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Jardiance (empagliflozin) is an oral diabetes medicine that helps control blood sugar levels. Empagliflozin works by helping the kidneys get rid of glucose from your bloodstream.
Jardiance is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Jardiance is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.
Jardiance is not for treating type 1 diabetes.
You should not use Jardiance if you have severe kidney disease or if you are on dialysis, or if you have diabetic ketoacidosis.
Taking Jardiance can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).
Jardiance can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.
You should not use Jardiance if you are allergic to empagliflozin, or if you have:
severe kidney disease (or if you are on dialysis).
To make sure Jardiance is safe for you, tell your doctor if you have ever had:
liver or kidney disease;
bladder infections or other urination problems;
low blood pressure;
heart problems;
problems with your pancreas, including surgery;
if you drink alcohol often; or
if you are on a low salt diet.
Follow your doctor's instructions about using this medicine if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.
You should not use Jardiance during the second or third trimester of pregnancy.
You should not breast-feed while using this medicine.
Jardiance is not approved for use by anyone younger than 18 years old.
Jardiance is usually taken once per day in the morning. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
You may take Jardiance with or without food.
Call your doctor if you are sick with vomiting or diarrhea, if you consume less food or fluid than usual, or if you are sweating more than usual.
Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. Empagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have ketones in the urine.
Low blood sugar (hypoglycemia) can happen to anyone who has diabetes. Symptoms may include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.
Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using empagliflozin.
Jardiance is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.
Store at room temperature away from moisture and heat.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
Get emergency medical help if you have signs of an allergic reaction to Jardiance: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical attention right away if you have signs of a genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.
Call your doctor at once if you have:
little or no urination;
dehydration symptoms - dizziness, weakness, feeling light-headed (like you might pass out);
ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or
signs of a bladder infection - pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back.
Older adults may be more likely to have side effects from this medicine.
Common Jardiance side effects may include:
bladder infection; or
vaginal yeast infection.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all your other medicines, especially:
insulin or other oral diabetes medications; or
a diuretic or "water pill."
This list is not complete. Other drugs may interact with empagliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Jardiance only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Jardiance (www.drugs.com/jardiance.html).
Note: This document contains side effect information about empagliflozin. Some of the dosage forms listed on this page may not apply to the brand name Jardiance.
Common side effects of Jardiance 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.
Applies to empagliflozin: oral tablet
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
Less common
Rare
Incidence not known
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
Applies to empagliflozin: oral tablet
The most common reported side effects included urinary tract infections and female genital mycotic infections.
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.
Common (1% to 10%): Increased low-density lipoprotein cholesterol
Frequency not reported: Hypoglycemia
Postmarketing reports: Diabetic ketoacidosis, ketoacidosis
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
In the 5 years (2013 to 2018) since SGLT2 inhibitor approval, 12 cases of Fournier's gangrene have been reported. Reports were almost equal in men and women (men=7; women=5), ages ranged from 38 to 78 years, and the average time to onset after starting an SGLT2 inhibitor was 9.2 months (range 7 days to 25 months). All SGLT2 inhibitor drugs except ertugliflozin were included in the reports. Ertugliflozin being the most recently approved agent, is expected to have the same risk, but insufficient patient use to assess risk. All patients were hospitalized, all required surgery, all required surgical debridement, 5 required more than 1 surgery and 1 required skin grafting. Four cases were complicated by diabetic ketoacidosis, acute kidney injury, and septic shock, leading to prolonged hospitalization, and death in 1 case. In the general population, Fournier's gangrene occurs in about 1.6 out of 100,000 males annually, with the highest incidence in men 50 to 79 years. Since diabetes is a risk factor for Fournier's gangrene, a review of the FAERS database for the last 34 years was done and only 6 cases (all males, median age 57 years) were found with several other classes of antidiabetic drugs. Findings with SGLT2 inhibitors appear to show an association over a shorter time frame and involve both males and females.
Common (1% to 10%): Female and male genital mycotic infections, urinary tract infection
Uncommon (0.1% to 1%): Phimosis
Postmarketing reports: Urosepsis, pyelonephritis, Fournier's gangrene
Volume depletion included decreased ambulatory blood pressure, decreased systolic blood pressure, dehydration, hypotension, hypovolemia, orthostatic hypotension, and syncope.
Uncommon (0.1% to 1%): Volume depletion
Postmarketing reports: Angioedema
Common (1% to 10%): Pruritus
Postmarketing reports: Skin reactions including rash, urticaria
Common (1% to 10%): Nausea
Common (1% to 10%): Increased hematocrit
Common (1% to 10%): Arthralgia
Common (1% to 10%): Upper respiratory tract infection
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Jardiance (www.drugs.com/jardiance.html).
August 9, 2016
June 26, 2020
June 25, 2020
June 27, 2020
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