Updated Zepbound and Mounjaro labels posted
Eli Lilly's updated Zepbound and Mounjaro labels, posted on DailyMed in late August 2026, add a new heart-risk-reduction use for Mounjaro and refresh safety warnings across every pen and vial version of the drugs.
Updated prescribing labels for Mounjaro and Zepbound, both containing tirzepatide, were posted to DailyMed in late August 2026, according to the government drug-label database [1][2]. The Zepbound label was updated August 28, 2026, and the Mounjaro label was updated August 27, 2026, with both officially revised as of 8/2026 [1][2]. The changes apply across the full lineup of dosing options: single-dose pens, single-dose vials, multi-dose vials, and KwikPens [1][2].
The most notable change is a new indication for Mounjaro. The label now says Mounjaro can be used "to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events" [2]. This cardiovascular indication is listed as a recent major change dated 08/2026 [2]. Mounjaro's label also confirms an existing use for pediatric patients 10 years of age and older with type 2 diabetes, with a maximum dosage of 10 mg weekly for that age group, compared with 15 mg weekly for adults [2].
Both drugs carry a boxed warning about thyroid C-cell tumors seen in rat studies, with labels stating it is "unknown whether" tirzepatide causes similar tumors, including medullary thyroid carcinoma, in humans [1][2]. Both remain contraindicated for people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 [1][2].
Other updates common to both labels include revised warnings on severe gastrointestinal adverse reactions, added language on diabetic retinopathy complications dated 08/2026, and a new instruction that a KwikPen should never be shared between patients, even with a new needle, dated 01/2026 [1][2]. The Zepbound label separately notes that a prior warning about suicidal behavior and ideation was removed as of 02/2026 [1]. Zepbound remains indicated for chronic weight management in adults with obesity or overweight with a related health condition, and for moderate to severe obstructive sleep apnea in adults with obesity, alongside diet and exercise [1].
Dosage forms listed for both drugs span 2.5 mg to 15 mg per 0.5 mL for single-dose presentations, and multi-dose vials or KwikPens ranging from 10 mg/2.4 mL up to 60 mg/2.4 mL, each providing four doses [1][2]. The most common side effects reported in at least 5% of patients include nausea, diarrhea, vomiting, constipation, abdominal pain, and dyspepsia for both drugs, with Zepbound's list also including injection site reactions, fatigue, hair loss, and gastroesophageal reflux disease [1][2].
Why it matters for patients
The label update means people with type 2 diabetes who are at high risk of heart attack or stroke now have an FDA-recognized use for Mounjaro tied specifically to lowering that cardiovascular risk, not just blood sugar control [2]. For anyone using any tirzepatide product, the labels reaffirm long-standing cautions, including the thyroid tumor warning, the need to avoid sharing pens, and monitoring for gastrointestinal problems and diabetic retinopathy changes [1][2]. The removal of the suicidal behavior and ideation warning from the Zepbound label is a change patients and prescribers may want to note when reviewing current safety information [1].
Because labels apply uniformly across single-dose pens, single-dose vials, multi-dose vials, and KwikPens, patients using any of these forms are covered by the same updated indications and warnings [1][2]. The sources do not describe how insurers or the FDA approval process specifically triggered these changes, so the underlying regulatory action behind the new cardiovascular indication is not detailed here.
What happens next
The labels themselves are dated as revised 8/2026, reflecting the most current versions posted on DailyMed [1][2]. The sources do not specify further dated milestones, such as when updated patient Medication Guides will be distributed at pharmacies or when additional label sections might change.
Sources
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