Three Mounjaro labeling supplements approved together

On November 1, 2024, the Food and Drug Administration approved three separate supplements to Eli Lilly's Mounjaro (tirzepatide) application at the same time. The actions, filed as supplements 10, 15 and 22 to New Drug Application 215866, updated the drug's package insert, and in the case of supplement 22, also revised the patient Medication Guide ^[1].

Mounjaro first won FDA approval on May 13, 2022, under a priority review as a new molecular entity for adults with type 2 diabetes ^[1]. Since then, Lilly has periodically returned to the FDA with labeling supplements to update the prescribing information that doctors and pharmacists rely on. The November 2024 actions were combined into a single label document, filed as 215866s010s015s022lbl.pdf, and covered by one approval letter addressing all three supplements together ^[1].

According to FDA's Drugs@FDA database, supplements 10 and 15 are each categorized only as "Labeling-Package Insert," while supplement 22 is categorized as both "Labeling-Package Insert" and "Labeling-Medication Guide" ^[1]. The database entry does not describe the specific wording, safety information, or dosing details that changed in these updates. That level of detail is not yet known from the available source.

This was not the first time Mounjaro's labeling had been revised. In July 2023, the FDA approved supplements 2 and 6, which touched the package insert, Medication Guide, and container and carton labels ^[1]. After the November 2024 update, Lilly continued to file labeling supplements, including a package insert revision in May 2025 (supplement 31), a package insert and Medication Guide update in September 2025 (supplement 34), and a supplement adding a new patient population in December 2025 (supplement 39), according to the same FDA database ^[1].

Why it matters for patients

The package insert and Medication Guide are the official documents that accompany a prescription drug. Pharmacies are required to hand out the Medication Guide with certain prescriptions, and doctors use the package insert as the primary reference for dosing, warnings, and side effect information. When the FDA approves changes to these documents, it typically reflects new safety data, clarified instructions, or other information the agency has determined patients or prescribers need to see ^[1].

However, because the FDA's public database entry for this action does not specify the content of the changes, patients and caregivers cannot tell from this record alone whether the update involved a new warning, a dosing clarification, or something else. Anyone using Mounjaro who wants to know exactly what changed would need to compare the current label text to the version that was in effect before November 1, 2024, since the source available here does not summarize the substantive differences ^[1].

What happens next

FDA records show Lilly continued to file additional supplements for Mounjaro's labeling after this action, including a manufacturing and packaging supplement in January 2026 (supplement 41), a Medication Guide, container label, and package insert update also in January 2026 (supplement 9), and supplements in August 2026 covering a new indication (supplement 44) and a new dosing regimen (supplement 45) ^[1]. As with the November 2024 filings, the FDA's database entries for these later actions list only the regulatory category of each change, not a description of what was added, removed, or clarified in the label text ^[1].