Zepbound and Mounjaro labels updated, with new heart-risk indication for Mounjaro

Updated prescribing labels for Zepbound and Mounjaro now cover the full range of approved packaging for the two tirzepatide injections, and the Mounjaro label adds a new cardiovascular indication. The Zepbound label was updated August 28, 2026 ^[1], and the Mounjaro label August 27, 2026 ^[2].

Both drugs are made by Eli Lilly and contain tirzepatide, described in the labels as a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist ^[1][2]. They are approved for different uses. Zepbound is indicated for weight reduction and long-term weight maintenance in adults with obesity, or with overweight plus at least one weight-related condition, and for moderate to severe obstructive sleep apnea in adults with obesity ^[1]. Mounjaro is indicated to improve blood sugar in adults and in children 10 years of age and older with type 2 diabetes ^[2].

The new Mounjaro indication is to reduce the risk of major adverse cardiovascular events — cardiovascular death, non-fatal heart attack or non-fatal stroke — in adults with type 2 diabetes who are at high risk for those events ^[2]. The label lists it as a recent major change dated 08/2026 ^[2]. The highlights section does not include the trial results behind the indication and directs readers to the full prescribing information ^[2].

Under dosage forms and strengths, both labels list the same range: single-dose pens or single-dose vials at 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg per 0.5 mL, and multi-dose vials or single-patient-use KwikPens from 10 mg/2.4 mL, which provides four 2.5 mg doses, up to 60 mg/2.4 mL, which provides four 15 mg doses ^[1][2].

Each label lists other recent changes. Both show revised warnings about diabetic retinopathy complications in patients with a history of diabetic retinopathy, dated 08/2026 ^[1][2]. Both state that a KwikPen should never be shared between patients, even if the needle is changed, dated 01/2026 ^[1][2]. The Zepbound label removed "suicidal behavior and ideation" from warnings and precautions in 02/2026 ^[1]. The Mounjaro label lists a pediatric indication for patients 10 years of age and older dated 12/2025 ^[2].

The two labels set different maximum doses. Mounjaro's maximum is 15 mg once weekly for adults and 10 mg once weekly for children 10 and older ^[2]. Zepbound's maximum is 15 mg once weekly; the label lists 10 mg or 15 mg weekly for obstructive sleep apnea and 5 mg, 10 mg or 15 mg weekly for weight reduction and long-term maintenance ^[1]. Both carry a boxed warning that tirzepatide causes thyroid C-cell tumors in rats and that it is unknown whether the drugs cause such tumors, including medullary thyroid carcinoma, in humans; both are contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 ^[1][2].

Why it matters for patients

The label is the reference document that prescribers, pharmacists and drug information systems use to describe what a medicine is approved to do ^[1][2]. The cardiovascular risk-reduction indication appears on the Mounjaro label and not on the Zepbound label, even though both contain the same molecule, so which product is indicated depends on the patient's diagnosis ^[1][2].

The expanded presentation lists describe the physical formats now covered — single-dose pens, single-dose vials, multi-dose vials and KwikPens — which matters because patients may receive different formats from a pharmacy over time ^[1][2]. Both labels warn against sharing a KwikPen between patients ^[1][2].

Whether the added Mounjaro indication changes insurance coverage, prior authorization criteria or pricing has not been reported.

What happens next

No future review dates, submission timelines or pending decisions appear in either label. The revisions are already posted, and any further changes would appear as new label dates on DailyMed ^[1][2].