Empagliflozin Side Effects
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
Adults: The most common reported side effects included volume depletion (especially in heart failure patients), urinary tract infections, and female genital mycotic infections.
Pediatric: A very common adverse effect included hypoglycemia (19.2%) and was higher in the pediatric population regardless of concomitant insulin use.[Ref]
Cardiovascular
Very common (10% or more): Adverse reactions related to volume depletion (up to 11.4%), including blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolemia, orthostatic hypotension, and syncope
Postmarketing reports: Hypotension[Ref]
Dermatologic
Common (1% to 10%): Pruritus
Postmarketing reports: Skin reactions including rash, urticaria[Ref]
Gastrointestinal
Common (1% to 10%): Nausea
Postmarketing reports: Constipation[Ref]
Genitourinary
Common (1% to 10%): Female genital mycotic infections, urinary tract infection including asymptomatic bacteriuria, cystitis
Uncommon (0.1% to 1%): Phimosis, male genital mycotic infections
Postmarketing reports: Urosepsis, pyelonephritis, Fournier's gangrene[Ref]
Hematologic
Common (1% to 10%): Increased hematocrit[Ref]
Hepatic
Frequency not reported: Hepatic injury
Hypersensitivity
Postmarketing reports: Angioedema, hypersensitivity reactions
Metabolic
Very common (10% or more): Hypoglycemia with the highest rates occurring in combination with multi-dose insulin with or without metformin (up to 41.3%)
Common (1% to 10%): Increased low-density lipoprotein cholesterol, dyslipidemia
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 up to 39.8% of patients taking the 10 mg dose and up to 41.3% 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]
Musculoskeletal
Common (1% to 10%): Arthralgia[Ref]
Other
Common (1% to 10%): Thirst[Ref]
Renal
Common (1% to 10%): Increased urination, including polyuria, pollakiuria, and nocturia
Uncommon (0.1% to 1%): Dysuria
Very rare (less than 0.01%): Tubulo-interstitial nephritis
Frequency not reported: Increased serum creatinine, decreased eGFR
Postmarketing reports: Acute kidney injury, urosepsis, pyelonephritis[Ref]
Respiratory
Common (1% to 10%): Upper respiratory tract infection[Ref]
Frequently asked questions
More about empagliflozin
- Check interactions
- Compare alternatives
- Reviews (336)
- Dosage information
- During pregnancy
- Drug class: SGLT-2 inhibitors
- Breastfeeding
- En español
Patient resources
Other brands
Professional resources
Other brands
Related treatment guides
References
1. Cerner Multum, Inc. UK Summary of Product Characteristics.
2. Cerner Multum, Inc. Australian Product Information.
3. Product Information. Jardiance (empagliflozin). Boehringer Ingelheim. 2014.
4. Product Information. Jardiance (empagliflozin). Boehringer Ingelheim. 2023;SUPPL-42.
5. FDA. FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes. https://www.fda.gov/downloads/Drugs/DrugSafety/UCM618466.pdf 2018.
6. 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 http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm446994.htm 2015.
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.