Spironolactone
Established medicineAlso known as Aldactazide, Aldactone, Cardalis, CaroSpir+6 more
Aldactazide, Aldactone, Cardalis, CaroSpir, Espironolactona, Hydrochlorothiazide-Spironolactone, Spironol, Spironolactone Plus, Spironolattone, Spironolactonum.
Recent clinical, regulatory, research and industry developments relating to this drug.
Label change: SPIRONOLACTONE (ANDA040750)
Label change: SPIRONOLACTONE (ANDA089424)
Label change: SPIRONOLACTONE (ANDA091426)
Label change: SPIRONOLACTONE (ANDA202187)
Guidelines of care for the management of acne vulgaris.
Spironolactone for heart failure with preserved ejection fraction.
Evidence confidence
How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.
High point estimate, but substantial uncertainty remains.
Confidence has a moderate point estimate but a wide uncertainty band — the evidence base is still thin.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and… Show full indicationShow less
In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2).
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes8
Journals, researchers & institutions
- Circulation. Heart failure3
- The New England journal of medicine2
- Circulation1
- Circulation. Arrhythmia and electrophysiology1
- Journal of the American Academy of Dermatology1
- Pitt B6
- Anand IS5
- Heitner JF5
- O'Meara E5
- Pfeffer MA5
- Shah SJ5
- Solomon SD5
- Sweitzer NK5
- Brigham and Women's Hospital4
- American Academy of Dermatology1
- Beth Israel Deaconess Medical Center1
- Emory University School of Medicine1
- From the University of Michigan School of Medicine1
- Massachusetts General Hospital1
Related diseases
Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Studied across the same disease area as Spironolactone in the shared literature.
Studied across the same disease area as Spironolactone in the shared literature.
Studied across the same disease area as Spironolactone in the shared literature.
Studied across the same disease area as Spironolactone in the shared literature.
Studied across the same disease area as Spironolactone in the shared literature.
Studied across the same disease area as Spironolactone in the shared literature.
Studied across the same disease area as Spironolactone in the shared literature.
Studied across the same disease area as Spironolactone in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.