Isotretinoin-related adverse sexual and reproductive outcomes: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System (FAERS)

Despite inherent FAERS limitations, including underreporting, reporting bias, and lack of causal inference, our findings underscore the need to monitor sexual and reproductive side effects during isotretinoin therapy. Since such symptoms are often underreported, routine inquiry and patient education are essential to ensure safe and informed use.