Flibanserin safety in real-world use: a decade of US Food and Drug Administration Adverse Event Reporting System pharmacovigilance evidence.

BACKGROUND

Flibanserin, a centrally acting 5-HT1A agonist and 5-HT2A antagonist, is the first approved therapy for acquired, generalized hypoactive sexual desire disorder in premenopausal women. Despite its clinical availability, post-marketing data on real-world safety remain limited.

METHODS

A retrospective pharmacovigilance analysis was conducted using the US Food and Drug Administration Adverse Event Reporting System from 2016 to 2025. Duplicate removal, data harmonization and standardized MedDRA coding were applied. Only reports in which flibanserin was designated as the primary suspect drug were included. Disproportionality analyses using proportional reporting ratio, reporting odds ratio, information component and empirical Bayes geometric mean algorithms identified flibanserin-associated safety signals. Sensitivity analyses were conducted according to recorded concomitant medication status.

RESULTS

A total of 1702 adverse event reports were identified, with 95% involving women. Most events were non-serious and occurred within the first week of therapy (median onset: 3 days). Prominent signals were nervous system and psychiatric disorders, notably somnolence, dizziness, insomnia and fatigue. Additional signals included hypotension, orthostatic hypotension and product use in unapproved populations, suggesting off-label exposure. Central nervous system-related signals remained directionally consistent in flibanserin-only and concomitant-medication cohorts, whereas hypotension was prominent among reports with recorded concomitant medications.

CONCLUSIONS

Flibanserin's real-world safety profile is largely consistent with preapproval data, dominated by early-onset, reversible central nervous system reactions linked to its serotonergic mechanism. However, persistent hypotension and off-label or product-use-related reports underscore the need for continued pharmacovigilance, clinician education, and strict adherence to Risk Evaluation and Mitigation Strategy requirements to maintain an optimal benefit-risk balance.