Drug Safety Information for OZEMPIC ()

FDA Safety-related Labeling Changes for OZEMPIC (SEMAGLUTIDE) Rx Drug: Safety Information Link

Risk of acute gallbladder disease; pregnancy risk; use with insulin may have an increased risk of hypoglycemia

Required post-approval safety study:

Conduct a medullary thyroid carcinoma registry-based case series of at least 15 years duration to systematically monitor the annual incidence of medullary thyroid carcinoma in the United States and to identify any increase related to the introduction of Ozempic (semaglutide) into the marketplace. This study will also establish a registry of incident cases of medullary thyroid carcinoma and characterize their medical histories related to diabetes and use of Ozempic (semaglutide). Due Date: 2035-05-31

Required post-approval safety study:

Original Indication: Improvement of blood sugar control in adults with type 2 diabetes mellitus (DM) when used in addition to diet and exercise. Due Date: 2017-12-05

Original FDA Drug Approval Date for OZEMPIC: 2017-12-05

FDA Adverse Event Summary for OZEMPIC (not avail) Unavailable