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Jardiance Side Effects

Generic Name: empagliflozin

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.

In Summary

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.

For the Consumer

Applies to empagliflozin: oral tablet

Side effects requiring immediate medical attention

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 genitals
  • loss of appetite
  • loss of consciousness
  • pain, tenderness, redness, or swelling of the area between the anus and genitals
  • stomach pain
  • troubled breathing
  • unexplained weight loss
  • vomiting
  • weight gain

Side effects not requiring immediate medical attention

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

For Healthcare Professionals

Applies to empagliflozin: oral tablet

General

The most common reported side effects included urinary tract infections and female genital mycotic infections.[Ref]

Metabolic

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

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 22.5% of patients taking the 10 mg dose and 29.7% 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]

Renal

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[Ref]

Genitourinary

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[Ref]

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.[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Volume depletion

Postmarketing reports: Hypotension[Ref]

Volume depletion included decreased ambulatory blood pressure, decreased systolic blood pressure, dehydration, hypotension, hypovolemia, orthostatic hypotension, and syncope.[Ref]

Hypersensitivity

Postmarketing reports: Angioedema, hypersensitivity reactions

Dermatologic

Common (1% to 10%): Pruritus

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

Gastrointestinal

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

Hepatic

Frequency not reported: Hepatic injury

Hematologic

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

Musculoskeletal

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

Respiratory

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

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Jardiance (empagliflozin)." Boehringer Ingelheim, Ridgefield, CT.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. 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 Available from: URL: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm44699" (2015 May 15):

5. FDA "FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes. Available from: URL: https://www.fda.gov/downloads/Drugs/DrugSafety/UCM618466.pdf." ([2018, Aug 29]):

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.

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