Last reviewed 2026-05-15 · How we verify

Jardiance (empagliflozin)

SYNJARDY combines empagliflozin, which inhibits SGLT2 to increase urinary glucose excretion, and metformin HCl, which improves glucose tolerance and insulin sensitivity.

Jardiance (empagliflozin) is a small molecule Sodium-Glucose Cotransporter 2 Inhibitor developed by Boehringer Ingelheim. It targets the sodium/glucose cotransporter 2 to treat Chronic heart failure and Diabetes mellitus type 2. Jardiance was FDA approved in 2014 and is currently owned by Boehringer Ingelheim. The commercial status of Jardiance is patented, with a single generic manufacturer available. Key safety considerations include potential increased risk of diabetic ketoacidosis and genital infections.

At a glance

Mechanism of action

Empagliflozin blocks SGLT2, reducing glucose reabsorption in the kidneys and increasing its excretion. Metformin HCl enhances glucose tolerance by decreasing liver glucose production, reducing intestinal glucose absorption, and improving insulin sensitivity in tissues.

Approved indications

• Chronic heart failure
• Diabetes mellitus type 2

Boxed warnings

• WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1) ] . Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information [see Dosage and Administration (2.1) , Contraindications (4) , Warnings and Precautions (5.1) , Drug Interactions (7) , and Use in Specific Populations (8.6 , 8.7) ]. If metformin-associated lactic acidosis is suspected, immediately discontinue SYNJARDY or SYNJARDY XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions (5.1) ]. WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL. ( 5.1 ) Risk factors include renal impairment, concomitant use of certain drugs, age ≥65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. ( 5.1 ) If lactic acidosis is suspected, discontinue SYNJARDY or SYNJARDY XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. ( 5.1 )

Common side effects

• hypoglycemia
• hypoglycemia
• urinary tract infection
• nasopharyngitis
• nasopharyngitis

Key clinical trials

• Antithrombotic Activities of Sotagliflozin vs. Empagliflozin (PHASE4)
• Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)
• Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors
• SGLT2i Therapy in Islet Transplantation (SIT) (PHASE4)
• Post Marketing Surveillance of JARDIANCE in Chronic Kidney Disease
• A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension (PHASE1)
• 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 (PHASE3)
• SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism (PHASE2)

Patents

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Jardiance CI brief — competitive landscape report
• Jardiance updates RSS · CI watch RSS
• Boehringer Ingelheim portfolio CI