Empagliflozin

Empagliflozin is an inhibitor of the sodium-glucose co-transporter 2 (SGLT2), the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

• JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.ICD-10: E11.9, I50.9

• Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred [see Warnings and Precautions (5.7) ] . Patients on dialysis [see Use in Specific Populations (8.6) ] .contraindicated

Assess volume status and correct volume depletion before initiating ( 2.1 ) Recommended dose is 10 mg once daily in the morning, taken with or without food ( 2.2 ) For additional glycemic control, dose may be increased to 25 mg in patients tolerating JARDIANCE ( 2.2 ) 2.1 Prior to Initiation of JARDIANCE Assess renal function before initiating JARDIANCE and as clinically indicated [see Warnings and Precautions (5.2) ] . In patients with volume depletion, correct this condition before initiating JARDIANCE [see Warnings and Precautions (5.2) , Use in Specific Populations (8.5 , 8.6) ]. 2.2 Recommended Dosage The recommended dose of JARDIANCE is 10 mg once daily in the morning, taken with or without food. For additional glycemic control, the dose may be increased to 25 mg in patients tolerating JARDIANCE. Use for glycemic control is not recommended in patients with an eGFR less than 30 mL/min/1.73 m 2 . Data are insufficient to provide a dosing recommendation in patients; who have type 2 diabetes and established cardiovascular disease with an eGFR less than 30 mL/min/1.73 m 2 , or who have heart failure with an eGFR less than 20 mL/min/1.73 m 2 [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6) ] . JARDIANCE is contraindicated in patients on dialysis [see Contraindications (4) ] .

Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue JARDIANCE, evaluate and treat promptly. Before initiating JARDIANCE, consider risk factors for ketoacidosis. Patients on JARDIANCE may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis. ( 5.1 ) Volume Depletion: Before initiating JARDIANCE, assess volume status and renal function in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for signs and symptoms during therapy. ( 5.2 , 6.1 ) Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated ( 5.3 ) Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating JARDIANCE ( 5.4 ) Necrotizing Fasciitis of the Perineum (Fournier's Gangrene): Serious, life-threatening cases have occurred in 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 as appropriate ( 5.6 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., angioedema) have occurred with JARDIANCE. If hypersensitivity reactions occur, discontinue JARDIANCE, treat promptly, and monitor until signs and symptoms resolve.

The following important adverse reactions are described below and elsewhere in the labeling: 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) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Most common adverse reactions (5% or greater incidence) were urinary tract infections and female genital mycotic infections ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 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 practice. JARDIANCE has been evaluated in clinical trials in patients with type 2 diabetes mellitus and in patients with heart failure. The overall safety profile of JARDIANCE was generally consistent across the studied indications.

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 ) Geriatric Patients: Higher incidence of adverse reactions related to volume depletion and reduced renal function ( 5.2 , 8.5 , 8.6 ) Renal Impairment: Higher incidence of adverse reactions related to reduced renal function ( 2.2 , 5.2 , 8.6 ) 8.1 Pregnancy Risk Summary Based on animal data showing adverse renal effects, JARDIANCE is not recommended during the second and third trimesters of pregnancy. The limited available data with JARDIANCE in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ] . In animal studies, adverse renal changes were observed in rats when empagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Doses approximately 13-times the maximum clinical dose caused renal pelvic and tubule dilatations that were reversible [see Data ] . The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20% to 25% in women with HbA1c >10.

Metabolism

Absorption The pharmacokinetics of empagliflozin has been characterized in healthy volunteers and patients with type 2 diabetes and no clinically relevant differences were noted between the two populations. After oral administration, peak plasma concentrations of empagliflozin were reached at 1.5 hours post-dose.

In the event of an overdose with JARDIANCE, contact the Poison Control Center. Removal of empagliflozin by hemodialysis has not been studied.

• Aug 1, 2014NDANDA204629Boehringer Ingelheim
• Jan 30, 2015NDANDA206073Boehringer Ingelheim
• Aug 26, 2015NDANDA206111Boehringer Ingelheim
• Dec 9, 2016NDANDA208658Boehringer Ingelheim
• Jan 27, 2020NDANDA212614Boehringer Ingelheim

1. 1Diabetic Ketoacidosis4,1456.0%
2. 2Nausea3,7145.4%
3. 3Blood Glucose Increased3,4965.0%
4. 4Diarrhoea3,2304.7%
5. 5Weight Decreased3,0944.5%
6. 6Fatigue2,9234.2%
7. 7Vomiting2,8124.1%
8. 8Off Label Use2,7544.0%
9. 9Dizziness2,7283.9%
10. 10Drug Ineffective2,4363.5%
11. 11Dyspnoea2,3213.3%
12. 12Fungal Infection2,2463.2%
13. 13Euglycaemic Diabetic Ketoacidosis2,1193.1%
14. 14Urinary Tract Infection2,0242.9%
15. 15Headache1,9352.8%

The 10 most recently updated of 615 ClinicalTrials.gov registrations naming Empagliflozin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data
  Active not recruiting · Observational · 39,614 enrolled · Brigham and Women's Hospital
  NCT07599293updated 2026-06-11
• Emulation of the EMPEROR-Reduced Trial Using Healthcare Claims Data
  Active not recruiting · Observational · 23,955 enrolled · Brigham and Women's Hospital
  NCT07599345updated 2026-06-11
• A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
  Recruiting · Phase 3 · Interventional · 120 enrolled · Boehringer Ingelheim
  NCT07107945updated 2026-06-11
• EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
  Recruiting · Phase 3 · Interventional · 11,000 enrolled · Boehringer Ingelheim
  NCT06531824updated 2026-06-11
• A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart
  Recruiting · Phase 3 · Interventional · 4,200 enrolled · Boehringer Ingelheim
  NCT06935370updated 2026-06-10
• Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 500 mg Tablets Under Fed Conditions.
  Completed · Interventional · 42 enrolled · ADIUM
  NCT07633054updated 2026-06-10
• A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease
  Active not recruiting · Phase 2 · Interventional · 491 enrolled · Boehringer Ingelheim
  NCT06926660updated 2026-06-10
• Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 1000 mg Tablets Under Fed Conditions.
  Completed · Interventional · 42 enrolled · ADIUM
  NCT07633041updated 2026-06-10
• Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 5 mg / 850 mg Tablets Under Fed Conditions.
  Completed · Interventional · 42 enrolled · ADIUM
  NCT07633015updated 2026-06-10
• EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
  Recruiting · Phase 3 · Interventional · 11,800 enrolled · Boehringer Ingelheim
  NCT07064473updated 2026-06-10

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

• DapagliflozinSodium-Glucose Cotransporter 2 Inhibitor97%
• CanagliflozinSodium-glucose co-transporter 2 (SGLT2) inhibitors79%

Frequently asked questions

How does Empagliflozin work?

Empagliflozin is an inhibitor of the sodium-glucose co-transporter 2 (SGLT2), the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

What is Empagliflozin used for?

According to FDA labeling, Empagliflozin carries indications including: JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Empagliflozin?

Empagliflozin 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 Empagliflozin?

Empagliflozin is marketed under brand names including Glyxambi, Jardiance, Synjardy, Trijardy.

What are the contraindications for Empagliflozin?

Empagliflozin labeling lists contraindications including: Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred [see Warnings and Precautions (5.7) ] . Patients on dialysis [see Use in Specific Populations (8.6) ] .. Always consult the full prescribing information and a clinician.