Tirzepatide

Zepbound is FDA approved for long-term weight management in eligible adults and for moderate-to-severe obstructive sleep apnea in adults with obesity. Approval is for the labeled tirzepatide product and populations.^[1]

Jurisdiction

United States

Product

ZEPBOUND (tirzepatide)

Indication

Adult chronic weight management meeting label criteria and moderate-to-severe obstructive sleep apnea in adults with obesity

Record date

2026-09-08

• This does not establish efficacy or quality of unapproved tirzepatide products.

Zepbound is contraindicated with a personal or family history of medullary thyroid carcinoma or MEN2. The thyroid C-cell tumor warning derives from rodent findings; human relevance remains uncertain. The current label records removal of the suicidal-behavior/ideation warning in February 2026.^[1]

• A rodent tumor finding should not be presented as established human thyroid-cancer causation; this summary is not the complete label.

Zepbound labeling warns of hypoglycemia, with increased risk when tirzepatide is combined with insulin or insulin secretagogues.^[1]

• This is a product-label warning, not a study of every possible drug pair.

Zepbound can cause severe gastrointestinal reactions and is not recommended with severe gastroparesis. Its label describes postmarketing acute kidney injury reports, mostly following gastrointestinal symptoms that led to dehydration.^[1]

• Postmarketing reports do not provide a reliable incidence or prove causality in every case.

Zepbound’s label reports a tirzepatide elimination half-life of approximately 5–6 days in people with overweight or obesity, including those with obstructive sleep apnea.^[1]

• This is the labeled subcutaneous formulation; it does not establish oral-product pharmacokinetics.

In SURMOUNT-1, mean weight change at 72 weeks ranged from −15.0% to −20.9% across tirzepatide dose groups versus −3.1% with placebo in adults without diabetes. Gastrointestinal adverse events were common.^[2]

• The figures are trial-specific averages, not a personalized outcome or evidence of superiority to another medicine.

ZEPBOUND labeling warns of increased hypoglycemia risk when tirzepatide is used with insulin and calls for consideration of a clinician-directed insulin reduction.^[3]

• A label warning for insulin coadministration, not a separate trial of every insulin preparation.

ZEPBOUND labeling does not recommend coadministration with another tirzepatide product or a GLP-1 receptor agonist such as semaglutide.^[3]

• Not classified as a formal contraindication; no amount of additive toxicity is established.