Empagliflozin (empagliflozin)
Empagliflozin is a sglt2 inhibitor (sodium-glucose co-transporter 2 inhibitor) from Boehringer Ingelheim, co-marketed with Eli Lilly and Company (licensed from Boehringer Ingelheim International GmbH), marketed originally as Jardiance. This monograph covers approved indications, mechanism, dosing, side effects and the manufacturer landscape.
Overview
Empagliflozin is an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor from Boehringer Ingelheim, co-marketed with Eli Lilly and Company and licensed from Boehringer Ingelheim International GmbH. It is sold as Jardiance - 欧唐静 in China and Chinese-language Southeast Asian markets - with Jardiance Duo as the metformin combination. It is approved as an adjunct to diet and exercise to improve glycaemic control in adults and in children aged 10 years and older with type 2 diabetes; the dose can be raised from 10 mg to 25 mg once daily for additional glucose lowering. Beyond diabetes, the label has expanded to outcome-based indications: reducing the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure (2025 US label); reducing sustained eGFR decline, end-stage kidney disease, cardiovascular death and hospitalisation in adults with chronic kidney disease at risk of progression; and reducing cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. In the EU the EMPEROR programme supports a heart failure indication covering the full ejection fraction range, so patients without diabetes can be treated. It is not recommended for glycaemic control in type 1 diabetes, when eGFR is below 30 mL/min/1. 73 m2, or in polycystic kidney disease or after recent intravenous immunosuppression for kidney disease. Empagliflozin is off patent in many markets.
How it works
Empagliflozin blocks the SGLT2 protein in the kidney so that less glucose is reabsorbed and more leaves the body in the urine. Blood sugar falls without extra insulin, and the extra salt and water loss lowers the workload on the heart and protects the kidneys. The same effect is why it helps people with heart failure or chronic kidney disease even if they do not have diabetes.
Selective, reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2) in the proximal renal tubule, the transporter responsible for most renal glucose reabsorption. It raises urinary glucose excretion (about 64 g/day at 10 mg and 78 g/day at 25 mg once daily in patients with type 2 diabetes) and produces osmotic and natriuretic diuresis. Reduced intraglomerular pressure, improved tubular energetics and a shift to ketone-body and fatty-acid myocardial metabolism are the proposed mechanisms for the EMPA-REG OUTCOME, EMPEROR and EMPA-KIDNEY outcome benefits.
Approved indications
- To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (US 2025 label)
- To reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression
- To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease
- As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus
- In the EU (EMPEROR programme), the heart failure indication covers adults with symptomatic chronic heart failure across the full ejection fraction range
- Not recommended for glycemic control in type 1 diabetes, when eGFR is less than 30 mL/min/1. 73 m2, or in polycystic kidney disease / recent intravenous immunosuppression for kidney disease
Dosage & administration
10 mg orally once daily in the morning, with or without food, for all indications. For additional glycemic control the dose may be increased to 25 mg once daily in patients who tolerate 10 mg. Heart failure and chronic kidney disease are treated with 10 mg once daily.
Dose adjustment
Assess renal function before initiation and as clinically indicated, and correct volume depletion before starting. Use for glycemic control is not recommended if eGFR is less than 30 mL/min/1. 73 m2. Data are insufficient for a dosing recommendation in type 2 diabetes with established cardiovascular disease and eGFR less than 30, or in heart failure with eGFR less than 20. Not for use in patients on dialysis. No dose adjustment based on age, but patients 75 years and older have a higher risk of volume depletion and reduced efficacy. No dose adjustment for hepatic impairment in the US label. Withhold for at least 3 days, if possible, before surgery or procedures involving prolonged fasting.
Side effects
Urinary tract infection · Female genital mycotic (yeast) infections · Volume depletion - hypotension, dehydration, dizziness · Necrotizing fasciitis of the perineum (Fournier's gangrene) - rare and serious · Hypoglycemia when combined with insulin or an insulin secretagogue (higher risk in pediatric patients)
- Diabetic ketoacidosis - consider ketone monitoring in patients at risk; may occur with normal blood glucose
- Genitourinary infections including urosepsis and pyelonephritis
- Lower limb amputation - monitor for infections or ulcers of the lower limbs
- Hypersensitivity reactions including angioedema
Monitoring
- Renal function (eGFR) before initiation and periodically
- Volume status and blood pressure, especially in impaired renal function, elderly patients and loop diuretic users
- Blood glucose and HbA1c (reassess around 3 months when used for glycemic control)
- Ketones / symptoms of ketoacidosis in patients at risk, regardless of blood glucose
- Signs and symptoms of genitourinary infection, and urgent review for perineal pain, tenderness, erythema or swelling with fever or malaise
- Lower-limb infections or ulcers
- Signs of hypoglycemia when on insulin or a secretagogue - consider lowering their dose
Generic and biosimilar landscape
Jardiance is the innovator and reference product (10 mg and 25 mg film-coated tablets); empagliflozin itself is off patent in many markets and local manufacturers are expected to show bioequivalence of the same strengths. As of the sources reviewed, the US market had no FDA-approved generic empagliflozin, so US-sourced generic claims should be treated with caution; Indian and Bangladeshi copies are locally approved rather than FDA/EMA approved. Confirm the specific brand against the local regulator's registered-products list before making equivalence claims.
Who makes it
| Manufacturer | Country | Brand | Strength | Notes |
|---|---|---|---|---|
| Beximco Pharmaceuticals Ltd. | Bangladesh | Jardian | 10 mg, 25 mg | Listed on MedEx with the data |
| Beacon Pharmaceuticals PLC | Bangladesh | Sinjard | 10 mg, 25 mg | Listed on MedEx with the data |
| Square Pharmaceuticals PLC | Bangladesh | Emjard | 10 mg, 25 mg | Listed on MedEx with the data |
| Incepta Pharmaceuticals Ltd. | Bangladesh | Empatab | 10 mg, 25 mg | Listed on MedEx with the data |
| Renata PLC | Bangladesh | Diampa | 10 mg, 25 mg | Listed on MedEx with the data |
| Eskayef Pharmaceuticals Ltd. | Bangladesh | Emazid | 10 mg, 25 mg | Listed on MedEx with the data |
| Lupin Ltd. | India | Gibtulio | 10 mg, 25 mg | Listed on 1mg with the data |
| Cipla Ltd. | India | No Cipla empagliflozin brand confirmed from the sources reviewed in this pass - verify on the Cipla product list | ||
| Natco Pharma | India | No Natco empagliflozin brand confirmed from the sources reviewed in this pass - the Natco launches captured were dapagliflozin (Dapnat) and semaglutide |
Availability in Southeast Asia
| Country | Status | Notes |
|---|---|---|
| Bangladesh | Available - originator Jardiance plus many local generics (Beximco, Beacon, Square, Incepta, Renata, Eskayef, DBL, ACI, Opsonin, ACME, Popular, Aristopharma and others) | MedEx lists about 30 brand/strength entries; local generics expense roughly -50 per tablet versus -84 for originator Jardiance |
| Malaysia | Approved and marketed (Jardiance and Jardiance Duo) | MIMS Malaysia carries Jardiance Duo dosage information, confirming local registration of the empagliflozin/metformin combination |
| Philippines | Approved and marketed (Jardiance) | Boehringer Ingelheim Philippines publishes an empagliflozin (Jardiance) prescribing information page |
| Indonesia | Not verified in this pass | Check BPOM registration database before publishing |
| Vietnam | Not verified in this pass | Check DAV registration database |
| Thailand | Not verified in this pass | Check Thai FDA registration database |
Frequently asked questions
What is the difference between Jardiance and Farxiga or Forxiga?
Empagliflozin (SGLT2 inhibitor (sodium-glucose co-transporter 2 inhibitor), originally Jardiance (欧唐静 in China / Chinese-language SEA markets); Jardiance Duo for the metformin combination by Boehringer Ingelheim, co-marketed with Eli Lilly and Company (licensed from Boehringer Ingelheim International GmbH)) Empagliflozin blocks the SGLT2 protein in the kidney so that less glucose is reabsorbed and more leaves the body in the urine. Blood sugar falls without extra insulin, and the extra salt and water loss lowers the workload on the heart and protects the kidneys. The same effect is why it helps people with heart failure or chronic kidney disease even if they do not have diabetes. 10 mg orally once daily in the morning, with or without food, for all indications. For additional glycemic control the dose may be increased to 25 mg once daily in patients who tolerate 10 mg. Heart failure and chronic kidney disease are treated with 10 mg once daily.
What is the usual starting dose of empagliflozin?
Standard dosing for empagliflozin: 10 mg orally once daily in the morning, with or without food, for all indications. For additional glycemic control the dose may be increased to 25 mg once daily in patients who tolerate 10 mg. Heart failure and chronic kidney disease are treated with 10 mg once daily. Dose adjustments: Assess renal function before initiation and as clinically indicated, and correct volume depletion before starting. Use for glycemic control is not recommended if eGFR is less than 30 mL/min/1. 73 m2. Data are insufficient for a dosing recommendation in type 2 diabetes with established cardiovascular disease and eGFR less than 30, or in heart failure with eGFR less than 20. Not for use in patients on dialysis. No dose adjustment based on age, but patients 75 years and older have a higher risk of volume depletion and reduced efficacy. No dose adjustment for hepatic impairment in the US label. Withhold for at least 3 days, if possible, before surgery or procedures involving prolonged fasting.
Can empagliflozin be used for heart failure without diabetes?
Empagliflozin is approved for: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (US 2025 label); To reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression; To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease; As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus; In the EU (EMPEROR programme), the heart failure indication covers adults with symptomatic chronic heart failure across the full ejection fraction range. It is a empagliflozin (SGLT2 inhibitor), originally marketed as Jardiance (欧唐静 in China / Chinese-language SEA markets); Jardiance Duo for the metformin combination by Boehringer Ingelheim, co-marketed with Eli Lilly and Company (licensed from Boehringer Ingelheim International GmbH).
Does empagliflozin help chronic kidney disease?
Empagliflozin (SGLT2 inhibitor (sodium-glucose co-transporter 2 inhibitor), originally Jardiance (欧唐静 in China / Chinese-language SEA markets); Jardiance Duo for the metformin combination by Boehringer Ingelheim, co-marketed with Eli Lilly and Company (licensed from Boehringer Ingelheim International GmbH)) Empagliflozin blocks the SGLT2 protein in the kidney so that less glucose is reabsorbed and more leaves the body in the urine. Blood sugar falls without extra insulin, and the extra salt and water loss lowers the workload on the heart and protects the kidneys. The same effect is why it helps people with heart failure or chronic kidney disease even if they do not have diabetes. 10 mg orally once daily in the morning, with or without food, for all indications. For additional glycemic control the dose may be increased to 25 mg once daily in patients who tolerate 10 mg. Heart failure and chronic kidney disease are treated with 10 mg once daily.
Can I take empagliflozin with metformin?
Empagliflozin (SGLT2 inhibitor (sodium-glucose co-transporter 2 inhibitor), originally Jardiance (欧唐静 in China / Chinese-language SEA markets); Jardiance Duo for the metformin combination by Boehringer Ingelheim, co-marketed with Eli Lilly and Company (licensed from Boehringer Ingelheim International GmbH)) Empagliflozin blocks the SGLT2 protein in the kidney so that less glucose is reabsorbed and more leaves the body in the urine. Blood sugar falls without extra insulin, and the extra salt and water loss lowers the workload on the heart and protects the kidneys. The same effect is why it helps people with heart failure or chronic kidney disease even if they do not have diabetes. 10 mg orally once daily in the morning, with or without food, for all indications. For additional glycemic control the dose may be increased to 25 mg once daily in patients who tolerate 10 mg. Heart failure and chronic kidney disease are treated with 10 mg once daily.
Does empagliflozin cause yeast infections or urinary tract infections?
Empagliflozin (SGLT2 inhibitor (sodium-glucose co-transporter 2 inhibitor), originally Jardiance (欧唐静 in China / Chinese-language SEA markets); Jardiance Duo for the metformin combination by Boehringer Ingelheim, co-marketed with Eli Lilly and Company (licensed from Boehringer Ingelheim International GmbH)) Empagliflozin blocks the SGLT2 protein in the kidney so that less glucose is reabsorbed and more leaves the body in the urine. Blood sugar falls without extra insulin, and the extra salt and water loss lowers the workload on the heart and protects the kidneys. The same effect is why it helps people with heart failure or chronic kidney disease even if they do not have diabetes. 10 mg orally once daily in the morning, with or without food, for all indications. For additional glycemic control the dose may be increased to 25 mg once daily in patients who tolerate 10 mg. Heart failure and chronic kidney disease are treated with 10 mg once daily.
Is there a generic version of Jardiance available in India or Bangladesh?
Jardiance is the innovator and reference product (10 mg and 25 mg film-coated tablets); empagliflozin itself is off patent in many markets and local manufacturers are expected to show bioequivalence of the same strengths. As of the sources reviewed, the US market had no FDA-approved generic empagliflozin, so US-sourced generic claims should be treated with caution; Indian and Bangladeshi copies are locally approved rather than FDA/EMA approved. Confirm the specific brand against the local regulator's registered-products list before making equivalence claims. Manufacturers supplying empagliflozin generic versions include Beacon Pharmaceuticals PLC, Beximco Pharmaceuticals Ltd. , Cipla Ltd. , Eskayef Pharmaceuticals Ltd. , Incepta Pharmaceuticals Ltd. , Lupin Ltd. , Natco Pharma, Renata PLC. Brands registered in Bangladesh include Adempa, Ajardy, Ardance, Coport, D-Fozin, Diampa.
Should empagliflozin be stopped before surgery?
Empagliflozin (SGLT2 inhibitor (sodium-glucose co-transporter 2 inhibitor), originally Jardiance (欧唐静 in China / Chinese-language SEA markets); Jardiance Duo for the metformin combination by Boehringer Ingelheim, co-marketed with Eli Lilly and Company (licensed from Boehringer Ingelheim International GmbH)) Empagliflozin blocks the SGLT2 protein in the kidney so that less glucose is reabsorbed and more leaves the body in the urine. Blood sugar falls without extra insulin, and the extra salt and water loss lowers the workload on the heart and protects the kidneys. The same effect is why it helps people with heart failure or chronic kidney disease even if they do not have diabetes. 10 mg orally once daily in the morning, with or without food, for all indications. For additional glycemic control the dose may be increased to 25 mg once daily in patients who tolerate 10 mg. Heart failure and chronic kidney disease are treated with 10 mg once daily.
Can empagliflozin be taken by children with type 2 diabetes?
Empagliflozin (SGLT2 inhibitor (sodium-glucose co-transporter 2 inhibitor), originally Jardiance (欧唐静 in China / Chinese-language SEA markets); Jardiance Duo for the metformin combination by Boehringer Ingelheim, co-marketed with Eli Lilly and Company (licensed from Boehringer Ingelheim International GmbH)) Empagliflozin blocks the SGLT2 protein in the kidney so that less glucose is reabsorbed and more leaves the body in the urine. Blood sugar falls without extra insulin, and the extra salt and water loss lowers the workload on the heart and protects the kidneys. The same effect is why it helps people with heart failure or chronic kidney disease even if they do not have diabetes. 10 mg orally once daily in the morning, with or without food, for all indications. For additional glycemic control the dose may be increased to 25 mg once daily in patients who tolerate 10 mg. Heart failure and chronic kidney disease are treated with 10 mg once daily.
Sources
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204629s063lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s042lbl.pdf
- https://www.ema.europa.eu/en/documents/product-information/jardiance-epar-product-information_en.pdf
- https://patient.boehringer-ingelheim.com/us/products/jardiance/taking-jardiance/dosing
- https://pro.boehringer-ingelheim.com/ph/metabolic-hf/empagliflozin/prescribing-information/empagliflozin-jardiance-prescribing-information-test
- https://www.mims.com/malaysia/drug/info/jardiance%20duo/dosage
- https://medex.com.bd/generics/1275/empagliflozin/brand-names
- https://medex.com.bd/brands/26447/jardiance-10-mg-tablet
- https://www.1mg.com/generics/empagliflozin-404140
- https://www.medsafe.govt.nz/profs/datasheet/j/jardiancetab.pdf
- https://www.medicines.org.uk/emc/product/7607/smpc
This page is an information resource for healthcare professionals, licensed importers and patients under medical care. It is not medical advice, not a prescription service, and not an offer to sell prescription medicines to the public.
Related molecules in the same therapeutic area
Need a verified quotation?
Send us the molecule, strength, pack size, quantity and destination country. We reply with a batch-traceable quotation, certificates of analysis and shipping documentation.
We supply licensed pharmacies, hospitals, importers and distributors — not direct-to-consumer patients.
