Analyzing real-world adverse events of spironolactone with the FAERS database.

ABSTRACT:

Background

Spironolactone, a potassium-sparing diuretic, is commonly prescribed for conditions such as heart failure, hypertension, and hyperaldosteronism. This study aims to explore and analyze the safety profile of spironolactone by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.

Methods

This study conducted a retrospective pharmacovigilance analysis using FAERS data (2004 Q1-2024 Q3). Adverse drug events (ADEs) related to spironolactone were identified and categorized by system organ class and specific adverse events. Statistical methods such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were employed to de

SUBMITTER: Lin G 

PROVIDER: S-EPMC12443299 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature