If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
Mounjaro ® (tirzepatide) injection
2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Is there a risk for nonarteritic anterior ischemic optic neuropathy (NAION) with Mounjaro® (tirzepatide) treatment?
Patient safety is Lilly’s top priority and we review safety data for all our medicines on an ongoing basis. We continue to monitor safety data from tirzepatide trials and postmarketing experience for all indications to evaluate any new safety signals.
See important safety information, including boxed warning, in the attached prescribing information.
Tirzepatide and Risk for NAION
Eli Lilly and Company is aware of publications on the risk of nonarteritic anterior ischemic optic neuropathy (NAION) in patients prescribed semaglutide or tirzepatide and notes their findings.1-5
Please note that this may not be the full list of publications available on this topic.
Patient safety is Lilly’s top priority and we review safety data from clinical trials and postmarketing experience for all our medicines on an ongoing basis. Lilly will continue to monitor the tirzepatide development program for all indications to evaluate any new safety signals. If a potential new risk is identified for the product or the class, the prescribing information will be assessed in consultation with regulatory authorities.6
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Hathaway JT, Shah MP, Hathaway DB, et al. Risk of nonarteritic anterior ischemic optic neuropathy in patients prescribed semaglutide. JAMA Ophthalmol. 2024;142(8):732-739. https://doi.org/10.1001/jamaophthalmol.2024.2296
2Chou CC, Pan SY, Sheen YJ, et al. Association between semaglutide and nonarteritic anterior ischemic optic neuropathy: a multinational population-based study. Ophthalmology. Published online November 2, 2024. https://doi.org/10.1016/j.ophtha.2024.10.030
3Grauslund J, Taha AA, Molander LD, et al. Once-weekly semaglutide doubles the five-year risk of nonarteritic anterior ischemic optic neuropathy in a Danish cohort of 424,152 persons with type 2 diabetes. Int J Retina Vitreous. 2024;10(1):97. https://doi.org/10.1186/s40942-024-00620-x
4Klonoff DC, Hui G, Gombar S. Real-world evidence assessment of the risk of nonarteritic anterior ischemic optic neuropathy in patients prescribed semaglutide. J Diabetes Sci Technol. 2024;18(6):1517-1518. https://doi.org/10.1177/19322968241268050
5Katz BJ, Lee MS, Lincoff NS, et al. Ophthalmic complications associated with the antidiabetic drugs semaglutide and tirzepatide. JAMA Ophthalmol. Published online January 30, 2025. https://doi.org/10.1001/jamaophthalmol.2024.6058
6US Food and Drug Administration. Frequently asked questions about labeling for prescription medicines for healthcare professionals. Updated April 1, 2024. Accessed August 19, 2024. https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/frequently-asked-questions-about-labeling-prescription-medicines
Date of Last Review: February 20, 2025