Spironolactone
Aldactazide, Aldactone, Carospir (spironolactone) is a small molecule pharmaceutical. Spironolactone was first approved as Spironolactone and hydrochlorothiazide on 1982-01-01. It is used to treat ascites, edema, heart failure, hirsutism, and hyperaldosteronism amongst others in the USA. The pharmaceutical is active against mineralocorticoid receptor.
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Trade Name
FDA
EMA
Aldactone, Carospir (generic drugs available since 1982-01-01)
CombinationsAldactazide (generic drugs available since 1982-01-01)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aldactazide | New Drug Application | 2021-11-15 |
| aldactone | New Drug Application | 2021-02-23 |
| carospir | New Drug Application | 2023-01-16 |
| spironolactone | ANDA | 2023-06-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ascites | HP_0001541 | D001201 | R18 |
| edema | — | D004487 | R60.9 |
| heart failure | EFO_0003144 | D006333 | I50 |
| hirsutism | HP_0001007 | D006628 | L68.0 |
| hyperaldosteronism | HP_0011736 | D006929 | E26 |
| hypertension | EFO_0000537 | D006973 | I10 |
| hypokalemia | HP_0002900 | D007008 | E87.6 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
201 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | 2 | 7 | 10 | 10 | 7 | 34 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 6 | 1 | 12 | 3 | 23 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 1 | 1 | 6 | — | 8 |
| Chronic renal insufficiency | D051436 | N18 | — | 3 | — | 2 | 2 | 7 | |
| Diabetic nephropathies | D003928 | EFO_0000401 | 1 | 2 | 2 | 3 | 1 | 7 | |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 2 | 3 | 1 | 2 | 7 |
| Hyperkalemia | D006947 | HP_0002153 | E87.5 | — | 2 | — | 2 | — | 4 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | — | 1 | 2 | — | 4 |
| Healthy volunteers/patients | — | 3 | — | — | 1 | — | 4 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | — | 2 | — | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 2 | 1 | — | 2 | 5 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 1 | 2 | — | 1 | 4 |
| Neoplasms | D009369 | C80 | — | 3 | 1 | — | — | 3 | |
| Covid-19 | D000086382 | U07.1 | — | 1 | 1 | — | — | 2 | |
| Proteinuria | D011507 | HP_0000093 | R80 | — | 1 | 1 | — | 1 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 2 | 1 | — | — | 2 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 1 | — | 1 | 2 |
| Duchenne muscular dystrophy | D020388 | 1 | — | 1 | — | — | 2 | ||
| Glomerulonephritis | D005921 | N05 | — | 1 | 1 | — | — | 1 | |
| St elevation myocardial infarction | D000072657 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 4 | 2 | — | — | 3 | 9 |
| Arrhythmogenic right ventricular dysplasia | D019571 | Orphanet_247 | I42.8 | — | 1 | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | 1 | — | — | — | 1 | |
| Fatty liver | D005234 | — | 1 | — | — | — | 1 | ||
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 1 | — | — | — | 1 |
| Acanthosis nigricans | D000052 | L83 | — | 1 | — | — | — | 1 | |
| Cerebral hemorrhage | D002543 | — | 1 | — | — | — | 1 | ||
| Lymphoma | D008223 | C85.9 | — | 1 | — | — | — | 1 | |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | 1 | — | — | — | 1 |
| Central serous chorioretinopathy | D056833 | H35.71 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperandrogenism | D017588 | 2 | — | — | — | — | 2 | ||
| Puberty | D011627 | EFO_0001382 | 2 | — | — | — | — | 2 | |
| Hiv | D006678 | O98.7 | 1 | — | — | — | — | 1 | |
| Gender dysphoria | D000068116 | F64 | 1 | — | — | — | — | 1 | |
| Glucose metabolism disorders | D044882 | 1 | — | — | — | — | 1 | ||
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | 1 | — | — | — | — | 1 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | 1 | — | — | — | — | 1 |
| Melanosis | D008548 | EFO_0003963 | L81.1 | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 4 | 4 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 2 | 2 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 1 | 1 |
| Coronary disease | D003327 | — | — | — | — | 1 | 1 | ||
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 1 | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 1 | 1 | |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | — | — | 1 | 1 |
| Sudden death cardiac | D016757 | EFO_0004278 | — | — | — | — | 1 | 1 | |
| Romano-ward syndrome | D029597 | Orphanet_101016 | I45.8 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SPIRONOLACTONE |
| INN | spironolactone |
| Description | Spironolactone is a steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7. It has a role as a diuretic, an aldosterone antagonist, an antihypertensive agent, an environmental contaminant and a xenobiotic. It is a steroid lactone, an oxaspiro compound, a thioester and a 3-oxo-Delta(4) steroid. |
| Classification | Small molecule |
| Drug class | Antimineralocorticoid; Steroidal antiandrogen |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)S[C@@H]1CC2=CC(=O)CC[C@]2(C)[C@H]2CC[C@@]3(C)[C@@H](CC[C@@]34CCC(=O)O4)[C@@H]21 |
Identifiers
| PDB | 2AB2 |
| CAS-ID | 52-01-7 |
| RxCUI | 9997 |
| ChEMBL ID | CHEMBL1393 |
| ChEBI ID | 9241 |
| PubChem CID | 5833 |
| DrugBank | DB00421 |
| UNII ID | 27O7W4T232 (ChemIDplus, GSRS) |
Target
Agency Approved
NR3C2
NR3C2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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