A Pharmacovigilance Analysis of Ocular Adverse Events Associated with GLP-1 Receptor Agonists

TL;DR

This study analyzes reports of eye-related side effects linked to GLP-1 receptor agonist medications, finding potential safety signals, especially with semaglutide.

Contribution

The study identifies emerging ocular safety signals in GLP-1 RA medications using pharmacovigilance data and trends.

Findings

Ocular adverse events accounted for 3.61% of GLP-1 RA reports, with semaglutide showing a modestly elevated risk signal.

Semaglutide and tirzepatide showed increasing proportional reporting over time, while exenatide declined.

Visual impairment and blurred vision were the most commonly reported ocular adverse events.

Abstract

Background/Objectives: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are increasingly prescribed for type 2 diabetes in addition to other conditions such as obesity. As their use expands, understanding potential ocular safety signals is important, particularly in populations already at risk for diabetic eye disease. The aim of this study is to identify potential pharmacovigilance safety signals for ocular adverse events (AEs) related to GLP-1 RA medications to better inform future clinical practice. Methods: This study utilized the publicly available FDA Adverse Event Reporting System (FAERS) to obtain AE reports related to exenatide, tirzepatide, dulaglutide, liraglutide, and semaglutide from 2005 to 2024. Reports were categorized by demographic and geographic variables. Disproportionality analysis using reporting odds ratios (RORs) was performed to detect potential safety signals. Year-over-year trends in the proportional representation of each drug were also assessed through linear regression and time series plots. Results: Ocular AEs represented 3.61% of all GLP-1 RA related reports. Median age was 63 years, and 62.6% of reports involved female patients. Exenatide accounted for 33.61% of ocular AEs but showed a significant annual decline in reporting (–5.15% per year, p < 0.001). Semaglutide (31.37%) and tirzepatide (12.19%) demonstrated significant year-over-year increases in proportional reporting (2.23% and 0.79% per year, respectively; both p < 0.05), consistent with rapid uptake in clinical practice. Semaglutide demonstrated a modestly elevated ROR (1.46), while tirzepatide showed a low ROR (0.42), though this likely reflects shorter post-marketing exposure rather than lower clinical risk. The most frequently reported events were visual impairment, followed by vision blurred, cataract, and blindness. Conclusions: This pharmacovigilance analysis identifies potential ocular AE signals associated with GLP-1 RAs, particularly semaglutide. While semaglutide showed a statistically significant disproportional reporting signal for ocular AEs, the absence of exposure denominators, comparator groups, and the susceptibility of FAERS to reporting bias means these findings are hypothesis-generating rather than causal. Clinicians should remain vigilant and consider eye care referrals when indicated. Further research is needed to validate these associations and clarify underlying mechanisms.

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