Dapagliflozin: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Dapagliflozin. Educational only — not medical advice.

Labeled uses

Dapagliflozin is indicated: •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 with type 2 diabetes mellitus. Limitations of Use • Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions ( 5.1 )] . • Dapagliflozin 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 m 2 . Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga ® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.

Source: FDA labeling via NIH DailyMed (set 5b436e9d…). Not affiliated with FDA or NIH.

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