Empagliflozin Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 5, 2023.

Applies to empagliflozin: oral tablet.

Serious side effects of Empagliflozin

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
• itching, skin rash
• 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
• redness of the skin
• stomach pain
• sunken eyes
• trouble breathing
• unexplained weight loss
• vomiting
• weight gain
• wrinkled skin

Other side effects of Empagliflozin

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
• runny or stuffy nose
• sneezing

For Healthcare Professionals

Applies to empagliflozin: oral tablet.

General

The most common adverse reactions (incidence of greater than 5%) were urinary tract infections, female genital mycotic infections, hypoglycemia, and adverse reactions related to volume depletion. Pediatric patients experienced a higher incidence of hypoglycemia.^[Ref]

Cardiovascular

Postmarketing reports: Hypotension

Dermatologic

Common (1% to 10%): Pruritus, rash

Postmarketing reports: Skin reactions including angioedema and urticaria

Gastrointestinal

Common (1% to 10%): Nausea

Postmarketing reports: Constipation

Genitourinary

Very common (10% or more): Female urinary tract infections (up to 18.4%)

Common (1% to 10%): Female genital mycotic infections, increased urination, male urinary tract infections

Uncommon (0.1% to 1%): Phimosis, male genital mycotic infections, nocturia, dysuria

Postmarketing reports: Urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene)

Hematologic

Common (1% to 10%): Increased hematocrit

Hepatic

Frequency not reported: Hepatic injury

Hypersensitivity

Postmarketing reports: Angioedema, hypersensitivity reactions

Metabolic

Very common (10% or more): Hypoglycemia, especially in combination with other glucose lowering therapies (up to 41.3%), adverse reactions related to volume depletion (up to 11.4%)

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

Postmarketing reports: Ketoacidosis

The risk of hypoglycemia (i.e., blood glucose less than 54 mg/dL) was higher in pediatric patients.

Reactions related to volume depletion included decreased ambulatory blood pressure, decreased systolic blood pressure, dehydration, hypotension, hypovolemia, orthostatic hypotension, and syncope with the highest rates occurring in patients with heart failure.

In clinical studies, ketoacidosis was not immediately recognized, especially in patients with type 1 diabetes, and treatment was delayed because presenting blood glucose levels were lower (often less than 250 mg/dL [14 mmol/l]) than those typically expected. In some, but not all cases, patients had an identifiable precipitating risk factor for ketoacidosis

Musculoskeletal

Common (1% to 10%): Arthralgia

Other

Common (1% to 10%): Thirst

Frequency not reported: Lower limb amputation

Renal

Very rare (less than 0.01%): Tubulo-interstitial nephritis

Frequency not reported: Increased serum creatinine, decreased estimated GFR

Postmarketing reports: Acute kidney injury, urosepsis, pyelonephritis

Respiratory

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

Frequently asked questions

• How long does it take for Jardiance to work?

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.

Medical Disclaimer