Sexual Safety Signals of Common Antidiabetic Drugs: Insights From FAERS Disproportionality Analysis

This FDA Adverse Event Reporting System-based pharmacovigilance analysis identified potential safety signals linking erectile dysfunction to semaglutide, sitagliptin, and dapagliflozin. These findings do not establish causality and should be regarded as preliminary and hypothesis-generating. Further mechanistic and prospective clinical studies are needed to determine whether these signals reflect true drug-related risks. Clinicians should be aware that erectile dysfunction has been reported in some users of these agents and may consider incorporating sexual health into routine discussions and shared decision-making with male patients.

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Publication Details

Journal
Andrology
Published
2026-03-26
DOI
https://doi.org/10.1111/andr.70222
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
Type
article
Field-Weighted Citation Impact
0.00
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article

Sexual Safety Signals of Common Antidiabetic Drugs: Insights From FAERS Disproportionality Analysis

Shan Lin, Qingyuan Zhan, Xin Dang, Xuefeng Ding
Andrology
Pharmacovigilance and Adverse Drug Reactions
article

Sexual Safety Signals of Common Antidiabetic Drugs: Insights From FAERS Disproportionality Analysis

Shan Lin, Qingyuan Zhan, Xin Dang, Xuefeng Ding
article en

Abstract

This FDA Adverse Event Reporting System-based pharmacovigilance analysis identified potential safety signals linking erectile dysfunction to semaglutide, sitagliptin, and dapagliflozin. These findings do not establish causality and should be regarded as preliminary and hypothesis-generating. Further mechanistic and prospective clinical studies are needed to determine whether these signals reflect true drug-related risks. Clinicians should be aware that erectile dysfunction has been reported in some users of these agents and may consider incorporating sexual health into routine discussions and shared decision-making with male patients.

Andrology
North Sichuan Medical University (CN), China-Japan Friendship Hospital (CN), Affiliated Hospital of North Sichuan Medical College (CN)
Gender equality
Openalex Percentile: Top 7%
Pharmacovigilance and Adverse Drug Reactions
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