Ozempic (semaglutide) label updated to include cardiovascular risk reduction indication
FDA approved a label expansion for Ozempic (semaglutide injection; Novo Nordisk) to include reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and established cardiovascular disease, based on the SELECT and SUSTAIN-6 trial data. The indication joins the existing glycaemic control label.
On 14 August 2026, Ozempic (semaglutide 0.5 mg, 1 mg, 2 mg injection) ↗ received an expanded indication for reduction of risk of major adverse cardiovascular events (MACE) — defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke — in adults with type 2 diabetes and established cardiovascular disease. This joins the existing HbA1c-lowering indication. The expanded label is available on DailyMed ↗.
Supporting trial evidence
The primary evidence came from the SUSTAIN-6 trial (NEJM, 2016) ↗, a cardiovascular outcomes trial (CVOT) showing a 26% reduction in MACE with semaglutide vs placebo (HR 0.74; 95% CI 0.58–0.95). Additional support came from the SELECT trial (NCT03574597) ↗, which studied semaglutide in patients with established cardiovascular disease without diabetes, further establishing the cardiovascular benefit profile of the GLP-1 receptor agonist class.
GLP-1 class context
Semaglutide is a GLP-1 receptor agonist (NCBI) ↗ that stimulates glucose-dependent insulin secretion, suppresses glucagon, slows gastric emptying, and reduces appetite. The cardiovascular benefits appear to be partly independent of glycaemic control, potentially mediated through weight loss, blood pressure reduction, and anti-inflammatory effects. Other approved agents in the class with CVOT data include liraglutide (LEADER trial ↗) and dulaglutide (REWIND trial). Related label change: see our GLP-1 suicidal ideation warning removal item.
Prescribing considerations
The cardiovascular indication is for Ozempic (injectable semaglutide) only — it does not apply to Rybelsus (oral semaglutide) or Wegovy (semaglutide 2.4 mg for obesity). Prescribers should confirm cardiovascular disease status before invoking this indication. The updated label and patient information are on DailyMed ↗. For drug interaction guidance (particularly with insulin), consult the FDA drug interaction table ↗.
FAQ
What triggers an FDA label update?
Label updates can be triggered by post-market safety data from the FAERS database ↗, new clinical trial results, manufacturer-initiated reviews, or FDA-directed safety communications. The FDA can require label changes under 21 CFR 314.81 or negotiate them with manufacturers. See the FDA Safety-related Labeling Changes (SrLC) database ↗ for a full history.
Where is the updated label published?
Updated labels are published on DailyMed (NLM) ↗ and Drugs@FDA ↗. DailyMed is typically the most current source, as manufacturers submit label updates there directly.