Approved

Semaglutide: Uses, Evidence, and Side Effects

Drafted by an automated content engine from FDA, PubChem, ClinicalTrials.gov, NIH DSLD, and Open Beauty Facts data.

Molecular formulaC187H291N45O59
Molecular weight4114 g/mol
Registered trials757
PubChem CID56843331
Drug classGLP-1 Receptor Agonist [EPC]
Brand namesOZEMPIC, RYBELSUS
Boxed warning: The FDA label for this compound includes a boxed warning, the FDA's strongest safety warning. See the full prescribing information for details.

Mechanism of Action

12.1 Mechanism of Action Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protectio

Source: FDA label

Key takeaways

  • Approved to improve blood sugar control in type 2 diabetes and to lower cardiovascular risk in high-risk adults.
  • Sold under the brand names Ozempic and Rybelsus, both GLP-1 receptor agonists.
  • The label carries a boxed warning.
  • More than 750 registered clinical trials have studied semaglutide, spanning early-phase and phase 4 research.
  • FAERS reports are led by gastrointestinal effects: nausea, vomiting, and diarrhoea.

What semaglutide is

Semaglutide is a GLP-1 (glucagon-like peptide-1) receptor agonist built to closely resemble the body's own GLP-1 hormone. It binds to and activates GLP-1 receptors, the same targets the natural hormone uses to influence glucose regulation. A key design feature lets it bind albumin in the blood, which slows its clearance from the body and extends how long it remains active.

What semaglutide is approved for

Semaglutide, marketed as Ozempic and Rybelsus, is approved as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes. It is also approved to reduce the risk of major cardiovascular events, including cardiovascular death, non-fatal heart attack, and non-fatal stroke, in adults with type 2 diabetes who are at high risk for these outcomes. The label carries a boxed warning.

What the evidence shows

Semaglutide has been studied in more than 750 registered clinical trials. Ongoing phase 4 research includes a trial examining low-dose semaglutide for weight loss in non-diabetic adults and another comparing semaglutide to energy restriction in type 2 diabetes, both currently recruiting. A completed phase 1 study evaluated blood levels of semaglutide delivered through a newer tablet formulation in healthy participants.

Reported side effects

FAERS data reflect adverse event reports, not confirmed incidence or proven causation. The most frequently reported reactions are gastrointestinal: nausea (9,513 reports), vomiting (6,161), diarrhoea (5,718), decreased appetite (4,352), and constipation (4,141). Reports of decreased weight (3,807) and increased blood glucose (2,953) also appear frequently, alongside a substantial number of reports coded as off-label use (6,280).

FAQ

What is semaglutide used for?
Semaglutide is approved to help adults with type 2 diabetes manage their blood sugar alongside diet and exercise. It is also approved to lower the risk of major cardiovascular events, such as heart attack or stroke, in adults with type 2 diabetes who are at high risk for these events.
What brand names contain semaglutide?
Semaglutide is sold under the brand names Ozempic and Rybelsus. Ozempic and Rybelsus tablets are the versions covered by the approved label referenced here.
Does semaglutide have a boxed warning?
Yes, the semaglutide label carries a boxed warning. Patients and prescribers should review the full label for details on this warning.
What are the most common side effects of semaglutide?
The most frequently reported side effects are gastrointestinal, including nausea, vomiting, diarrhoea, decreased appetite, and constipation. These figures come from adverse event reports, which reflect what has been reported rather than confirmed rates or causes.
How much research exists on semaglutide?
More than 750 clinical trials have been registered studying semaglutide. These include completed early-phase pharmacology studies as well as ongoing phase 4 trials examining its use in diabetes management and weight-related outcomes.
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Sources: FDA label (DailyMed) ClinicalTrials.gov FDA FAERS PubChem

Updated 2026-08-03