Dapagliflozin

Generic Name: Dapagliflozin

Brand Names: Farxiga

Dapagliflozin is an SGLT2 inhibitor for type 2 diabetes, heart failure, and chronic kidney disease.

EndocrineDiabetesSGLT2 InhibitorsCardiovascularNephrology

Drug Class

Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor

Pregnancy

Not assigned a legacy letter (post-2015 labeling). Avoid use in the second and third trimesters because SGLT2 inhibition has caused adverse renal development in animal studies during the period corresponding to human renal maturation. Discontinue dapagliflozin when pregnancy is recognized and use insulin for glycemic control during pregnancy.

Available Forms

Oral tablet (5 mg, 10 mg), Combination tablet with metformin extended-release (Xigduo XR: 2.5/1000, 5/500, 5/1000, 10/500, 10/1000 mg), Combination tablet with saxagliptin (Qtern: 5/5, 10/5 mg), Combination tablet with saxagliptin and metformin XR (Qternmet XR)

What It's Used For

Type 2 diabetes mellitus glycemic control
Heart failure with reduced ejection fraction
Chronic kidney disease progression prevention
Cardiovascular risk reduction in diabetes
Reducing hospitalization for heart failure

Dosage Quick Reference

These are general dosage guidelines. Your doctor will determine the appropriate dose for your specific situation.

Condition	Starting Dose	Maintenance Dose
Type 2 diabetes (glycemic control)	5 mg orally once daily in the morning	5–10 mg once daily; max 10 mg/day
Heart failure (HFrEF and HFpEF)	10 mg orally once daily	10 mg once daily
Chronic kidney disease (eGFR ≥ 25 mL/min/1.73 m²)	10 mg orally once daily	10 mg once daily
Patients with hepatic impairment (severe)	5 mg once daily; consider risk-benefit	5 mg once daily

Side Effects

Common Side Effects:

Genital yeast infections (more common in women)
Urinary tract infections
Increased urination and thirst
Back pain
Nasopharyngitis
Nausea and constipation

Serious Side Effects (seek immediate medical attention):

Signs of diabetic ketoacidosis (nausea, vomiting, abdominal pain, unusual fatigue, difficulty breathing)
Severe genital or perineal pain, tenderness, swelling, or redness (Fournier's gangrene)
Signs of severe dehydration or low blood pressure (dizziness, lightheadedness, weakness)
Signs of kidney problems (decreased urination, swelling in legs)
Severe allergic reactions

Drug Interactions

Dapagliflozin works on the kidney and has fewer pharmacokinetic interactions than many other diabetes drugs, but several pharmacodynamic combinations require attention.

Insulin and insulin secretagogues (sulfonylureas, glinides): Adding dapagliflozin to insulin or a sulfonylurea increases hypoglycemia risk. Anticipate a 10–25 percent reduction in insulin or sulfonylurea dose at initiation, and monitor blood glucose closely.
Loop and thiazide diuretics (e.g., furosemide, hydrochlorothiazide): Additive volume depletion may cause hypotension, dizziness, and acute kidney injury, especially in older adults. Reassess diuretic need; reduce diuretic dose if appropriate before starting dapagliflozin.
ACE inhibitors, ARBs, and aldosterone antagonists: Generally compatible and often used together for cardiorenal protection, but combined RAAS blockade can transiently lower eGFR and raise potassium. Recheck renal function and electrolytes 2–4 weeks after starting.
Lithium: Dapagliflozin may decrease lithium levels via increased renal clearance. Monitor lithium concentrations.
Strong CYP3A4 inducers (e.g., rifampin): May modestly reduce dapagliflozin exposure; clinical significance is limited but monitor glucose response.
Drugs causing dehydration (e.g., aggressive bowel preps, NSAIDs in volume-depleted patients): Increase risk of acute kidney injury when combined with SGLT2 inhibitors.

Additional Information

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that has revolutionized the treatment of type 2 diabetes, heart failure, and chronic kidney disease. By blocking glucose reabsorption in the kidneys, it provides multiple cardiometabolic benefits beyond glucose control, including cardiovascular protection, renal preservation, and modest weight loss.

Mechanism of Action

Dapagliflozin selectively inhibits SGLT2, the primary transporter responsible for reabsorbing approximately 90% of filtered glucose in the proximal renal tubule. By blocking this transporter, dapagliflozin causes the excretion of approximately 70 grams of glucose per day in the urine, lowering blood glucose levels through an insulin-independent mechanism. This glucosuria also results in an osmotic diuresis and natriuresis, which contributes to blood pressure reduction and volume effects that benefit heart failure patients.

Beyond glucose effects, SGLT2 inhibition provides cardiorenal protection through multiple mechanisms including improved cardiac energetics, reduced preload and afterload, decreased inflammation, and favorable effects on kidney hemodynamics that reduce hyperfiltration and slow progression of kidney disease.

Available Formulations

Dapagliflozin (Farxiga) is available as tablets in 5 mg and 10 mg strengths. It is also available in fixed-dose combinations with metformin (Xigduo XR) and saxagliptin (Qtern) for patients requiring combination therapy for diabetes management.

FDA-Approved Indications

Dapagliflozin has received FDA approval for multiple conditions, reflecting its broad cardiometabolic benefits. These indications include improving glycemic control in adults with type 2 diabetes mellitus, reducing the risk of hospitalization for heart failure in adults with type 2 diabetes and cardiovascular disease or multiple cardiovascular risk factors, reducing the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF), and reducing the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.

Dosing Guidelines

For type 2 diabetes, the recommended dose is 10 mg once daily in the morning, taken with or without food. For heart failure, the dose is 10 mg once daily. For chronic kidney disease, the dose is also 10 mg once daily. No dose adjustment is needed for mild to moderate hepatic impairment. The medication should be initiated only when eGFR is 25 mL/min/1.73m² or higher, though it may be continued at lower levels once started.

Clinical Trial Evidence

The cardiovascular and renal benefits of dapagliflozin have been demonstrated in landmark clinical trials. The DECLARE-TIMI 58 trial showed reduced hospitalization for heart failure in patients with type 2 diabetes. The DAPA-HF trial demonstrated significant reductions in cardiovascular death and heart failure hospitalization in patients with HFrEF, regardless of diabetes status. The DAPA-CKD trial showed remarkable renal protection in patients with chronic kidney disease, leading to early trial termination due to overwhelming efficacy.

Important Safety Considerations

While generally well-tolerated, dapagliflozin carries important safety considerations. Diabetic ketoacidosis, including euglycemic DKA with normal glucose levels, can occur and requires heightened awareness. Genital mycotic infections (yeast infections) are common due to glucosuria. Rare but serious cases of necrotizing fasciitis of the perineum (Fournier's gangrene) have been reported. Volume depletion and hypotension may occur, particularly in elderly patients or those on diuretics. Patients should be educated about these risks and advised to maintain adequate hydration.

Drug Interactions and Monitoring

Diuretics may increase the risk of volume depletion when combined with dapagliflozin. Insulin and insulin secretagogues may need dose reduction to prevent hypoglycemia. Regular monitoring of renal function, potassium, and volume status is recommended. Patients should be counseled about symptoms of ketoacidosis and instructed to hold the medication during periods of reduced oral intake or acute illness.

Learn more at MedlinePlus

Frequently Asked Questions

Dapagliflozin lowers blood sugar by causing the kidneys to excrete excess glucose into the urine, which pulls water with it (osmotic diuresis). Increased urination usually peaks in the first few weeks and then settles as your body adjusts. Drink fluids steadily through the day to stay hydrated, and ask your doctor before resuming long workouts in the Florida heat.

Large trials (DAPA-HF, DELIVER, DAPA-CKD) showed dapagliflozin reduces hospitalizations and death in heart failure and slows progression of chronic kidney disease, regardless of whether diabetes is present. These cardiorenal benefits stem from improved sodium handling, reduced cardiac preload, and protective metabolic effects on the heart and kidney.

Higher urine glucose levels can encourage yeast growth in the genital area. Practical steps include keeping the area clean and dry, wearing breathable cotton underwear, changing out of wet swimsuits or sweaty clothes promptly, and gently rinsing after urination. Mild infections respond to over-the-counter antifungals, but recurrent or severe infections should be evaluated.

SGLT2 inhibitors can cause "euglycemic" diabetic ketoacidosis, in which dangerous ketones build up while blood sugar remains near-normal. Warning signs include nausea, vomiting, abdominal pain, fatigue, and shortness of breath. If you have these symptoms, check ketones (urine or blood) and seek urgent care — do not assume normal glucose readings rule it out. Hold the medication during prolonged fasting, surgery, severe illness, or very low-carb dieting.

Yes — current guidance recommends pausing SGLT2 inhibitors at least 3 days before scheduled surgery (4 days for ertugliflozin) and during any illness with reduced oral intake, vomiting, or dehydration. This minimizes the risk of euglycemic ketoacidosis. Resume only after you are eating normally and your physician approves.

Questions to Ask Your Doctor

Consider discussing these topics at your next appointment:

✓Given my kidney function, am I a candidate for dapagliflozin and what eGFR would prompt us to stop it?
✓Should my diuretic or insulin dose be reduced when I start this medication?
✓When should I check ketones, and what symptoms warrant an emergency visit?
✓How will we monitor whether dapagliflozin is helping my heart or kidneys, not just my blood sugar?

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Medical Disclaimer: This information is for educational purposes only and should not be considered medical advice. Always consult with your healthcare provider before starting, stopping, or changing any medication. Your doctor can provide personalized recommendations based on your specific health condition and medical history.