Jardiance Side Effects
Generic name: empagliflozin
Note: This document provides detailed information about Jardiance.
Applies to empagliflozin: oral tablet Side Effects associated with empagliflozin. Some dosage forms listed on this page may not apply specifically to the brand name Jardiance.
Applies to empagliflozin: oral tablet.
Precautions
It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.
Tell your doctor if you are pregnant or planning to become pregnant. It is not safe to take this medicine during the second and third trimester of pregnancy. It could harm an unborn baby.
Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Taking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.
Diabetic ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, or increased thirst or urination.
This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with other diabetes medicines (eg, insulin, glipizide, or glyburide). The symptoms of low blood sugar must be treated before they cause you to pass out. People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Some symptoms of low blood sugar include: behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headaches that continue, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about how to treat low blood sugar.
This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.
This medicine may increase your risk of having urinary tract infections (eg, pyelonephritis, urosepsis). Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.
This medicine may increase your risk of having lower leg or toe amputation (leg removal surgery). Check with your doctor right away if you have pain, tenderness, sores or ulcers, or infections on your leg or foot.
This medicine may cause a rare but serious bacterial infection, called necrotizing fasciitis of the perineum or Fournier's gangrene, which can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). Fournier's gangrene may lead to hospitalization, multiple surgeries, or death. Check with your doctor right away if you have fever, unusual tiredness or weakness, or pain, tenderness, redness, or swelling of the area between and around your anus and genitals.
This medicine may cause serious allergic reactions, including angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, urine glucose tests may not be accurate). Also, you may need to stop using this medicine at least 3 days before having a surgery or other procedures that require fasting.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of Jardiance
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 side effects
- 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 side effects
- 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 side effects
- 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 Jardiance
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 side effects
- 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 adverse events
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
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References
1. (2023) "Product Information. Jardiance (empagliflozin)." Boehringer Ingelheim Ltd
2. (2023) "Product Information. Jardiance (empagliflozin)." Boehringer Ingelheim, SUPPL-42
3. (2024) "Product Information. Jardiance (empagliflozin)." Boehringer Ingelheim Pty Ltd
Frequently asked questions
- How to avoid yeast infections on Jardiance?
- Does Jardiance cause weight loss?
- How long does it take for Jardiance to work?
- What does Jardiance do to your perineum?
- Can Jardiance cause kidney problems?
- How does Jardiance help with heart failure?
- What is Jardiance used for and how does it work?
- When is the best time of day to take Jardiance?
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Further information
Jardiance side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.