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Empagliflozin Side Effects

In Summary

Commonly reported side effects of empagliflozin 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

Along with its needed effects, empagliflozin 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

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

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.[Ref]

Common (1% to 10%): Increased low-density lipoprotein cholesterol
Frequency not reported: Hypoglycemia
Postmarketing reports: Diabetic ketoacidosis, ketoacidosis[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[Ref]

Cardiovascular

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

Uncommon (0.1% to 1%): Volume depletion[Ref]

Hypersensitivity

Postmarketing reports: Angioedema

Dermatologic

Common (1% to 10%): Pruritus
Postmarketing reports: Skin reactions including rash, urticaria[Ref]

Gastrointestinal

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

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

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

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):

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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