Wegovy FDA prescribing information 2026: BMI thresholds, contraindications, breastfeeding

The FDA-approved Wegovy (semaglutide 2.4 mg) label sets out who qualifies for the medication, the boxed warning, the contraindications, and the pregnancy and breastfeeding guidance. This is a plain-English summary of what the current label says. It is not medical advice and does not replace the full label or your prescriber. Source: the FDA DrugsatFDA record for Wegovy (application 215256) and the current label on DailyMed.

Who qualifies under the Wegovy label

The label indicates Wegovy for chronic weight management in adults with an initial body mass index (BMI) of 30 or higher, or 27 or higher with at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. It is used alongside a reduced-calorie diet and increased physical activity. The label also covers adolescents 12 and older with obesity, and, separately, reducing cardiovascular risk in adults with established heart disease who also have obesity or overweight.

Boxed warning and contraindications

Wegovy carries a boxed warning for the risk of thyroid C-cell tumors. In rodent studies, semaglutide caused thyroid C-cell tumors; whether it causes such tumors, including medullary thyroid carcinoma (MTC), in humans is not known. The label says Wegovy is contraindicated in anyone with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), and in anyone with a known serious allergic reaction to semaglutide or any ingredient in Wegovy.

Pregnancy and breastfeeding

The label advises against using Wegovy during pregnancy. Because semaglutide stays in the body for weeks, the label recommends stopping Wegovy at least 2 months before a planned pregnancy. If you become pregnant while taking it, the guidance is to stop.

On breastfeeding, the label states there is no data on whether semaglutide passes into human milk, on its effects on a breastfed infant, or on milk production. The label says the developmental and health benefits of breastfeeding should be weighed against the mother's clinical need for Wegovy and any potential effect on the infant. Many prescribers advise stopping Wegovy while breastfeeding given the absence of safety data. Make this decision with your own clinician.

Is the Wegovy label updated for 2026

The authoritative version of the prescribing information is always the one on the FDA DrugsatFDA record and DailyMed; label supplements are posted there first. For a clinical or coverage decision, read the current label rather than any summary, including this one.

Frequently asked questions

What is the FDA prescribing information BMI threshold for Wegovy?

The FDA-approved Wegovy label indicates use in adults with a BMI of 30 or higher, or 27 or higher with at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol, used alongside a reduced-calorie diet and more physical activity. Source: the FDA Wegovy label.

What does the FDA Wegovy label say about breastfeeding?

The Wegovy label states there is no data on whether semaglutide passes into human milk, on its effects on a breastfed infant, or on milk production. It says the benefits of breastfeeding should be weighed against the mother's clinical need for Wegovy. Many clinicians recommend stopping Wegovy while breastfeeding because safety data is lacking. Discuss it with your prescriber. Source: the FDA Wegovy label, Lactation section.

What is the Wegovy boxed warning?

Wegovy carries a boxed warning for the risk of thyroid C-cell tumors, based on rodent studies. It is contraindicated in people with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Source: the FDA Wegovy label.

For dosing, side effects, and current cash and insurance pricing, see the Wegovy drug guide and the GLP-1 cost guide.