Mounjaro label adds use in children 10 and older and a severe gastrointestinal warning
The Mounjaro label now covers children 10 and older with type 2 diabetes at a lower maximum dose, and a new warning says the drug is not recommended for people with severe gastroparesis.
In December 2025, the prescribing information for Mounjaro (tirzepatide) changed in two ways: the type 2 diabetes indication was extended to children 10 years of age and older, and a warning was added for severe gastrointestinal adverse reactions [1][2]. Both appear under "Recent Major Changes" and are dated 12/2025 [1][2].
What changed for children
Mounjaro is now indicated as an adjunct to diet and exercise to improve blood sugar control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus [1][2]. In pediatric patients, the maximum dose is 10 mg injected subcutaneously once weekly, compared with 15 mg once weekly for adults [1][2].
The starting dose is the same at any age: 2.5 mg once weekly, increasing to 5 mg once weekly after 4 weeks, then by 2.5 mg increments after at least 4 more weeks on the current dose if more blood sugar control is needed [1][2]. The 2.5 mg dose is for treatment initiation and is not intended to control blood sugar on its own [2]. The label includes a section describing use of Mounjaro with metformin, basal insulin, or both in pediatric patients 10 years and older [2]. How many children were studied, and how much their blood sugar changed, is not given in the prescribing highlights [1][2].
The new gastrointestinal warning
The second change created section 5.6, "Severe Gastrointestinal Adverse Reactions." It states that use of Mounjaro has been associated with gastrointestinal adverse reactions, sometimes severe, and that "MOUNJARO is not recommended in patients with severe gastroparesis" [1][2]. Gastroparesis is delayed emptying of the stomach. The label notes separately that Mounjaro delays gastric emptying and may affect how oral medicines taken at the same time are absorbed [1][2].
The most common adverse reactions, reported in at least 5% of patients, are nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain [1][2]. The label does not state how often the severe gastrointestinal reactions occurred or how many patients stopped treatment because of them.
A related warning, acute kidney injury due to volume depletion, tells clinicians to monitor kidney function in patients who report reactions that could lead to dehydration [1][2]. That warning is not new, but vomiting and diarrhea are the reactions most likely to cause fluid loss.
Mounjaro is tirzepatide, a GIP and GLP-1 receptor agonist that received its initial U.S. approval in 2022 and is made by Eli Lilly [1]. It is a different molecule from semaglutide (Ozempic, Wegovy, Rybelsus).
Why it matters for patients
Families of children aged 10 and older with type 2 diabetes now have an approved injectable option that carries a lower maximum weekly dose than the adult version [1][2]. Whether insurers will cover Mounjaro for children, or what prior authorization would require, has not been reported in the labeling documents.
For adults and children alike, the new warning draws a line at severe gastroparesis: the label says the drug is not recommended in that group [1][2]. Patients who already have a gastroparesis diagnosis, or who have persistent vomiting or a stomach that empties slowly, may find that this changes how their clinician weighs options. The label does not specify what alternative treatments to use instead.
The warning also makes clear that the digestive side effects are not always mild. Because severe vomiting or diarrhea can cause dehydration and, in turn, kidney injury, the label directs monitoring of kidney function in patients reporting these reactions [1][2]. Symptoms that are severe, or that do not let up, are the ones the labeling singles out — not the occasional queasy first weeks on a new dose.
What happens next
The DailyMed version of the Mounjaro label was updated August 27, 2026, and lists later revisions, including entries dated 01/2026 and 08/2026, alongside the 12/2025 pediatric indication and gastrointestinal warning [1]. No additional FDA action on the pediatric use or the gastrointestinal warning is described in the labeling documents [1][2]. Whether the company plans further pediatric studies, and whether other GLP-1 or dual-agonist labels will add similar gastroparesis language, has not been disclosed.
Sources
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