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Male sexual dysfunction associated with GLP-1 receptor agonists: a cross-sectional analysis of FAERS data

Abstract

Glucagon-like peptide-1 (GLP-1) receptor agonists, widely prescribed for type 2 diabetes and weight management, are known for their metabolic benefits but may have unrecognized side effects. This study investigates the association between GLP-1 receptor agonists and male sexual dysfunction using data from the FDA Adverse Event Reporting System (FAERS). Reports from Q4 2003 to Q1 2024 were analyzed using the OpenVigil 2.1 platform to identify male patients experiencing orgasmic dysfunction, erectile dysfunction, or decreased libido linked to GLP-1 receptor agonists (tirzepatide, semaglutide, dulaglutide, exenatide, lixisenatide, and liraglutide). After cleaning duplicate entries, disproportionality measures (reporting odds ratio (ROR), proportional reporting ratio (PRR), and relative reporting ratio (RRR)) were calculated, with Evans’ criteria applied to assess signal significance. Among 182 cases identified, patients were predominantly aged 40–60 years, with exenatide accounting for 24.2% of reports, followed by semaglutide (21.4%). Diabetes was the most common indication (43.9%). Despite statistically significant chi-squared values (P < 0.0001), low ROR (0.41, 95% Confidence interval (CI): 0.36–0.48), PRR (0.41, 95% CI: 0.36–0.48), and RRR (0.42, 95% CI: 0.36–0.48) suggest a weak association. These findings underscore the need for monitoring as GLP-1 use expands, though overall patient risk remains low.

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Fig. 1: Annual distribution of adverse event reports related to male sexual dysfunction received by the FDA Adverse Event Reporting System (FAERS) for each GLP-1 receptor agonists from 2005-2024.

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Data availability

The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.

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Authors and Affiliations

Authors

Contributions

APL: Conceptualization, Data curation, Formal analysis, Methodology, Supervision, Validation, Visualization, Writing; ALC: Conceptualization, Writing, review & editing. SB: Methodology, Visualization, Writing, review & editing; ERS: Writing draft, review & editing, JS: Writing draft, review & editing; YSC: Supervision, Writing, review & editing, FDG: Writing draft, review & editing; MS: review & editing; MLE: Conceptualization, Methodology, Supervision, Validation, Visualization, review & editing.

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Correspondence to Michael L. Eisenberg.

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The authors declare no competing interests.

Ethics approval and consent to participate

All methods were performed in accordance with relevant guidelines and regulations. This study utilized publicly available, de-identified data from the FDA Adverse Event Reporting System (FAERS), and therefore did not involve direct interaction with human participants or identifiable private information. As such, the Stanford University School of Medicine Institutional Review Board determined that the study was exempt from review (IRB exemption granted; no reference number applicable for de-identified dataset studies). Because the research did not involve the collection of identifiable human data or images, informed consent to participate and consent for publication were not required.

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Pourabhari Langroudi, A., Chen, A.L., Basran, S. et al. Male sexual dysfunction associated with GLP-1 receptor agonists: a cross-sectional analysis of FAERS data. Int J Impot Res 37, 661–667 (2025). https://doi.org/10.1038/s41443-025-01061-2

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