Abstract
Background:
Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 receptor agonist (GLP-1 RA), has demonstrated significant efficacy in weight reduction and glycemic control in patients with type 2 diabetes and obesity. However, concerns have emerged regarding its potential association with ophthalmic adverse events, particularly non-arteritic anterior ischemic optic neuropathy (NAION).
Objective:
This study aimed to investigate the possible link between tirzepatide and ischemic optic neuropathy (ION) through pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) and to complement these findings with an infodemiology assessment using Google Trends.
Methods:
FAERS reports from January 2022 to June 2025 were analyzed using OpenVigil 2.1 to identify cases of ION with tirzepatide as the primary suspect drug. Disproportionality analyses were performed using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Relative Reporting Ratio (RRR), and Evans criteria were applied for causality assessment. In parallel, global search interest in tirzepatide was evaluated using Google Trends data from 2020 to 2025 to explore public awareness and its potential impact on reporting patterns.
Results:
A total of 28 ION cases were identified for tirzepatide. The event is rare but serious. Disproportionality analysis yielded significant signals (ROR: 2.599, 95% CI: 1.778; 3.799; PRR: 2.598 95% CI: 1.778; 3.797; RRR: 2.522, 95% CI: 1.726; 3.685; Chi-Squared: 24.692), with Evans criteria supporting a “probable” drug-event association. Google Trends demonstrated an exponential rise in global search interest for tirzepatide, particularly in Western countries with high prevalence of obesity and type 2 diabetes, reflecting increased accessibility and use.
Conclusions:
The pharmacovigilance analysis suggests a potential association between tirzepatide and ION, warranting cautious clinical consideration and further investigation. The event is rare but serious. Integrating pharmacovigilance data with digital epidemiology may enhance early signal detection and risk management for rare but clinically significant adverse events such as NAION.
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