Victoza and Saxenda labels add warning on severe gastrointestinal reactions
The October 2025 labeling change tells prescribers that liraglutide is not recommended for people with severe gastroparesis, and it is listed as a warning rather than a contraindication.
Victoza and Saxenda, the two brand-name forms of the once-daily injection liraglutide sold by Novo Nordisk, now carry a Warnings and Precautions subsection on severe gastrointestinal adverse reactions. Both labels state that liraglutide "is not recommended in patients with severe gastroparesis" [1][2]. Each label lists the addition in its Recent Major Changes table under the date 10/2025 [1][2].
The two products use the same molecule for different purposes. Victoza is approved as an adjunct to diet and exercise to improve blood sugar control in adults and children aged 10 and older with type 2 diabetes, and to reduce the risk of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease [2]. Saxenda is approved with a reduced-calorie diet and increased physical activity for weight management in adults and children aged 12 and older with obesity or with overweight plus at least one weight-related condition [1]. Both were first approved in the U.S. in 2010 [1][2].
The new language appears as section 5.6 in the Victoza label and section 5.7 in the Saxenda label. Both describe use of the drug as "associated with gastrointestinal adverse reactions, sometimes severe" [1][2]. Neither label defines what counts as severe gastroparesis or describes how it should be diagnosed [1][2].
Gastroparesis is listed as a warning, not as a contraindication. The contraindications sections of these labels cover a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2, and, for Victoza, a serious hypersensitivity reaction to liraglutide or its ingredients [1][2]. The labels do not explain how prescribers should apply the difference between "not recommended" and "contraindicated" in this case [1][2].
Gastrointestinal side effects were already the most common complaints in the trials behind these products. In Saxenda trials, adverse reactions reported in at least 5% of patients included nausea, diarrhea, constipation, vomiting, injection site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, upper abdominal pain, fever and gastroenteritis [1]. For Victoza, the most common reactions at that threshold were nausea, diarrhea, vomiting, decreased appetite, dyspepsia and constipation [2]. Both labels also note that liraglutide delays gastric emptying and may affect how oral medicines are absorbed [1][2].
Dosing in both labels is built around tolerating the drug slowly. Saxenda starts at 0.6 mg daily for one week and steps up weekly to a 3 mg maintenance dose; adults who cannot tolerate 3 mg discontinue [1]. Victoza starts at 0.6 mg daily, rises to 1.2 mg after a week, and tops out at 1.8 mg, with the pediatric instructions telling prescribers to increase in 0.6 mg steps "to reduce the risk of gastrointestinal adverse reactions" [2].
The Saxenda label carries a revision date of 02/2026 and lists other recent changes, including removal of the Suicidal Behavior and Ideation subsection as of 02/2026 [1]. The Victoza label is dated 10/2025 [2].
Why it matters for patients
For people already taking Victoza or Saxenda, the new language gives prescribers a stated reason to think about how the stomach empties when nausea, vomiting or abdominal pain is persistent or severe. It does not set out monitoring steps, dose changes or discontinuation rules for gastroparesis, and it does not say what to do if someone already on liraglutide is found to have the condition [1][2].
How often severe gastrointestinal reactions or gastroparesis occurred in people taking liraglutide is not stated in the labels' warning text, and the labels do not report how many cases prompted the change or whether the Food and Drug Administration required it [1][2]. Whether labels for semaglutide, tirzepatide or other GLP-1 drugs carry the same wording has not been reported here.
What happens next
The labels give no timeline for further changes. Victoza's prescribing information is dated 10/2025 and Saxenda's is dated 02/2026, and no additional steps by the manufacturer or regulators are described in either document [1][2].
Sources
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