Zepbound label drops suicidal ideation warning and updates gastrointestinal section
Zepbound's label no longer carries a suicidal ideation warning as of February 2026, while severe gastrointestinal risks stay in the warnings section and the thyroid tumor boxed warning is unchanged.
In February 2026, the prescribing information for Zepbound (tirzepatide) stopped listing suicidal behavior and ideation as a warning, and it updated the section covering severe gastrointestinal adverse reactions, according to the label's own revision history [1][2].
The "Recent Major Changes" table at the top of the label lists "Suicidal Behavior and Ideation (Removed)" with the date 02/2026, and "Severe Gastrointestinal Adverse Reactions (5.2)" with the same 02/2026 date [1][2]. Two other changes carry January 2026 dates: updated administration instructions in section 2.4, and a new warning against sharing a Zepbound KwikPen between patients, even if the pen needle is changed [1][2]. A separate change covering diabetic retinopathy complications in patients with type 2 diabetes is dated 08/2026 [1][2]. The version posted by the National Library of Medicine's DailyMed was updated August 28, 2026, and the label itself is marked "Revised: 8/2026" [1][2].
Zepbound is made by Eli Lilly and Company and was first approved in the U.S. in 2022 [1]. It is approved to reduce excess body weight and maintain weight reduction in adults with obesity, or adults who are overweight with at least one weight-related condition, and to treat moderate to severe obstructive sleep apnea in adults with obesity [1][2].
What the label now says about severe gastrointestinal reactions is that use "has been associated with gastrointestinal adverse reactions, sometimes severe," and that Zepbound "is not recommended in patients with severe gastroparesis" [1][2]. The revision history does not describe what specific wording changed in that section, or what data prompted the update.
Several other warnings are unchanged. The boxed warning about thyroid C-cell tumors in rats remains at the top of the label, along with the contraindication for people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 [1][2]. Warnings also remain for acute kidney injury due to volume depletion, acute gallbladder disease, acute pancreatitis, serious hypersensitivity reactions, low blood sugar when used with insulin or an insulin secretagogue, diabetic retinopathy progression, and pulmonary aspiration during general anesthesia or deep sedation [1][2].
Labeling records show the same suicidality removal from the Wegovy (semaglutide) label in the same month. Mounjaro (tirzepatide) was not affected because its label never carried the warning.
The labels do not state why the suicidal behavior and ideation warning was removed, and no FDA announcement, advisory committee meeting or study result explaining the decision is described in the labeling documents.
Why it matters for patients
Anyone who reads the Zepbound label to check on mood-related risks will no longer find a suicidal behavior and ideation warning there [1][2]. A label change is not a finding that a risk does not exist, and the labeling documents do not present the evidence behind the removal [1][2]. People who had been tracking that warning have no new explanation from the label to work from.
Gastrointestinal effects remain the most common reactions listed for Zepbound, reported in at least 5% of patients: nausea, diarrhea, vomiting, constipation, abdominal pain, indigestion, injection site reactions, fatigue, hypersensitivity reactions, belching, hair loss and gastroesophageal reflux disease [1][2]. Severe gastrointestinal reactions stay in the Warnings and Precautions section, and the label says the drug is not recommended for patients with severe gastroparesis [1][2]. That language is still in the current version.
The change applies to what the label says, not to what a prescriber may discuss with a patient. Whether the warning was dropped from any other GLP-1 or dual-agonist label besides Wegovy has not been detailed in the labeling documents available for Zepbound.
What happens next
Labels are revised as new information comes in. The Zepbound label's most recent revision is dated August 2026, and no dates for further changes to the suicidal behavior and ideation section have been disclosed [1][2].
Sources
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