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Jardiance Side Effects

Generic name: empagliflozin

Medically reviewed by Philip Thornton, DipPharm. Last updated on Sep 17, 2023.

Note: This document contains side effect information about empagliflozin. Some dosage forms listed on this page may not apply to the brand name Jardiance.

Applies to empagliflozin: oral tablet.

Serious side effects of Jardiance

Along with its needed effects, empagliflozin (the active ingredient contained in Jardiance) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking empagliflozin:

More common

Less common

Rare

Incidence not known

Other side effects of Jardiance

Some side effects of empagliflozin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

For Healthcare Professionals

Applies to empagliflozin: oral tablet.

General

Adults: The most common reported side effects included volume depletion (especially in heart failure patients), urinary tract infections, and female genital mycotic infections.

Pediatric: A very common adverse effect included hypoglycemia (19.2%) and was higher in the pediatric population regardless of concomitant insulin use.[Ref]

Cardiovascular

Very common (10% or more): Adverse reactions related to volume depletion (up to 11.4%), including blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolemia, orthostatic hypotension, and syncope

Postmarketing reports: Hypotension[Ref]

Dermatologic

Common (1% to 10%): Pruritus

Postmarketing reports: Skin reactions including rash, urticaria[Ref]

Gastrointestinal

Common (1% to 10%): Nausea

Postmarketing reports: Constipation[Ref]

Genitourinary

Common (1% to 10%): Female genital mycotic infections, urinary tract infection including asymptomatic bacteriuria, cystitis

Uncommon (0.1% to 1%): Phimosis, male genital mycotic infections

Postmarketing reports: Urosepsis, pyelonephritis, Fournier's gangrene[Ref]

Hematologic

Common (1% to 10%): Increased hematocrit[Ref]

Hepatic

Frequency not reported: Hepatic injury

Hypersensitivity

Postmarketing reports: Angioedema, hypersensitivity reactions

Metabolic

Very common (10% or more): Hypoglycemia with the highest rates occurring in combination with multi-dose insulin with or without metformin (up to 41.3%)

Common (1% to 10%): Increased low-density lipoprotein cholesterol, dyslipidemia

Frequency not reported: Hypoglycemia

Postmarketing reports: Diabetic ketoacidosis, ketoacidosis[Ref]

Frequency of hypoglycemia depended on the type of background therapy used. In combination with metformin and sulfonylurea, hypoglycemia was reported in 16.1% of patients taking the 10 mg dose and 11.5% in patients taking the 25 mg dose. In combination with insulin, hypoglycemia was reported in up to 39.8% of patients taking the 10 mg dose and up to 41.3% in patients taking the 25 mg dose.

Reports of ketoacidosis have been identified during postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving SGLT2 inhibitors including this drug. For many of the reports, especially among patients with type 1 diabetes, ketoacidosis was not immediately recognized and treatment was delayed because presenting blood glucose levels were lower (often less than 250 mg/dL [14 mmol/l]) than those typically expected. Signs and symptoms on presentation were consistent with ketoacidosis and included nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. In some, but not all cases, patients had an identifiable risk factor such as insulin dose reduction, acute febrile illness, reduced caloric intake, surgery, pancreatic disorder suggesting insulin deficiency (e.g., type 1 diabetes, history of pancreatitis or pancreatic surgery), and alcohol abuse.[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia[Ref]

Other

Common (1% to 10%): Thirst[Ref]

Renal

Common (1% to 10%): Increased urination, including polyuria, pollakiuria, and nocturia

Uncommon (0.1% to 1%): Dysuria

Very rare (less than 0.01%): Tubulo-interstitial nephritis

Frequency not reported: Increased serum creatinine, decreased eGFR

Postmarketing reports: Acute kidney injury, urosepsis, pyelonephritis[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection[Ref]

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Jardiance (empagliflozin). Boehringer Ingelheim. 2014.

4. Product Information. Jardiance (empagliflozin). Boehringer Ingelheim. 2023;SUPPL-42.

5. FDA. FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes. https://www.fda.gov/downloads/Drugs/DrugSafety/UCM618466.pdf 2018.

6. FDA. U.S. Food and Drug Administration. FDA: SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm446994.htm 2015.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer