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This analysis aims to evaluate the real-world safety profile of flibanserin based on FDA adverse event reports over a decade.

July 7, 2026

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

GLGuojun LiangGuangzhou University of Chinese Medicine HHHao HuangJinan University HWHaokui WangJinan University

Key Points

This analysis aims to evaluate the real-world safety profile of flibanserin based on FDA adverse event reports over a decade.
Conducted a retrospective pharmacovigilance analysis using the FDA Adverse Event Reporting System from 2016 to 2025.
Included reports where flibanserin was the primary suspect drug, applying methods like duplicate removal and standardized coding.
Performed disproportionality analyses to identify safety signals and conducted sensitivity analyses for concomitant medications.
Identified 1702 adverse event reports, predominantly from women (95%), with most events being non-serious and occurring within the first week of therapy.
Key safety signals included somnolence, dizziness, insomnia, and fatigue, with reports of hypotension mainly in conjunction with other medications.
Persistently reported hypotension and off-label usage indicate the necessity for ongoing pharmacovigilance and clinician education.

Abstract

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.

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Cite This Study

Liang et al. (Mon,) studied this question.

synapsesocial.com/papers/6a4c96be331bc25c9e5f403f https://doi.org/https://doi.org/10.1071/sh25248

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