Published July 23, 2026
In January 2025, the FDA revised Ozempic's official prescribing information to add a warning about severe gastrointestinal adverse reactions and to state that the drug is "not recommended in patients with severe gastroparesis." The update built on an earlier label change from September 2023, when the FDA had already added a warning for ileus — a form of bowel blockage — following growing reports of gastrointestinal complications among GLP-1 drug users.
The label change came after years of mounting reports and litigation pressure connecting semaglutide-based drugs to delayed gastric emptying and related gastrointestinal injuries. Novo Nordisk, Ozempic's manufacturer, has continued to maintain that its drugs are safe and effective when used as directed and according to their approved labeling.
The January 2025 revision stops short of stating that Ozempic itself can cause gastroparesis in patients who didn't already have it — instead, it simply advises against using the drug in patients who already have severe gastroparesis. Plaintiffs' attorneys involved in the federal gastroparesis litigation have pointed to that gap as central to their failure-to-warn claims, arguing the label still doesn't clearly tell patients and doctors that new-onset gastroparesis is a risk of taking the drug in the first place. That argument underlies much of the litigation now consolidated in the federal MDL for GLP-1 gastrointestinal injury claims.
A label change on its own doesn't create or resolve a legal claim, but it can be relevant evidence in a case alleging a manufacturer failed to adequately warn about known risks. If you developed gastroparesis, ileus, or another serious gastrointestinal condition while taking Ozempic or a similar GLP-1 drug, a free eligibility review can help you understand your options. See Atumio's Ozempic/GLP-1 Lawsuit page or start a free case review.