Last reviewed · How we verify
Spironolacton
At a glance
| Generic name | Spironolacton |
|---|---|
| Also known as | Spironolacton Sandoz |
| Sponsor | ACS Biomarker |
| Target | Cytochrome P450 2C19, Multidrug and toxin extrusion protein 1, Nuclear receptor subfamily 1 group I member 2 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Approved indications
- Aldosteronism
- Ascites
- Chronic heart failure
- Diagnostic Test for Primary Aldosteronism
- Edema
- Edema due to Hepatic Cirrhosis
- Edema due to Nephrotic Syndrome
- Hypertensive disorder
- Hypokalemia Prevention
- Peripheral Edema due to Chronic Heart Failure
- Pulmonary Edema due to Chronic Heart Failure
Common side effects
- Gynecomastia
- Hyperkalemia
- Nausea
- Diarrhea
- Vomiting
- Headache
- Dizziness
- Leg cramps
- Drowsiness
- Lethargy
- Irregular menses or amenorrhea
- Decreased libido
Serious adverse events
- Stevens-Johnson Syndrome (SJS)
- Toxic epidermal necrolysis (TEN)
- Anaphylactic reactions
- Renal failure
- Hepatocellular toxicity
- Agranulocytosis
- Thrombocytopenia
- Gastric bleeding
- Vasculitis
- Drug rash with eosinophilia and systemic symptoms (DRESS)
Key clinical trials
- OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure (PHASE2)
- The Role of Skin Sodium Accumulation in Chronic Kidney Disease (NA)
- Bioprofiling Response to Mineralocorticoid Receptor Antagonists for the Prevention of Heart Failure (PHASE2)
- A Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Spironolacton CI brief — competitive landscape report
- Spironolacton updates RSS · CI watch RSS
- ACS Biomarker portfolio CI