Dapagliflozin

Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2.

• FARXIGA (dapagliflozin) is indicated: • To reduce 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. • To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure.ICD-10: I50.9, N18.9

• • History of a serious hypersensitivity reaction to FARXIGA, such as anaphylactic reactions or angioedema [see Adverse Reactions (6.1) ] . • History of serious hypersensitivity reaction to FARXIGA.contraindicated

• Assess volume status and correct volume depletion before initiating. (2.1) eGFR (mL/min/1.73 m 2 ) Recommended Dose eGFR 45 or greater To improve glycemic control, the recommended starting dose is 5 mg orally once daily. Dose can be increased to 10 mg orally once daily for additional glycemic control. For all other indications, the recommended starting dose is 10 mg orally once daily. eGFR 25 to less than 45 10 mg orally once daily eGFR less than 25 Initiation is not recommended; however, patients may continue 10 mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death and hHF. • Withhold FARXIGA for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. (2.3) 2.1 Prior to Initiation of FARXIGA Assess renal function prior to initiation of FARXIGA therapy and then as clinically indicated [see Warnings and Precautions (5.2) ]. Assess volume status. In patients with volume depletion, correct this condition before initiating FARXIGA [see Warnings and Precautions (5.2) and Use in Specific Populations (8.5 , 8.6) ] . 2.2 Recommended Dosage See Table 1 for dosage recommendations based on estimated glomerular filtration rate (eGFR). Table 1: Recommended Dosage eGFR (mL/min/1.73 m 2 ) Recommended Dose eGFR 45 or greater To improve glycemic control, the recommended starting dose is 5 mg orally once daily.

• Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue FARXIGA if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. (5.1) • Volume depletion: Before initiating FARXIGA, assess volume status and renal function in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. ( 5.2 ) • Urosepsis and Pyelonephritis: Evaluate for signs and symptoms of urinary tract infections and treat promptly, if indicated. (5.3) • Hypoglycemia: Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with FARXIGA. (5.4) • Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases have occurred in patients with diabetes, both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment. (5.5) • Genital Mycotic Infections: Monitor and treat if indicated.

The following important adverse reactions are described below and elsewhere in the labeling: • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.1) ] • Volume Depletion [see Warnings and Precautions (5.2) ] • Urosepsis and Pyelonephritis [see Warnings and Precautions (5.3) ] • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.4) ] • Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) [see Warnings and Precautions (5.5) ] • Genital Mycotic Infections [see Warnings and Precautions (5.6) ] • Most common adverse reactions (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. FARXIGA has been evaluated in clinical trials in patients with type 2 diabetes mellitus, in patients with heart failure, and in patients with chronic kidney disease. The overall safety profile of FARXIGA was consistent across the studied indications. Severe hypoglycemia and diabetic ketoacidosis (DKA) were observed only in patients with diabetes mellitus.

• Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters. (8.1) • Lactation: Not recommended when breastfeeding. (8.2) • Geriatrics: Higher incidence of adverse reactions related to hypotension. ( 8.5 ) • Renal Impairment: Higher incidence of adverse reactions related to volume depletion. ( 8.6 ) 8.1 Pregnancy Risk Summary Based on animal data showing adverse renal effects, FARXIGA is not recommended during the second and third trimesters of pregnancy. Limited data with FARXIGA in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes and untreated heart failure in pregnancy (see Clinical Considerations ) . In animal studies, adverse renal pelvic and tubule dilatations, that were not fully reversible, were observed in rats when dapagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at all doses tested; the lowest of which provided an exposure 15-times the 10 mg clinical dose ( see Data ). The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a HbA1c greater than 7% and has been reported to be as high as 20 to 25% in women with HbA1c greater than 10%.

Metabolism

Absorption Following oral administration of dapagliflozin, the maximum plasma concentration (C max ) is usually attained within 2 hours under fasting state. The C max and AUC values increase dose proportionally with increase in dapagliflozin dose in the therapeutic dose range.

There were no reports of overdose during the clinical development program for FARXIGA. In the event of an overdose, contact the Poison Control Center. It is also reasonable to employ supportive measures as dictated by the patient’s clinical status. The removal of dapagliflozin by hemodialysis has not been studied.

• Jan 8, 2014NDANDA202293Astrazeneca Ab
• Oct 29, 2014NDANDA205649Astrazeneca Ab
• Apr 6, 2026ANDAANDA211312Sandoz
• Apr 6, 2026ANDAANDA211468Aurobindo Pharma
• Apr 6, 2026ANDAANDA211470Biocon Pharma
• Apr 6, 2026ANDAANDA211479Msn
• Apr 6, 2026ANDAANDA211478Msn
• Apr 6, 2026ANDAANDA211482Ajanta Pharma Ltd

1. 1Death7,61413%
2. 2Nausea2,5384.5%
3. 3Fatigue2,5144.4%
4. 4Diarrhoea2,3294.1%
5. 5Dizziness2,3064.1%
6. 6Dyspnoea2,1283.8%
7. 7Blood Glucose Increased2,1093.7%
8. 8Weight Decreased2,0593.6%
9. 9Off Label Use2,0173.6%
10. 10Vomiting1,8803.3%
11. 11Acute Kidney Injury1,8603.3%
12. 12Diabetic Ketoacidosis1,6903.0%
13. 13Headache1,6502.9%
14. 14Pain1,4992.6%
15. 15Malaise1,4912.6%

The 10 most recently updated of 737 ClinicalTrials.gov registrations naming Dapagliflozin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)
  Recruiting · Phase 1 · Interventional · 20 enrolled · Washington University School of Medicine
  NCT05521984updated 2026-06-10
• Dapagliflozin Versus Metformin for the Management of Antipsychotic-Induced Weight Gain: A Pragmatic Pilot Randomized Controlled Trial
  Not yet recruiting · Phase 4 · Interventional · 110 enrolled · Sultan Qaboos University
  NCT07342764updated 2026-06-10
• SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome
  Recruiting · Phase 2 · Phase 3 · Interventional · 75 enrolled · Mansoura University
  NCT07214818updated 2026-06-09
• The Fontan Dapagliflozin Pilot Study
  Enrolling by invitation · Phase 4 · Interventional · 29 enrolled · Johns Hopkins University
  NCT05741658updated 2026-06-08
• Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients
  Completed · Phase 3 · Interventional · 52 enrolled · University Health Network, Toronto
  NCT04965935updated 2026-06-08
• STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure
  Not yet recruiting · Phase 4 · Interventional · 80 enrolled · Kyungsub Song
  NCT07631156updated 2026-06-05
• Effect of Dapagliflozin on Right Ventricular-Pulmonary Artery Coupling After Off-Pump Coronary Atery Bypass Grafting
  Not yet recruiting · Observational · 72 enrolled · Pyatigorsk City Clinical Hospital Number 1
  NCT07601867updated 2026-06-04
• HF Patients With LVADs Being Treated With SGLT2i
  Completed · Phase 4 · Interventional · 32 enrolled · University of Chicago
  NCT05278962updated 2026-06-03
• A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
  Not yet recruiting · Phase 3 · Interventional · 2,800 enrolled · AstraZeneca
  NCT07624305updated 2026-06-03
• Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome
  Completed · Phase 3 · Interventional · 200 enrolled · Beni-Suef University
  NCT06405178updated 2026-06-02

Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

• EmpagliflozinSodium-Glucose Cotransporter 2 Inhibitor97%
• CanagliflozinSodium-glucose co-transporter 2 (SGLT2) inhibitors81%

Frequently asked questions

How does Dapagliflozin work?

Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2.

What is Dapagliflozin used for?

According to FDA labeling, Dapagliflozin carries indications including: FARXIGA (dapagliflozin) is indicated: • To reduce 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. • To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dapagliflozin?

Dapagliflozin is classified as Sodium-glucose co-transporter 2 (SGLT2) inhibitors, Sodium-Glucose Cotransporter 2 Inhibitor, Sodium-Glucose Transporter 2 Inhibitors, Increased Renal Organic Ion Excretion, Renal Ion Transport Alteration.

What are the brand names for Dapagliflozin?

Dapagliflozin is marketed under brand names including Farxiga, Qtern, Xigduo.

What are the contraindications for Dapagliflozin?

Dapagliflozin labeling lists contraindications including: • History of a serious hypersensitivity reaction to FARXIGA, such as anaphylactic reactions or angioedema [see Adverse Reactions (6.1) ] . • History of serious hypersensitivity reaction to FARXIGA.. Always consult the full prescribing information and a clinician.