FDA adds intestinal obstruction and kidney injury to Ozempic label and updates Wegovy

The Food and Drug Administration approved revised prescribing information for Ozempic and Wegovy on October 14, 2025, adding intestinal obstruction and severe constipation including fecal impaction to the postmarketing experience sections of both semaglutide injections ^[1][2]. Ozempic's label also gained acute kidney injury and headache ^[1].

What each letter changes

Ozempic's updates came through two supplemental applications: S-035, received March 21, 2025, and S-037, received June 20, 2025 ^[1]. The first rewrites Section 5.2 on acute pancreatitis, along with related language in Section 17, so they line up with the rest of the GLP-1 receptor agonist class ^[1]. It also inserts a sentence into Warnings and Precautions Section 5.7: "Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists" ^[1]. Together with intestinal obstruction and severe constipation including fecal impaction, S-035 places acute kidney injury into Section 6.2, Postmarketing Experience ^[1]. S-037 contributes headache to that same section ^[1].

Wegovy's revisions arrived in a single supplement, S-026, also received March 21, 2025 ^[2]. It puts the identical postmarketing sentence in Warnings and Precautions Section 5.6 and files the two gastrointestinal entries — intestinal obstruction and severe constipation including fecal impaction — under Section 6.2 ^[2]. Neither acute kidney injury nor headache appears in the Wegovy letter, and the pancreatitis section is untouched there ^[2].

The Wegovy approval carries three editorial corrections as well: the recent major changes list drops the 10/2025 addition of Section 6.2, the date attached to Severe Gastrointestinal Adverse Reactions becomes 10/2025, and a cross-reference under Section 5.6 is fixed ^[2].

Both letters are signed by Monika Houstoun, Pharm.D., M.P.H., deputy director for safety in the Division of Diabetes, Lipid Disorders, and Obesity at the FDA's Center for Drug Evaluation and Research — at 3:32 p.m. for Ozempic and 3:34 p.m. for Wegovy ^[1][2].

Neither document supplies counts, rates or timeframes for the reported events, and neither states that semaglutide caused them ^[1][2]. How often these reactions occur has not been disclosed.

Why it matters for patients

Section 6.2 collects problems reported after a medicine is already on the market; entries there are not proof that the drug caused them ^[1][2]. Warnings and Precautions is where the agency puts its safety cautions ^[1][2]. The visible change for anyone reading the labels is therefore narrow but concrete: two digestive-tract events now appear on both semaglutide injection labels, and two more entries show up only on Ozempic's ^[1][2].

The two labels are no longer identical in this area ^[1][2]. The approval letters do not account for the gap. Nor do they alter dosing, approved uses, or the instructions patients receive ^[1][2].

One further detail: the pancreatitis edits were made to bring Ozempic's wording in line with the drug class, rather than from a semaglutide-specific finding ^[1].

What happens next

Novo Nordisk has 14 days from October 14 to submit the updated labeling in structured product labeling format and to amend pending supplements that carry labeling changes ^[1][2]. A written statement of intent to comply with promotional-material rules is due within 7 days, and advertising has to be brought in line with the new labeling ^[1][2]. Patent information for the Orange Book, where required, goes on Form FDA 3542 within 30 days ^[1][2].

The enclosed Medication Guides are the versions previously approved on January 28, 2025 for Ozempic and August 15, 2025 for Wegovy ^[1][2]. Whether either guide will be reissued has not been reported.