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 1840.72 9.71 1398 140899 49311 46494454
Acute kidney injury 918.30 9.71 2138 140159 233717 46310048
Cardiac failure 856.18 9.71 1134 141163 78814 46464951
Drug ineffective 535.07 9.71 777 141520 677061 45866704
Hyponatraemia 512.82 9.71 1023 141274 100309 46443456
Right ventricular failure 437.20 9.71 375 141922 15718 46528047
Pulmonary arterial hypertension 433.33 9.71 462 141835 25466 46518299
Rheumatoid arthritis 383.98 9.71 127 142170 240088 46303677
Ascites 356.30 9.71 496 141801 36088 46507677
Pulmonary hypertension 347.57 9.71 486 141811 35507 46508258
Hepatic encephalopathy 345.92 9.71 270 142027 9887 46533878
Bradycardia 246.94 9.71 592 141705 65706 46478059
Drug interaction 243.95 9.71 1243 141054 201851 46341914
Fluid retention 235.05 9.71 496 141801 50550 46493215
Oedema peripheral 232.83 9.71 1034 141263 158672 46385093
Cardiac failure congestive 228.10 9.71 706 141591 91044 46452721
Hypotension 220.29 9.71 1335 140962 231254 46312511
Dyspnoea 216.79 9.71 2460 139837 513088 46030677
Renal impairment 215.12 9.71 604 141693 73768 46469997
Renal failure 211.94 9.71 794 141503 112800 46430965
Completed suicide 190.04 9.71 104 142193 145816 46397949
International normalised ratio increased 173.83 9.71 418 141879 46465 46497300
Blood creatinine increased 170.82 9.71 567 141730 75836 46467929
Hepatic cirrhosis 169.35 9.71 224 142073 15508 46528257
Joint swelling 162.33 9.71 160 142137 165913 46377852
Fluid overload 156.31 9.71 290 142007 26895 46516870
Dehydration 152.89 9.71 919 141378 158621 46385144
Pain 151.58 9.71 845 141452 476103 46067662
Treatment failure 150.63 9.71 48 142249 93039 46450726
Maternal exposure during pregnancy 150.49 9.71 62 142235 102487 46441278
Oedema 149.25 9.71 497 141800 66574 46477191
Synovitis 141.36 9.71 12 142285 61063 46482702
Exposure during pregnancy 136.72 9.71 80 142217 108132 46435633
Atrial fibrillation 133.31 9.71 647 141650 102943 46440822
Blood potassium increased 125.02 9.71 202 142095 16765 46527000
Drug intolerance 118.60 9.71 165 142132 146884 46396881
Drug hypersensitivity 117.73 9.71 367 141930 243458 46300307
Infusion related reaction 114.09 9.71 85 142212 101123 46442642
Arthralgia 113.45 9.71 650 141647 363953 46179812
Contraindicated product administered 113.04 9.71 51 142246 79896 46463869
General physical health deterioration 112.82 9.71 670 141627 115099 46428666
Drug abuse 109.35 9.71 29 142268 63379 46480386
Therapeutic product effect decreased 108.75 9.71 58 142239 82543 46461222
Cardiac failure chronic 107.85 9.71 88 142209 3436 46540329
Pemphigus 107.27 9.71 8 142289 45266 46498499
Blood urea increased 107.10 9.71 238 142059 25114 46518651
Arthropathy 106.44 9.71 63 142234 84637 46459128
Musculoskeletal stiffness 100.87 9.71 90 142207 97903 46445862
Toxicity to various agents 99.90 9.71 322 141975 211444 46332321
Gastrointestinal haemorrhage 93.63 9.71 475 141822 76898 46466867
Off label use 90.80 9.71 732 141565 379109 46164656
Dyspnoea exertional 90.75 9.71 348 141949 49941 46493824
Rash 90.37 9.71 676 141621 355836 46187929
Injection site erythema 89.85 9.71 58 142239 74369 46469396
Systemic lupus erythematosus 85.45 9.71 46 142251 65134 46478631
Hepatic failure 82.81 9.71 257 142040 33159 46510606
Melaena 82.63 9.71 228 142069 27544 46516221
Alopecia 82.23 9.71 239 142058 162175 46381590
Cardioactive drug level increased 81.75 9.71 60 142237 1999 46541766
Injection site pain 81.69 9.71 125 142172 107027 46436738
Syncope 80.90 9.71 572 141725 104231 46439534
Anaemia 80.69 9.71 1159 141138 254620 46289145
Cardiac failure acute 79.30 9.71 110 142187 7968 46535797
Hand deformity 76.79 9.71 8 142289 34566 46509199
Febrile neutropenia 75.44 9.71 107 142190 94520 46449245
N-terminal prohormone brain natriuretic peptide increased 75.12 9.71 53 142244 1658 46542107
Atrioventricular block 74.87 9.71 98 142199 6713 46537052
Hypokalaemia 74.21 9.71 491 141806 87533 46456232
Abortion spontaneous 73.31 9.71 21 142276 43625 46500140
Transfusion 72.13 9.71 138 142159 13093 46530672
Hypersensitivity 71.94 9.71 227 142070 150094 46393671
Product prescribing error 70.29 9.71 175 142122 19872 46523893
Blood bilirubin increased 69.60 9.71 246 142051 33938 46509827
Intentional overdose 68.82 9.71 58 142239 64886 46478879
Therapeutic product effect incomplete 67.79 9.71 83 142214 78070 46465695
Glossodynia 64.78 9.71 27 142270 44346 46499419
Brain natriuretic peptide increased 62.49 9.71 74 142223 4576 46539189
Orthopnoea 62.16 9.71 83 142214 5797 46537968
Cardiogenic shock 61.68 9.71 147 142150 16237 46527528
Injection site reaction 60.93 9.71 35 142262 47814 46495951
Atrial flutter 58.19 9.71 102 142195 9046 46534719
Pain in jaw 56.93 9.71 250 142047 38122 46505643
Congestive cardiomyopathy 56.39 9.71 78 142219 5635 46538130
Tricuspid valve incompetence 55.94 9.71 127 142170 13590 46530175
Pulmonary oedema 55.79 9.71 305 141992 50800 46492965
Catheter management 54.25 9.71 54 142243 2741 46541024
Pulmonary arterial pressure increased 53.22 9.71 58 142239 3274 46540491
Paracentesis 52.81 9.71 34 142263 911 46542854
Orthostatic hypotension 52.40 9.71 180 142117 24478 46519287
Injection site pruritus 52.15 9.71 28 142269 39715 46504050
Left ventricular failure 52.08 9.71 70 142227 4920 46538845
Anaphylactic reaction 52.02 9.71 51 142246 53061 46490704
Hepatocellular carcinoma 51.72 9.71 53 142244 2786 46540979
Concomitant disease aggravated 51.59 9.71 89 142208 7793 46535972
Arthritis 50.86 9.71 99 142198 77217 46466548
Electrolyte imbalance 50.82 9.71 141 142156 17085 46526680
Chronic kidney disease 50.17 9.71 252 142045 40619 46503146
Cor pulmonale 50.17 9.71 44 142253 1899 46541866
Urticaria 49.65 9.71 188 142109 117704 46426061
Paraesthesia 49.63 9.71 187 142110 117250 46426515
Glomerular filtration rate decreased 48.50 9.71 109 142188 11585 46532180
Ventricular tachycardia 48.21 9.71 137 142160 16830 46526935
Pleural effusion 48.15 9.71 424 141873 82528 46461237
Neutropenia 47.28 9.71 250 142047 142954 46400811
Atrioventricular block complete 47.17 9.71 84 142213 7543 46536222
Abdominal distension 45.76 9.71 381 141916 72970 46470795
Hepatic function abnormal 45.67 9.71 217 142080 34204 46509561
Catheter site infection 45.58 9.71 64 142233 4689 46539076
Cardiomegaly 44.74 9.71 136 142161 17346 46526419
Arrhythmia 43.60 9.71 216 142081 34625 46509140
Oesophageal varices haemorrhage 42.70 9.71 33 142264 1190 46542575
Generalised oedema 42.62 9.71 118 142179 14281 46529484
Sinoatrial block 42.22 9.71 28 142269 790 46542975
Mobility decreased 40.36 9.71 77 142220 60517 46483248
Anuria 40.29 9.71 100 142197 11331 46532434
Congestive hepatopathy 39.63 9.71 43 142254 2415 46541350
Multiple sclerosis relapse 39.49 9.71 42 142255 42083 46501682
Blood sodium decreased 38.89 9.71 150 142147 21576 46522189
Seizure 38.86 9.71 218 142079 122836 46420929
Device related infection 38.26 9.71 146 142151 20895 46522870
Prothrombin time prolonged 38.19 9.71 88 142209 9508 46534257
Abdominal discomfort 38.00 9.71 287 142010 150878 46392887
Fall 37.64 9.71 1289 141008 327808 46215957
Wound 37.59 9.71 45 142252 42757 46501008
Blood pressure decreased 36.77 9.71 299 141998 56860 46486905
Oxygen saturation decreased 36.31 9.71 346 141951 68818 46474947
Blood aldosterone increased 35.83 9.71 15 142282 157 46543608
Hypoxia 35.45 9.71 275 142022 51563 46492202
Discomfort 35.01 9.71 55 142242 46615 46497150
Catheter placement 34.93 9.71 36 142261 1905 46541860
Epistaxis 34.91 9.71 324 141973 63981 46479784
Hepatic enzyme increased 34.70 9.71 130 142167 81657 46462108
Psoriasis 34.62 9.71 123 142174 78481 46465284
Pregnancy 34.33 9.71 20 142277 27117 46516648
Product monitoring error 34.32 9.71 36 142261 1945 46541820
Therapeutic response decreased 34.15 9.71 49 142248 43096 46500669
Lower respiratory tract infection 34.13 9.71 73 142224 55016 46488749
Injection site bruising 34.00 9.71 35 142262 35601 46508164
Neuropathy peripheral 33.85 9.71 152 142145 90741 46453024
Portal hypertension 33.55 9.71 47 142250 3436 46540329
Ammonia increased 33.46 9.71 53 142244 4324 46539441
Depression 33.45 9.71 344 141953 169760 46374005
Haematoma 33.30 9.71 188 142109 31684 46512081
Sinusitis 33.26 9.71 245 142052 129523 46414242
Foetal exposure during pregnancy 33.13 9.71 27 142270 30720 46513045
Renal disorder 33.07 9.71 165 142132 26521 46517244
Anxiety 32.97 9.71 375 141922 181582 46362183
Stomatitis 32.73 9.71 103 142194 68194 46475571
Electrocardiogram QRS complex prolonged 32.41 9.71 59 142238 5390 46538375
Psoriatic arthropathy 32.21 9.71 38 142259 36341 46507424
Nasopharyngitis 32.13 9.71 307 141990 153691 46390074
Product quality issue 31.81 9.71 37 142260 35611 46508154
Asthma 31.79 9.71 157 142140 91385 46452380
Injection site swelling 31.73 9.71 46 142251 40281 46503484
Condition aggravated 31.66 9.71 974 141323 244078 46299687
Hepatic cancer 31.64 9.71 43 142254 3054 46540711
Palpitations 31.28 9.71 435 141862 94824 46448941
Hypertrophic cardiomyopathy 31.01 9.71 28 142269 1256 46542509
Pericardial effusion 30.30 9.71 156 142141 25387 46518378
Aspartate aminotransferase increased 30.29 9.71 370 141927 78330 46465435
Hepatorenal syndrome 29.80 9.71 32 142265 1776 46541989
Cardioversion 29.57 9.71 26 142271 1126 46542639
Respiratory failure 29.54 9.71 429 141868 94387 46449378
Haematemesis 29.49 9.71 169 142128 28637 46515128
Osteoarthritis 29.40 9.71 94 142203 61931 46481834
Lung transplant 29.32 9.71 40 142257 2852 46540913
Blood alkaline phosphatase increased 29.26 9.71 214 142083 39395 46504370
Suicidal ideation 29.21 9.71 82 142215 56300 46487465
Upper gastrointestinal haemorrhage 28.69 9.71 114 142183 16624 46527141
Varices oesophageal 28.59 9.71 39 142258 2780 46540985
Product use issue 28.10 9.71 171 142126 94473 46449292
Fatigue 27.87 9.71 1545 140752 607152 45936613
Suicide attempt 27.81 9.71 81 142216 54955 46488810
Hypoaesthesia 27.40 9.71 231 142066 118638 46425127
Left ventricular dysfunction 27.40 9.71 81 142216 10174 46533591
Waist circumference increased 27.39 9.71 21 142276 748 46543017
Vascular resistance pulmonary decreased 27.38 9.71 10 142287 70 46543695
Tachyarrhythmia 27.35 9.71 50 142247 4582 46539183
Gamma-glutamyltransferase increased 27.30 9.71 178 142119 31562 46512203
Atrial tachycardia 27.28 9.71 33 142264 2087 46541678
Oliguria 27.14 9.71 73 142224 8686 46535079
Jugular vein distension 27.07 9.71 22 142275 854 46542911
Pericarditis 27.06 9.71 20 142277 23907 46519858
Back pain 26.95 9.71 464 141833 209575 46334190
Sight disability 26.63 9.71 11 142286 111 46543654
Renin increased 26.57 9.71 12 142285 153 46543612
Thermohypoaesthesia 26.54 9.71 11 142286 112 46543653
Ischaemic stroke 26.38 9.71 111 142186 16611 46527154
Intentional product misuse 26.34 9.71 66 142231 47062 46496703
Left-to-right cardiac shunt 26.20 9.71 11 142286 116 46543649
Mitral valve incompetence 25.84 9.71 120 142177 18732 46525033
Shock haemorrhagic 25.84 9.71 71 142226 8553 46535212
Haemoptysis 25.74 9.71 152 142145 26037 46517728
Catheterisation cardiac 25.58 9.71 45 142252 4002 46539763
Mucosal inflammation 25.54 9.71 50 142247 38926 46504839
Hyperthyroidism 25.33 9.71 86 142211 11625 46532140
Dyspnoea paroxysmal nocturnal 25.32 9.71 21 142276 839 46542926
Multiple sclerosis 25.21 9.71 23 142274 24768 46518997
Product use in unapproved indication 24.80 9.71 167 142130 90106 46453659
Lymphatic fistula 24.53 9.71 21 142276 877 46542888
Ventricular fibrillation 24.49 9.71 84 142213 11412 46532353
Wound infection pseudomonas 24.42 9.71 26 142271 1429 46542336
Abdominal cavity drainage 24.36 9.71 15 142282 371 46543394
Femoral hernia incarcerated 24.31 9.71 21 142276 888 46542877
Metabolic alkalosis 24.30 9.71 35 142262 2625 46541140
Sleep disorder 24.28 9.71 68 142229 46727 46497038
Cardiac output decreased 24.25 9.71 21 142276 891 46542874
Catheter site discharge 24.24 9.71 30 142267 1942 46541823
Psychotic disorder 24.20 9.71 20 142277 22601 46521164
Hypochloraemia 23.84 9.71 29 142268 1844 46541921
Herpes zoster 23.79 9.71 116 142181 67756 46476009
Body tinea 23.79 9.71 21 142276 914 46542851
Sinus node dysfunction 23.70 9.71 45 142252 4244 46539521
Oropharyngeal pain 23.62 9.71 131 142166 74037 46469728
Concomitant disease progression 23.60 9.71 31 142266 2131 46541634
Catheter site erythema 23.53 9.71 43 142254 3940 46539825
N-terminal prohormone brain natriuretic peptide abnormal 23.38 9.71 8 142289 45 46543720
Accidental exposure to product 23.36 9.71 18 142279 21063 46522702
Cardiomyopathy 23.29 9.71 104 142193 15969 46527796
Diffuse large B-cell lymphoma refractory 23.24 9.71 21 142276 943 46542822
Lactic acidosis 23.24 9.71 180 142117 33729 46510036
Fear of eating 23.11 9.71 14 142283 336 46543429
Device stimulation issue 23.09 9.71 9 142288 77 46543688
Sinus bradycardia 22.93 9.71 93 142204 13689 46530076
Cortisol increased 22.85 9.71 14 142283 343 46543422
Intentional self-injury 22.75 9.71 24 142273 24142 46519623
Hypovolaemia 22.62 9.71 74 142223 9814 46533951
Bundle branch block left 22.57 9.71 56 142241 6343 46537422
Female sexual arousal disorder 22.56 9.71 6 142291 11 46543754
Arterial haemorrhage 22.52 9.71 27 142270 1691 46542074
Pancreatic steatosis 22.49 9.71 21 142276 984 46542781
Infection 22.39 9.71 280 142017 133312 46410453
Bundle branch block right 22.36 9.71 47 142250 4772 46538993
Joint stiffness 22.24 9.71 30 142267 27078 46516687
Oxygen consumption increased 22.21 9.71 40 142257 3623 46540142
Cytomegalovirus infection 22.08 9.71 14 142283 18130 46525635
Neonatal respiratory failure 21.97 9.71 11 142286 179 46543586
Adverse drug reaction 21.90 9.71 66 142231 44296 46499469
Premature labour 21.83 9.71 4 142293 11295 46532470
Drug resistance 21.69 9.71 13 142284 17355 46526410
Nodal arrhythmia 21.66 9.71 23 142274 1260 46542505
Aortic valve stenosis 21.40 9.71 36 142261 3088 46540677
Chest pain 21.21 9.71 695 141602 175629 46368136
Haemorrhagic disorder 20.98 9.71 18 142279 754 46543011
Inhibitory drug interaction 20.84 9.71 28 142269 1967 46541798
Jaundice 20.82 9.71 155 142142 28690 46515075
Acute pulmonary oedema 20.77 9.71 62 142235 7829 46535936
Brain stem stroke 20.74 9.71 12 142285 264 46543501
Acute respiratory failure 20.71 9.71 156 142141 28982 46514783
Bursitis 20.67 9.71 18 142279 19824 46523941
Cirrhosis alcoholic 20.59 9.71 11 142286 206 46543559
Hepatomegaly 20.39 9.71 78 142219 11175 46532590
Multiple organ dysfunction syndrome 20.28 9.71 244 142053 51466 46492299
Dyspnoea at rest 20.27 9.71 38 142259 3550 46540215
Red blood cell sedimentation rate increased 20.16 9.71 24 142273 22865 46520900
Right ventricular dysfunction 20.14 9.71 24 142273 1494 46542271
Pulmonary congestion 20.14 9.71 94 142203 14705 46529060
Viral diarrhoea 20.12 9.71 9 142288 112 46543653
Cardiorenal syndrome 20.07 9.71 16 142281 604 46543161
Portopulmonary hypertension 19.98 9.71 9 142288 114 46543651
Sudden death 19.86 9.71 69 142228 9435 46534330
Metastases to central nervous system 19.59 9.71 5 142292 11216 46532549
Ejection fraction decreased 19.53 9.71 107 142190 17830 46525935
Migraine 19.51 9.71 129 142168 69897 46473868
Transplant evaluation 19.44 9.71 20 142277 1056 46542709
Urine output decreased 19.36 9.71 76 142221 11021 46532744
Hepatic cyst 19.29 9.71 44 142253 4722 46539043
Pemphigoid 19.23 9.71 49 142248 5642 46538123
Bradyarrhythmia 19.22 9.71 27 142270 1979 46541786
Pulmonary arterial pressure abnormal 19.19 9.71 14 142283 462 46543303
Decreased appetite 19.12 9.71 747 141550 193089 46350676
Injection site warmth 19.12 9.71 9 142288 13763 46530002
Shock 19.08 9.71 123 142174 21722 46522043
No adverse event 19.08 9.71 48 142249 34183 46509582
Insomnia 19.05 9.71 371 141926 164553 46379212
Cardiac disorder 19.01 9.71 211 142086 43647 46500118
Atrial enlargement 18.93 9.71 11 142286 244 46543521
White blood cell count decreased 18.89 9.71 235 142062 111996 46431769
Inappropriate antidiuretic hormone secretion 18.77 9.71 89 142208 14013 46529752
Subdural haematoma 18.76 9.71 84 142213 12913 46530852
Stress 18.71 9.71 87 142210 51464 46492301
Cyanosis 18.57 9.71 97 142200 15874 46527891
Haemarthrosis 18.56 9.71 33 142264 2960 46540805
Polyuria 18.43 9.71 56 142241 7139 46536626
Confusional state 18.40 9.71 627 141670 159265 46384500
Bilirubin conjugated increased 18.36 9.71 31 142266 2667 46541098
Exercise tolerance decreased 18.24 9.71 42 142255 4535 46539230
Oesophageal variceal ligation 18.20 9.71 5 142292 11 46543754
Seroma 18.20 9.71 27 142270 2080 46541685
Hip arthroplasty 18.19 9.71 17 142280 18095 46525670
Catheter removal 18.17 9.71 12 142285 336 46543429
Diet noncompliance 18.16 9.71 11 142286 264 46543501
Vascular access site infection 18.12 9.71 6 142291 30 46543735
Progressive multifocal leukoencephalopathy 18.08 9.71 6 142291 11340 46532425
Vessel puncture site haemorrhage 18.07 9.71 8 142289 97 46543668
Blood cholesterol increased 18.03 9.71 62 142235 39951 46503814
Vascular access site thrombosis 17.96 9.71 6 142291 31 46543734
Joint range of motion decreased 17.95 9.71 12 142285 15112 46528653
Hypertrichosis 17.95 9.71 18 142279 922 46542843
Cardiac hypertrophy 17.94 9.71 19 142278 1038 46542727
Hypovolaemic shock 17.91 9.71 45 142252 5138 46538627
Prerenal failure 17.89 9.71 22 142275 1415 46542350
Bone marrow failure 17.81 9.71 40 142257 29629 46514136
Loss of personal independence in daily activities 17.66 9.71 102 142195 57081 46486684
Knee arthroplasty 17.64 9.71 28 142269 23637 46520128
Electrocardiogram T wave amplitude increased 17.62 9.71 5 142292 13 46543752
Red cell distribution width abnormal 17.57 9.71 9 142288 154 46543611
Premature delivery 17.53 9.71 25 142272 22044 46521721
Catheter site pain 17.52 9.71 37 142260 3769 46539996
Pulmonary arterial wedge pressure increased 17.51 9.71 11 142286 282 46543483
Colitis ulcerative 17.39 9.71 17 142280 17715 46526050
Drug dependence 17.39 9.71 21 142276 19880 46523885
Diverticulum intestinal 17.38 9.71 49 142248 5992 46537773
Helicobacter infection 17.36 9.71 7 142290 11729 46532036
Incision site impaired healing 17.31 9.71 9 142288 159 46543606
Live birth 17.29 9.71 5 142292 10325 46533440
Glaucoma 17.13 9.71 14 142283 15907 46527858
Haemoglobin decreased 17.01 9.71 514 141783 128435 46415330
Night sweats 16.97 9.71 36 142261 27214 46516551
Blood loss anaemia 16.91 9.71 61 142236 8496 46535269
Blood potassium decreased 16.90 9.71 184 142113 37879 46505886
Plasma cell myeloma 16.78 9.71 74 142223 44404 46499361
Liver transplant 16.75 9.71 28 142269 2389 46541376
Generalised tonic-clonic seizure 16.75 9.71 36 142261 27086 46516679
Drug monitoring procedure not performed 16.63 9.71 12 142285 389 46543376
Right ventricular dilatation 16.53 9.71 17 142280 897 46542868
Chronic hepatic failure 16.53 9.71 13 142284 481 46543284
Ejection fraction 16.49 9.71 14 142283 578 46543187
Pulmonary veno-occlusive disease 16.43 9.71 17 142280 904 46542861
Blood catecholamines decreased 16.43 9.71 4 142293 4 46543761
Intentional product use issue 16.38 9.71 94 142203 52686 46491079
Drug withdrawal syndrome 16.37 9.71 37 142260 27347 46516418
Hyperuricaemia 16.35 9.71 41 142256 4676 46539089
Osteoporosis 16.28 9.71 66 142231 40542 46503223
Packed red blood cell transfusion 16.27 9.71 26 142271 2137 46541628
Hyperbilirubinaemia 16.24 9.71 69 142228 10369 46533396
Nodal rhythm 16.20 9.71 23 142274 1702 46542063
Dystonia 16.19 9.71 7 142290 11250 46532515
Right atrial dilatation 16.14 9.71 13 142284 498 46543267
Sinus arrest 16.14 9.71 23 142274 1708 46542057
Central venous catheterisation 16.10 9.71 25 142272 2005 46541760
Multimorbidity 16.06 9.71 15 142282 703 46543062
Leukaemic infiltration renal 16.00 9.71 5 142292 20 46543745
Walking distance test abnormal 15.99 9.71 13 142284 505 46543260
Premature baby 15.94 9.71 19 142278 18093 46525672
Cardiac murmur 15.93 9.71 73 142224 11331 46532434
Device expulsion 15.84 9.71 38 142259 27504 46516261
Occult blood positive 15.62 9.71 34 142263 3536 46540229
Liver disorder 15.60 9.71 178 142119 37068 46506697
Amaurosis 15.60 9.71 13 142284 523 46543242
Therapeutic embolisation 15.51 9.71 8 142289 139 46543626
Malignant neoplasm progression 15.49 9.71 125 142172 64801 46478964
Colitis 15.42 9.71 60 142237 37287 46506478
Walking disability 15.41 9.71 20 142277 1358 46542407
Ventricular failure 15.40 9.71 11 142286 351 46543414
Prothrombin consumption time prolonged 15.33 9.71 6 142291 52 46543713
Electrocardiogram U wave present 15.31 9.71 7 142290 92 46543673
Blood pressure increased 15.22 9.71 283 142014 126383 46417382
Creatinine renal clearance decreased 15.13 9.71 51 142246 6869 46536896
Device difficult to use 15.11 9.71 3 142294 8001 46535764
Aortic arteriosclerosis 15.10 9.71 45 142252 5676 46538089
Foetal death 15.06 9.71 4 142293 8739 46535026
Bone erosion 15.03 9.71 5 142292 9438 46534327
Blood culture negative 15.01 9.71 8 142289 149 46543616
Torsade de pointes 14.95 9.71 75 142222 12079 46531686
Volume blood decreased 14.82 9.71 8 142289 153 46543612
Immunodeficiency 14.76 9.71 11 142286 13095 46530670
Renin decreased 14.73 9.71 7 142290 101 46543664
Platelet count decreased 14.64 9.71 404 141893 99620 46444145
Intra-abdominal fluid collection 14.59 9.71 24 142273 2021 46541744
Chronic respiratory failure 14.57 9.71 22 142275 1722 46542043
Sensitisation 14.52 9.71 14 142283 683 46543082
Catheter site swelling 14.51 9.71 19 142278 1302 46542463
Iron deficiency anaemia 14.49 9.71 96 142201 17110 46526655
Inflammatory marker increased 14.39 9.71 43 142254 5432 46538333
Abnormal precordial movement 14.39 9.71 3 142294 0 46543765
Aspiration pleural cavity 14.37 9.71 15 142282 806 46542959
Tremor 14.32 9.71 257 142040 115382 46428383
Alcoholic liver disease 14.20 9.71 7 142290 110 46543655
Photophobia 14.20 9.71 14 142283 14530 46529235
Breast cancer 14.16 9.71 81 142216 45437 46498328
Purpura 14.10 9.71 64 142233 9894 46533871
Pain in extremity 13.99 9.71 645 141652 258035 46285730
Asterixis 13.98 9.71 18 142279 1213 46542552
Throat tightness 13.94 9.71 26 142271 20613 46523152
Nasal congestion 13.93 9.71 215 142082 47898 46495867
Hepatorenal failure 13.85 9.71 13 142284 613 46543152
Glomerular filtration rate abnormal 13.84 9.71 12 142285 510 46543255
Asthenia 13.83 9.71 1114 141183 309961 46233804
Urine output increased 13.82 9.71 18 142279 1227 46542538
Polycystic ovaries 13.81 9.71 19 142278 1365 46542400
Bleeding varicose vein 13.79 9.71 9 142288 247 46543518
Portal vein thrombosis 13.78 9.71 26 142271 2441 46541324
Device alarm issue 13.75 9.71 19 142278 1371 46542394
Osteonecrosis of jaw 13.74 9.71 56 142241 34346 46509419
Vascular device infection 13.72 9.71 32 142265 3485 46540280
Sputum culture positive 13.71 9.71 16 142281 974 46542791
Mixed hepatocellular cholangiocarcinoma 13.68 9.71 4 142293 12 46543753
Pulmonary aplasia 13.68 9.71 4 142293 12 46543753
Cardiac failure high output 13.54 9.71 9 142288 255 46543510
Splenomegaly 13.52 9.71 62 142235 9626 46534139
Pericarditis constrictive 13.50 9.71 10 142287 338 46543427
Electrocardiogram QT shortened 13.50 9.71 7 142290 123 46543642
Injection site rash 13.49 9.71 17 142280 15796 46527969
Myocarditis infectious 13.44 9.71 4 142293 13 46543752
Hypervolaemia 13.37 9.71 21 142276 1701 46542064
Erysipelas 13.33 9.71 49 142248 6889 46536876
Venous pressure jugular increased 13.23 9.71 11 142286 441 46543324
Ventricular arrhythmia 13.21 9.71 31 142266 3390 46540375
Posterior reversible encephalopathy syndrome 13.20 9.71 16 142281 15125 46528640
Injection site haemorrhage 13.20 9.71 27 142270 20682 46523083
Cortisol free urine increased 13.12 9.71 5 142292 40 46543725
Primary biliary cholangitis 13.11 9.71 17 142280 1154 46542611
Visual impairment 13.04 9.71 135 142162 66554 46477211
Brain natriuretic peptide 13.01 9.71 5 142292 41 46543724
Left ventricular enlargement 13.01 9.71 5 142292 41 46543724
Brain natriuretic peptide abnormal 13 9.71 10 142287 358 46543407
Gamma-glutamyltransferase abnormal 13.00 9.71 9 142288 273 46543492
Hypocoagulable state 12.99 9.71 16 142281 1031 46542734
Fibromyalgia 12.96 9.71 62 142235 36401 46507364
Cognitive disorder 12.94 9.71 63 142234 36820 46506945
Blood bilirubin abnormal 12.90 9.71 13 142284 670 46543095
Sedation 12.86 9.71 32 142265 22878 46520887
Ballismus 12.79 9.71 6 142291 84 46543681
Stress fracture 12.79 9.71 3 142294 7124 46536641
Gastrointestinal angiectasia 12.72 9.71 6 142291 85 46543680
Mixed liver injury 12.70 9.71 29 142268 3114 46540651
Haptoglobin decreased 12.68 9.71 12 142285 572 46543193
Malignant ascites 12.63 9.71 15 142282 930 46542835
Coagulopathy 12.56 9.71 98 142199 18401 46525364
CREST syndrome 12.51 9.71 10 142287 379 46543386
Catheter site pruritus 12.50 9.71 22 142275 1957 46541808
Ill-defined disorder 12.47 9.71 41 142256 26786 46516979
Muscle spasticity 12.38 9.71 10 142287 11430 46532335
Joint effusion 12.35 9.71 11 142286 11984 46531781
Influenza like illness 12.32 9.71 114 142183 57456 46486309
Injection site urticaria 12.29 9.71 11 142286 11956 46531809
Caesarean section 12.04 9.71 20 142277 16583 46527182
Urogenital haemorrhage 12.02 9.71 7 142290 156 46543609
Blood uric acid increased 12.01 9.71 34 142263 4167 46539598
Pharyngitis 12.01 9.71 22 142275 17561 46526204
Hypertension 11.98 9.71 483 141814 195873 46347892
Poisoning 11.98 9.71 15 142282 13979 46529786
Atrial septal defect repair 11.96 9.71 8 142289 229 46543536
Tenosynovitis 11.93 9.71 4 142293 7511 46536254
Labelled drug-drug interaction medication error 11.92 9.71 57 142240 9004 46534761
Postpericardiotomy syndrome 11.92 9.71 4 142293 21 46543744
Neonatal hyponatraemia 11.89 9.71 5 142292 53 46543712
Epstein-Barr virus infection 11.89 9.71 3 142294 6781 46536984
Gastric varices haemorrhage 11.85 9.71 6 142291 100 46543665
Urine potassium increased 11.77 9.71 4 142293 22 46543743
Mucocutaneous haemorrhage 11.73 9.71 5 142292 55 46543710
Aortic valve calcification 11.69 9.71 10 142287 417 46543348
Rhabdomyolysis 11.64 9.71 186 142111 41723 46502042
Cardiac pacemaker insertion 11.63 9.71 31 142266 3668 46540097
Erythema 11.57 9.71 339 141958 142481 46401284
Drug therapeutic incompatibility 11.57 9.71 5 142292 57 46543708
Inability to afford medication 11.52 9.71 16 142281 1160 46542605
Cardiac flutter 11.49 9.71 29 142268 3320 46540445
Biopsy lung 11.48 9.71 7 142290 170 46543595
Chronic right ventricular failure 11.48 9.71 4 142293 24 46543741
Blood pressure systolic decreased 11.45 9.71 39 142258 5279 46538486
Hypertonic bladder 11.36 9.71 27 142270 2977 46540788
Ventricular assist device insertion 11.34 9.71 4 142293 25 46543740
Right ventricular systolic pressure increased 11.30 9.71 11 142286 543 46543222
Gait inability 11.30 9.71 62 142235 35141 46508624
Congenital musculoskeletal anomaly 11.30 9.71 10 142287 437 46543328
Lymphadenopathy 11.29 9.71 58 142239 33430 46510335
Schizophrenia 11.29 9.71 6 142291 8562 46535203
Dependence on oxygen therapy 11.28 9.71 9 142288 340 46543425
Duodenal ulcer perforation 11.14 9.71 6 142291 8496 46535269
Fibrinous bronchitis 11.11 9.71 3 142294 6 46543759
Aphasia 11.10 9.71 47 142250 28520 46515245
Vital capacity decreased 11.06 9.71 11 142286 558 46543207
Cataract 11.03 9.71 87 142210 45328 46498437
Infective pulmonary exacerbation of cystic fibrosis 11.02 9.71 10 142287 10797 46532968
Infection susceptibility increased 10.99 9.71 22 142275 2157 46541608
Blood urea abnormal 10.97 9.71 11 142286 563 46543202
Alanine aminotransferase increased 10.97 9.71 350 141947 88101 46455664
Extensor plantar response 10.91 9.71 16 142281 1220 46542545
Gastrointestinal arteriovenous malformation 10.89 9.71 11 142286 568 46543197
Haemorrhage subcutaneous 10.86 9.71 26 142271 2880 46540885
Neuromyelitis optica spectrum disorder 10.83 9.71 13 142284 815 46542950
Optic ischaemic neuropathy 10.81 9.71 14 142283 949 46542816
Ulcer 10.81 9.71 23 142274 17369 46526396
Foot deformity 10.80 9.71 19 142278 15406 46528359
Vasodilatation 10.76 9.71 23 142274 2362 46541403
Hospitalisation 10.73 9.71 261 142036 63124 46480641
Marasmus 10.70 9.71 10 142287 469 46543296
Subchorionic haematoma 10.70 9.71 6 142291 124 46543641
Blood creatinine abnormal 10.69 9.71 23 142274 2373 46541392
Cardiac ablation 10.68 9.71 16 142281 1243 46542522
Electrocardiogram T wave inversion 10.59 9.71 29 142268 3487 46540278
Product availability issue 10.57 9.71 15 142282 1110 46542655
Blood potassium abnormal 10.55 9.71 21 142276 2051 46541714
Nephrocalcinosis 10.54 9.71 14 142283 973 46542792
Hypernatraemia 10.49 9.71 43 142254 6358 46537407
Toxic neuropathy 10.49 9.71 9 142288 377 46543388
Ischaemic cardiomyopathy 10.46 9.71 24 142273 2586 46541179
Creatinine renal clearance abnormal 10.42 9.71 7 142290 202 46543563
Blood bilirubin unconjugated increased 10.41 9.71 9 142288 381 46543384
Respiratory depression 10.39 9.71 12 142285 11588 46532177
Hepatic hydrothorax 10.39 9.71 4 142293 33 46543732
Blood corticotrophin increased 10.39 9.71 4 142293 33 46543732
Femur fracture 10.38 9.71 68 142229 36929 46506836
Coma hepatic 10.33 9.71 11 142286 605 46543160
Electrocardiogram T wave peaked 10.30 9.71 7 142290 206 46543559
Tachypnoea 10.29 9.71 77 142220 14274 46529491
Ejection fraction abnormal 10.24 9.71 11 142286 611 46543154
Osteonecrosis 10.22 9.71 42 142255 25702 46518063
Gouty arthritis 10.22 9.71 10 142287 497 46543268
Ovarian cyst 10.19 9.71 17 142280 14070 46529695
Nephrolithiasis 10.18 9.71 59 142238 32992 46510773
Sleep apnoea syndrome 10.17 9.71 108 142189 22093 46521672
Poor peripheral circulation 10.17 9.71 26 142271 3001 46540764
Metastases to bone 10.14 9.71 24 142273 17452 46526313
Musculoskeletal disorder 10.13 9.71 20 142277 15525 46528240
Swelling face 10.13 9.71 108 142189 52951 46490814
Injection site mass 10.11 9.71 19 142278 15021 46528744
Catheter culture positive 10.09 9.71 6 142291 139 46543626
Hyperinsulinaemia 10.00 9.71 5 142292 81 46543684
Lymphocyte count decreased 10.00 9.71 42 142255 25547 46518218
International normalised ratio abnormal 9.99 9.71 26 142271 3033 46540732
Embolic stroke 9.97 9.71 29 142268 3610 46540155
Cardiac cirrhosis 9.94 9.71 6 142291 143 46543622
Abnormal dreams 9.91 9.71 10 142287 10269 46533496
Electrocardiogram abnormal 9.88 9.71 45 142252 6967 46536798
Left atrial dilatation 9.84 9.71 19 142278 1814 46541951
Balloon atrial septostomy 9.84 9.71 5 142292 84 46543681
Inflammation 9.84 9.71 98 142199 48683 46495082
QRS axis abnormal 9.83 9.71 14 142283 1039 46542726
Malignant melanoma 9.82 9.71 10 142287 10224 46533541
Electrocardiogram QT prolonged 9.82 9.71 215 142082 51110 46492655
Cheilosis 9.80 9.71 3 142294 11 46543754
Nephrectomy 9.77 9.71 10 142287 525 46543240
Neutropenic sepsis 9.75 9.71 14 142283 12310 46531455
Aggression 9.74 9.71 36 142261 22708 46521057
Nail disorder 9.73 9.71 6 142291 7890 46535875
Swelling 9.72 9.71 297 142000 124214 46419551
Cardiac valve thickening 9.72 9.71 4 142293 40 46543725

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 2020.61 10.63 1743 103135 64267 29783333
Acute kidney injury 774.59 10.63 2404 102474 271438 29576162
Cardiac failure 720.27 10.63 1149 103729 82269 29765331
Hepatic encephalopathy 567.84 10.63 439 104439 13753 29833847
Ascites 504.00 10.63 625 104253 35296 29812304
Hyponatraemia 259.97 10.63 663 104215 66539 29781061
Cardiac failure congestive 258.20 10.63 764 104114 83643 29763957
Drug ineffective 231.21 10.63 534 104344 339853 29507747
Hepatic cirrhosis 228.41 10.63 281 104597 15718 29831882
Hepatic failure 208.71 10.63 404 104474 33639 29813961
Cardiac failure chronic 207.90 10.63 169 104709 5694 29841906
Completed suicide 203.69 10.63 49 104829 99443 29748157
Gynaecomastia 191.21 10.63 188 104690 8163 29839437
Right ventricular failure 186.03 10.63 182 104696 7854 29839746
Hypotension 183.85 10.63 1266 103612 199299 29648301
Drug abuse 178.99 10.63 35 104843 82037 29765563
Oedema peripheral 170.40 10.63 778 104100 105054 29742546
Pulmonary hypertension 149.96 10.63 252 104626 18784 29828816
Dehydration 149.51 10.63 838 104040 122701 29724899
Blood potassium increased 133.56 10.63 219 104659 15994 29831606
Dyspnoea 122.00 10.63 1736 103142 331559 29516041
Renal failure 120.81 10.63 819 104059 128147 29719453
Hepatic cancer 118.56 10.63 130 104748 6418 29841182
Oesophageal varices haemorrhage 114.65 10.63 91 104787 2960 29844640
International normalised ratio increased 113.82 10.63 397 104481 47342 29800258
Febrile neutropenia 113.13 10.63 124 104754 106569 29741031
Hepatorenal syndrome 112.15 10.63 83 104795 2428 29845172
Renal impairment 111.14 10.63 585 104293 83599 29764001
Toxicity to various agents 108.86 10.63 292 104586 176891 29670709
Ejection fraction decreased 107.88 10.63 192 104686 14983 29832617
Brain natriuretic peptide increased 105.97 10.63 98 104780 3937 29843663
Oedema 105.50 10.63 361 104517 42632 29804968
Drug interaction 104.21 10.63 1112 103766 198456 29649144
Pulmonary arterial hypertension 104.17 10.63 145 104733 9156 29838444
Ventricular tachycardia 103.32 10.63 246 104632 23616 29823984
Neutropenia 99.17 10.63 187 104691 128353 29719247
Bradycardia 96.03 10.63 469 104409 65057 29782543
Rheumatoid arthritis 95.38 10.63 15 104863 41182 29806418
Blood creatinine increased 89.52 10.63 587 104291 90788 29756812
Intentional overdose 83.71 10.63 21 104857 41460 29806140
Atrioventricular block complete 83.01 10.63 124 104754 8353 29839247
Off label use 79.52 10.63 529 104349 248761 29598839
Fluid retention 76.95 10.63 227 104651 24771 29822829
Orthopnoea 76.80 10.63 87 104791 4453 29843147
Hepatocellular carcinoma 76.71 10.63 128 104750 9482 29838118
Arthralgia 76.56 10.63 233 104645 135558 29712042
Blood urea increased 74.79 10.63 261 104617 31120 29816480
Congestive cardiomyopathy 72.26 10.63 102 104776 6525 29841075
Foetal exposure during pregnancy 71.86 10.63 20 104858 36851 29810749
Syncope 66.60 10.63 517 104361 84386 29763214
Cardiogenic shock 63.67 10.63 165 104713 16696 29830904
Orthostatic hypotension 62.92 10.63 206 104672 23773 29823827
Breast tenderness 61.69 10.63 36 104842 696 29846904
N-terminal prohormone brain natriuretic peptide increased 61.26 10.63 45 104833 1301 29846299
Varices oesophageal 58.95 10.63 67 104811 3442 29844158
Pyrexia 58.60 10.63 705 104173 293784 29553816
Mitral valve incompetence 57.89 10.63 137 104741 13097 29834503
Infusion related reaction 56.68 10.63 36 104842 40528 29807072
Ammonia increased 56.53 10.63 72 104806 4169 29843431
General physical health deterioration 55.35 10.63 564 104314 99380 29748220
Rash 53.46 10.63 423 104455 191466 29656134
Melaena 53.21 10.63 240 104638 32197 29815403
Gastrointestinal haemorrhage 53.14 10.63 485 104393 82961 29764639
Cardiac failure acute 51.23 10.63 105 104773 9104 29838496
Urticaria 50.93 10.63 70 104808 54536 29793064
Tricuspid valve incompetence 49.97 10.63 100 104778 8523 29839077
Intentional product misuse 49.49 10.63 30 104848 34637 29812963
Dyspnoea exertional 49.31 10.63 250 104628 35180 29812420
Ischaemic cardiomyopathy 49.09 10.63 83 104795 6214 29841386
Nipple pain 48.26 10.63 29 104849 593 29847007
Depression 48.24 10.63 159 104719 90278 29757322
Anxiety 47.94 10.63 158 104720 89713 29757887
Concomitant disease aggravated 47.35 10.63 73 104805 5056 29842544
Suicidal ideation 46.53 10.63 35 104843 36079 29811521
Neuropathy peripheral 46.38 10.63 112 104766 70363 29777237
Blood bilirubin increased 45.83 10.63 251 104627 36385 29811215
Death 45.74 10.63 930 103948 356353 29491247
Electrocardiogram T wave peaked 45.23 10.63 26 104852 488 29847112
Therapeutic product effect incomplete 44.62 10.63 32 104846 33802 29813798
Product dose omission issue 44.26 10.63 168 104710 91463 29756137
Suicide attempt 44.24 10.63 38 104840 36659 29810941
Treatment failure 44.18 10.63 34 104844 34645 29812955
Chronic kidney disease 43.87 10.63 254 104624 37584 29810016
Hypokalaemia 43.49 10.63 313 104565 49879 29797721
Plasma cell myeloma 42.75 10.63 76 104802 53386 29794214
Pain 42.49 10.63 393 104485 172248 29675352
Lactic acidosis 41.18 10.63 217 104661 30996 29816604
Bradyarrhythmia 41.10 10.63 42 104836 1910 29845690
Brain natriuretic peptide abnormal 40.11 10.63 17 104861 158 29847442
Ventricular fibrillation 39.66 10.63 130 104748 15008 29832592
Headache 39.46 10.63 428 104450 181878 29665722
Arrhythmia 39.33 10.63 224 104654 32945 29814655
Quadriparesis 39.01 10.63 31 104847 1010 29846590
Mucosal inflammation 38.72 10.63 30 104848 30464 29817136
Bundle branch block left 38.47 10.63 67 104811 5137 29842463
Breast pain 38.32 10.63 34 104844 1293 29846307
Chronic hepatic failure 38.07 10.63 23 104855 475 29847125
Leukopenia 37.94 10.63 88 104790 56071 29791529
Left ventricular dilatation 37.83 10.63 25 104853 607 29846993
Drug dependence 37.17 10.63 14 104864 21281 29826319
Injection site pain 37.01 10.63 31 104847 30279 29817321
Pulmonary arterial pressure abnormal 36.38 10.63 16 104862 164 29847436
Product use in unapproved indication 36.30 10.63 134 104744 73559 29774041
Hypersensitivity 36.23 10.63 85 104793 53943 29793657
Cytomegalovirus infection 35.92 10.63 19 104859 23655 29823945
Joint swelling 35.53 10.63 69 104809 46877 29800723
Anaphylactic reaction 34.93 10.63 28 104850 27954 29819646
Seizure 34.89 10.63 202 104676 98273 29749327
Congestive hepatopathy 34.81 10.63 38 104840 1866 29845734
Polyuria 34.55 10.63 78 104800 7228 29840372
Cardioactive drug level increased 34.03 10.63 35 104843 1604 29845996
Sinusitis 33.94 10.63 40 104838 33305 29814295
Blood pressure decreased 33.79 10.63 281 104597 46794 29800806
Atrial fibrillation 33.76 10.63 549 104329 107575 29740025
Fall 33.06 10.63 852 104026 181020 29666580
Portal hypertension 32.81 10.63 53 104825 3820 29843780
Anaemia 32.36 10.63 955 103923 207037 29640563
White blood cell count decreased 31.48 10.63 169 104709 83778 29763822
Abdominal cavity drainage 31.31 10.63 18 104860 338 29847262
Pneumonitis 31.22 10.63 30 104848 27424 29820176
Insomnia 31.20 10.63 195 104683 93141 29754459
Aggression 30.84 10.63 51 104827 36856 29810744
Nodal rhythm 30.66 10.63 31 104847 1392 29846208
Therapeutic product effect decreased 30.54 10.63 34 104844 29042 29818558
Blood sodium decreased 30.38 10.63 123 104755 15733 29831867
Electrolyte imbalance 30.34 10.63 99 104779 11401 29836199
Hypovolaemia 30.24 10.63 82 104796 8523 29839077
Cardiomyopathy 29.44 10.63 118 104760 15025 29832575
Overdose 29.34 10.63 174 104704 84163 29763437
N-terminal prohormone brain natriuretic peptide abnormal 29.24 10.63 12 104866 102 29847498
Premature baby 29.08 10.63 11 104867 16680 29830920
Cardiomegaly 28.96 10.63 114 104764 14395 29833205
Protein-losing gastroenteropathy 28.93 10.63 16 104862 278 29847322
Liver transplant 28.89 10.63 42 104836 2760 29844840
Hepatic function abnormal 28.84 10.63 248 104630 41697 29805903
Subarachnoid haemorrhage 28.74 10.63 88 104790 9798 29837802
Glomerular filtration rate decreased 28.36 10.63 96 104782 11266 29836334
Neutrophil count decreased 28.29 10.63 67 104811 42387 29805213
Abdominal distension 28.22 10.63 264 104614 45445 29802155
Cirrhosis alcoholic 27.90 10.63 23 104855 790 29846810
Musculoskeletal stiffness 27.79 10.63 52 104826 35829 29811771
Faecal volume decreased 27.71 10.63 11 104867 85 29847515
Paraesthesia 27.27 10.63 98 104780 54229 29793371
Oxygen saturation increased 27.25 10.63 14 104864 208 29847392
Condition aggravated 27.15 10.63 653 104225 137213 29710387
Pneumonia 27.12 10.63 929 103949 333377 29514223
Intentional self-injury 27.00 10.63 7 104871 13525 29834075
Osteonecrosis of jaw 26.73 10.63 16 104862 18602 29828998
Neuroleptic malignant syndrome 26.36 10.63 12 104866 16283 29831317
Agitation 26.18 10.63 99 104779 53974 29793626
Tremor 25.94 10.63 156 104722 75207 29772393
Generalised oedema 25.87 10.63 96 104782 11789 29835811
Ventricular hypokinesia 25.71 10.63 50 104828 4173 29843427
Hyperhidrosis 25.18 10.63 135 104743 66955 29780645
Hallucination 24.95 10.63 88 104790 48971 29798629
Intentional product use issue 24.69 10.63 57 104821 36383 29811217
Fluid overload 24.68 10.63 132 104746 18960 29828640
Diaphragmatic spasm 24.68 10.63 10 104868 82 29847518
Blood aldosterone increased 24.64 10.63 7 104871 15 29847585
Jaundice 24.43 10.63 196 104682 32290 29815310
Blood thyroid stimulating hormone abnormal 24.38 10.63 12 104866 162 29847438
Arthropathy 24.33 10.63 22 104856 20705 29826895
Scrotal oedema 24.28 10.63 28 104850 1461 29846139
Oliguria 24.28 10.63 69 104809 7370 29840230
Blood loss anaemia 24.17 10.63 70 104808 7557 29840043
Electrocardiogram QRS complex abnormal 24.07 10.63 14 104864 269 29847331
Anuria 23.87 10.63 85 104793 10231 29837369
Transfusion 23.18 10.63 68 104810 7393 29840207
Platelet count normal 22.98 10.63 7 104871 21 29847579
Labelled drug-drug interaction medication error 22.84 10.63 85 104793 10453 29837147
Accidental exposure to product 22.70 10.63 4 104874 10111 29837489
Coma hepatic 22.41 10.63 16 104862 442 29847158
Fractured coccyx 22.38 10.63 11 104867 148 29847452
Pulmonary oedema 22.34 10.63 244 104634 43731 29803869
Portal vein thrombosis 22.30 10.63 42 104836 3422 29844178
Jugular vein distension 22.23 10.63 17 104861 523 29847077
Left ventricular dysfunction 22.20 10.63 74 104804 8617 29838983
Drug withdrawal syndrome 22.11 10.63 22 104856 19787 29827813
Chronic obstructive pulmonary disease 22.10 10.63 253 104625 45873 29801727
Low cardiac output syndrome 21.85 10.63 14 104864 322 29847278
Pleural effusion 21.60 10.63 372 104506 73694 29773906
Bone marrow failure 21.49 10.63 45 104833 29740 29817860
Azotaemia 21.37 10.63 51 104827 4901 29842699
Adverse drug reaction 21.24 10.63 30 104848 23115 29824485
Spur cell anaemia 21.20 10.63 8 104870 53 29847547
Left ventricular failure 21.10 10.63 51 104827 4940 29842660
Resting tremor 21.10 10.63 17 104861 565 29847035
Multiple sclerosis relapse 20.96 10.63 6 104872 10856 29836744
Torsade de pointes 20.90 10.63 64 104814 7126 29840474
Product monitoring error 20.79 10.63 28 104850 1713 29845887
Product quality issue 20.78 10.63 21 104857 18753 29828847
Urine output decreased 20.69 10.63 78 104800 9651 29837949
Back pain 20.53 10.63 245 104633 102351 29745249
Renin increased 20.47 10.63 8 104870 59 29847541
Ejection fraction 20.35 10.63 8 104870 60 29847540
Infective pulmonary exacerbation of cystic fibrosis 20.11 10.63 3 104875 8569 29839031
Liver disorder 20.05 10.63 175 104703 29547 29818053
Sudden cardiac death 19.95 10.63 42 104836 3710 29843890
Paracentesis 19.89 10.63 14 104864 378 29847222
Gastric varices 19.82 10.63 14 104864 380 29847220
Feeling abnormal 19.78 10.63 117 104761 56639 29790961
Nasopharyngitis 19.63 10.63 123 104755 58726 29788874
Atrioventricular block 19.49 10.63 63 104815 7219 29840381
Pulmonary congestion 19.46 10.63 90 104788 12197 29835403
Localised oedema 19.44 10.63 37 104841 3039 29844561
Blood cholesterol 19.14 10.63 9 104869 109 29847491
Graft versus host disease 18.87 10.63 6 104872 10144 29837456
Respiratory arrest 18.84 10.63 47 104831 29211 29818389
Drug intolerance 18.78 10.63 88 104790 45203 29802397
Thrombosis 18.75 10.63 80 104798 42151 29805449
Myasthenic syndrome 18.63 10.63 13 104865 346 29847254
Tuberculosis 18.55 10.63 3 104875 8074 29839526
Metabolic alkalosis 18.48 10.63 23 104855 1301 29846299
Dyskinesia 18.40 10.63 30 104848 21804 29825796
Injection site erythema 18.35 10.63 13 104865 13821 29833779
Neutrophil count increased 18.30 10.63 16 104862 15307 29832293
Metabolic acidosis 18.18 10.63 206 104672 37255 29810345
Blood ketone body increased 18.15 10.63 13 104865 361 29847239
Iron deficiency anaemia 18.09 10.63 71 104807 8953 29838647
Colitis 17.97 10.63 52 104826 30768 29816832
Acute myeloid leukaemia 17.89 10.63 22 104856 17984 29829616
Amyloidosis 17.75 10.63 29 104849 2110 29845490
Malignant neoplasm progression 17.55 10.63 165 104713 72122 29775478
Pancreatitis 17.54 10.63 67 104811 36423 29811177
Vision blurred 17.49 10.63 81 104797 41735 29805865
Primary hyperaldosteronism 17.42 10.63 7 104871 56 29847544
Infection 17.37 10.63 182 104696 77892 29769708
Therapeutic drug monitoring analysis not performed 17.22 10.63 13 104865 392 29847208
Oesophageal variceal ligation 17.21 10.63 7 104871 58 29847542
Hydrothorax 17.06 10.63 14 104864 478 29847122
Pancytopenia 17.05 10.63 203 104675 84849 29762751
Encephalopathy 16.96 10.63 180 104698 32025 29815575
Hypoaesthesia 16.74 10.63 116 104762 54114 29793486
Inability to afford medication 16.73 10.63 17 104861 768 29846832
Conjunctival scar 16.71 10.63 7 104871 63 29847537
Pulmonary embolism 16.64 10.63 184 104694 77951 29769649
Cytokine release syndrome 16.56 10.63 7 104871 9926 29837674
Therapeutic response decreased 16.56 10.63 38 104840 24311 29823289
Electrolyte depletion 16.49 10.63 10 104868 208 29847392
Hypochromic anaemia 16.39 10.63 17 104861 787 29846813
Bladder irrigation 16.33 10.63 7 104871 67 29847533
Weight increased 16.33 10.63 360 104518 74553 29773047
Exposure during pregnancy 16.31 10.63 6 104872 9255 29838345
Rales 16.29 10.63 55 104823 6445 29841155
Sedation 16.28 10.63 20 104858 16353 29831247
Psoriasis 16.24 10.63 85 104793 42421 29805179
Colitis ulcerative 16.14 10.63 16 104862 14418 29833182
Drug ineffective for unapproved indication 16.11 10.63 9 104869 10871 29836729
Xanthopsia 16.09 10.63 9 104869 160 29847440
Dyspnoea at rest 16.04 10.63 31 104847 2575 29845025
Base excess decreased 16.04 10.63 10 104868 219 29847381
Poisoning 16.03 10.63 10 104868 11372 29836228
Respiratory syncytial virus infection 15.97 10.63 36 104842 3332 29844268
Psychotic disorder 15.95 10.63 32 104846 21483 29826117
Psoriatic arthropathy 15.93 10.63 19 104859 15742 29831858
Influenza 15.91 10.63 88 104790 43310 29804290
Dyspnoea paroxysmal nocturnal 15.88 10.63 20 104858 1145 29846455
Pain in extremity 15.82 10.63 281 104597 109940 29737660
Oral lichen planus 15.70 10.63 9 104869 168 29847432
Schizophrenia 15.70 10.63 6 104872 9042 29838558
Irritability 15.66 10.63 36 104842 23014 29824586
Oxygen consumption decreased 15.61 10.63 9 104869 170 29847430
Basal cell carcinoma 15.58 10.63 20 104858 16048 29831552
Memory impairment 15.55 10.63 72 104806 37102 29810498
Upper gastrointestinal haemorrhage 15.54 10.63 131 104747 21897 29825703
Haematemesis 15.50 10.63 150 104728 26053 29821547
Bundle branch block right 15.43 10.63 57 104821 6985 29840615
Sudden death 15.42 10.63 100 104778 15392 29832208
Diabetic ketoacidosis 15.40 10.63 20 104858 15966 29831634
Cardioversion 15.34 10.63 17 104861 849 29846751
International normalised ratio abnormal 15.34 10.63 34 104844 3112 29844488
Gastrointestinal disorder 15.31 10.63 49 104829 28088 29819512
Fungal infection 15.30 10.63 15 104863 13585 29834015
Dependence on oxygen therapy 15.27 10.63 8 104870 124 29847476
Blood potassium abnormal 15.25 10.63 19 104859 1076 29846524
Potentiating drug interaction 15.15 10.63 43 104835 4588 29843012
Pulmonary vein stenosis 15.15 10.63 6 104872 46 29847554
Hypoparathyroidism secondary 15.05 10.63 8 104870 128 29847472
Herpes zoster 15.03 10.63 54 104824 29889 29817711
Sopor 15.01 10.63 10 104868 10981 29836619
Blood urea abnormal 15.01 10.63 15 104863 664 29846936
Scrotal swelling 14.91 10.63 21 104857 1340 29846260
Fatigue 14.87 10.63 946 103932 319727 29527873
Hyperthyroidism 14.87 10.63 62 104816 8036 29839564
Product prescribing error 14.86 10.63 105 104773 16628 29830972
Breast mass 14.82 10.63 14 104864 578 29847022
Road traffic accident 14.81 10.63 23 104855 17048 29830552
Neck pain 14.81 10.63 32 104846 20912 29826688
Erysipelas 14.80 10.63 42 104836 4482 29843118
Tachycardia 14.78 10.63 176 104702 73563 29774037
Burning feet syndrome 14.66 10.63 7 104871 88 29847512
Oropharyngeal pain 14.56 10.63 51 104827 28445 29819155
Tooth disorder 14.42 10.63 7 104871 9154 29838446
Abnormal behaviour 14.38 10.63 44 104834 25579 29822021
Withdrawal syndrome 14.36 10.63 11 104867 11239 29836361
Aspergillus infection 14.35 10.63 9 104869 10205 29837395
Concomitant disease progression 14.33 10.63 29 104849 2491 29845109
Gouty arthritis 14.20 10.63 18 104860 1037 29846563
Transplant evaluation 14.18 10.63 13 104865 516 29847084
Packed red blood cell transfusion 14.11 10.63 22 104856 1538 29846062
Cardiac arrest 14.03 10.63 425 104453 92425 29755175
Macroangiopathy 13.97 10.63 3 104875 0 29847600
Secondary sexual characteristics absence 13.97 10.63 3 104875 0 29847600
Adrenal adenoma 13.95 10.63 10 104868 278 29847322
Pulmonary veno-occlusive disease 13.92 10.63 12 104866 439 29847161
Nephrogenic anaemia 13.85 10.63 26 104852 2113 29845487
Performance enhancing product use 13.75 10.63 7 104871 102 29847498
Erythema 13.62 10.63 190 104688 77261 29770339
Circulatory collapse 13.62 10.63 119 104759 20095 29827505
Electrocardiogram change 13.60 10.63 14 104864 642 29846958
Neutropenic sepsis 13.52 10.63 12 104866 11397 29836203
Preternatural anus 13.51 10.63 7 104871 106 29847494
Diplopia 13.50 10.63 17 104861 13755 29833845
Subdural haematoma 13.47 10.63 113 104765 18859 29828741
Disease recurrence 13.35 10.63 18 104860 14143 29833457
Hepatomegaly 13.35 10.63 70 104808 9977 29837623
Bronchopulmonary aspergillosis 13.30 10.63 14 104864 12270 29835330
Pulmonary hypertensive crisis 13.21 10.63 8 104870 166 29847434
Pulmonary renal syndrome 13.21 10.63 8 104870 166 29847434
Prothrombin time prolonged 13.18 10.63 66 104812 9237 29838363
Hyperaldosteronism 13.17 10.63 7 104871 112 29847488
Injection site reaction 13.14 10.63 11 104867 10749 29836851
Endometriosis male 13.13 10.63 4 104874 12 29847588
Portal shunt procedure 13.13 10.63 4 104874 12 29847588
Hypertensive cardiomyopathy 13.13 10.63 8 104870 168 29847432
Transplant rejection 13.09 10.63 8 104870 9198 29838402
Pneumocystis jirovecii pneumonia 13.09 10.63 25 104853 17095 29830505
Depressed mood 12.90 10.63 25 104853 17004 29830596
Hepatic pain 12.72 10.63 19 104859 1279 29846321
Haematotoxicity 12.68 10.63 3 104875 6167 29841433
Hypertrophy 12.60 10.63 10 104868 325 29847275
Prothrombin level decreased 12.60 10.63 18 104860 1164 29846436
Creatinine renal clearance decreased 12.60 10.63 33 104845 3360 29844240
Haemodynamic test abnormal 12.55 10.63 5 104873 39 29847561
Somnolence 12.55 10.63 251 104627 96512 29751088
International normalised ratio decreased 12.55 10.63 40 104838 4550 29843050
Ejection fraction abnormal 12.54 10.63 14 104864 705 29846895
Glucose tolerance decreased 12.46 10.63 6 104872 77 29847523
Tricuspid valve replacement 12.45 10.63 4 104874 15 29847585
Swelling of eyelid 12.45 10.63 10 104868 331 29847269
Prerenal failure 12.44 10.63 23 104855 1848 29845752
Atrioventricular block first degree 12.43 10.63 46 104832 5642 29841958
Coordination abnormal 12.42 10.63 5 104873 7300 29840300
Diastolic dysfunction 12.39 10.63 38 104840 4233 29843367
Asthma 12.37 10.63 75 104803 36099 29811501
Diffuse large B-cell lymphoma 12.33 10.63 6 104872 7835 29839765
Multiple sclerosis 12.31 10.63 5 104873 7262 29840338
Deep vein thrombosis 12.28 10.63 144 104734 60357 29787243
Postrenal failure 12.27 10.63 11 104867 424 29847176
Enteritis 12.23 10.63 4 104874 6641 29840959
Generalised tonic-clonic seizure 12.13 10.63 32 104846 19519 29828081
Serotonin syndrome 12.10 10.63 28 104850 17863 29829737
COVID-19 12.08 10.63 28 104850 17850 29829750
Retroperitoneal mass 12.06 10.63 4 104874 17 29847583
Eye haematoma 12.03 10.63 5 104873 44 29847556
Electrocardiogram T wave amplitude increased 12.03 10.63 5 104873 44 29847556
Dilatation ventricular 12.00 10.63 28 104850 2652 29844948
Epistaxis 11.98 10.63 256 104622 52725 29794875
Osteonecrosis 11.95 10.63 24 104854 16111 29831489
Shock haemorrhagic 11.94 10.63 67 104811 9798 29837802
Stomatitis 11.87 10.63 79 104799 37200 29810400
Cyanosis central 11.87 10.63 6 104872 86 29847514
Restlessness 11.85 10.63 40 104838 22559 29825041
Pemphigoid 11.82 10.63 55 104823 7473 29840127
Lichenoid keratosis 11.79 10.63 24 104854 2070 29845530
Cardiac amyloidosis 11.73 10.63 14 104864 758 29846842
Left atrial dilatation 11.71 10.63 22 104856 1789 29845811
Goitre 11.65 10.63 20 104858 1516 29846084
Cardiac disorder 11.49 10.63 200 104678 39693 29807907
Respiratory depression 11.49 10.63 14 104864 11489 29836111
Ventricular internal diameter abnormal 11.39 10.63 5 104873 51 29847549
Loss of personal independence in daily activities 11.37 10.63 38 104840 21497 29826103
International normalised ratio fluctuation 11.33 10.63 16 104862 1024 29846576
Secondary hypogonadism 11.25 10.63 9 104869 296 29847304
Infected skin ulcer 11.25 10.63 19 104859 1421 29846179
Thrombocytopenia 11.24 10.63 380 104498 136664 29710936
Lymphocyte count decreased 11.21 10.63 32 104846 19023 29828577
Hypoglycaemic coma 11.15 10.63 25 104853 2306 29845294
Breath odour 11.12 10.63 14 104864 801 29846799
Influenza like illness 11.06 10.63 49 104829 25556 29822044
Atrial enlargement 11.02 10.63 6 104872 101 29847499
Rash erythematous 10.93 10.63 41 104837 22411 29825189
Alkalosis hypochloraemic 10.90 10.63 9 104869 310 29847290
Myocardial fibrosis 10.83 10.63 13 104865 708 29846892
Crepitations 10.81 10.63 29 104849 2995 29844605
Parkinsonism 10.78 10.63 6 104872 7263 29840337
Blood pressure increased 10.76 10.63 182 104696 71746 29775854
Mental impairment 10.70 10.63 10 104868 9267 29838333
Subcutaneous haematoma 10.70 10.63 15 104863 953 29846647
Anticoagulation drug level abnormal 10.70 10.63 3 104875 6 29847594
Injection site swelling 10.69 10.63 9 104869 8771 29838829
Kidney congestion 10.66 10.63 8 104870 239 29847361
Hepatitis C 10.66 10.63 81 104797 13124 29834476

Pharmacologic Action:

SourceCodeDescription
ATC C03DA01 CARDIOVASCULAR SYSTEM
DIURETICS
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)

None

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
Cytochrome P450 2C19 Enzyme IC50 5.52 DRUG MATRIX
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor WOMBAT-PK
Progesterone receptor Nuclear hormone receptor EC50 6.03 WOMBAT-PK
Glucocorticoid receptor Nuclear hormone receptor IC50 6.23 WOMBAT-PK
Androgen receptor Nuclear hormone receptor Ki 7.40 CHEMBL
Estrogen receptor beta Nuclear hormone receptor EC50 5.48 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 4.73 CHEMBL
Progesterone receptor Transcription factor Ki 6.66 DRUG MATRIX
Androgen receptor Transcription factor IC50 6.17 CHEMBL

External reference:

IDSource
4017881 VUID
N0000146234 NUI
D00443 KEGG_DRUG
4017881 VANDF
C0591054 UMLSCUI
CHEBI:9241 CHEBI
SNL PDB_CHEM_ID
CHEMBL1393 ChEMBL_ID
5267 PUBCHEM_CID
D013148 MESH_DESCRIPTOR_UI
2875 IUPHAR_LIGAND_ID
987 INN_ID
DB00421 DRUGBANK_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 0603-5763 TABLET, FILM COATED 25 mg ORAL ANDA 27 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 0603-5764 TABLET, FILM COATED 50 mg ORAL ANDA 27 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 0603-5765 TABLET, FILM COATED 100 mg ORAL ANDA 27 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 0615-1535 TABLET, FILM COATED 25 mg ORAL ANDA 17 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 0615-5592 TABLET, FILM COATED 50 mg ORAL ANDA 17 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 0615-6591 TABLET, FILM COATED 100 mg ORAL ANDA 17 sections
Spironolactone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8031 TABLET, FILM COATED 25 mg ORAL ANDA 27 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