Ozempic label updated to say it is not recommended in severe gastroparesis

Novo Nordisk updated the U.S. prescribing label for Ozempic in January 2025 to state the drug "is not recommended in patients with severe gastroparesis." The label change does not say Ozempic causes gastroparesis, a distinction that sits at the center of ongoing litigation over the drug ^[1].

The update came after years of complaints from patients who say they developed gastroparesis, a condition where the stomach empties too slowly, after using Ozempic. Since the FDA approved Ozempic in 2017, Novo Nordisk had not included a specific warning that the drug can cause gastroparesis ^[1]. The company has warned about other Ozempic side effects, and in September 2023 the FDA added a warning about ileus, a condition in which the intestines stop working properly, to the label ^[1].

The gap between the new gastroparesis language and an outright causation warning matters because it is a key issue in Ozempic lawsuits now consolidated in multidistrict litigation, known as MDL 3094. As of September 2026, 4,022 lawsuits had been filed against Novo Nordisk and other GLP-1 drugmakers, according to Drugwatch, a legal information site that tracks the litigation ^[1]. Plaintiffs allege severe gastroparesis, ileus, intestinal obstruction and, in a separate and growing set of cases, permanent vision loss from a condition called non-arteritic anterior ischemic optic neuropathy, or NAION ^[1]. Lawyers involved in the litigation say Novo Nordisk knew or should have known about these risks and failed to warn patients and doctors ^[1].

No global settlement has been reached in the gastroparesis or ileus cases as of September 2026, and no cases have gone to trial or resulted in a verdict, according to Drugwatch ^[1]. The NAION vision-loss litigation is a separate track that has been moving faster: more than 200 federal lawsuits have been filed and consolidated before the same judge overseeing the gastroparesis MDL, and the New Jersey Supreme Court has agreed to let related state-court cases be grouped together in Novo Nordisk's home state ^[1].

Why it matters for patients

The January 2025 label change tells prescribers not to start or continue Ozempic in patients who already have severe gastroparesis, but it does not confirm that the drug caused the condition in people who did not have it before ^[1]. For patients weighing whether to take Ozempic, or trying to understand what happened to them after taking it, that distinction shapes what they can expect from their doctor's guidance and from the legal system. A label warning against use in an existing condition is different, legally and medically, from a warning that a drug can cause that condition in someone who did not have it.

There is no cure for gastroparesis or for NAION, according to Drugwatch, and people who developed either condition after using Ozempic say it has affected their quality of life and led to ongoing medical costs ^[1]. Patients considering GLP-1 drugs, including other semaglutide products such as Wegovy and Rybelsus, and tirzepatide products such as Mounjaro and Zepbound, are also named in similar gastroparesis claims tracked by plaintiffs' lawyers, according to Drugwatch ^[1]. It is not yet known from the sources reviewed here whether the FDA or Novo Nordisk plans further label changes specific to gastroparesis causation.

What happens next

As of September 2026, no settlements had been announced in the gastroparesis and ileus MDL, and the vision-loss cases remain in earlier stages of consolidation before the same federal judge ^[1]. Court proceedings in both tracks are ongoing, and further scheduling or bellwether trial dates were not specified in the available sources.