Empagliflozin (Jardiance®) is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and also to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.

Empagliflozin (Jardiance®) is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
 

What is the most important information I should know about Empagliflozin (Jardiance®)?

Empagliflozin (Jardiance®) can cause serious side effects, including:
 

• Dehydration. Empagliflozin (Jardiance®) can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause patients to feel dizzy, faint, light-headed, or weak, especially when they stand up. There may be a higher risk of dehydration if the patient: has low blood pressure, take medicines to lower their blood pressure, including water pills (diuretics), are on a low salt diet, have kidney problems, are 65 years of age or older.


• Ketoacidosis (increased ketones in the blood or urine). Ketoacidosis is a serious condition and may need to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking Empagliflozin (Jardiance®), even if blood sugar is less than 250 mg/dL. Advise your patient to stop taking Empagliflozin (Jardiance®) if they present any of the following symptoms, and if possible, check for ketones in their urine: nausea, vomiting, stomach-area (abdominal) pain, tiredness, or trouble breathing.


• Serious urinary tract infections. Serious urinary tract infections can occur in people taking Empagliflozin (Jardiance®) and may lead to hospitalization. Symptoms of a urinary tract infection usually include a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis, or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.


• Vaginal yeast infection. Women who take Empagliflozin (Jardiance®) may get vaginal yeast infections. Symptoms may include vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.


• Yeast infection of the penis. Men who take Empagliflozin (Jardiance®) may get a yeast infection of the skin around the penis, especially uncircumcised males and those with chronic infections. Symptoms may include redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and /or pain in the skin around the penis.

Who should not take Empagliflozin (Jardiance®)?
 

• Do not give Empagliflozin (Jardiance®) to your patients if they are allergic to empagliflozin or any of the ingredients in Empagliflozin (Jardiance®).


• Do not give Empagliflozin (Jardiance®) if your patients have severe kidney problems or are on dialysis.

What should I check before I give Empagliflozin (Jardiance®) to my patient?
 

• Check your patient’s kidney function before and during your treatment with Empagliflozin (Jardiance®). Also check if they have liver problems; have a history of urinary tract infections or problems with urination; are going to have surgery; are eating less due to illness, surgery, or a change in diet; currently have or have had problems with the pancreas, including pancreatitis or surgery on the pancreas; drink alcohol very often, or drink a lot of alcohol in the short term (“binge” drinking); have any other medical conditions; are pregnant or plan to become pregnant. Empagliflozin (Jardiance®) may harm an unborn baby. If the patient becomes pregnant while taking Empagliflozin (Jardiance®), tell your patient to inform you as soon as possible. Ask your patient if they are breastfeeding, or plan to breastfeed. Empagliflozin (Jardiance®) may pass into breast milk and may harm the baby. Tell your patient not to breastfeed while taking Empagliflozin (Jardiance®).


• Ask your patient about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Also ask your patients if they take water pills (diuretics) or medicines that can lower blood sugar such as insulin.

What are other possible side effects of Empagliflozin (Jardiance®)?
 

• Low blood sugar (hypoglycemia): Empagliflozin (Jardiance®) when taken with sulfonylurea or insulin, can increase the risk of low blood sugar. The dose of sulfonylurea or insulin may need to be lowered. Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking or feeling jittery.


• Kidney problems. Sudden kidney injury has happened in people taking Empagliflozin (Jardiance®). Ask your patient right away if they reduce the amount they eat or drink, or if they lose liquids; for example, from vomiting, diarrhea, or being in the sun too long.


• Allergic (hypersensitivity) reactions. Symptoms of serious allergic reactions to Empagliflozin (Jardiance®) may include: swelling of the face, lips, throat and other areas of the skin, difficulty with swallowing or breathing, raised, red areas on the skin (hives). If any of these symptoms are present, tell your patient to stop taking Empagliflozin (Jardiance®) and go to the nearest emergency room right away.


• Increased fats in the blood (cholesterol).

 

The most common side effects of Empagliflozin (Jardiance®) include urinary tract infections and yeast infections in females.

For more information, please see Prescribing Information and Patient Information.