Evidence mapPaperPMID 41883294Full record

ArticleAndrology2026

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

Shan Lin, Xuefeng Ding, Xin Dang, Qingyuan Zhan

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In one paragraph

Article in Andrology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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4 · The record

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5 · Who and what money

Authors and funding

4 authors.

Shan LinDepartment of Respiratory and Critical Care Medicine, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China.ORCID https://orcid.org/0000-0001-5163-6533
Xuefeng DingDepartment of Critical Care Medicine, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China.
Xin DangDepartment of Respiratory and Critical Care Medicine, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China.
Qingyuan ZhanDepartment of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Center for Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China.ORCID https://orcid.org/0000-0003-0021-0270

Funding

Key Project of the Affiliated Hospital of North Sichuan Medical CollegeProject of the Doctoral Initiation FundResearch Development Plan Project of Affiliated Hospital of North Sichuan Medical CollegeScience and Technology Project of NanchongScientific Research and Development Program ProjectSichuan Province Clinical Key Specialty Construction Project
6 · The paper itself

Abstract

backgroundErectile dysfunction is a prevalent and distressing complication of diabetes mellitus that markedly affects quality of life in male patients. Although the role of diabetes in erectile dysfunction is well-established, potential drug-induced sexual dysfunction associated with commonly prescribed antidiabetic medications remains underrecognized. The objective of this study was to investigate whether commonly prescribed antidiabetic medications, including glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, metformin, and sodium-glucose cotransporter-2 inhibitors, are associated with an increased reporting of erectile dysfunction in real-world clinical practice.

methodsThis retrospective pharmacovigilance study was conducted using the FDA Adverse Event Reporting System. A disproportionality analysis was performed to evaluate the reporting frequency of erectile dysfunction associated with commonly prescribed antidiabetic medications. The reporting odds ratio served as the primary metric for evaluating disproportionality in adverse event reporting. In addition, time-to-onset and Weibull shape parameter analyses were performed to assess temporal trends in adverse event occurrence.

resultsWe identified 49 semaglutide-, 54 sitagliptin-, and 42 dapagliflozin-associated erectile dysfunction reports. All three drugs demonstrated significant disproportionality signals: semaglutide (reporting odds ratio: 1.53, 95% confidence interval: 1.16-2.03; information component

conclusionsThis 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.

Indexed as

Erectile DysfunctionHypoglycemic AgentsAdultAdverse Drug Reaction Reporting SystemsAgedBenzhydryl CompoundsDipeptidyl-Peptidase IV InhibitorsGlucagon-Like PeptidesGlucosidesHumansMaleMetforminMiddle AgedPharmacovigilanceRetrospective StudiesSemaglutideBenzhydryl CompoundsdapagliflozinDipeptidyl-Peptidase IV InhibitorsGlucagon-Like PeptidesGlucosidesHypoglycemic AgentsMetforminSemaglutideSitagliptin PhosphateSodium-Glucose Transporter 2 Inhibitorsantidiabetic agentsdisproportionality analysiserectile dysfunctionFAERSpharmacovigilance

Identifiers

PMID41883294
PMCPMC13432634

What Socratic holds

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.