Evaluating the Evolving Real-World Adverse Events of GLP-1RAs Using FDA Adverse Event Reporting System (FAERS)

David Stone; Mary Playdon; Stephen D Hursting; Aik Choon Tan

doi:10.1002/oby.70176

Evaluating the Evolving Real-World Adverse Events of GLP-1RAs Using FDA Adverse Event Reporting System (FAERS)

Obesity (Silver Spring). 2026 Mar 9. doi: 10.1002/oby.70176. Online ahead of print.

Authors

David Stone^{1

2}, Mary Playdon^{2

3}, Stephen D Hursting^{4

5

6}, Aik Choon Tan^{1

2}

Affiliations

¹ Departments of Oncological Sciences and Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA.
² Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.
³ Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah, USA.
⁴ Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
⁵ Nutrition Research Institute, University of Carolina at Chapel Hill, Kannapolis, North Carolina, USA.
⁶ Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

PMID: 41797511
DOI: 10.1002/oby.70176

Abstract

Objective: This study aimed to assess the spectrum and frequency of adverse events (AEs) linked to glucagon-like peptide-1 receptor agonists (GLP-1RAs) using the US FDA Adverse Event Reporting System (FAERS). Emphasis was placed on emerging safety concerns in context-specific use.

Methods: A retrospective analysis of FAERS reports between 2012 and 2025 was conducted. Five commonly prescribed FDA-approved GLP-1RAs were included. Disproportionality analyses were applied to detect AE signals. Subgroup analyses evaluated associations by indication, GLP-1RAs compared to other drugs, and AEs specific to individual GLP-1RAs.

Results: From over 18 million FAERS reports, 137,451 involved GLP-1RAs. The most frequent AEs were gastrointestinal, nutritional and metabolic, and psychiatric disorders, occurring at higher rates compared to other drugs. In diabetes use, GLP-1RAs were associated with retinopathy, hearing loss, and cataracts. In contrast, when prescribed for weight management/obesity, nutritional, metabolic, and psychiatric AEs predominated. We also developed an open-access portal for AE exploration, available at http://glp1.tanlab.org.

Conclusions: GLP-1RAs are linked to a broad range of AEs across indications. These findings stress the need for careful clinical monitoring and long-term safety evaluation. This study also illustrates how real-world evidence can inform safety communications, as well as hypothesis generation for research on next-generation GLP-1RAs.

Grants and funding

Huntsman Cancer Institute, University of Utah