Semaglutide

Approval status

FDA-approved as Ozempic injection, and as Rybelsus and Ozempic tablets, for type 2 diabetes, and as Wegovy injection and tablets for weight management and heart risk; Wegovy injection is also approved for MASH. The EMA has authorised Ozempic and Wegovy in the EU. Compounded semaglutide is not FDA-approved: FDA declared the shortage over in February 2025, and its shortage-era leniency for compounders ended by May 2025.^1235679

What it’s used or studied for

• Approved use

  Improves blood sugar control in adults with type 2 diabetes, alongside diet and exercise (Ozempic injection, Rybelsus and Ozempic tablets).¹³

• Approved use

  Lowers heart attack, stroke and heart-related death risk in type 2 diabetes with heart disease (Ozempic injection) or high heart risk (Rybelsus, Ozempic tablets), and in heart disease with excess weight (Wegovy).¹²³

• Approved use

  Lowers the risk of kidney function decline, kidney failure and heart-related death in adults with type 2 diabetes and chronic kidney disease (Ozempic).¹

• Approved use

  Weight loss and long-term weight maintenance in adults with obesity, or overweight with a weight-related condition, and in adolescents 12 and older with obesity (Wegovy).²

• Approved use

  Treats MASH (fatty liver inflammation) with moderate to advanced scarring but no cirrhosis in adults (Wegovy injection; accelerated approval that depends on a confirmatory trial).²

• Human studies

  Reduced symptoms and improved walking distance in people with obesity and heart failure with preserved ejection fraction (STEP-HFpEF trial).¹⁰

Each label shows how strong the evidence is: an approved use, human studies, animal or lab studies only, or a popular claim with no published studies. Being studied is not the same as being proven safe or effective.

Side effects

These come from the Ozempic, Wegovy and Rybelsus labels. Stomach and bowel side effects are the most common. The labels also warn about serious allergic reactions, severe stomach and bowel reactions, and a faster heart rate.¹²³

Cautions

• Not for people with a personal or family history of medullary thyroid cancer or MEN 2, or a past serious allergic reaction to semaglutide.¹²
• Taken with insulin or a sulfonylurea, it raises the risk of low blood sugar, including severe low blood sugar.¹²
• It slows stomach emptying, which can change how well oral medicines are absorbed.¹
• The labels advise stopping it at least 2 months before a planned pregnancy because it stays in the body a long time.¹²
• Compounded, counterfeit and "research use" semaglutide are not FDA-approved. FDA has reports of harm from dosing mistakes, and of salt forms (semaglutide sodium or acetate) that differ from the approved drug.⁷⁸