Adverse Events of Spironolactone
Description
Study Hypothesis This study hypothesized that analyzing real-world adverse drug event (ADE) reports from the FDA Adverse Event Reporting System (FAERS) could identify both known and previously unrecognized safety signals of spironolactone, particularly rare or underdocumented adverse reactions not listed in drug labels, to enhance its safety assessment and clinical management. Data Overview: Collection and Processing The dataset includes 8,566 ADE reports linked to spironolactone extracted from FAERS (2004 Q1–2024 Q3). Source: Data were retrieved from the public FAERS database, which aggregates voluntary reports from healthcare providers, consumers, and pharmaceutical companies. Processing: Duplicate entries were removed using CASEID and ISR identifiers (retaining only the most recent reports). ADEs were classified using MedDRA v26.1, and safety signals were detected using four statistical methods (PRR, ROR, BCPNN, EBGM), with signals validated only if all methods met predefined thresholds. Key Findings Known ADEs: Consistent with existing labels, hyperkalemia (n=1,308; ROR=90.35) and nipple pain (n=42; ROR=46.19) showed strong signals. Notable New Signals: Rare but significant associations included male endometriosis (n=7; ROR=13,615.84), 5-alpha-reductase deficiency (n=5; ROR=1,620.81), congenital bulbospinal muscular atrophy (n=6; ROR=402.42), and double-hit lymphoma (n=5; ROR=243.12)—none are currently listed in drug labels. Interpretation and Usage The data confirm spironolactone’s known safety profile while highlighting potential new risks, particularly in hormonal and genetic disorders. These signals indicate disproportional reporting, not definitive causality, requiring further validation.