Mounjaro package insert revised

On May 28, 2025, the U.S. Food and Drug Administration recorded a new labeling action for Mounjaro (tirzepatide), the type 2 diabetes drug made by Eli Lilly. The action, filed as Supplement 31 (SUPPL-31) under New Drug Application 215866, is classified in FDA's Drugs@FDA database as "Labeling-Package Insert" ^[1]. This means the official prescribing information that comes with the drug was revised, but the database entry does not spell out exactly what text changed ^[1].

Mounjaro was first approved on May 13, 2022, as a new molecular entity for type 2 diabetes ^[1]. Since then, Lilly has filed a long string of supplements to update its label. Some of these have added new patient populations or dosing regimens, while others were narrower package insert or Medication Guide updates ^[1]. For example, a supplement filed July 28, 2023, updated container labels, the Medication Guide, and the package insert together ^[1]. Another set of supplements finalized November 1, 2024, covered both the package insert and the Medication Guide ^[1]. The May 28, 2025 action, by contrast, is listed only under the narrower "Labeling-Package Insert" category, without a matching Medication Guide update ^[1].

The FDA record includes links to the updated label PDF and the agency's approval letter for this supplement, but the source provided here does not include the text of either document ^[1]. As a result, it is not yet known from this record whether the May 2025 change involved new safety warnings, updated dosing instructions, revised clinical trial data, or another type of wording change. Package insert updates can range from minor administrative corrections to significant new safety information, and the category label alone does not indicate which applies here.

Why it matters for patients

People taking Mounjaro rely on the package insert and Medication Guide for information about how to use the drug safely, what side effects to watch for, and how it should be stored or dosed. When the FDA approves a labeling supplement, it means the agency has reviewed and signed off on some change to that official document ^[1]. Patients and their pharmacists typically see the effects of these updates when they pick up a new prescription with an updated insert, or when a doctor mentions a new warning or instruction.

Because the underlying content of this particular May 2025 change is not detailed in available records, patients should not assume it involves a specific new warning or benefit. It could be something as routine as formatting or minor wording fixes, or it could reflect newer safety data. Without the actual label text, it is not possible to say more from the sources at hand.

What happens next

FDA records show Lilly continued to file additional labeling supplements for Mounjaro after this one. A package insert and Medication Guide update followed on September 25, 2025 (SUPPL-34), and a supplement adding a new patient population was recorded December 19, 2025 (SUPPL-39) ^[1]. Packaging-related manufacturing changes appear dated January 7, 2026 (SUPPL-41), and a further Medication Guide, container label, and package insert update is listed for January 20, 2026 (SUPPL-9) ^[1]. Broader supplements covering a new indication and a new dosing regimen appear dated August 27, 2026 (SUPPL-44 and SUPPL-45) ^[1]. As with the May 2025 update, the specific content of these later label changes is not described in the source material reviewed for this article.