FDA approves Ozempic, the first semaglutide product, for type 2 diabetes

On December 5, 2017, the FDA approved Ozempic (semaglutide) injection to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise ^[1][3][4]. It was the first approved product containing semaglutide, the molecule now sold under several brand names ^[1][3].

FDA application records list the original submission as a Type 1 application, meaning a new molecular entity, approved on December 5, 2017 ^[4]. Novo Nordisk had filed for approval on December 5, 2016, and an FDA advisory committee voted 16-0 in favor of approval on October 18, 2017 ^[1].

The original label carried a boxed warning about thyroid C-cell tumors. In rodents, semaglutide causes thyroid C-cell tumors. Whether Ozempic causes them in humans, including medullary thyroid carcinoma, is not known, because the relevance of the rodent findings to people has not been determined ^[3]. Ozempic is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 ^[3].

Other warnings in the current label include acute pancreatitis, diabetic retinopathy complications, low blood sugar (especially with insulin or medicines that raise insulin release), acute kidney injury from volume depletion, severe gastrointestinal reactions, serious allergic reactions, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation ^[1][3]. The most common side effects, reported in at least 5% of patients, are nausea, vomiting, diarrhea, abdominal pain and constipation ^[1][3]. Ozempic injection is given once a week under the skin ^[3].

Semaglutide's approved uses grew over the following years. Rybelsus, an oral semaglutide for type 2 diabetes, was first approved September 20, 2019; Ozempic gained an indication to reduce the risk of major cardiovascular events in adults with type 2 diabetes and established heart disease on January 16, 2020; a 2 mg dose was approved March 28, 2022; and an indication covering worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease was approved January 28, 2025 ^[1]. Wegovy, the same molecule approved for weight reduction, was first approved June 4, 2021, and a Wegovy tablet followed on December 22, 2025 ^[1]. An Ozempic tablet, formerly the R2 formulation of Rybelsus, was approved January 30, 2026 ^[1].

One FDA notice describes Wegovy as first approved in 2017 ^[2], while approval records list Wegovy's own first approval as June 4, 2021 ^[1], the year the brand was launched for weight management.

Why it matters for patients

Ozempic's approved uses are type 2 diabetes, reducing the risk of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, and reducing the risk of sustained kidney function decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease ^[1][3]. Weight reduction is not among Ozempic's approved uses; that indication belongs to Wegovy, which contains the same molecule, semaglutide ^[1]. Because the brands share an active ingredient but not a label, the boxed warning, warnings and side-effect profile described for Ozempic apply to semaglutide generally, while the approved uses differ by product ^[1][3].

The thyroid tumor warning has stayed in place since 2017. The label states that human risk remains undetermined rather than established either way ^[3]. Labeling has continued to change after approval: the current prescribing information lists a warnings update on severe gastrointestinal adverse reactions dated October 2025 and is marked as revised May 2026 ^[3].

A separate FDA notice about Wegovy's later approval for the liver disease MASH reports that about 6% of U.S. adults, or 14.9 million people, have MASH, and that Wegovy was approved for that use under the accelerated approval pathway, which requires confirmatory data after approval ^[2]. That notice concerns Wegovy, not Ozempic ^[2].