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Matched label
OZEMPIC
ORAL SEMAGLUTIDE - Novo Nordisk
and OZEMPIC tablets are indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.
Label facts
- Application
- NDA213051
- Route
- ORAL
- Label updated
- January 30, 2026
Indication
and OZEMPIC tablets are indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.
Dose and administration
• RYBELSUS and OZEMPIC tablets are not substitutable on a mg-to-mg basis. • Take RYBELSUS or OZEMPIC tablets orally once daily on an empty stomach in the morning with water (up to 4 ounces of water); do not take with other liquids besides water. • Swallow tablets whole.
Side effects
- nausea
- abdominal pain
- diarrhea
- decreased appetite
- vomiting
- constipation
Safety flags
Acute Pancreatitis
Diabetic Retinopathy Complications
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
Acute Kidney Injury Due to Volume Depletion
Severe Gastrointestinal Adverse Reactions
Hypersensitivity Reactions
Contraindication: • A personal
Contraindication: family history of medullary thyroid carcinoma
Contraindication: in patients with Multiple Endocrine Neoplasia syndrome type 2
Source links
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