Neuropsychiatric adverse events associated with Glucagon-like peptide-1 receptor agonists: a pharmacovigilance analysis of the FDA Adverse Event Reporting System database

• DOI: 10.1192/j.eurpsy.2024.1803
• Publication Date: 2025-02-04T06:10:26Z
• Authors: Wenchao Lu; Shihan Wang; Huilin Tang; Tao Yuan; Wei Zuo; Yuling Liu
• Keywords: Psychiatry; FAERS; pharmacovigilance analysis; RC435-571; neuropsychiatric adverse events; GLP-1RAs

Abstract Background Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are widely used due to their profound efficacy in glycemic control and weight management. Real-world observations have revealed potential neuropsychiatric adverse events (AEs) associated with GLP-1RAs. This study aimed comprehensively investigate characterize these AEs Methods We analyzed GLP-1RA reaction reports using the FDA Adverse Event Reporting System database. Disproportionality analysis reporting odds ratio (ROR) identified eight categories of conducted descriptive time-to-onset (TTO) analyses explored AE signals among individual GLP-1RAs for loss diabetes mellitus (DM) indications. Results 25,110 cases GLP-1RA-related AEs. showed an association headache (ROR 1.74, 95% confidence interval [CI] 1.65–1.84), migraine 1.28, 95%CI 1.06–1.55), olfactory sensory nerve abnormalities 2.44, 1.83–3.25; ROR 1.69, 1.54–1.85). Semaglutide a moderate suicide-related signal population 2.55, 1.97–3.31). The median TTO was 16 days (interquartile range: 3–66 days). Conclusions In this study, we and, first time, detected positive migraine, abnormalities, abnormalities. also observed semaglutide, population. provides reliable basis further investigation However, as exploratory our findings require confirmation through large-scale prospective studies.