Mounjaro approved for children 10 and older with type 2 diabetes

Mounjaro (tirzepatide) can now be prescribed to children and teens aged 10 and older with type 2 diabetes, the Pediatric Endocrine Society reported on February 24, 2026 ^[1]. The drug is approved as an add-on to diet and exercise to lower hemoglobin A1c, and the maximum dose for pediatric patients is 10 mg once weekly — lower than the 15 mg weekly maximum for adults ^[1][2].

The FDA-approved prescribing information now lists the indication as "an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus" ^[2]. The label's "Recent Major Changes" section dates the pediatric addition to 12/2025, while the Pediatric Endocrine Society's write-up describing the approval was posted February 24, 2026 ^[1][2]. The sources do not explain that gap; it is not yet known whether the announcement simply followed the label change by several weeks.

What the trial showed

The approval rests on SURPASS-PEDS, a randomized, double-blind, placebo-controlled phase 3 trial published in The Lancet ^[1]. It enrolled 99 patients aged 10 and older with type 2 diabetes. Every participant was already taking metformin, basal insulin, or both at the start ^[1].

Participants were randomly assigned to tirzepatide 5 mg weekly, tirzepatide 10 mg weekly, or placebo for 30 weeks ^[1]. At the end of the study, A1c fell by a mean of 2 percentage points from baseline when both tirzepatide doses were pooled, a difference of –1.8 percentage points compared with placebo ^[1]. Both results were statistically significant ^[1].

The Pediatric Endocrine Society also reported a significant drop in BMI — a mean reduction of 8.8 kg/m², and a difference of –8.3 kg/m² versus placebo ^[1]. That figure is unusually large for a 30-week trial, and the summary does not give baseline BMI or body weight, so the underlying numbers cannot be checked against the source provided here.

Side effects in kids

Side effects in the pediatric trial were described as consistent with what has been seen in adults, but rates of vomiting, abdominal pain, and hypoglycemia "appear to be higher in the pediatric population" ^[1]. The summary does not give specific percentages for those events.

The adult label lists nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and abdominal pain as the most common adverse reactions, each reported in at least 5% of treated patients ^[2]. Mounjaro carries a boxed warning about thyroid C-cell tumors seen in rats; it is unknown whether the drug causes medullary thyroid carcinoma in humans, and it is contraindicated in people with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 ^[2]. Other labeled warnings include acute pancreatitis, hypoglycemia when combined with insulin or insulin secretagogues, serious allergic reactions, acute kidney injury from dehydration, severe gastrointestinal reactions, gallbladder disease, diabetic retinopathy progression, and pulmonary aspiration during anesthesia ^[2].

Why it matters for patients

Until now, families of children with type 2 diabetes had few options beyond metformin and insulin — and in SURPASS-PEDS, all 99 participants were already on one or both ^[1]. An FDA-approved pediatric indication changes the practical picture in two ways. It gives pediatric endocrinologists a labeled, dosed option rather than off-label use, and it typically strengthens the case for insurance coverage, since payers often key their rules to approved indications.

The lower 10 mg ceiling matters too. Dosing in the label starts at 2.5 mg weekly and increases in 2.5 mg steps after at least four weeks on a given dose, but pediatric patients stop at 10 mg while adults can go to 15 mg ^[2]. That means a child will not have the highest adult dose available even if blood sugar remains above target.

Separately, the label warns that tirzepatide delays stomach emptying and can affect absorption of oral medicines, and it advises people using oral contraceptives to switch to a non-oral method or add a barrier method for four weeks after starting and after each dose increase ^[2]. That guidance is relevant for adolescent patients.

Mounjaro is approved for type 2 diabetes, not for weight management; the separate tirzepatide brand for weight is Zepbound. The sources here do not address pediatric approval for obesity, pricing, or when supply of pediatric-labeled product reaches pharmacies.