Ozempic label revised again in May 2026 and still omits NAION warning

The prescribing information for Ozempic (semaglutide) carries a revision date of May 2026 and still does not list non-arteritic anterior ischemic optic neuropathy (NAION) among its warnings, even though European regulators concluded in June 2025 that the eye condition is a very rare side effect of semaglutide ^[1][2].

The DailyMed entry for the Ozempic label shows it was updated June 1, 2026, and the prescribing information is marked "Revised: 5/2026" ^[1]. The label lists ten Warnings and Precautions, numbered 5.1 through 5.10: risk of thyroid C-cell tumors, acute pancreatitis, diabetic retinopathy complications, a warning never to share a pen between patients, hypoglycemia when used with insulin or insulin secretagogues, acute kidney injury due to volume depletion, severe gastrointestinal adverse reactions, hypersensitivity reactions, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation ^[1]. NAION is not one of them ^[1].

The label's "Recent Major Changes" section lists a single change: Warnings and Precautions, Severe Gastrointestinal Adverse Reactions, dated 10/2025 ^[1].

In Europe, the picture is different. On June 6, 2025, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) concluded that NAION is a very rare side effect of semaglutide, which means it may affect up to 1 in 10,000 people taking the medicine ^[2]. PRAC reviewed non-clinical studies, clinical trials, post-marketing surveillance and the medical literature ^[2]. Several large epidemiological studies suggested that exposure to semaglutide in adults with type 2 diabetes is associated with about a two-fold increase in the risk of developing NAION compared with people not taking the medicine, corresponding to roughly one additional case per 10,000 person-years of treatment — one person-year meaning one person taking semaglutide for one year ^[2]. Data from clinical trials also pointed to a slightly higher risk in people taking semaglutide compared with placebo ^[2]. The agency recommended that product information for semaglutide medicines be updated to list NAION as a side effect with a frequency of "very rare" ^[2].

Why it matters for patients

Labeling is one of the main places US patients and their clinicians learn what to watch for after starting a medicine. A difference between what European and US product information says means a US patient taking Ozempic may not encounter NAION anywhere in the printed or online label, while a patient in Europe would ^[1][2].

The European committee described the risk as rare but real: about one extra case per 10,000 people treated for a year, with a roughly two-fold relative increase in risk among adults with type 2 diabetes in the epidemiological studies it reviewed ^[2]. It also stated that patients who experience sudden loss of vision or rapidly worsening eyesight during treatment should contact their doctor without delay, and that treatment should be stopped if NAION is confirmed ^[2].

The reason the US label does not carry the same information has not been disclosed, and the Food and Drug Administration's position on NAION and semaglutide has not been reported. Whether the US labels for other semaglutide products, Wegovy and Rybelsus, are worded the same way has not been reported either.

What happens next

There is no announced US timeline. The label as posted lists a May 2026 revision and one recent change, dated 10/2025, for severe gastrointestinal adverse reactions ^[1]. Once PRAC made its recommendation in Europe, the matter went to the Committee for Medicinal Products for Human Use, which adopts the agency's opinion ^[2]; the revised European announcement of June 13, 2025 removed a reference to the European Commission issuing a legally binding decision on the procedure ^[2].

A new US revision could appear at any time, but no date for one has been given ^[1].