Of the five products whose labels we reviewed, only two carry an indication for people under 18. Wegovy injection is indicated for weight reduction and long-term maintenance in pediatric patients aged 12 years and older with obesity, and Mounjaro is indicated for type 2 diabetes in pediatric patients aged 10 years and older. The labels for Zepbound, Foundayo and Ozempic each say safety and effectiveness have not been established in pediatric patients, and the Wegovy label says the same for the Wegovy tablets and the 7.2 mg injection dose. In the 68-week adolescent trial reported in the Wegovy label, BMI fell 16.1% with Wegovy versus a 0.6% rise with placebo, with more gastrointestinal side effects and more gallstones than placebo. Decisions for a child or teenager belong with a pediatric clinician.
Why this question deserves a label-by-label answer
Parents searching for GLP-1 information often find adult-focused pricing guides and telehealth ads. The FDA prescribing information is clearer than most of what surfaces in search results, and it says something specific for each product. Some GLP-1 medicines have been studied and approved for adolescents, with an age floor that differs by medicine and indication. Others carry a flat statement that safety and effectiveness have not been established under 18.
This article reads the pediatric sections of the Wegovy (revised 06/2026), Mounjaro (revised 08/2026), Zepbound (revised 08/2026), Foundayo (revised 07/2026) and Ozempic labels, and the two pediatric trials those labels describe. We checked the documents on 9 October 2026. Other GLP-1 medicines, including older products, have their own labels that we did not review for this piece, so this is not a complete list of every pediatric option. It also is not guidance on whether a particular child should be treated.
What each label says about age
| Medicine | Pediatric statement in the label | Indication or limit |
|---|---|---|
| Wegovy injection | Safety and effectiveness established in pediatric patients aged 12 years and older with obesity (section 8.4). | To reduce excess body weight and maintain weight reduction long term, with a reduced-calorie diet and increased physical activity. Not established for cardiovascular risk reduction, for the 7.2 mg dose, for children under 12, or for MASH. |
| Wegovy tablets | Safety and effectiveness not established in pediatric patients. | Adult use only on the label. |
| Mounjaro | Safety and effectiveness established in pediatric patients 10 years of age and older with type 2 diabetes (section 8.4). Not established under 10. | As an adjunct to diet and exercise to improve glycemic control in type 2 diabetes. |
| Zepbound | Safety and effectiveness have not been established in pediatric patients (section 8.4). | Adult use only on the label. |
| Foundayo | Safety and effectiveness have not been established in pediatric patients (section 8.4). | Adult use only on the label. |
| Ozempic | Safety and efficacy have not been established in pediatric patients (section 8.4). | Adult use only on the label. |
Notice that “approved for adolescents” is narrow. The two approvals concern different conditions: obesity for Wegovy from age 12, and type 2 diabetes for Mounjaro from age 10. Mounjaro is a diabetes medicine, and its pediatric indication is about glycemic control rather than weight. Zepbound, which contains the same active ingredient as Mounjaro and is the version labeled for weight management in adults, has no established pediatric use.
The adolescent obesity trial behind Wegovy
The Wegovy pediatric indication rests on a 68-week, double-blind, placebo-controlled trial described in label section 14.3 and published in the New England Journal of Medicine (Weghuber and colleagues, 2022). It is registered on ClinicalTrials.gov as NCT04102189.
Who was studied and how
The trial enrolled 201 pubertal patients aged 12 years and older with a BMI at or above the 95th percentile for age and sex. After a 12-week lifestyle run-in period that included dietary recommendations and physical activity counseling, patients were randomized 2:1 to weekly Wegovy or placebo. The dose was escalated to 2.4 mg or the maximally tolerated dose over 16 weeks, followed by 52 weeks on the maintenance dose. The mean age was 15 years, and the mean baseline body weight was 108 kg with a mean BMI of 37. Of the Wegovy-treated patients who completed the trial, 86.7% were on the 2.4 mg dose at the end, and for 5% the maximum tolerated dose was 1.7 mg. Discontinuation of study drug was 10% in each group.
What it found
| Measure at week 68 | Placebo | Wegovy 2.4 mg |
|---|---|---|
| Change in BMI (primary endpoint) | +0.6% | -16.1% |
| Difference from placebo | -16.7 percentage points (95% CI -20.3 to -13.2) | |
| Patients with at least 5% BMI reduction | 19.7% | 77.1% |
| Patients with at least 10% BMI reduction | 7.7% | 65.1% |
| Patients with at least 15% BMI reduction | 4% | 57.8% |
The label reports the BMI result as statistically significant compared with placebo. It also reports percent change in body weight (+2.7% with placebo and -14.7% with Wegovy), but notes that body weight and the responder proportions were not part of the pre-specified hierarchical testing, so we treat them as descriptive. These are trial averages in a population that had a structured lifestyle program, and they are not predictions for any one child.
What the adolescent safety data show
The label says adverse reactions in pediatric patients were generally similar to those in adults, with some differences. Pediatric patients aged 12 and older treated with Wegovy had greater incidences of cholelithiasis (gallstones), cholecystitis, hypotension, rash and urticaria compared with adults treated with Wegovy. Table 5 in section 6.1 lists reactions at or above 3% and more frequent than placebo:
| Adverse reaction | Placebo (N=67) | Wegovy 2.4 mg (N=133) |
|---|---|---|
| Nausea | 18% | 42% |
| Vomiting | 10% | 36% |
| Diarrhea | 19% | 22% |
| Abdominal pain | 6% | 15% |
| Dizziness | 3% | 8% |
| Constipation | 2% | 6% |
| Cholelithiasis | 0% | 4% |
Gastrointestinal effects were the main difference, with vomiting more than three times as common on Wegovy as on placebo. Gallstones appeared in 4% of Wegovy patients and none in the placebo group. Our articles on gallbladder disease labeling and side effects in the labels and trials go deeper on these reactions. Section 8.4 of the label also addresses hypoglycemia: there are insufficient data to determine whether the risk is higher in pediatric patients with type 2 diabetes and obesity, so it says to inform them of the risk, monitor blood glucose before and during treatment, and consider reducing the dose of any insulin or sulfonylurea when starting. We cover that language in our article on low blood sugar and insulin or sulfonylurea labels.
Dosing for adolescents follows the same escalation table as adults, from 0.25 mg once weekly, increasing at 4-week steps to 1.7 mg, and the maintenance dose for pediatric patients aged 12 and older is either 2.4 mg (recommended) or 1.7 mg once weekly, depending on response and tolerability. The label says the 7.2 mg dose has not been established in this age group. Our guide to missed-dose instructions in the labels covers what the Wegovy label says when doses are missed during escalation.
The pediatric type 2 diabetes trial behind Mounjaro
Mounjaro’s pediatric use is supported by SURPASS-PEDS (NCT05260021), published in The Lancet (Hannon and colleagues, 2025) and summarized in label section 14.5. It was a 30-week double-blind placebo-controlled trial with a 22-week open-label extension, and randomized 99 patients aged 10 years and older with type 2 diabetes and inadequate control on metformin, basal insulin, or both. Patients received Mounjaro 5 mg, 10 mg or placebo weekly as add-on therapy. The mean age was 15, mean HbA1c 8.0% and mean BMI 35.
At week 30 the label reports an HbA1c change of -0.2 with placebo and -2.0 for the pooled Mounjaro groups, a difference of -1.8 percentage points (95% CI -2.4 to -1.2). Label section 8.4 says adverse reactions in patients 10 and older were similar to those in adults, with a higher incidence of vomiting, abdominal pain and hypoglycemia. Because this is a diabetes indication, it should not be read as an approval of tirzepatide for weight loss in children; the weight-management product, Zepbound, carries no established pediatric use.
What the labels do not say
A label that says safety and effectiveness have not been established is a statement about evidence, not a prohibition. It means the manufacturer has not provided data supporting that use in children, and the FDA has not approved it. Clinicians can sometimes prescribe a medicine outside its labeled use, which the FDA calls unapproved or off-label use of an approved drug, but that decision rests on the clinician’s judgment, and the label’s evidence limits still apply. We do not evaluate whether any provider prescribes to minors.
The label also does not answer questions that parents often ask, such as how long treatment should last or what happens after stopping in a growing child. For related label background on mental health questions that families raise, see our article on the removal of the suicidal ideation warning from labels. Talk with a pediatrician or adolescent medicine specialist about any such concerns.
Questions to bring to a pediatric clinician
- Is the diagnosis one the label covers: obesity at or above the 95th percentile for Wegovy, or type 2 diabetes for Mounjaro?
- What lifestyle support is part of the plan? The Wegovy trial began with a 12-week lifestyle run-in, and the label describes use with a reduced-calorie diet and increased physical activity.
- How will gastrointestinal side effects and hydration be monitored during dose escalation?
- What are the signs of gallbladder problems, and when should the family call?
- Does the child take other medicines, including insulin or a sulfonylurea, that may need adjusting?
- What is the plan if a dose is missed, and who should the family call?
We have deliberately left prices out of this article. Cost and coverage vary by plan, and our guide to prior authorization appeals explains how coverage decisions can be challenged.
Common mistakes
- Assuming any GLP-1 medicine is cleared for teens. Only Wegovy injection (age 12 and older, obesity) and Mounjaro (age 10 and older, type 2 diabetes) have a pediatric indication in the labels reviewed.
- Using the adult tablet. The Wegovy tablet label says safety and effectiveness have not been established in pediatric patients.
- Treating trial averages as promises. The adolescent trial paired medicine with a lifestyle program.
- Buying from sources with no age check. Compounded and non-approved products are not covered by any of these pediatric studies.
Questions people ask
Is Wegovy approved for a 12-year-old?
Yes for the injection, according to the label: it is indicated for weight reduction and long-term maintenance in pediatric patients aged 12 years and older with obesity, alongside a reduced-calorie diet and increased physical activity. The label says this is not established for the tablets or the 7.2 mg dose.
Can a teenager use Zepbound?
The Zepbound label says safety and effectiveness have not been established in pediatric patients. Mounjaro, which has the same active ingredient, is labeled for pediatric type 2 diabetes from age 10.
Does Foundayo have a pediatric indication?
No. The Foundayo label says safety and effectiveness have not been established in pediatric patients.
What side effects were most common in the adolescent Wegovy trial?
Nausea (42% vs 18% on placebo), vomiting (36% vs 10%), diarrhea (22% vs 19%) and abdominal pain (15% vs 6%), plus gallstones in 4% of Wegovy patients and none on placebo.
Where can I read the trial itself?
The adolescent Wegovy trial is on PubMed and ClinicalTrials.gov under the links in the sources, and the tirzepatide pediatric diabetes trial is linked the same way.
Sources
- Novo Nordisk, Wegovy (semaglutide) injection and tablets prescribing information, sections 1, 2.2, 5.4, 6.1, 8.4 and 14.3, revised 06/2026, checked 9 October 2026.
- Eli Lilly and Company, Mounjaro (tirzepatide) prescribing information, sections 1, 8.4 and 14.5, revised 08/2026, checked 9 October 2026.
- Eli Lilly and Company, Zepbound (tirzepatide) prescribing information, section 8.4, revised 08/2026, checked 9 October 2026.
- Eli Lilly and Company, Foundayo (orforglipron) tablets prescribing information, section 8.4, revised 07/2026, checked 9 October 2026.
- Novo Nordisk, Ozempic (semaglutide) injection prescribing information, section 8.4, checked 9 October 2026.
- FDA, Understanding Unapproved Use of Approved Drugs “Off Label”, checked 9 October 2026.
- Weghuber D, et al. Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med 2022. PubMed 36322838. ClinicalTrials.gov NCT04102189.
- Hannon TS, et al. Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS). Lancet 2025. PubMed 40975112. ClinicalTrials.gov NCT05260021.
Medical disclaimer. This article is informational, was prepared by the GLP-1.Reviews editorial team from the public sources listed above, and is not medical advice. Decisions about medicines for a child or teenager should be made with a pediatric clinician who knows the child’s health history. Talk to your prescriber or pharmacist about your own treatment, and see our medical disclaimer and editorial standards.
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