Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Spironolactone
Drug ID BADD_D02066
Description Spironolactone is a potassium sparing diuretic like [eplerenone] that competitively inhibits mineralocorticoid receptors in the distal convoluted tubule to promote sodium and water excretion and potassium retention.[A11837]. Spironolactone was originally developed purely for this ability before other pharmacodynamic properties of the drug were discovered.[A11837,A178246] It is indicated to treat a number of conditions including heart failure, deem, hyperaldosteronism, adrenal hyperplasia, hypertension, and nephrotic syndrome.[Label] Off label uses of spironolactone involving its antiandrogenic activity include hirsutism, female pattern hair loss, and adult acne vulgaris.[A178135] Spironolactone is also frequently used in medical gender transition.[A178138] Spironolactone was developed in 1957, marketed in 1959, and approved by the FDA on January 21, 1960.[A178243,L6187]
Indications and Usage Spironolactone is indicated for the treatment of New York Heart Association Class III-IV heart failure, management of edema in cirrhotic adults not responsive to fluid and sodium restrictions, primary hyperaldosteronism short-term preoperatively, primary hyperaldosteronism long-term in patients with aldosterone producing adrenal adenomas that are not candidates for surgery or patients with bilarteral micro/macronodular adrenal hyperplasia, as an add-on therapy in hypertension, and in nephrotic syndrome when treatment of the disease as well as fluid and sodium restriction with other diuretics is inadequate.[Label] Spironolactone has antiandrogenic activity which leads to many of its off label uses. Spironolactone is used off label in the treatment of hirsutism, female pattern hair loss, and adult acne vulgaris.[A178135] Spironolactone is also frequently used for its antiandrogenic effects in transgender female patients due to its low cost and reducing male-pattern hair growth.[A178138]
Marketing Status approved
ATC Code C03DA01
DrugBank ID DB00421
KEGG ID D00443
MeSH ID D013148
PubChem ID 5833
TTD Drug ID D0EP0C
NDC Product Code 72603-136; 72789-292; 43063-832; 50090-6458; 0025-1041; 59746-216; 63629-1093; 63629-1830; 67296-1403; 68071-2977; 69584-853; 70518-0563; 70518-2585; 70771-1029; 71205-147; 71205-772; 76420-556; 76420-558; 79572-032; 16714-639; 43063-974; 50090-3580; 51655-153; 53489-329; 53746-515; 59651-428; 59746-218; 63629-1092; 63629-1094; 63629-2437; 0378-2146; 68071-2606; 68382-661; 70518-1334; 70518-2386; 70518-2588; 71335-0401; 72189-497; 0904-6927; 42708-126; 51655-861; 53746-514; 55700-953; 0025-1031; 60687-476; 63629-1065; 63629-1066; 63629-2438; 63629-8539; 65162-515; 68071-2968; 68071-2989; 68788-7297; 69584-852; 70518-1746; 71610-288; 55154-5517; 59746-217; 60687-465; 63187-841; 67544-310; 68382-660; 69584-854; 70518-3118; 70518-3625; 70518-3750; 0615-8178; 0615-8221; 0615-8451; 38779-0096; 57582-030; 82298-121; 50090-3747; 50090-6432; 50090-6539; 53002-4720; 55700-968; 0025-1001; 63629-2436; 68071-2936; 68071-2962; 68071-2988; 68788-7019; 68788-8381; 68788-8452; 70518-0603; 70518-2461; 70518-3655; 71205-146; 71335-0966; 71610-287; 72162-1626; 76420-557; 16714-637; 16729-225; 51655-344; 51655-636; 53002-1707; 54348-340; 63187-634; 63187-861; 63629-1067; 63739-545; 67296-1692; 70518-0455; 71335-0053; 51552-0276; 51927-1377; 55525-0002; 61907-031; 70966-0028; 16714-085; 16714-086; 59651-426; 63629-1064; 63629-1095; 63629-4094; 71205-148; 76420-063; 49452-7220; 16729-227; 51079-103; 55154-3556; 60687-487; 61919-772; 63629-1061; 63629-1062; 68382-662; 68788-7051; 70518-2384; 70518-2385; 72162-1624; 72603-134; 72789-291; 50090-1292; 50090-6408; 53746-511; 59651-427; 0378-0437; 65162-511; 65162-514; 70518-1314; 70771-1027; 70771-1028; 71335-0304; 72162-1627; 72189-495; 0615-8452; 72789-290; 16714-084; 16729-226; 42708-101; 50090-0136; 50090-6369; 51079-979; 53489-328; 55154-1495; 63629-5341; 63739-544; 0378-0243; 70518-1742; 70518-2589; 70518-3721; 71610-102; 72189-329; 72189-496; 72603-135; 76420-062; 16637-0020; 45541-1134; 16714-638; 43063-835; 50090-1308; 53489-143
UNII 27O7W4T232
Synonyms Spironolactone | Spirolactone | Veroshpiron | Verospirone | Spiractin | Spirobeta | Spirogamma | Spirolang | Spirono-Isis | Spirono Isis | Spironone | Spirospare | Aldactone | Verospiron | Aldactone A | Aquareduct | Duraspiron | Espironolactona Alter | Espironolactona Mundogen | Flumach | Frumikal | Jenaspiron | Novo-Spiroton | Novo Spiroton | NovoSpiroton | Practon | SC-9420 | SC 9420 | SC9420 | Spiro L.U.T. | Spiro Von Ct | Ct, Spiro Von | Von Ct, Spiro
Chemical Information
Molecular Formula C24H32O4S
CAS Registry Number 52-01-7
SMILES CC(=O)SC1CC2=CC(=O)CCC2(C3C1C4CCC5(C4(CC3)C)CCC(=O)O5)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.0010.000241%
Abdominal pain upper07.01.05.003--
Acidosis hyperchloraemic14.01.01.0070.000037%-
Acne23.02.01.0010.000197%-
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.000055%-
Ageusia17.02.07.001; 07.14.03.0030.000037%-
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.0010.000110%-
Alopecia23.02.02.0010.000625%
Altered state of consciousness19.07.01.003; 17.02.04.0010.000073%-
Amenorrhoea21.01.02.001; 05.05.01.002--
Anaemia01.03.02.0010.000417%
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Anaphylactic shock24.06.02.004; 10.01.07.002---
Anger19.04.02.001---
Angina pectoris24.04.04.002; 02.02.02.0020.000037%
Angioedema23.04.01.001; 10.01.05.009; 22.04.02.0080.000164%-
Anosmia22.04.03.006; 17.04.04.0010.000037%
Anuria20.01.03.0020.000055%-
Aortic stenosis24.04.01.0010.000055%-
Aphasia19.21.01.001; 17.02.03.0010.000117%
Arrhythmia02.03.02.0010.000146%-
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000219%
Asthenia08.01.01.001---
Ataxia17.02.02.001; 08.01.02.004--
Atrial fibrillation02.03.03.0020.000128%
Atrioventricular block02.03.01.0020.000073%-
Atrioventricular block first degree02.03.01.0040.000055%
Atrioventricular block second degree02.03.01.0050.000037%
Basal cell carcinoma23.08.02.001; 16.03.02.0010.000037%-
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