Jardiance (Empagliflozin) Regulatory Status: US, EU, Canada, and UK Approvals

United States: FDA approval and current label

Drugs@FDA records the original approval of Jardiance (empagliflozin) 10 mg and 25 mg tablets under NDA 204629 on August 1, 2014 [2]. The approval history also lists efficacy-new-indication supplements on August 18, 2021, February 24, 2022 and September 21, 2023 [2]. The current label, effective January 30, 2026, lists four uses: reduce cardiovascular death and hospitalization for heart failure in adults with heart failure; reduce sustained eGFR decline, end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease at risk of progression; reduce cardiovascular death in adults with type 2 diabetes and established cardiovascular disease; and improve glycemic control in adults and children aged 10 and older with type 2 diabetes [1].

The heart failure indication is written for adults with heart failure without an ejection fraction cutoff in the indication statement [1]. The label does not include a weight-loss indication [1]. The label says it is not recommended for glycemic control in type 1 diabetes or for glycemic control in type 2 diabetes when eGFR is under 30 mL/min/1.73 m2 [1].

European Union: EMA authorisation

The EMA page for Jardiance says the medicine is authorised in the EU for type 2 diabetes, chronic heart failure and chronic kidney disease [3]. In type 2 diabetes it is used in adults whose condition is not controlled well enough, with diet and exercise when metformin cannot be taken, or as add-on treatment [3]. In chronic heart failure it is used in adults to treat symptoms; in chronic kidney disease it is used in adults [3]. The recommended dose is 10 mg once daily for all three uses, and for type 2 diabetes the dose may be increased in suitable patients [3].

Canada and the UK

Health Canada and MHRA approval dates and indications for empagliflozin are not covered on this page.

Safety items on the US label

The Jardiance label's Warnings and Precautions section names ketoacidosis, including with blood glucose below 250 mg/dL; volume depletion and acute kidney injury; genitourinary infections including urosepsis, pyelonephritis and Fournier's gangrene; hypoglycemia with insulin or sulfonylureas; lower limb amputation; and serious hypersensitivity including angioedema [1]. Across four Jardiance outcome trials, amputation rates were 5.0 vs 4.3 events per 1,000 patient-years (HR 1.05, 95% CI 0.81 to 1.36) [1].