FDA approves October 2025 gastrointestinal labeling changes for semaglutide

The FDA on October 14, 2025, approved labeling changes for two semaglutide products, Ozempic and Wegovy, that expand what the prescribing information says about severe gastrointestinal problems and add several new entries to the postmarketing sections of both labels ^[1][2].

Both approval letters were signed the same afternoon by Monika Houstoun, Pharm.D., M.P.H., Deputy Director for Safety in the FDA's Division of Diabetes, Lipid Disorders, and Obesity ^[1][2].

What changed on the Ozempic label

Ozempic's changes came through two supplements to NDA 209637 — S-035 and S-037 — submitted by Novo Nordisk on March 21, 2025, and June 20, 2025 ^[1].

Supplement S-035 revised Warnings and Precautions Section 5.2, Acute Pancreatitis, and related language in Section 17, "for consistency with the class" ^[1]. It also revised Warnings and Precautions Section 5.7, Severe Gastrointestinal Adverse Reactions, to add the sentence: "Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists" ^[1].

The same supplement added "intestinal obstruction, severe constipation including fecal impaction" and "acute kidney injury" to Section 6.2, Postmarketing Experience ^[1]. A second supplement, S-037, added "headache" to that same Section 6.2 ^[1].

The FDA also made minor editorial fixes, including updating the date for "Warnings and Precautions Severe Gastrointestinal Adverse Reactions" in the Recent Major Changes box and correcting a cross-reference to Section 6 ^[1].

What changed on the Wegovy label

Wegovy's update came through a single supplement, S-026 to NDA 215256, also dated March 21, 2025 ^[2]. It revised Warnings and Precautions Section 5.6, Severe Gastrointestinal Adverse Reactions, to include the same sentence about postmarketing reports with GLP-1 receptor agonists, and added "intestinal obstruction, severe constipation including fecal impaction" to Section 6.2, Postmarketing Experience ^[2].

Notably, the Wegovy supplement approved that day did not add acute kidney injury or headache to the postmarketing list; those two additions appear only in the Ozempic letter ^[1][2]. The two products contain the same molecule, semaglutide, but are approved under separate applications with separate labels. The letters do not explain the difference.

FDA's editorial notes on the Wegovy letter show the agency removed a proposed 10/2025 listing of "6.2 Postmarketing Experience" from the Recent Major Changes section and instead updated the date to 10/2025 for "Severe Gastrointestinal Adverse Reactions" ^[2].

Why it matters for patients

Section 6.2, Postmarketing Experience, is the part of a drug label that lists events reported voluntarily after a medicine reaches the market. The FDA letters state only that these terms were added; they do not include case counts, reporting rates, or any estimate of how often these events occur ^[1][2]. They also do not say whether the agency concluded the drug caused the events. That information is not in these documents.

What the change does do is put specific terms in front of prescribers and patients who read the label. Intestinal obstruction (a blockage in the bowel), severe constipation including fecal impaction, acute kidney injury, and headache are now named in writing rather than left under the broader heading of gastrointestinal side effects ^[1][2]. Severe vomiting and diarrhea can lead to dehydration, which is one reason kidney injury is often discussed alongside GI problems, though the letters themselves do not spell out that link.

The new sentence in Warnings and Precautions also broadens the framing from clinical-trial data to the full GLP-1 receptor agonist class ^[1][2]. Anyone with questions about symptoms or their own risk would need to take that up with their own clinician.

What happens next

Novo Nordisk had until 14 days after October 14, 2025 — roughly October 28 — to submit the final content of labeling in structured product labeling format, which is how updated labels reach public databases ^[1][2]. Once posted, the revised prescribing information becomes the version patients see online and in pharmacy handouts.

The company was also required to submit, within 7 days of receiving each letter, a statement of intent to comply with the rule requiring promotional materials to be promptly revised to match the new labeling, including "prominent disclosure of the important new safety-related information" ^[1][2]. Patent information tied to the supplements was due within 30 days of approval ^[1][2].

Because these are supplements rather than new indications or dosage forms, both letters state the applications are exempt from pediatric assessment requirements under the Pediatric Research Equity Act ^[1][2].