Aldactazide, Qaialdo(spironolactone)
Aldactazide, Aldactone, Carospir, Qaialdo, Spironolactone (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. It has been approved in Europe to treat ascites, edema, essential hypertension, heart failure, and hyperaldosteronism amongst others. The pharmaceutical is active against mineralocorticoid receptor.
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Commercial
Trade Name
FDA
EMA
Aldactone, Carospir, Spironolactone (discontinued: Spironolactone)
CombinationsAldactazide, Spironolactone hydrochlorothiazide (discontinued: Aldactazide, Spironolactone hydrochlorothiazide, Spironolactone w/ hydrochlorothiazide)
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 |
|---|---|---|
| 011054 niacinamide 4% / spironolactone 5% | unapproved drug other | 2020-07-02 |
| 011218 niacinamide 2% / spironolactone 5% / tretinoin 0.025% | unapproved drug other | 2020-07-02 |
| 011220 niacinamide 2% / spironolactone 5% / tretinoin 0.05% | unapproved drug other | 2020-07-02 |
| 011503 dapsone 6% / niacinamide 2% / spironolactone 5% | unapproved drug other | 2020-07-02 |
| aldactone | New Drug Application | 2025-11-28 |
| benzoyl peroxide 5% / clindamycin 1% / niacinamide 2% / spironolactone 2% | unapproved drug other | 2019-05-10 |
| benzoyl peroxide 5% / clindamycin 1% / niacinamide 2% / spironolactone 2% / tretinoin 0.025% | unapproved drug other | 2019-05-03 |
| benzoyl peroxide 5% / clindamycin 1% / niacinamide 2% / spironolactone 2% / tretinoin 0.05% | unapproved drug other | 2019-05-02 |
| carospir | New Drug Application | 2024-04-12 |
| clindamycin 1% / niacinamide 4% / spironolactone 2% / tretinoin 0.025% | unapproved drug other | 2020-06-04 |
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Agency Specific
FDA
EMA
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HCPCS
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Clinical
Clinical Trials
323 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 | 3 | 12 | 13 | 26 | 21 | 72 |
| Hypertension | D006973 | EFO_0000537 | I10 | 3 | 10 | 7 | 21 | 20 | 61 |
| Hyperaldosteronism | D006929 | — | E26 | — | — | 1 | 6 | 13 | 20 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 9 | 1 | 5 | 5 | 19 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 10 | 2 | 3 | 4 | 19 |
| Fibrosis | D005355 | — | — | — | 3 | 3 | 9 | 5 | 19 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 3 | 3 | 6 | — | 12 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 3 | 2 | 3 | 4 | 12 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 1 | 4 | 2 | 4 | 2 | 11 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 3 | 3 | 2 | 3 | 11 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 2 | 3 | — | 3 | 7 |
| Essential hypertension | D000075222 | — | I10 | — | 3 | 1 | — | 2 | 6 |
| Inflammation | D007249 | MP_0001845 | — | 1 | 2 | 1 | — | 3 | 6 |
| Proteinuria | D011507 | — | R80 | — | 1 | 1 | — | 3 | 4 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 3 | — | 1 | 4 |
| Infarction | D007238 | EFO_0009463 | — | — | — | 3 | — | 1 | 4 |
| Acute kidney injury | D058186 | — | N17 | — | 1 | 2 | — | 1 | 4 |
| Wounds and injuries | D014947 | — | T14.8 | — | 1 | 1 | — | 2 | 4 |
| Congenital heart defects | D006330 | — | Q24.9 | — | 2 | 1 | — | 2 | 4 |
| Aortic valve stenosis | D001024 | EFO_0000266 | — | — | 1 | 1 | — | 2 | 4 |
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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 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 2 | 2 | — | — | — | 3 |
| Gender identity | D005783 | — | — | 1 | 1 | — | — | 2 | 3 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | 1 | 1 | — | — | — | 2 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 2 | — | — | — | 2 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 2 | — | — | — | 2 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 2 | — | — | — | 2 |
| Univentricular heart | D000080039 | — | Q20.4 | 1 | 1 | — | — | 1 | 2 |
| Aortic aneurysm | D001014 | EFO_0001666 | I71.9 | 1 | 1 | — | — | 1 | 2 |
| Arrhythmogenic right ventricular dysplasia | D019571 | Orphanet_247 | I42.8 | — | 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 | — | — | 3 | — | — | — | 1 | 4 |
| Gender dysphoria | D000068116 | — | F64 | 1 | — | — | — | 2 | 3 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 1 | — | — | — | 1 | 2 |
| Puberty | D011627 | EFO_0001382 | — | 2 | — | — | — | — | 2 |
| Glucose metabolism disorders | D044882 | — | — | 1 | — | — | — | — | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | — | — | — | — | 1 |
| Disorders of sex development | D012734 | — | Q56.3 | 1 | — | — | — | — | 1 |
| Melanosis | D008548 | EFO_0003963 | L81.1 | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Takotsubo cardiomyopathy | D054549 | EFO_1002000 | I51.81 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypokalemia | D007008 | — | E87.6 | — | — | — | — | 3 | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 3 | 3 |
| Transgenes | D019076 | — | — | — | — | — | — | 3 | 3 |
| Mitral valve insufficiency | D008944 | — | — | — | — | — | — | 3 | 3 |
| Hyperemia | D006940 | EFO_0003822 | H34.82 | — | — | — | — | 3 | 3 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 2 | 2 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 2 | 2 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 2 | 2 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 2 | 2 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 2 | 2 |
Show 97 more
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 | — |
| CAS-ID | 52-01-7 |
| RxCUI | — |
| 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
No data
Financial
Revenue by drug
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Estimated US medical usage
Spironolactone
+
Hydrochlorothiazide
Total medical expenditures per year (USD, in millions)
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Spironolactone
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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32,096 adverse events reported
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