FDA label
What is Mounjaro used for?
Mounjaro contains tirzepatide. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “MOUNJARO® is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus; to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.”
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Mounjaro, injection, solution
Indications and Usage, quoted from the label by Eli Lilly and Company (NDA215866). Cross-references to other label sections are left out.
MOUNJARO® is indicated:
- as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
- to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.
Source: DailyMed label, set id d2d7da5d-ad07-4228-955f-cf7e355c8cc0, version 40, effective August 27, 2026. NDC 0002-1152, one of 30 listings for this product.
Questions
What is Mounjaro used for?
The FDA label says: “MOUNJARO® is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus; to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.”
What drug class is Mounjaro?
FDA lists tirzepatide in the GLP-1 Receptor Agonist and Glucose-dependent Insulinotropic Polypeptide Receptor Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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