Post-marketing adverse event databases are used to assess reported safety signals linked to commonly prescribed metabolic therapies. In the American Journal of Ophthalmology, a retrospective clinical cohort disproportionality analysis evaluated eye disorder reports associated with glucagon-like peptide-1 receptor agonists (GLP-1RAs). Data were obtained from the Food and Drug Administration Adverse Event Reporting System (FAERS). Reports submitted between January 2017 and September 2025 were included. For tirzepatide, reports from January 2022 to September 2025 were analyzed. Reporting odds ratios (RORs) and 95% confidence intervals (CIs) were calculated. Metformin and orlistat served as comparator drugs. Analyses were stratified by the presence or absence of Type 2 diabetes mellitus (T2DM).
In T2DM cases, semaglutide showed increased reporting of optic ischemic neuropathy (ROR 12.269; 95% CI, 0.915-1.967). Cataract reporting was also higher (ROR 31.879; 95% CI, 2.463-4.461). Retinopathy reporting increased as well (ROR 5.185; 95% CI, 0.556-2.736). In non-T2DM cases, semaglutide showed higher reporting of retinopathy (ROR 9.424; 95% CI, 1.081-3.406). Retinal hemorrhage was also reported more frequently (ROR 10.253; 95% CI, 0.319-4.336).
Tirzepatide showed increased reporting of optic ischemic neuropathy (ROR 4.619; 95% CI, 0.726-2.335) and macular degeneration (ROR 15.579; 95% CI, 0.554-4.938) in T2DM cases. In non-T2DM cases, eye swelling showed increased reporting (ROR 6.475; 95% CI, 0.407-3.329). Liraglutide showed higher reporting of cataract (ROR 53.866; 95% CI, 2.945-5.028), diabetic retinopathy (ROR 18.162; 95% CI, 1.753-4.045), and macular degeneration (ROR 26.261; 95% CI, 1.076-5.460) in T2DM cases. In non-T2DM cases, cataract (ROR 9.628; 95% CI, 1.387-3.142) and macular degeneration (ROR 9.557; 95% CI, 0.110-4.405) were reported more frequently.
This FAERS disproportionality analysis identified reporting signals for multiple eye disorders associated with GLP-1RA use compared with metformin, without establishing biological causation.
