Ozempic label adds severe gastroparesis caution but does not say the drug causes it

Ozempic's prescribing information was updated in January 2025 to state that the drug is "not recommended in patients with severe gastroparesis," according to a review of the litigation and label history ^[1]. The same update does not indicate that the drug itself may cause gastroparesis, a distinction at the center of the ongoing federal lawsuits over Ozempic and other GLP-1 medications ^[1].

What the label says

The January 2025 change added a warning for severe gastrointestinal adverse reactions to the Ozempic label ^[1]. The label says the drug is not recommended for patients who already have severe gastroparesis, and it does not state that Ozempic causes the condition ^[1]. Since the FDA approved Ozempic in 2017, manufacturer Novo Nordisk has not included warnings that the medication can cause gastroparesis in its prescription information ^[1].

Earlier label actions were narrower. In September 2023, the FDA added an Ozempic warning for ileus, a condition in which the intestines stop working properly ^[1]. The label also cautions that "vision changes" are a potential serious side effect and highlights concerns about diabetic retinopathy, but it does not name NAION, a form of optic nerve damage, as a risk ^[1].

The litigation

Lawsuits over Ozempic and other GLP-1 drugs have been grouped into two separate multidistrict litigations, one focused on gastroparesis and the other on vision loss ^[1]. The count stood at 4,022 lawsuits as of September 2026 ^[1]. The first Ozempic stomach paralysis lawsuit was filed on Aug. 2, 2023 ^[1]. No global settlements had been announced as of September 2026 ^[1].

Plaintiffs allege failure to warn of side effects, that the manufacturer knew or should have known about the risks, and that safety information was false, misleading or incomplete ^[1]. The injuries claimed across the cases include severe gastroparesis, ileus, intestinal obstruction, intestinal pseudo-obstruction and permanent vision loss from NAION ^[1].

The litigation also covers other drugs in the same class. Wegovy (semaglutide), Rybelsus (semaglutide tablets), Mounjaro (tirzepatide), Zepbound (tirzepatide), Saxenda (liraglutide) and Trulicity (dulaglutide) are named in gastroparesis claims ^[1]. In the vision-loss track, more than 200 lawsuits have been filed in federal court, and the New Jersey Supreme Court is allowing those cases to be grouped in Novo Nordisk's home state ^[1].

Why it matters for patients

Label wording shapes what prescribers see when they write or renew a prescription. Saying a drug is "not recommended" in severe gastroparesis tells clinicians to avoid it in that group. It does not tell them the drug caused the problem, which is the question the lawsuits turn on ^[1].

For people already diagnosed with gastroparesis or a related gastrointestinal injury, the label change does not by itself resolve whether a GLP-1 drug was responsible. There is no cure for gastroparesis or for NAION, and plaintiffs in these cases are seeking compensation for loss of quality of life, past and future medical bills, and other damages ^[1]. People taking Ozempic or another GLP-1 medicine who have questions about their own diagnosis or symptoms would need to raise them with the clinician who prescribed the drug.

The label update applies to the Ozempic brand of semaglutide. The same wording has not been reported here for every other GLP-1 product named in the litigation.

What happens next

No global settlement in the GLP-1 litigation had been announced as of September 2026, and the cases remain active in both the gastroparesis and vision-loss tracks ^[1]. The review does not report a trial date for either group of cases.