BetaEntity Annotation Prototype
← Back to drugs

Annotated abstract

5PSQ-043 Rare adverse event monitoring: nonarteritic anterior ischaemic optic neuropathy associated with tirzepatide – a pharmacovigilance disproportionality study

ejhpharm · 2026-03-18 · canonical JSON source

20 visible annotations · policy: published · automated confidence ≥ 75.00%

Document resource

Background and Importance Nonarteritic anterior ischaemic optic neuropathy (NAION) represents the most common acute optic neuropathy in patients over 50 years, potentially causing permanent vision loss. Recent pharmacovigilance signals have emerged regarding Glucagon-like peptide-1 receptor agonists and ocular adverse events. While semaglutide has been studied, limited data exist on tirzepatide’s association with NAION. Given tirzepatide’s increasing clinical use, investigating potential ocular safety signals is crucial for patient safety.Aim and Objectives This study aimed to investigate the association between tirzepatide and NAION through disproportionality analysis using real-world pharmacovigilance data. The primary objective was assessing reporting patterns and statistical significance of ischaemic optic neuropathy (ION) events in patients receiving tirzepatide compared to other medications.Material and Methods A retrospective disproportionality analysis was conducted using Food and Drug Administration Adverse Event Reporting System (FAERS) Public Dashboard from January 1, 2022, to June 30, 2025. The study focused on reports containing tirzepatide as suspected drug and ‘Ischaemic optic neuropathy’ as adverse event, since NAION is not included in Medical Dictionary for Regulatory Activities version 27.0. Analysis was performed using IBM SPSS Modeler 15.0. Multiple disproportionality measures were calculated: Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR) with 95% confidence intervals (CI), and Chi-squared statistics. Evans 1 criteria (n > 2, chi-square > 4, PRR > 2) were applied to assess drug adverse event association probability.Results The analysis revealed significant statistical associations between tirzepatide and ischaemic optic neuropathy. Results were: PRR (95% CI): 2.49 (1.68–3.68), ROR (95% CI): 2.49 (1.68–3.69), and Chi-squared: 20.72. All parameters exceeded Evans’ thresholds, indicating that the combination is ‘likely an adverse reaction.’Conclusion and Relevance This pharmacovigilance analysis provides evidence for significant disproportionality between tirzepatide and ischaemic optic neuropathy in FAERS database. According to Evans criteria, the association suggests a probable adverse drug reaction. These findings extend safety observations beyond semaglutide to tirzepatide. Healthcare providers should consider this potential risk when prescribing tirzepatide, particularly in patients with ocular risk factors. Further prospective studies are needed to establish causality and define clinical risk magnitude.References and/or Acknowledgements 1. Evans SJ, et al. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001;10(6):483–486. doi: 10.1002/pds.677.Conflict of Interest No conflict of interest