Alopecia is added to the Mounjaro label, validating a long-running search query

The FDA approved a labeling change for Mounjaro (tirzepatide) that adds the term "alopecia," meaning hair loss, to Section 6.2 of the drug's Prescribing Information, which covers postmarketing experience ^[1]. The approval letter, dated May 28, 2025, was signed by Monika Houstoun, Pharm.D., M.P.H., Deputy Director for Safety in the FDA's Division of Diabetes, Lipid Disorders, and Obesity ^[1]. Eli Lilly had submitted the supplemental application on February 28, 2025, after the agency requested the addition in a Supplement Request letter dated February 3, 2025 ^[1].

The change is a Prior Approval supplemental new drug application, filed under section 505(b) of the Federal Food, Drug, and Cosmetic Act ^[1]. Postmarketing experience sections list side effects that have been reported after a drug reaches the market, rather than effects measured in controlled clinical trials, so the FDA's letter does not include data on how many patients experienced hair loss or how it was identified ^[1].

The same approval also made other changes to align Mounjaro's labeling with other drugs in its class, glucagon-like peptide-1 receptor agonists. The FDA removed two "Limitations of Use" statements from Section 1: that Mounjaro is not indicated for patients with type 1 diabetes, and that it has not been studied in patients with a history of pancreatitis ^[1]. Lilly also made unspecified edits throughout the Prescribing Information and Medication Guide described as modernizing the labeling and improving readability ^[1].

Why it matters for patients

For people taking or considering Mounjaro, the addition means alopecia is now an officially recognized postmarketing side effect rather than an informal or anecdotal report. This does not tell patients how common hair loss is, how severe it might be, or how it compares to hair loss from other causes, because the source document is an approval letter, not a clinical study ^[1]. The letter also does not say whether hair loss reported to date has been temporary or permanent, or whether it appears linked to weight loss itself rather than to the drug directly, since none of that information is in the source ^[1].

Patients researching side effects online may have noticed that many websites previously described tirzepatide-related hair loss as anecdotal, based on user reports rather than official drug safety information. This label update changes that status for Mounjaro specifically. It does not, however, extend to other tirzepatide products by default; the letter addresses NDA 215866, which covers Mounjaro ^[1]. Whether the same change applies to Zepbound, which also contains tirzepatide, is not addressed in this source and is not yet known from the material provided.

The letter also carries a requirement that Lilly revise all promotional materials to be consistent with the updated safety information, and prominently disclose the new information ^[1]. That suggests patients may start seeing updated safety disclosures in Mounjaro marketing and packaging materials, though the source does not specify a timeline for when that will visibly change in doctor's offices or advertising beyond Lilly's own compliance deadlines.

What happens next

Under the terms of the approval, Lilly must submit the final content of labeling in structured product labeling format within 14 days of the May 28, 2025 letter, after which it becomes accessible through public labeling repositories ^[1]. Lilly was also required to submit a statement of intent to comply with promotional material update rules within 7 days of receiving the letter ^[1]. Separately, the company must submit any related patent information to the FDA within 30 days of the supplement's approval ^[1]. The source does not indicate when updated Mounjaro packaging or patient materials reflecting the alopecia listing will be widely available at pharmacies.