Alopecia risk with GLP-1 receptor agonists: A disproportionality analysis using the FDA adverse event reporting system (FAERS)

Abstract

Glucagon-like peptide-1 receptor agonists (GLP-1-RAs), a class of drugs indicated for diabetes mellitus and weight control, have been implicated in alopecia. We mined data from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to better understand the relationship between alopecia and GLP-1-RAs. Using 2016–2025 FAERS data, we conducted disproportionality analyses for 7 GLP-1-RAs (albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tirzepatide) and alopecia-related adverse events (AEs); we also conducted descriptive analyses for drug-related information. Semaglutide had the highest number of reports (n = 697); furthermore, signals were identified with this GLP-1-RA in 2022 (reporting odds ratio (ROR) = 1.43, 95% confidence interval (CI): 1.15–1.77), and 2024 (ROR = 1.55, 95% CI: 1.35–1.77). We found that 25% and 18% of reports with semaglutide documented positive dechallenge and positive rechallenge, respectively. Our work, at the time of our pharmacovigilance study, is the first to include the latest FAERS data in disproportionality analyses for GLP-1-RAs and alopecia. Our descriptive analyses of salient drug-related phenomena (including rechallenge and dechallenge information) have never been reported elsewhere. Our findings merit further monitoring of GLP-1-RAs for hair loss.