Dapagliflozin
SGLT2 inhibitor for type 2 diabetes, heart failure, and chronic kidney disease
Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor used to treat type 2 diabetes, heart failure, and chronic kidney disease. It works by blocking glucose reabsorption in the kidneys, leading to glucose excretion in the urine. Landmark clinical trials — DAPA-HF, DAPA-CKD, and DELIVER — have established dapagliflozin as a cornerstone therapy for heart failure and kidney protection, even in patients without diabetes. Available as film-coated tablets in 5 mg and 10 mg strengths, dapagliflozin is sold under brand names including Forxiga, Farxiga, and several generic formulations.
Quick Facts
Key Takeaways
- Dapagliflozin is approved for type 2 diabetes, heart failure (all ejection fractions), and chronic kidney disease — regardless of diabetes status for the latter two indications.
- The DAPA-HF trial showed a 26% reduction in cardiovascular death or heart failure hospitalization; DAPA-CKD showed a 39% reduction in kidney failure progression.
- The most common side effects are genital fungal infections (7–8% of women) and urinary tract infections (4–6%). Serious but rare risks include diabetic ketoacidosis and Fournier’s gangrene.
- Dapagliflozin should be withheld for at least 3 days before major surgery to prevent euglycemic diabetic ketoacidosis.
- Available as Forxiga (EU, UK, Australia), Farxiga (US, Canada), and multiple generic formulations from Krka, Viatris, Adalvo, Orion, Devatis, and Dr. Reddy’s.
What Is Dapagliflozin and What Is It Used For?
Quick Answer: Dapagliflozin is an SGLT2 inhibitor that lowers blood sugar by blocking glucose reabsorption in the kidneys. It is approved for type 2 diabetes, heart failure, and chronic kidney disease, and has been shown to significantly reduce cardiovascular death and kidney failure in landmark clinical trials.
Dapagliflozin belongs to a class of medications known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. These drugs represent one of the most significant advances in cardiovascular and renal medicine in the past decade. Originally developed as a glucose-lowering agent for type 2 diabetes, dapagliflozin has since demonstrated remarkable benefits for the heart and kidneys that extend far beyond blood sugar control.
Mechanism of Action
SGLT2 is a protein found in the proximal tubule of the kidney, responsible for reabsorbing approximately 90% of the glucose filtered by the kidneys back into the bloodstream. By selectively and reversibly inhibiting SGLT2, dapagliflozin lowers the renal threshold for glucose, causing the kidneys to excrete roughly 70 grams of glucose per day in the urine (glycosuria). This mechanism is independent of insulin secretion and insulin sensitivity, meaning it works regardless of the stage of diabetes or pancreatic beta-cell function.
Beyond glucose lowering, dapagliflozin exerts several additional effects that contribute to its cardiovascular and renal benefits. It promotes natriuresis and osmotic diuresis, reducing intravascular volume and lowering both cardiac preload and afterload. It activates tubuloglomerular feedback in the kidney, reducing intraglomerular pressure and hyperfiltration — a key mechanism underlying its nephroprotective effects. Additionally, dapagliflozin promotes a metabolic shift toward fatty acid oxidation and ketone body production, providing a more efficient cardiac fuel source, and modestly reduces body weight (approximately 2–3 kg) through caloric loss from glycosuria.
Approved Indications
Regulatory agencies including the FDA (United States) and EMA (European Union) have approved dapagliflozin for the following indications:
- Type 2 diabetes mellitus: As an adjunct to diet and exercise to improve glycemic control in adults, and in pediatric patients aged 10 years and older (FDA). The EMA approves its use as monotherapy when metformin is not tolerated, or in combination with other glucose-lowering agents including insulin.
- Heart failure: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with symptomatic heart failure, regardless of ejection fraction (HFrEF and HFpEF, NYHA class II–IV) and regardless of diabetes status. This indication was established through the DAPA-HF and DELIVER trials.
- Chronic kidney disease (CKD): To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with CKD at risk of progression. The DAPA-CKD trial demonstrated benefits in patients both with and without diabetes.
Important: Dapagliflozin is not approved for type 1 diabetes in any market. While a limited indication for type 1 diabetes (as adjunct to insulin) was briefly authorized by the EMA, it was subsequently withdrawn due to the unacceptable risk of diabetic ketoacidosis.
Key Clinical Trials
Dapagliflozin’s clinical evidence base is exceptionally strong, supported by four major randomized controlled trials involving over 32,000 patients:
- DAPA-HF (NEJM, 2019): In 4,744 patients with heart failure and reduced ejection fraction (LVEF ≤40%), dapagliflozin reduced the combined endpoint of cardiovascular death or worsening heart failure by 26% (HR 0.74, p < 0.001) compared with placebo, with benefits consistent regardless of diabetes status.
- DAPA-CKD (NEJM, 2020): In 4,304 patients with CKD (eGFR 25–75 mL/min/1.73 m²), dapagliflozin reduced the primary composite endpoint (sustained ≥50% eGFR decline, ESKD, or renal/CV death) by 39% (HR 0.61, p < 0.001). The trial was stopped early for overwhelming efficacy.
- DELIVER (NEJM, 2022): In 6,263 patients with heart failure and preserved ejection fraction (LVEF >40%), dapagliflozin reduced worsening heart failure or cardiovascular death by 18% (HR 0.82, p < 0.001), establishing benefit across the full ejection fraction spectrum.
- DECLARE-TIMI 58 (NEJM, 2019): In 17,160 patients with type 2 diabetes, dapagliflozin demonstrated cardiovascular safety and reduced the composite of cardiovascular death or hospitalization for heart failure by 17% (HR 0.83, p = 0.005).
What Should You Know Before Taking Dapagliflozin?
Quick Answer: Do not take dapagliflozin if you are allergic to it or any of its ingredients. Tell your doctor if you have type 1 diabetes, a history of diabetic ketoacidosis, severe kidney disease, are pregnant or breastfeeding, or are scheduled for surgery. Dapagliflozin requires careful monitoring in patients taking insulin, sulfonylureas, or diuretics.
Before starting dapagliflozin, it is essential that your healthcare provider has a complete picture of your medical history, current medications, and any planned procedures. Dapagliflozin is generally well-tolerated, but certain conditions and circumstances require special consideration or may preclude its use entirely.
Contraindications
Dapagliflozin must not be used in the following situations:
- Hypersensitivity: Known allergy to dapagliflozin or any excipient in the formulation. Cases of anaphylaxis and angioedema have been reported in post-marketing experience.
- Type 1 diabetes: Dapagliflozin is not approved for type 1 diabetes due to an unacceptable risk of diabetic ketoacidosis (DKA).
- Severe renal impairment (for glycemic control): For glycemic efficacy in type 2 diabetes, do not initiate dapagliflozin if eGFR is below 45 mL/min/1.73 m², as glucose-lowering efficacy is diminished at lower renal function levels.
- End-stage renal disease: Do not initiate in patients with eGFR below 15 mL/min/1.73 m² or on dialysis (no therapeutic experience).
Note on kidney function thresholds: For heart failure and CKD indications, dapagliflozin may be initiated at eGFR ≥25 mL/min/1.73 m². Patients already on treatment who develop lower eGFR may continue therapy, as evidence from DAPA-CKD supports continued benefit.
Warnings and Precautions
Several important warnings and precautions apply to dapagliflozin therapy:
Diabetic Ketoacidosis (DKA): Dapagliflozin can cause DKA, including atypical euglycemic DKA where blood glucose may be only mildly elevated or even normal (below 250 mg/dL or 14 mmol/L). Risk factors include fasting, low carbohydrate diets, acute illness, dehydration, surgery, excessive alcohol intake, and reduced insulin doses. In the DECLARE-TIMI 58 trial, DKA occurred in 27 of 8,574 patients on dapagliflozin versus 12 of 8,569 on placebo. Withhold dapagliflozin for at least 3 days before scheduled major surgery.
- Volume depletion: Dapagliflozin causes osmotic diuresis, which can lead to intravascular volume contraction, symptomatic hypotension, and acute kidney injury. Risk is highest in elderly patients, those on loop diuretics, and patients with low systolic blood pressure. Assess and correct volume status before initiating therapy.
- Genital mycotic infections: Increased urinary glucose provides a substrate for fungal growth. Vulvovaginal candidiasis in women (6.9–8.4%) and balanitis in men (2.7–2.8%) occur more frequently than with placebo. Patients with a history of genital infections are at higher risk.
- Urinary tract infections (UTIs): Glucose excretion in urine may increase UTI risk. Serious cases including urosepsis and pyelonephritis have been reported. If a complicated UTI develops, temporarily discontinue dapagliflozin.
- Fournier’s gangrene: Rare but life-threatening necrotizing fasciitis of the perineum reported with all SGLT2 inhibitors. The FDA identified 55 cases across the class between March 2013 and January 2019, of which 16 involved dapagliflozin. If suspected (pain, tenderness, erythema, or swelling in the genital or perineal area with fever), discontinue immediately and initiate broad-spectrum antibiotics and surgical debridement.
- Lower limb amputation: While primarily associated with canagliflozin (HR 1.97 in the CANVAS program), meta-analyses of dapagliflozin trials have not shown a significantly increased amputation risk. Caution is advised in patients with prior amputation, peripheral vascular disease, neuropathy, or diabetic foot ulcers.
- Hypotension: Symptomatic hypotension may occur, particularly in patients on antihypertensive therapy or diuretics. Correct hypovolemia before starting dapagliflozin.
Pregnancy and Breastfeeding
Dapagliflozin is not recommended during pregnancy, particularly during the second and third trimesters. While no adequate human studies exist, animal studies in juvenile rats demonstrated renal pelvic and tubular dilatations at all dose levels tested. Because SGLT2 is expressed in the developing kidney, inhibiting it during organogenesis could adversely affect renal maturation. If pregnancy is detected, dapagliflozin should be discontinued.
Dapagliflozin is not recommended during breastfeeding. The drug was detected in rat milk at a milk-to-plasma ratio of 0.49, and it is unknown whether it is excreted in human breast milk. The potential effect on renal development in the nursing infant is the primary concern. No adverse effects on fertility have been observed in animal studies.
How Does Dapagliflozin Interact with Other Drugs?
Quick Answer: Dapagliflozin has clinically significant interactions with insulin and sulfonylureas (increased hypoglycemia risk), diuretics (increased dehydration and hypotension risk), and lithium (reduced lithium levels). Dose adjustments of concomitant insulin or sulfonylureas may be needed when starting dapagliflozin.
Drug interactions with dapagliflozin are generally manageable but require clinical awareness. Dapagliflozin is primarily metabolized by UGT1A9 (uridine diphosphate-glucuronosyltransferase 1A9) and is a substrate of P-glycoprotein. It does not significantly inhibit or induce cytochrome P450 enzymes, resulting in a relatively limited interaction profile.
Major Interactions
| Drug | Interaction | Management |
|---|---|---|
| Insulin | Increased risk of hypoglycemia; incidence rises to approximately 50% when dapagliflozin is added to insulin | Consider reducing insulin dose when initiating dapagliflozin; monitor blood glucose closely |
| Sulfonylureas (glimepiride, glipizide, glyburide) | Increased risk of hypoglycemia; incidence approximately 7–14% with combination | Consider reducing sulfonylurea dose; educate patient on hypoglycemia symptoms |
| Loop diuretics (furosemide, bumetanide) | Additive diuretic effect with increased risk of dehydration, hypovolemia, and hypotension; volume depletion events up to 9.7% in clinical trials | Assess and correct volume status before initiating; consider temporarily reducing diuretic dose; monitor blood pressure and renal function |
| Lithium | May increase renal lithium excretion, leading to decreased serum lithium levels and reduced therapeutic efficacy | Monitor serum lithium levels more frequently after dapagliflozin initiation and dose changes |
Minor Interactions
| Drug | Interaction | Management |
|---|---|---|
| Thiazide diuretics (hydrochlorothiazide) | Mild additive diuretic effect; less pronounced than with loop diuretics | Monitor blood pressure and hydration status |
| Rifampicin (UGT1A9 inducer) | Reduces dapagliflozin exposure (AUC) by approximately 22% | No dose adjustment recommended; monitor glycemic control |
| Metformin | No clinically meaningful pharmacokinetic interaction | No dose adjustment required; commonly prescribed together |
| Pioglitazone | No clinically meaningful interaction; potential additive fluid retention | Monitor for edema and heart failure symptoms |
Laboratory interference: Dapagliflozin will cause persistently positive urine glucose tests as an expected pharmacological effect. Do not rely on urine glucose monitoring. Additionally, 1,5-anhydroglucitol (1,5-AG) assays are unreliable in patients on SGLT2 inhibitors and should not be used for glycemic monitoring.
What Is the Correct Dosage of Dapagliflozin?
Quick Answer: The recommended dose is 10 mg once daily for heart failure and CKD. For type 2 diabetes, 5 mg once daily initially (may increase to 10 mg). Take in the morning with or without food. No dose adjustment needed for mild-to-moderate liver or kidney impairment. Do not initiate below eGFR 25 (HF/CKD) or 45 (T2D glycemic control).
Dapagliflozin dosing varies by indication and patient characteristics. It is taken orally once daily, usually in the morning, and can be taken with or without food. The tablet should be swallowed whole with water.
Adults
| Indication | Starting Dose | Maximum Dose | Notes |
|---|---|---|---|
| Type 2 Diabetes | 5 mg once daily (FDA); 10 mg once daily (EMA) | 10 mg once daily | Requires eGFR ≥45 for initiation; may increase to 10 mg for additional glycemic control |
| Heart Failure | 10 mg once daily | 10 mg once daily | Requires eGFR ≥25 for initiation; may continue at lower eGFR if already on treatment |
| Chronic Kidney Disease | 10 mg once daily | 10 mg once daily | Requires eGFR ≥25 for initiation; evidence supports continued use if eGFR falls below 25 |
Children
The FDA has approved dapagliflozin for type 2 diabetes in pediatric patients aged 10 years and older, at a starting dose of 5 mg once daily (which may be increased to 10 mg once daily for additional glycemic control). Dapagliflozin is not recommended for children under 10 years of age or for heart failure and CKD indications in patients under 18 years of age, as safety and efficacy have not been established in these populations.
Elderly
No dose adjustment is required based on age alone. However, elderly patients are more likely to have reduced renal function and to be taking medications that may affect renal function or volume status, such as diuretics and ACE inhibitors. Therefore, particular attention should be paid to renal function monitoring and volume status in patients over 65 years of age. Clinical trial data from DAPA-HF and DAPA-CKD included significant numbers of elderly patients, and benefits were consistent across age subgroups.
Renal Impairment
eGFR-Based Dosing Guidance
| Indication | eGFR ≥45 | eGFR 25–44 | eGFR 15–24 | eGFR <15 |
|---|---|---|---|---|
| T2D (glycemic) | Standard dosing | Do not initiate | Do not initiate | Not recommended |
| Heart Failure | Standard dosing | Standard dosing | Do not initiate* | Not recommended |
| CKD | Standard dosing | Standard dosing | Do not initiate* | Not recommended |
* May continue if already on treatment and eGFR declines below initiation threshold.
Hepatic Impairment
No dose adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh A or B). For patients with severe hepatic impairment (Child-Pugh C), limited clinical data are available; a starting dose of 5 mg is recommended, with an increase to 10 mg if well tolerated.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and take your next dose at the regular time. Do not take two doses at the same time or take extra doses to make up for a missed dose. If you miss doses frequently, discuss strategies with your healthcare provider to help you remember.
Overdose
In clinical studies, single doses up to 500 mg (50 times the maximum recommended dose) were well tolerated in healthy subjects. In the event of overdose, supportive care is recommended. Dapagliflozin is not expected to be efficiently removed by hemodialysis due to its high protein binding (approximately 91%). There is no specific antidote for dapagliflozin overdose. Monitoring for hypoglycemia, dehydration, electrolyte imbalances, and hypotension is advised.
Perioperative management: Withhold dapagliflozin for at least 3 days before scheduled major surgery or prolonged fasting to minimize the risk of perioperative diabetic ketoacidosis. Dapagliflozin may be restarted when oral intake is resumed and the patient’s clinical condition is stable.
What Are the Side Effects of Dapagliflozin?
Quick Answer: The most common side effects are genital fungal infections (affecting 7–8% of women and about 3% of men) and urinary tract infections (4–6%). Increased urination, dizziness, and rash are also common. Serious but rare side effects include diabetic ketoacidosis, Fournier’s gangrene, and acute kidney injury. Most side effects are mild-to-moderate and manageable.
Like all medications, dapagliflozin can cause side effects, although not everybody gets them. The side effect profile of dapagliflozin is well-characterized from large clinical trials involving over 30,000 patients. Most adverse effects are related to its pharmacological mechanism of action — primarily the excretion of glucose and sodium in the urine. Understanding the frequency and nature of side effects allows patients and prescribers to monitor appropriately and take preventive measures.
The side effects listed below are classified according to the MedDRA (Medical Dictionary for Regulatory Activities) frequency convention, based on data from randomized controlled trials and post-marketing surveillance:
Very Common
Affects more than 1 in 10 people
- Genital infections — vulvovaginal candidiasis in women (6.9–8.4%), balanitis in men (2.7–2.8%); classified as very common for the combined genital infection term in the EMA SmPC
Common
Affects 1 in 100 to 1 in 10 people
- Urinary tract infection (4.3–5.7%)
- Back pain (up to 4.2%)
- Increased urination, polyuria (2.9–3.8%)
- Dizziness
- Rash
- Nasopharyngitis (6.3–6.6%, similar to placebo)
- Hypoglycemia (when used with insulin or sulfonylureas)
- Mild increase in LDL cholesterol (approximately 2.9%)
- Increased hematocrit (hemoconcentration effect)
Uncommon
Affects 1 in 1,000 to 1 in 100 people
- Non-genital fungal infections
- Volume depletion (dehydration, hypovolemia, hypotension)
- Excessive thirst
- Constipation
- Dry mouth
- Nocturia (night-time urination)
- Dysuria (painful urination)
- Vulvovaginal pruritus
Rare
Affects fewer than 1 in 1,000 people
- Diabetic ketoacidosis (DKA) — including euglycemic DKA with near-normal blood glucose
- Fournier’s gangrene — necrotizing fasciitis of the perineum
- Tubulointerstitial nephritis
- Angioedema
- Increased blood creatinine
Post-Marketing Reports
The following adverse reactions have been reported during post-marketing surveillance. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency:
- Acute kidney injury
- Anaphylaxis
- Severe skin reactions (rare reports within the broader SGLT2 inhibitor class)
- Phimosis
When to seek immediate medical attention: Contact your healthcare provider immediately if you experience signs of ketoacidosis (nausea, vomiting, abdominal pain, excessive tiredness, difficulty breathing), severe genital or perineal pain with fever, signs of a severe allergic reaction (swelling of face, lips, tongue, or throat; difficulty breathing), or significantly reduced urine output.
Managing Common Side Effects
Many common side effects of dapagliflozin can be prevented or effectively managed with appropriate measures. Adequate hydration (drinking sufficient water throughout the day) helps reduce the risk of dehydration and urinary tract infections. Good genital hygiene practices can help prevent fungal infections. Patients should report recurrent or persistent infections to their healthcare provider, as treatment with appropriate antifungal or antibiotic agents may be needed. If polyuria (increased urination) is bothersome, taking the dose in the morning rather than later in the day can help minimize nocturia.
How Should You Store Dapagliflozin?
Quick Answer: Store dapagliflozin at room temperature below 30°C (86°F). Keep in the original blister packaging to protect from moisture. No refrigeration is needed. Do not use after the expiry date. Keep out of reach of children.
Proper storage of dapagliflozin ensures the medication remains effective and safe throughout its shelf life. The following guidelines apply to all formulations of dapagliflozin:
- Temperature: Store at or below 30°C (86°F). In the United States, the labeling recommends storage at 20–25°C (68–77°F), with excursions permitted to 15–30°C (59–86°F).
- Moisture protection: Keep tablets in the original blister package until time of use to protect from moisture.
- No refrigeration: Do not freeze or refrigerate. No special storage conditions beyond the temperature range are required.
- Shelf life: 3 years from the date of manufacture (as stated on the packaging).
- Expiry date: Do not use dapagliflozin after the expiry date printed on the blister and carton. The expiry date refers to the last day of that month.
- Children: Keep out of the sight and reach of children.
- Disposal: Do not dispose of medications via wastewater or household waste. Ask your pharmacist about proper medication disposal to protect the environment.
What Does Dapagliflozin Contain?
Quick Answer: Each dapagliflozin tablet contains the active substance dapagliflozin (as propanediol monohydrate) in 5 mg or 10 mg strengths. Inactive ingredients include microcrystalline cellulose, anhydrous lactose, crospovidone, silicon dioxide, magnesium stearate, and a film-coating containing polyvinyl alcohol, titanium dioxide, macrogol, talc, and yellow iron oxide.
The composition of dapagliflozin tablets is designed to ensure optimal drug delivery, stability, and bioavailability. Understanding the ingredients is particularly important for patients with known allergies or intolerances to specific excipients.
Active Substance
The active pharmaceutical ingredient is dapagliflozin, supplied as dapagliflozin propanediol monohydrate. Each 5 mg tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg of dapagliflozin. Each 10 mg tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg of dapagliflozin. Dapagliflozin has the molecular formula C21H25ClO6 (free base) and a molecular weight of 408.87 g/mol.
Inactive Ingredients (Excipients)
Tablet core:
- Microcrystalline cellulose
- Anhydrous lactose
- Crospovidone
- Silicon dioxide (colloidal anhydrous silica)
- Magnesium stearate
Film coating:
- Polyvinyl alcohol (PVA)
- Titanium dioxide (E171)
- Macrogol (polyethylene glycol)
- Talc
- Yellow iron oxide (E172)
Lactose content: Dapagliflozin tablets contain anhydrous lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Inform your healthcare provider if you have any of these conditions.
Available Brand Names and Generics
Dapagliflozin is available worldwide under several brand names and as generic formulations:
- Forxiga — AstraZeneca; EU, UK, Japan, Australia, Brazil, and most international markets
- Farxiga — AstraZeneca; United States and Canada
- Edistride — AstraZeneca; alternative brand in EU (EMA-authorized)
- Dapagliflozin Krka — KRKA d.d.; generic formulation
- Dapagliflozin Viatris — Viatris; EMA-authorized generic
- Dapagliflozin Adalvo — Adalvo; EU-approved generic
- Dapagliflozin Orion — Orion Corporation; Nordic markets
- Dapagliflozin Devatis — Devatis; select EU markets
- Dapagliflozin Reddy — Dr. Reddy’s Laboratories; multiple markets
Combination products containing dapagliflozin include Xigduo XR (dapagliflozin + metformin extended-release), Qtern (dapagliflozin + saxagliptin), and Qtrilmet (dapagliflozin + saxagliptin + metformin).
Frequently Asked Questions
Dapagliflozin is an SGLT2 inhibitor approved for three main indications: type 2 diabetes mellitus (to improve blood sugar control), heart failure (to reduce cardiovascular death and hospitalization, regardless of ejection fraction or diabetes status), and chronic kidney disease (to slow disease progression and reduce cardiovascular events). It works by blocking glucose reabsorption in the kidneys, leading to glucose excretion in the urine.
The most common side effects are genital fungal infections (vulvovaginal candidiasis in women, balanitis in men), affecting approximately 7–8% of female and 3% of male patients. Other common side effects include urinary tract infections (4–6%), increased urination, back pain, dizziness, and rash. Most side effects are mild-to-moderate and can be managed with appropriate hygiene and hydration measures.
Yes, dapagliflozin can cause diabetic ketoacidosis (DKA), including atypical cases where blood glucose levels are only mildly elevated or even normal (euglycemic DKA). Risk factors include fasting, surgery, illness, dehydration, and reduced insulin doses. Patients should stop dapagliflozin at least 3 days before scheduled surgery and seek immediate medical attention if experiencing symptoms such as nausea, vomiting, abdominal pain, or excessive fatigue.
Yes, dapagliflozin is not only safe but specifically indicated for chronic kidney disease (CKD). The DAPA-CKD trial demonstrated a 39% reduction in the risk of kidney failure, cardiovascular death, or sustained decline in kidney function. Dapagliflozin can be initiated in patients with an eGFR of 25 mL/min/1.73 m² or above for CKD or heart failure. It should not be started in patients on dialysis or with eGFR below 15 mL/min/1.73 m².
Forxiga and Farxiga are the same medication (dapagliflozin) manufactured by AstraZeneca under different brand names depending on the market. Farxiga is the brand name used in the United States and Canada, while Forxiga is used in Europe, the UK, Australia, Japan, and most other international markets. Both contain the same active ingredient (dapagliflozin propanediol monohydrate) in the same strengths and formulations. Generic versions are also available from several manufacturers.
Yes. Dapagliflozin is approved for heart failure and chronic kidney disease regardless of whether you have diabetes. The landmark DAPA-HF and DAPA-CKD trials demonstrated significant cardiovascular and kidney benefits in patients both with and without type 2 diabetes. Your doctor may prescribe dapagliflozin for heart failure or CKD even if your blood sugar levels are normal.
All information is based on international medical guidelines and peer-reviewed research: the FDA Prescribing Information for Farxiga, the EMA Summary of Product Characteristics for Forxiga, the DAPA-HF trial (NEJM 2019), the DAPA-CKD trial (NEJM 2020), the DELIVER trial (NEJM 2022), and the DECLARE-TIMI 58 trial (NEJM 2019). All medical claims have evidence level 1A, the highest quality of evidence based on randomized controlled trials.
References
- McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019;381(21):1995-2008. doi:10.1056/NEJMoa1911303
- Heerspink HJL, Stefánsson BV, Correa-Rotter R, et al. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020;383(15):1436-1446. doi:10.1056/NEJMoa2024816
- Solomon SD, McMurray JJV, Claggett B, et al. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2022;387(12):1089-1098. doi:10.1056/NEJMoa2206286
- Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019;380(4):347-357. doi:10.1056/NEJMoa1812389
- U.S. Food and Drug Administration. FARXIGA (dapagliflozin) Prescribing Information. Revised 2024. FDA Label
- European Medicines Agency. Forxiga (dapagliflozin) — Summary of Product Characteristics. EMA EPAR
- National Institute for Health and Care Excellence (NICE). Type 2 diabetes in adults: management (NG28). Updated 2024. NICE Guideline
- KDIGO 2024 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney International. 2024. KDIGO Guideline
- McDonagh TA, Metra M, Adamo M, et al. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023;44(37):3627-3639. doi:10.1093/eurheartj/ehad195
- World Health Organization. WHO Model List of Essential Medicines — 23rd List (2023). WHO EML
- British National Formulary (BNF). Dapagliflozin monograph. BNF Monograph
- U.S. Food and Drug Administration. FDA Drug Safety Communication: SGLT2 Inhibitors — Fournier’s Gangrene. 2018. FDA Safety Communication
Medical Editorial Team
Author: iMedic Medical Editorial Team — Specialists in Endocrinology, Cardiology, Nephrology, and Clinical Pharmacology
Medical Review: iMedic Medical Review Board — Independent panel of board-certified physicians reviewing content according to FDA, EMA, NICE, KDIGO, and ESC guidelines
Evidence Level: 1A — Based on systematic reviews and randomized controlled trials (DAPA-HF, DAPA-CKD, DELIVER, DECLARE-TIMI 58)
Last Updated: December 22, 2025
Editorial Standards: All content follows the GRADE evidence framework and is reviewed for accuracy by medical professionals with no conflicts of interest. iMedic receives no commercial funding or pharmaceutical company sponsorship. View our editorial standards