FDA adds alopecia to the Mounjaro label and drops two Limitations of Use

The Food and Drug Administration approved a labeling supplement for Mounjaro (tirzepatide) on May 28, 2025, adding hair loss, known medically as alopecia, to the list of side effects reported after the drug reaches the market ^[1]. The same action removed two "Limitations of Use" statements that had appeared in the drug's prescribing information ^[1].

The supplement, filed by Eli Lilly and Company on February 28, 2025, and reviewed under section 505(b) of the Federal Food, Drug, and Cosmetic Act, revised Section 6.2 of the Prescribing Information, the part that lists side effects identified after a drug is approved and in wider use ^[1]. The FDA had requested the alopecia addition in a supplement request letter dated February 3, 2025 ^[1].

Along with that change, the FDA removed language stating that Mounjaro "is not indicated for use in patients with type 1 diabetes mellitus" and that it "has not been studied in patients with a history of pancreatitis" ^[1]. The agency said these edits were made to align Mounjaro's label with recently approved changes made to other drugs in the same class, glucagon-like peptide-1 receptor agonists ^[1]. The approval letter also notes additional edits throughout the Prescribing Information and Medication Guide meant to modernize the language and improve readability, without describing specific new safety findings tied to those two removed statements ^[1].

Monika Houstoun, Pharm.D., M.P.H., Deputy Director for Safety in the FDA's Division of Diabetes, Lipid Disorders, and Obesity, signed the approval letter ^[1]. The letter states the changes are effective immediately and instructs Lilly to submit the updated labeling content within 14 days ^[1].

Why it matters for patients

Adding alopecia to the label means the FDA has determined there is enough reported evidence of hair loss among people taking Mounjaro to include it in the drug's official safety information ^[1]. This does not by itself tell patients how common the side effect is, since the letter does not include incidence numbers or a description of case reports ^[1].

The removal of the type 1 diabetes and pancreatitis statements changes what the label says, but the letter does not state that Mounjaro is now recommended or approved for people with type 1 diabetes, nor does it say the drug has been newly studied in people with a history of pancreatitis ^[1]. The source material describes only the removal of these limiting statements and does not explain what, if anything, replaces them in terms of new guidance for patients or doctors ^[1]. Patients and clinicians who relied on those exact label statements in the past will need to look at the full revised Prescribing Information and Medication Guide, which the FDA enclosed with its approval letter, for the complete current wording ^[1].

The agency's framing of these edits as bringing Mounjaro's label in line with "recently approved changes in other products in the glucagon-like peptide-1 receptor agonist class" suggests this is part of a broader pattern of label harmonization across GLP-1 drugs, though the letter does not name which other products or list their specific changes ^[1].

What happens next

Under the terms of the approval, Lilly must submit the updated labeling content in structured product labeling format no later than 14 days after the May 28, 2025, letter, and that content will become accessible through public labeling repositories once filed ^[1]. Lilly was also required to submit a statement of intent to update promotional materials within 7 days of receiving the letter, and any patent information tied to the labeling changes was due within 30 days of approval ^[1]. The source material does not indicate any additional studies planned specifically related to alopecia, type 1 diabetes, or pancreatitis history in Mounjaro users ^[1].