Note: This document contains side effect information about empagliflozin. Some of the dosage forms listed on this page may not apply to the brand name Jardiance.
Common side effects of Jardiance include: urinary tract infection. Other side effects include: vulvovaginal candidiasis, cervicitis, genital candidiasis, genitourinary infection, vaginal infection, vulvitis, and vulvovaginitis. See below for a comprehensive list of adverse effects.
Applies to empagliflozin: oral tablet
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:
Incidence not known
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:
Applies to empagliflozin: oral tablet
The most common reported side effects included urinary tract infections and female genital mycotic infections.
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 22.5% of patients taking the 10 mg dose and 29.7% in patients taking the 25 mg dose.
Twenty reports of acidosis have been identified in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database during the period March 2013 through 06 June 2014. All patients required emergency room treatment or hospitalization. These cases were not typical of ketoacidosis or diabetic ketoacidosis (DKA) in that they occurred in patients with type 2 diabetes and their blood sugar levels were only slightly increased. Some factors identified as potentially triggering the acidosis included major illness, reduced food and fluid intake, and reduced insulin dose.
Common (1% to 10%): Increased low-density lipoprotein cholesterol
Frequency not reported: Hypoglycemia
Postmarketing reports: Diabetic ketoacidosis, ketoacidosis
Common (1% to 10%): Increased urination
Uncommon (0.1% to 1%): Dysuria
Frequency not reported: Increased serum creatinine, decreased eGFR
Postmarketing reports: Acute kidney injury, urosepsis, pyelonephritis
In the 5 years (2013 to 2018) since SGLT2 inhibitor approval, 12 cases of Fournier's gangrene have been reported. Reports were almost equal in men and women (men=7; women=5), ages ranged from 38 to 78 years, and the average time to onset after starting an SGLT2 inhibitor was 9.2 months (range 7 days to 25 months). All SGLT2 inhibitor drugs except ertugliflozin were included in the reports. Ertugliflozin being the most recently approved agent, is expected to have the same risk, but insufficient patient use to assess risk. All patients were hospitalized, all required surgery, all required surgical debridement, 5 required more than 1 surgery and 1 required skin grafting. Four cases were complicated by diabetic ketoacidosis, acute kidney injury, and septic shock, leading to prolonged hospitalization, and death in 1 case. In the general population, Fournier's gangrene occurs in about 1.6 out of 100,000 males annually, with the highest incidence in men 50 to 79 years. Since diabetes is a risk factor for Fournier's gangrene, a review of the FAERS database for the last 34 years was done and only 6 cases (all males, median age 57 years) were found with several other classes of antidiabetic drugs. Findings with SGLT2 inhibitors appear to show an association over a shorter time frame and involve both males and females.
Common (1% to 10%): Female and male genital mycotic infections, urinary tract infection
Uncommon (0.1% to 1%): Phimosis
Postmarketing reports: Urosepsis, pyelonephritis, Fournier's gangrene
Volume depletion included decreased ambulatory blood pressure, decreased systolic blood pressure, dehydration, hypotension, hypovolemia, orthostatic hypotension, and syncope.
Uncommon (0.1% to 1%): Volume depletion
Postmarketing reports: Angioedema
Common (1% to 10%): Pruritus
Postmarketing reports: Skin reactions including rash, urticaria
Common (1% to 10%): Nausea
Common (1% to 10%): Increased hematocrit
Common (1% to 10%): Arthralgia
Common (1% to 10%): Upper respiratory tract infection
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Jardiance