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Empagliflozin Side 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
  • frequent or painful urination
  • fruit-like breath odor
  • increased thirst
  • loss of appetite
  • loss of consciousness
  • stomach pain
  • swelling of the face, fingers, or lower legs
  • 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

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]

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[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: Acidosis including diabetic ketoacidosis, ketoacidosis, or ketosis[Ref]

General

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

Dermatologic

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

Gastrointestinal

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

Hematologic

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

Musculoskeletal

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

Other

Common (1% to 10%): Polydipsia[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):

Some side effects of empagliflozin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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