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FDA Approves Dapagliflozin Tablets (dapagliflozin) for Heart Failure Risk Reduction and Glycemic Control in Type 2 DiabetesFDA approves a diabetes pill that also helps protect the heart from failure

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Key Takeaway
Consider for heart failure risk reduction and glycemic control in adults with type 2 diabetes and CV disease/risk factors.

The FDA has approved dapagliflozin tablets, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, for two indications in adults with type 2 diabetes mellitus. The approval includes its use to reduce the risk of hospitalization for heart failure in patients with either established cardiovascular disease or multiple cardiovascular risk factors. It is also approved 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 a specific patient population with type 2 diabetes. The label includes specific dosing guidance and limitations of use, including recommendations against use for glycemic control in patients with type 1 diabetes or in those with type 2 diabetes and an eGFR less than 45 mL/min/1.73 m².

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 tablets are 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 they are likely to be ineffective in this setting based on 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 type 2 diabetes and renal impairment, the recommended dosage for glycemic control in patients with eGFR ≥45 mL/min/1.73 m² is the same as for normal renal function. Not recommended for glycemic control if eGFR <45 mL/min/1.73 m².

For all other indications (e.g., heart failure risk reduction): The recommended dosage is 10 mg orally once daily. For adults with renal impairment receiving dapagliflozin for indications other than glycemic control, the recommended dosage in patients with eGFR ≥25 mL/min/1.73 m² is the same as for normal renal function. Initiation is not recommended in patients with eGFR <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 pill, taken by mouth, works to lower blood sugar levels. It is also specifically approved to help reduce the risk of hospitalization due to heart failure in patients who either have known heart disease or have several risk factors for it. This makes it a tool that can address two important health concerns at once.

This approval is for a specific group of adults. It is intended for those with type 2 diabetes who are also focused on their heart health. The drug's label clearly states it is not for people with type 1 diabetes. It also recommends against using it primarily for blood sugar control in patients with more advanced kidney disease.

For doctors and patients, this approval provides a new choice among existing diabetes medications. It highlights a growing understanding of the link between diabetes and heart health, offering a treatment that can work on both fronts. It is important to remember that every patient's situation is unique.

One key point for patients to know is that this is a prescription medication with specific guidelines for who should use it. The most important step for anyone interested in this new option is to have a detailed conversation with their own doctor. A healthcare provider can review an individual's full health history to determine if this treatment is a suitable and safe choice for them.

What this means for you:
A new diabetes pill can also help 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 tablets are 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 tablets are 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 m 2 . Dapagliflozin tablets are likely to be ineffective in this setting based upon its mechanism of action. ( 1 )
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