FDA adds ileus to the Ozempic label after postmarketing reports

The FDA added ileus — a blockage of normal movement in the intestines — to the adverse reactions section of the Ozempic label after postmarketing reports of the condition in people taking the drug ^[1][4]. Ozempic is the brand name for semaglutide, a GLP-1 receptor agonist approved for type 2 diabetes ^[1]. The FDA's labeling change database lists the action as September 22, 2023 ^[2], and HCPLive reported the change was announced September 20, 2023 ^[1]. The updated label and approval letter carry a September 25, 2023 date ^[2].

The label carries its own caution about what these reports can show: "Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure" ^[4]. Healthline reported that, despite the label change, the FDA has not directly attributed cases of blocked intestines to Ozempic use ^[5]. Novo Nordisk said in a statement that "ileus is a gastrointestinal reaction that was reported in the postmarketing setting with Ozempic and with other GLP-1 receptor agonists," and that it stands behind the safety and efficacy of Ozempic when used consistent with the product labeling and approved indications ^[4].

On the same day, the FDA issued a second Ozempic labeling update about low blood sugar. The new labeling says people taking semaglutide in combination with an insulin secretagogue, such as a sulfonylurea, or with insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. The label states that reducing the dose of the insulin secretagogue or insulin should be considered when semaglutide is started, to lower that risk ^[1].

The numbers behind the ileus reports differ by outlet. HCPLive reported that the FDA's Adverse Event Reporting System listed 2,951 total adverse event cases associated with Ozempic during 2023 as of June 30, 2023, of which 1,274 were gastrointestinal-related. Within that same dashboard, HCPLive reported 6 total ileus cases, 2 of them involving hospitalization, and said the 2023 count was more than double the total reported in 2019 ^[1]. Healthline, citing the same reporting system and the same June 30, 2023 cutoff, reported that ileus was reported 16 times by Ozempic users ^[5]. The two figures do not match.

Ileus was not new to GLP-1 labeling. Wegovy, the semaglutide 2.4 mg product approved for obesity, already listed ileus among gastrointestinal disorders based on postmarketing reports, including "acute pancreatitis and necrotizing pancreatitis, sometimes resulting in death, ileus" ^[4]. Labeling for tirzepatide (Mounjaro), a dual GIP/GLP-1 receptor agonist approved for type 2 diabetes, was changed to add ileus as a possible side effect in July 2023 ^[4]. Mounjaro and Zepbound are tirzepatide, a different molecule from semaglutide. Both drug types can also slow stomach emptying, which their labels mention under drug interactions rather than under warnings or adverse reactions ^[4].

Why it matters for patients

The practical effect of the change is on the printed information that comes with the drug. Ileus now appears where clinicians and patients look for possible reactions, alongside the FDA's caveat that the reports were voluntary and that a cause-and-effect link to semaglutide has not been established ^[1][4]. How often ileus occurs in people taking Ozempic has not been established.

Ileus can cause cramping and pain, the inability to have a bowel movement, swelling, vomiting, or lack of appetite, according to the Mayo Clinic, as cited by MedPage Today ^[4]. It often leads to hospitalization to stabilize the condition first, followed by a barium or air enema or, for a complete intestinal obstruction, surgery; a pseudo-obstruction may be treated with medication to cause muscle contractions, stopping the medication causing the obstruction, or a decompression treatment ^[4].

The hypoglycemia labeling affects a different group: people who take Ozempic along with insulin or a sulfonylurea ^[1]. That change points to dose review of the other medication when semaglutide is started, rather than to any change in semaglutide itself.

Ileus and other gastrointestinal injuries later became part of product liability litigation. Drugwatch reports 4,022 lawsuits as of September 2026, grouped into two multidistrict litigations — one on gastroparesis and one on vision loss — with the first stomach paralysis lawsuit filed on August 2, 2023 ^[3]. Drugwatch also reports that in January 2025 the Ozempic label was updated to say the drug is "not recommended in patients with severe gastroparesis," while not stating that the drug causes the condition ^[3].

What happens next

No global settlements have been announced as of September 2026 ^[3]. No date for a resolution of the consolidated litigation has been disclosed.