Retrospective analysis of adverse events with spironolactone in females reported to the United States Food and Drug Administration.

BACKGROUND

Spironolactone is an off-label acne treatment that is commonly prescribed due to its low cost, efficacy, and tolerability.

OBJECTIVE

This study aimed to classify the most common adverse reactions associated with spironolactone in women of all ages and analyze the relative risk of hyperkalemia for different age groups.

METHODS

The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database was analyzed for common adverse reactions associated with female patients taking spironolactone. Reported hyperkalemia adverse events with spironolactone were further subdivided by age group. Google Trends was used to examine public interest, and Altmetric was used to quantitate scholarly mentions of spironolactone. Yearly data were compared with adverse events in the FAERS database.

RESULTS

The most common adverse reaction in women taking spironolactone was hyperkalemia (16.1% of all adverse events), but it was extremely uncommon in women age ≤45 years (1.9% of all hyperkalemia cases). Increased Google searches and scholarly mentions in the Altmetric database for spironolactone were also associated with increased reporting of adverse events in the FAERS database for men and women combined.

CONCLUSION

Women taking spironolactone should be counseled that hyperkalemia is the most common adverse event but is uncommon in those age ≤45 years. Public and academic interest in spironolactone has increased in recent years, and although prescribing data are not available, this interest may account for the increased reporting to FAERS during the same time period.