Boehringer Ingelheim Jardiance (empagliflozin) Monograph

Jardiance (empagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that was initially approved by the U.S. Food and Drug Administration in August 2014 as an addition to diet and exercise to improve blood sugar control in adults with type 2 diabetes. It has since received additional approvals, including indications for adults with chronic kidney disease (CKD) and type 2 diabetes mellitus (DM). Read on to learn more about Jardiance, including its warnings and precautions, dosage and administration information, and more.

Medication Overview:

• Brand Name: Jardiance
• Generic Name: Empagliflozin
• Indicated for: Adults with heart failure, adults with CKD at the risk of progression, adults with type 2 DM and established CVD, and as an adjunct to diet and exercise for improved glycemic control in adults and pediatric patients 10 years and older with type 2 DM.
• Manufacturer(s): Boehringer Ingelheim
• Initial FDA Approval: August 2014

Limitations of Use:

Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.

Not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m². 

Not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease. Jardiance is not expected to be effective in these populations.

Warnings and Precautions:

• 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 Jardiance if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. 
• 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.
• Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections: Monitor patients for signs and symptoms of genitourinary infections and treat promptly, if indicated. Immediately evaluate patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise, for necrotizing fasciitis and if suspected, discontinue Jardiance, and promptly institute appropriate medical and/or surgical intervention.
• Hypoglycemia: Adult patients taking an insulin secretagogue or insulin may have an increased risk of hypoglycemia. In pediatric patients 10 years of age and older, the risk of hypoglycemia was higher regardless of insulin use. Consider lowering the dosage of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating Jardiance.
• Lower Limb Amputation: Monitor patients for infections or ulcers of lower limbs, and institute appropriate treatment.
• 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.

Dosage and Administration:

Assess renal function before initiating and as clinically indicated. Assess volume status and correct volume depletion before initiating.

Recommended dosage is 10 mg orally once daily in the morning, taken with or without food.

For additional glycemic control, dosage may be increased to 25 mg orally once daily in patients tolerating Jardiance.

Withhold Jardiance for at least three days, if possible, prior to surgery or procedures associated with prolonged fasting.

Contraindications:

Hypersensitivity to empagliflozin or any of the excipients in Jardiance.

Drug Interactions:

See full prescribing information for information on drug interactions and interference of Jardiance with laboratory tests.

Adverse Reactions:

Most common adverse reactions (5% or greater incidence) were urinary tract infections and female genital mycotic infections.

Examples of Empagliflozin in Guidelines

Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery

• American College of Cardiology (ACC), American Heart Association (AHA), September 2024
• “In patients with HF undergoing elective NCS, sodium-glucose cotransporter-2 inhibitors (SGLT2i) should be withheld for 3 to 4 days* before surgery when feasible to reduce the risk of perioperative metabolic acidosis. *Canagliflozin, dapagliflozin, and empagliflozin should be stopped ≥3 days and ertugliflozin ≥4 days before scheduled surgery.”

Management of Patients with Lower Extremity Peripheral Artery Disease

• American College of Cardiology (ACC), American Heart Association (AHA), May 2024
• “In patients with PAD and type 2 diabetes, use of glucagon-like peptide-1 agonists (liraglutide and semaglutide) and sodium-glucose cotransporter-2 (SGLT-2) inhibitors (canagliflozin, dapagliflozin, and empagliflozin) are effective to reduce the risk of MACE.”

Please note: This article is current as of May 1, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.

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