Disproportionate Reporting of Optic Ischemic Neuropathy in FAERS with GLP-1-Based Therapies Compared with SGLT2 Inhibitors

This study aimed to evaluate whether FDA Adverse Event Reporting System (FAERS) reports coded with the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term “optic ischemic neuropathy” were reported disproportionately with glucagon-like peptide-1 (GLP-1)-based therapies versus sodium-glucose cotransporter 2 (SGLT2) inhibitors. We performed a retrospective disproportionality analysis of unique adverse event reports received from 1 January 2018, to 31 December 2025, using the FAERS database. Reporting odds ratios (RORs) and 95% confidence intervals (CIs) were calculated. Secondary analyses examined semaglutide separately and reporting during 2018–2023, 2024, and 2025. Stratified analysis was performed for age, sex, and diabetes-restricted indications. There were 599 optic ischemic neuropathy reports among 293,554 GLP-1-based therapy reports and 8 among 101,810 SGLT2 inhibitor reports. Semaglutide accounted for 509 (85.0%). The crude ROR was 26.02 (95% CI, 12.95–52.27) and the semaglutide-specific ROR was 89.13 (44.33–179.22). Period-specific RORs were 0.58 (0.20–1.67) for 2018–2023, 15.56 (3.83–63.18) for 2024, and 216.10 (13.50–3460.04) for 2025. Of 599 exposure-group reports, 585 (97.7%) were received from July 2024 onward. The diabetes-restricted ROR was 30.36 (9.72–94.79). FAERS showed disproportionate reporting of optic ischemic neuropathy with GLP-1-based therapies compared with SGLT2 inhibitors. The signal was driven largely by semaglutide and reports received from July 2024 onward. The diabetes-restricted analysis also showed disproportionate reporting but was based on only 3 comparator outcome reports and should be considered exploratory.