FDA approves Mounjaro for children 10 and older with type 2 diabetes
Mounjaro is now cleared for patients 10 and older with type 2 diabetes at a 10 mg weekly maximum, giving families another option alongside metformin and insulin, with higher child-specific rates of stomach side effects.
The FDA has approved Mounjaro (tirzepatide) for children and adolescents aged 10 years and older with type 2 diabetes, the Pediatric Endocrine Society reported on February 24, 2026 [1]. The drug is indicated as an addition to diet and exercise to help lower hemoglobin A1c, and the maximum pediatric dose is 10 mg injected once weekly [1][2].
The approval rests on the SURPASS-PEDS trial, which enrolled 99 patients aged 10 and older with type 2 diabetes [1]. All of them were already taking metformin, basal insulin, or both when the trial began. Participants were randomly assigned to receive Mounjaro 5 mg weekly, Mounjaro 10 mg weekly, or a placebo for 30 weeks [1].
At the end of that period, A1c fell by a mean of 2% from baseline when both Mounjaro doses were pooled, and the difference compared with placebo was a mean of 1.8 percentage points [1]. BMI also dropped, by a mean of 8.8 kg/m2 from baseline and 8.3 kg/m2 relative to placebo [1]. The trial results were published in The Lancet [1].
Reported side effects in children were consistent with those seen in adults, though vomiting, abdominal pain, and low blood sugar appeared at higher rates in the pediatric group [1]. The prescribing information lists nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and abdominal pain as the most common adverse reactions, reported in at least 5% of patients [2].
Mounjaro carries a boxed warning that tirzepatide causes thyroid C-cell tumors in rats, and it is not known whether it causes thyroid C-cell tumors, including medullary thyroid carcinoma, in humans [2]. The drug is contraindicated for people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 [2]. Other listed warnings include acute pancreatitis, hypoglycemia when used with insulin or insulin secretagogues, acute kidney injury from volume depletion, severe gastrointestinal reactions, progression of diabetic retinopathy in patients with that history, gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation [2].
On dosing, the label says treatment starts at 2.5 mg weekly and can be increased in 2.5 mg steps after at least four weeks at the current dose. The maximum is 15 mg weekly for adults and 10 mg weekly for patients 10 and older [2].
There is a date difference between the two documents. The Pediatric Endocrine Society item is dated February 24, 2026 [1], while the Mounjaro prescribing information lists "Pediatric Patients 10 Years of Age and Older" under recent major changes with a date of 12/2025 [2]. The sources do not explain the gap or give the exact day the FDA cleared the pediatric indication.
Why it matters for patients
Type 2 diabetes in children has had fewer medication options than in adults, and this approval adds a weekly injection to a list that has largely centered on metformin and insulin. Families whose child already takes metformin, basal insulin, or both now have another category to discuss with a pediatric endocrinologist, though the label caps the dose for children at 10 mg weekly, below the 15 mg adult maximum [1][2].
Monitoring matters more in this age group on two counts. Rates of vomiting, abdominal pain, and low blood sugar were higher in children than in adults in the trial [1], and low blood sugar risk rises when the drug is combined with insulin or with drugs that prompt the pancreas to release insulin. The label notes that reducing the dose of insulin or an insulin secretagogue may be necessary [2].
Screening before starting is part of the label: a personal or family history of medullary thyroid carcinoma or MEN 2 rules the drug out [2].
Several practical questions are not answered by these documents. Cost, insurance coverage for pediatric patients, and how long a child would stay on the drug have not been reported. The trial's controlled comparison ran 30 weeks, so effects and side effects beyond that window are not established here [1]. Whether the approval leads to updated pediatric treatment guidelines also has not been reported.
Sources
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