292 32390236
Xanthopsia 15.83 10.69 9 113989 165 32399363
Hydrothorax 15.79 10.69 14 113984 531 32398997
Scrotal swelling 15.72 10.69 22 113976 1394 32398134
Stomatitis 15.70 10.69 80 113918 40149 32359379
Injection site erythema 15.62 10.69 17 113981 14651 32384877
Epstein-Barr virus infection 15.52 10.69 3 113995 7087 32392441
Influenza 15.52 10.69 96 113902 45918 32353610
Hypochromic anaemia 15.50 10.69 17 113981 838 32398690
Poisoning 15.49 10.69 10 113988 11148 32388380
Oral lichen planus 15.37 10.69 9 113989 175 32399353
Akathisia 15.32 10.69 3 113995 7022 32392506
Upper gastrointestinal haemorrhage 15.27 10.69 139 113859 23710 32375818
Oxygen consumption decreased 15.23 10.69 9 113989 178 32399350
Injection site reaction 15.21 10.69 11 113987 11558 32387970
Hypoparathyroidism secondary 15.04 10.69 8 113990 128 32399400
Asthma 14.82 10.69 92 113906 43973 32355555
Pulmonary vein stenosis 14.82 10.69 6 113992 49 32399479
Burning feet syndrome 14.65 10.69 7 113991 88 32399440
Haematoma 14.62 10.69 146 113852 25538 32373990
Haematotoxicity 14.55 10.69 3 113995 6773 32392755
Circulatory collapse 14.50 10.69 125 113873 21000 32378528
Atrioventricular block first degree 14.42 10.69 49 113949 5754 32393774
International normalised ratio abnormal 14.30 10.69 34 113964 3255 32396273
Generalised tonic-clonic seizure 14.26 10.69 32 113966 20607 32378921
Breast mass 14.21 10.69 14 113984 608 32398920
Transplant evaluation 14.11 10.69 13 113985 519 32399009
Diffuse large B-cell lymphoma 14.08 10.69 6 113992 8456 32391072
Enteritis 14.06 10.69 4 113994 7257 32392271
Performance enhancing product use 14.05 10.69 7 113991 97 32399431
Respiratory syncytial virus infection 14.01 10.69 37 113961 3781 32395747
Potentiating drug interaction 13.98 10.69 44 113954 4964 32394564
Herpes zoster 13.97 10.69 62 113936 32279 32367249
Secondary sexual characteristics absence 13.97 10.69 3 113995 0 32399528
Pacemaker generated arrhythmia 13.97 10.69 3 113995 0 32399528
Concomitant disease progression 13.85 10.69 29 113969 2549 32396979
Abnormal behaviour 13.83 10.69 47 113951 26419 32373109
Dyspnoea at rest 13.83 10.69 34 113964 3325 32396203
Transplant rejection 13.82 10.69 9 113989 9990 32389538
Coordination abnormal 13.71 10.69 5 113993 7743 32391785
Left atrial dilatation 13.68 10.69 24 113974 1848 32397680
Somnolence 13.66 10.69 269 113729 103528 32296000
Subdural haematoma 13.66 10.69 118 113880 19835 32379693
Gouty arthritis 13.55 10.69 18 113980 1085 32398443
Erysipelas 13.55 10.69 43 113955 4873 32394655
Electrocardiogram change 13.52 10.69 14 113984 646 32398882
Left ventricular enlargement 13.46 10.69 14 113984 649 32398879
Multiple sclerosis 13.41 10.69 5 113993 7639 32391889
Thrombocytopenia 13.33 10.69 407 113591 147892 32251636
Hepatomegaly 13.26 10.69 72 113926 10385 32389143
Pulmonary hypertensive crisis 13.20 10.69 8 113990 166 32399362
Diplopia 13.17 10.69 19 113979 14493 32385035
Portal shunt procedure 13.12 10.69 4 113994 12 32399516
Preternatural anus 13.10 10.69 7 113991 113 32399415
Hyperaldosteronism 13.10 10.69 7 113991 113 32399415
Blood chloride increased 13.03 10.69 31 113967 2968 32396560
Cytokine release syndrome 13.01 10.69 17 113981 13518 32386010
Osteonecrosis 12.99 10.69 24 113974 16598 32382930
Influenza like illness 12.99 10.69 50 113948 27090 32372438
Withdrawal syndrome 12.96 10.69 14 113984 12108 32387420
Lichenoid keratosis 12.93 10.69 27 113971 2369 32397159
Serotonin syndrome 12.92 10.69 30 113968 19087 32380441
Arthritis 12.89 10.69 49 113949 26643 32372885
Hypertensive cardiomyopathy 12.87 10.69 8 113990 174 32399354
Rash erythematous 12.86 10.69 42 113956 23897 32375631
Pulmonary veno-occlusive disease 12.86 10.69 12 113986 487 32399041
Acquired haemophilia 12.85 10.69 16 113982 904 32398624
Road traffic accident 12.80 10.69 26 113972 17355 32382173
Clostridium difficile infection 12.78 10.69 27 113971 17769 32381759
Disease recurrence 12.73 10.69 23 113975 16041 32383487
Eye pain 12.72 10.69 16 113982 12932 32386596
Nephrogenic anaemia 12.72 10.69 26 113972 2247 32397281
Creatinine renal clearance decreased 12.71 10.69 34 113964 3500 32396028
Product prescribing error 12.67 10.69 115 113883 19602 32379926
Pulmonary renal syndrome 12.63 10.69 8 113990 180 32399348
Epistaxis 12.57 10.69 270 113728 55585 32343943
Exercise tolerance decreased 12.53 10.69 40 113958 4548 32394980
Dependence on oxygen therapy 12.51 10.69 8 113990 183 32399345
Glucose tolerance decreased 12.45 10.69 6 113992 77 32399451
Parkinsonism 12.44 10.69 6 113992 7863 32391665
Urogenital haemorrhage 12.32 10.69 12 113986 514 32399014
International normalised ratio decreased 12.30 10.69 40 113958 4591 32394937
Respiratory depression 12.28 10.69 17 113981 13194 32386334
Angina pectoris 12.23 10.69 166 113832 31260 32368268
Type V hyperlipidaemia 12.16 10.69 14 113984 728 32398800
Prothrombin level decreased 12.14 10.69 18 113980 1202 32398326
Prerenal failure 12.08 10.69 24 113974 2031 32397497
Left ventricular hypertrophy 12.07 10.69 52 113946 6828 32392700
Electrocardiogram T wave amplitude increased 12.03 10.69 5 113993 44 32399484
Diastolic dysfunction 12.02 10.69 43 113955 5181 32394347
Psychotic disorder 11.95 10.69 41 113957 22979 32376549
Haemodynamic test abnormal 11.93 10.69 5 113993 45 32399483
Stress 11.91 10.69 43 113955 23739 32375789
Postrenal failure 11.88 10.69 11 113987 442 32399086
Muscle rigidity 11.87 10.69 13 113985 11173 32388355
Hepatic pain 11.78 10.69 19 113979 1366 32398162
Acute pulmonary oedema 11.71 10.69 56 113942 7685 32391843
Dilatation ventricular 11.70 10.69 28 113970 2692 32396836
Erythema 11.67 10.69 213 113785 82892 32316636
Tachycardia 11.64 10.69 201 113797 78887 32320641
Low birth weight baby 11.57 10.69 5 113993 6989 32392539
Periarthritis calcarea 11.56 10.69 6 113992 91 32399437
Fatigue 11.52 10.69 1066 112932 349635 32049893
Conduction disorder 11.41 10.69 23 113975 1967 32397561
Articular calcification 11.39 10.69 6 113992 94 32399434
Hepatic calcification 11.38 10.69 10 113988 375 32399153
Tricuspid valve replacement 11.37 10.69 4 113994 21 32399507
Mental impairment 11.34 10.69 11 113987 10001 32389527
Nightmare 11.21 10.69 18 113980 13148 32386380
Angina unstable 11.20 10.69 78 113920 12277 32387251
Crepitations 11.19 10.69 30 113968 3092 32396436
Secondary hypogonadism 11.19 10.69 9 113989 298 32399230
Acute respiratory distress syndrome 11.16 10.69 48 113950 25205 32374323
Haemophagocytic lymphohistiocytosis 11.14 10.69 14 113984 11321 32388207
Cardiac asthma 11.10 10.69 8 113990 224 32399304
Systemic infection 11.08 10.69 24 113974 2159 32397369
Fungal infection 11.08 10.69 23 113975 15232 32384296
Type 2 diabetes mellitus 11.06 10.69 91 113907 15081 32384447
Deep vein thrombosis 11.04 10.69 157 113841 63556 32335972
Goitre 11.00 10.69 20 113978 1584 32397944
Ejection fraction abnormal 10.94 10.69 15 113983 932 32398596
Neoplasm progression 10.90 10.69 34 113964 19624 32379904
Breath odour 10.90 10.69 14 113984 816 32398712
Shock haemorrhagic 10.73 10.69 69 113929 10576 32388952
Walking distance test abnormal 10.73 10.69 7 113991 166 32399362
Anticoagulation drug level abnormal 10.70 10.69 3 113995 6 32399522

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
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Chronic heart failure indication 48447003
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

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
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
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 42708-126 TABLET 25 mg ORAL ANDA 25 sections