Ozempic (Semaglutide) Indications
Ozempic is FDA-approved for two specific indications in adults with type 2 diabetes: improving glycemic control as an adjunct to diet and exercise, and reducing the risk of major adverse cardiovascular events in those with established cardiovascular disease. 1
Primary FDA-Approved Uses
Type 2 Diabetes Management
- Ozempic is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 1
- It is a once-weekly GLP-1 receptor agonist administered subcutaneously 1, 2
- The medication lowers blood glucose by stimulating insulin release and also reduces body weight 2
Cardiovascular Risk Reduction
- Ozempic is specifically indicated to reduce the risk of major adverse cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes and established cardiovascular disease 1
- The SUSTAIN-6 trial demonstrated a 26% reduction in the primary cardiovascular outcome (HR 0.74 [95% CI 0.58–0.95]; P < 0.001) compared to placebo 3
- This cardiovascular benefit includes reductions in cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke 3, 4
Critical Limitations and Contraindications
What Ozempic Is NOT For
- Ozempic is not indicated for type 1 diabetes mellitus or treatment of diabetic ketoacidosis 1
- It is not a substitute for insulin 1
- It has not been studied in patients with a history of pancreatitis; consider alternative antidiabetic therapy in these patients 1
- It is not approved for use in children under 18 years of age 1
Absolute Contraindications
- Personal or family history of medullary thyroid carcinoma (MTC) 1
- Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) 1
- Known hypersensitivity to semaglutide or any ingredients 1
Important Clinical Context
Off-Label Weight Management Use
- While semaglutide is approved for weight management under the brand name Wegovy, Ozempic itself is not FDA-approved for weight loss as a primary indication 5, 6
- Off-label prescribing of Ozempic for weight loss has created supply shortages affecting patients with diabetes who need the medication for its approved indications 5, 6