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FDA Approves Dapagliflozin Tablets (dapagliflozin) to Reduce Heart Failure Hospitalization Risk and Improve Glycemic Control in Adults with Type 2 DiabetesFDA approves a diabetes drug that also helps protect the heart in certain adults

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Key Takeaway
Consider dapagliflozin for glycemic control and heart failure risk reduction in adults with type 2 diabetes, noting renal function and surgical hold requirements.

The FDA has approved dapagliflozin tablets for two indications in adults with type 2 diabetes mellitus: to reduce the risk of hospitalization for heart failure in those with established cardiovascular disease or multiple cardiovascular risk factors, and as an adjunct to diet and exercise to improve glycemic control. This approval provides clinicians with an SGLT2 inhibitor option for managing both glycemic control and cardiovascular risk in this patient population. The label includes specific dosing guidance and limitations of use, particularly regarding renal function. For glycemic control, the recommended starting dose is 5 mg once daily, which can be increased to 10 mg. For the heart failure hospitalization risk reduction indication, the recommended dose is 10 mg once daily. The label advises assessing renal function and volume status prior to initiation and recommends withholding the drug before major surgery.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor.

Indication & Patient Population

Dapagliflozin tablets are indicated: 1) To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. 2) As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. Dapagliflozin tablet 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, as it is likely to be ineffective in this setting based upon its mechanism of action.

Dosing & Administration

Assess renal function prior to initiation and then as clinically indicated. Assess volume status and correct volume depletion before initiating. For glycemic control: The recommended starting dosage is 5 mg orally once daily. Dosage can be increased to 10 mg orally once daily for additional glycemic control. For patients with an eGFR greater than or equal to 45 mL/min/1.73 m2, the dosage is the same as for normal renal function. Not recommended for glycemic control if eGFR is less than 45 mL/min/1.73 m2. For reducing the risk of hospitalization for heart failure: The recommended dosage is 10 mg orally once daily. For patients with an eGFR greater than or equal to 25 mL/min/1.73 m2, the dosage is the same as for normal renal function. Initiation is not recommended in patients with an eGFR less than 25 mL/min/1.73 m2. Withhold dapagliflozin tablets for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

The U.S. Food and Drug Administration (FDA) has approved a medication called dapagliflozin for adults with type 2 diabetes. This drug is approved for two main purposes. First, it can be used along with diet and exercise to help lower blood sugar levels. Second, and importantly, it is approved to reduce the risk of hospitalization for heart failure in people who also have known heart disease or several risk factors for it.

This approval is significant because it means doctors now have a single medication option that can address both blood sugar management and a major heart-related risk for many people with type 2 diabetes. It belongs to a class of drugs known as SGLT2 inhibitors.

The medication is not for everyone. The prescribing information includes specific guidance on dosing and notes that a person's kidney function should be checked before starting. It also advises that the drug may be paused before major surgeries. As with any new treatment option, this approval expands choices for healthcare providers.

It is important to remember that this is a prescription medication. The most important step for any patient is to have a conversation with their own doctor. A doctor can review an individual's full health history to determine if this new option is a suitable and safe part of their care plan.

What this means for you:
This diabetes drug also helps protect the heart. Talk to your doctor to see if it's right for you.

Study Details

Study typeFda approval
PublishedApr 2026
View Original Abstract ↓
1 INDICATIONS AND USAGE Dapagliflozin tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions ( 5.1 )]. Dapagliflozin tablet 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 tablet 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. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. ( 1 ) As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) 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. Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. ( 1 )
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