Still no NAION warning on any US tirzepatide label

A review of the current US prescribing information for both tirzepatide products found no mention of NAION or optic neuropathy. A full-text search of the Zepbound label, last updated August 28, 2026, and the Mounjaro label, last updated August 27, 2026, returns no occurrence of either term ^[1][2]. Both labels are marked "Revised: 8/2026" ^[1][2].

NAION stands for non-arteritic anterior ischemic optic neuropathy. It is a sudden loss of blood flow to the optic nerve that can cause permanent vision loss in one eye.

The FDA named both drugs in a class-wide safety signal more than 21 months ago. In its quarterly listing of potential signals of serious risk covering October through December 2024, the agency listed "Non-arteritic anterior ischemic optic neuropathy (NAION)" under the heading of glucagon-like peptide-1 (GLP-1) receptor agonists, and included Mounjaro (tirzepatide) injection and Zepbound (tirzepatide) injection alongside Ozempic, Wegovy, Rybelsus, Saxenda, Victoza, Trulicity and others ^[3]. The status listed for that entry, as of March 6, 2025, was "FDA is evaluating the need for regulatory action" ^[3]. We did not locate any later FDA statement explaining why no labeling change has followed for tirzepatide.

What the labels do say about eyes

Both tirzepatide labels were in fact revised in August 2026 for a different eye problem. The Zepbound "Recent Major Changes" table lists an 08/2026 update to Section 5.8, "Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus," which directs prescribers to monitor patients with a history of diabetic retinopathy for progression ^[1]. Mounjaro carries a parallel 08/2026 update to its Section 5.7 on diabetic retinopathy ^[2]. Neither warning addresses optic nerve injury.

The warnings sections of both labels otherwise cover severe gastrointestinal reactions, acute kidney injury from volume depletion, gallbladder disease, pancreatitis, hypersensitivity reactions, hypoglycemia, pulmonary aspiration during anesthesia, and not sharing a KwikPen between patients ^[1][2].

On the semaglutide side, the Ozempic label was last updated June 1, 2026, with its most recent major change listed as severe gastrointestinal adverse reactions in 10/2025 ^[5]. One litigation-tracking site describes the US semaglutide labeling as having "no mention of NAION specifically," while cautioning about "vision changes" and diabetic retinopathy ^[4]. The summary prompting this refresh states that European regulators added NAION to semaglutide labeling about 15 months ago; that action is not documented in the sources reviewed here, so the transatlantic comparison is not verified by this reporting.

Why it matters for patients

The prescribing information is the document that pharmacists, prescribers and patients use to learn what a drug's known and suspected risks are. When a potential risk is under FDA evaluation but not yet in the label, a patient reading the Mounjaro or Zepbound Medication Guide will not see it, and a clinician deciding between agents will not find it there either.

It also matters legally. According to Drugwatch, a site that markets legal services to injured patients and so has an interest in the topic, 4,022 GLP-1 lawsuits had been filed as of September 2026, split between multidistrict litigation over gastroparesis and a separate group over vision loss ^[4]. The same site says more than 200 NAION cases have been filed in federal court and have been consolidated before the judge already handling the gastroparesis litigation ^[4], with the vision-loss docket identified as MDL-3163 ^[6]. No global settlements had been announced as of September 2026 ^[4].

What is not known from these sources: how many NAION reports FDA has received for tirzepatide specifically, whether the agency has decided against labeling changes or is still reviewing, and whether any manufacturer has proposed language. Nothing in the available documents quantifies the risk, if any, for tirzepatide users.

What happens next

FDA publishes its potential-signal tables quarterly, and any movement on this entry would normally appear there or in a revised "Recent Major Changes" line on the labels themselves ^[1][2][3]. The next tirzepatide label revision after 8/2026 is the practical place to watch ^[1][2].