Jardiance

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:

More common

• Bladder pain
• bloody or cloudy urine
• change in the color, amount, or odor of vaginal discharge
• difficult, burning, or painful urination
• frequent urge to urinate
• itching, stinging, or redness of the vaginal area
• lower back or side pain
• pain during sexual intercourse

Less common

• Discharge with a strong odor from the penis
• increased volume of pale, dilute urine
• redness, itching, swelling, or pain around the penis
• waking to urinate at night

Rare

• Anxiety
• blurred vision
• chills
• cold sweats
• confusion
• decreased urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• headache
• increased hunger
• nausea
• nightmares
• rapid breathing
• seizures
• shakiness
• slurred speech
• sweating
• unusual tiredness or weakness

Incidence not known

• Dry mouth
• fever
• flushed, dry skin
• fruit-like breath odor
• increased thirst
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• loss of consciousness
• stomach pain
• troubled breathing
• unexplained weight loss
• vomiting
• weight gain

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

• Body aches or pain
• cough
• loss of voice
• muscle pain or stiffness
• nasal congestion

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