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These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA® (dapagliflozin) tablets, for oral useInitial U.S. Approval: 2014
Medication labelWhy this: Advisory · dailymed-prescription
FARXIGA (dapagliflozin) is indicated: •To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. •To reduce the risk of CV death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. •To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. •As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Limitations of Use • FARXIGA is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. •FARXIGA is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. FARXIGA is likely to be ineffective in this setting based upon its mechanism of action. •FARXIGA is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. FARXIGA is not expected to be effective in these populations.
- generic_name
- dapagliflozin
- product_names
- DAPAGLIFLOZIN
- ndc
- 50090-3481, 50090-3482, 0310-6210, 50090-3481-0, 0310-6205, 50090-3482-0
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en