Wegovy's label now covers adolescents aged 12 and older with obesity

The Wegovy prescribing information now lists an obesity indication for pediatric patients aged 12 years and older alongside the existing adult indication ^[1]. Wegovy is the brand name for semaglutide, a GLP-1 receptor agonist given as a weekly subcutaneous injection ^[1].

The label says Wegovy injection, used with a reduced calorie diet and increased physical activity, is intended to reduce excess body weight and maintain weight reduction long term in adults and in pediatric patients aged 12 years and older with obesity ^[1]. The evidence for adolescents is summarized in the label's clinical studies section, which describes a weight reduction and long-term maintenance study of Wegovy injection in pediatric patients aged 12 and older with obesity ^[1].

The most common adverse reactions reported in adults or pediatric patients aged 12 and older — those occurring in at least 5% of patients — are nausea, diarrhea, vomiting, constipation, abdominal pain, dysesthesia, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease and hair loss ^[1].

The label carries a boxed warning that semaglutide caused thyroid C-cell tumors in rodents at clinically relevant exposures, and that it is unknown whether Wegovy causes thyroid C-cell tumors, including medullary thyroid carcinoma, in humans ^[1]. Wegovy is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 ^[1]. Other warnings include acute pancreatitis, acute gallbladder disease, hypoglycemia when used with insulin or an insulin secretagogue, acute kidney injury due to volume depletion, severe gastrointestinal reactions including gastroparesis, hypersensitivity reactions such as anaphylaxis and angioedema, diabetic retinopathy complications in patients with type 2 diabetes, increased heart rate, and pulmonary aspiration during general anesthesia or deep sedation ^[1].

The label says Wegovy may cause fetal harm, and that patients taking it for weight reduction should discontinue it at least two months before a planned pregnancy because of semaglutide's long half-life; breastfeeding is not recommended during treatment with Wegovy tablets ^[1]. It also states the FlexTouch pen should never be shared between patients, even if the needle is changed ^[1].

The same document shows the label has been revised repeatedly, most recently in June 2026, with indication changes listed in August 2025 and December 2025 ^[1]. It now also covers a tablet form of Wegovy for reducing major cardiovascular events in adults with established cardiovascular disease and either obesity or overweight, and an accelerated-approval indication for noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis in adults ^[1]. The label does not recommend using Wegovy with another semaglutide-containing product or with any other GLP-1 receptor agonist ^[1].

Why it matters for patients

For families of adolescents with obesity, the label means an FDA-approved medication option exists for that age group, with the pediatric study summarized in the prescribing information and the same boxed warning, contraindications and warnings that apply to adults ^[1]. The indication is written for obesity and for long-term weight reduction and maintenance, not for short-term or cosmetic use, and it is tied to a reduced calorie diet and increased physical activity ^[1].

Much of the day-to-day experience described in the label is gastrointestinal — nausea, vomiting, diarrhea and constipation are among the most common reactions — and some listed risks, including pancreatitis, gallbladder disease, kidney injury and severe gastrointestinal reactions such as gastroparesis, can be serious ^[1]. Patients who take insulin or a sulfonylurea, or who have type 2 diabetes or a history of diabetic retinopathy, have additional monitoring considerations spelled out in the label ^[1]. Because the label advises against combining Wegovy with other GLP-1 receptor agonists, an adolescent already taking another drug in this class raises a question the prescribing information addresses directly ^[1].

How insurers cover Wegovy for adolescents is not addressed in the prescribing information, and cost is not discussed there ^[1].