Safety Profile Overview
Potassium-sparing diuretic for heart failure, hypertension, and ascites. Also used off-label for acne and hirsutism. Monitored for hyperkalemia.
Generic Name
spironolactone
Brand Names
Aldactone
Therapeutic Class
Mineralocorticoid Receptor Antagonist
Manufacturer
Pfizer
What Pharma Signal Tracks for Spironolactone
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Spironolactone, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Spironolactone products.
- Label Changes — Boxed warning additions, new contraindications, dosing modifications, and safety-related labeling supplements.
- Risk Score — Composite risk score (0–100) combining adverse event rates, recall history, and label severity with explainable breakdown.
- Pharmacovigilance Signals — Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR) analysis detecting disproportionate adverse reactions.
- Trend Analysis — Monthly time series with anomaly detection for emerging safety signals.
Data Disclaimer: Pharma Signal aggregates data from the FDA Adverse Event Reporting System (FAERS) and other public regulatory sources. FAERS reports do not establish causation. Report counts may reflect prescription volume rather than relative safety. Always consult healthcare professionals for medical decisions.
Get Spironolactone Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Spironolactone.
curl "https://api.pharma-signal.com/drug/safety/spironolactone" \ -H "X-API-Key: your_key" # Returns risk score, adverse event counts, # serious/death rates, recalls, and signals
Related Safety Intelligence
Pharma Signal provides comparative analysis across therapeutic classes. Compare Spironolactone against other Mineralocorticoid Receptor Antagonist drugs, or explore the full manufacturer portfolio for Pfizer.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Spironolactone ranks within Mineralocorticoid Receptor Antagonist on serious event rates.
- Company portfolio risk — View all drugs from Pfizer with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.