Safety-Related Labeling Changes for Semaglutide

Post-marketing safety reports prompt updates to labeling for semaglutide.

June 2024

Safety-Related Labeling Changes for Semaglutide

Post-marketing experience

Additions and/or underlined revisions:

The following adverse reactions have been reported during post-approval use of semaglutide. Because these reactions are reported voluntarily by a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship with drug exposure.

  • Gastrointestinal disorders : ileus.
     
  • Hypersensitivity : anaphylaxis, angioedema, rash, urticaria.
     
  • Hepatobiliary : cholecystitis, cholecystectomy.

Drug interactions

Concomitant use with an insulin secretagogue (e.g., sulfonylurea) or insulin

Additions and/or underlined revisions:

Semaglutide stimulates the release of insulin in the presence of elevated blood glucose concentrations. Patients receiving semaglutide in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may be at increased risk of hypoglycemia , including severe hypoglycemia .

When initiating semaglutide, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.