September 18, 2025PLoS ONEOpen Access

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

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A total of 8,566 adverse drug event reports linked to spironolactone were analyzed, revealing potential safety signals.
Significant disproportionality was found in 25 system organ classes, highlighting various rare adverse drug events associated with spironolactone.
Statistical methods like the proportional reporting ratio and Bayesian networks were employed to detect new safety signals not previously recognized.
Findings suggest a potential association between spironolactone and male endometriosis, prompting further research for thorough assessment.

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Retrospective pharmacovigilance study identified significant safety signals in spironolactone, suggesting the need for improved monitoring.

Lin et al. (2025) studied this question.

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Retrospective pharmacovigilance study identified significant safety signals in spironolactone, suggesting the need for improved monitoring.