SYNJARDY is a prescription medicine that contains 2 diabetes medicines, empagliflozin (JARDIANCE) and metformin HCl immediate-release. SYNJARDY XR is a prescription medicine that contains 2 diabetes medicines, empagliflozin (JARDIANCE) and metformin HCl extended-release. SYNJARDY can be used along with diet and exercise to improve blood sugar in adults and children who are 10 years of age and older with type 2 diabetes. SYNJARDY XR can be used along with diet and exercise to improve blood sugar in adults with type 2 diabetes.
One of the medicines in SYNJARDY and SYNJARDY XR, empagliflozin (JARDIANCE), can also be used in adults with type 2 diabetes:
- who have known cardiovascular disease to reduce the risk of cardiovascular death
- who have heart failure (when the heart cannot pump enough blood to the rest of your body) to reduce the risk of cardiovascular death and hospitalization for heart failure
- to reduce the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization in adults with chronic kidney disease
SYNJARDY or SYNJARDY XR is not for use to lower blood sugar in people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in the blood or urine).
SYNJARDY or SYNJARDY XR is only for use in people with type 2 diabetes, because they contain the prescription medicine metformin hydrochloride (HCl).
One of the medicines in SYNJARDY or SYNJARDY XR, empagliflozin (JARDIANCE), is not for people with polycystic kidney disease, or who are taking or have recently received certain types of immunosuppressive therapy to treat kidney disease. Empagliflozin (JARDIANCE) is not expected to work if you have these conditions.
SYNJARDY or SYNJARDY XR can cause serious side effects, including:
Lactic acidosis (a build‐up of lactic acid in the blood). Metformin HCl, one of the medicines in SYNJARDY and SYNJARDY XR, can cause lactic acidosis, a rare but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.
Stop taking SYNJARDY or SYNJARDY XR and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms of lactic acidosis: feel very weak and tired; have unusual (not normal) muscle pain; have trouble breathing; have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea; have unusual sleepiness or sleep longer than usual; feel cold, especially in your arms and legs; feel dizzy or lightheaded; have a slow or irregular heartbeat.
You have a higher chance of getting lactic acidosis with SYNJARDY or SYNJARDY XR if you: have moderate to severe kidney problems; have liver problems; drink a lot of alcohol (very often or short term “binge” drinking); get dehydrated (lose a large amount of body fluids); have certain x-ray tests with injectable dyes or contrast agents; have surgery or other procedure for which you need to restrict the amount of food and liquid you eat and drink; have congestive heart failure; have a heart attack, severe infection, or stroke, or are 65 years of age or older.
Do not take SYNJARDY or SYNJARDY XR if you:
have severe kidney problems
have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine)
are allergic to empagliflozin (JARDIANCE), metformin HCl, or any of the ingredients in SYNJARDY or SYNJARDY XR. Symptoms of an allergic reaction may include:
- rash
- raised, red areas on your skin (hives)
- swelling of your face, lips, mouth, and throat that may cause difficulty in breathing or swallowing
If you have any of these symptoms, stop taking SYNJARDY or SYNJARDY XR and call your healthcare provider right away or go to the nearest hospital emergency room.
SYNJARDY or SYNJARDY XR may cause serious side effects, including:
Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 and other ketoacidosis. SYNJARDY or SYNJARDY XR can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who: are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Stop taking SYNJARDY or SYNJARDY XR and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL:
- nausea
- vomiting
- stomach-area (abdominal) pain
- tiredness
- trouble breathing
- ketones in your urine or blood
Dehydration. SYNJARDY or SYNJARDY XR can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light‐headed, or weak, especially when you stand up. Sudden worsening of kidney function has happened in people who are taking SYNJARDY or SYNJARDY XR. You may be at higher risk of dehydration if you:
- take medicines to lower your blood pressure, including water pills (diuretics)
- are on a low salt diet
- have kidney problems
- are 65 years of age or older
Talk to your healthcare provider about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, if you are sick or cannot eat, or start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long.
Genital and urinary tract infections. Empagliflozin, one of the medicines in SYNJARDY and SYNJARDY XR, can cause serious infections in your genital area or urinary tract that could require hospitalization. A rare but serious bacterial infection called necrotizing fasciitis can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). This infection may require hospitalization, multiple surgeries, and could lead to death. Seek medical attention immediately if you have a fever or you are feeling very weak, tired, or uncomfortable (malaise), and you develop pain or tenderness, swelling, or redness of skin (erythema) in the area between and around your anus and genitals. Also tell your healthcare provider if you have any of these signs or symptoms of infections:
Urinary tract infection:
- burning feeling when you urinate
- need to urinate often or right away
- pain in the lower part of your stomach (pelvis)
- blood in your urine
You may also have a fever, back pain, nausea, or vomiting.
Vaginal yeast infection:
- vaginal odor
- white or yellowish vaginal discharge (may be lumpy or look like cottage cheese)
- vaginal itching
Yeast infection of the skin around the penis: Swelling of an uncircumcised penis may make it difficult to pull back the skin around the tip of your penis. Other symptoms include:
- redness, itching, or swelling of the penis
- bad smelling discharge from the penis
- rash on the penis
- pain in the skin around the penis.
Talk to your healthcare provider about what to do if you get symptoms of a yeast infection. They may suggest you use an over-the-counter antifungal medicine. Contact your healthcare provider right away if your symptoms do not improve after using an over-the-counter antifungal medicine.
Low blood sugar (hypoglycemia). In adults, if you take SYNJARDY or SYNJARDY XR with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. In children 10 years of age and older, the risk for low blood sugar is higher with SYNJARDY even if you do not use another medicine that can lower blood sugar. The dose of your sulfonylurea medicine or insulin may need to be lowered. Symptoms of low blood sugar may include headache, drowsiness, weakness, irritability, hunger, fast heartbeat, confusion, shaking or feeling jittery, dizziness, or sweating.
Amputations. SGLT2 inhibitors may increase your risk of lower limb amputations. You may be at a higher risk of lower limb amputation if you:
- have a history of amputation
- have blocked or narrowed blood vessels, usually in your leg
- have had diabetic foot infection, ulcers, or sores
Call your healthcare provider right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Talk to your healthcare provider about proper foot care.
Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking SYNJARDY or SYNJARDY XR and call your healthcare provider right away or go to the nearest emergency room.
Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 blood levels before. Your healthcare provider may do blood tests to check your vitamin B12 levels.
The most common side effects of SYNJARDY or SYNJARDY XR include urinary tract infections, female genital infections, diarrhea, nausea, vomiting, gas, stomach pain, indigestion, weakness, headache, and stuffy or runny nose and sore throat.
These are not all the possible side effects of SYNJARDY or SYNJARDY XR. For more information, ask your healthcare provider or pharmacist.
Before taking SYNJARDY or SYNJARDY XR, tell your healthcare provider about all of your medical conditions, including if you:
- have type 1 diabetes or have had diabetic ketoacidosis
- have a decrease in your insulin dose
- have a serious infection
- have a history of infection of the vagina or penis
- have a history of amputation
- have kidney problems
- have liver problems
- have heart problems, including congestive heart failure
- are 65 years of age or older
- have a history of urinary tract infections or problems with urination
- are on a low sodium (salt) diet. Your healthcare provider may change your diet or dose
- are going to have surgery. Your healthcare provider may stop SYNJARDY or SYNJARDY XR before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking SYNJARDY or SYNJARDY XR and when to start it again
- are eating less, or there is a change in your diet
- are dehydrated
- have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
- drink alcohol very often, or drink a lot of alcohol in the short term (“binge” drinking)
- have ever had an allergic reaction to SYNJARDY or SYNJARDY XR
- are going to get an injection of dye or contrast agents for an x‐ray procedure. SYNJARDY or SYNJARDY XR may need to be stopped for a short time. Talk to your healthcare provider about when you should stop SYNJARDY or SYNJARDY XR and when you should start SYNJARDY or SYNJARDY XR again
- have low levels of vitamin B12 in your blood
- are pregnant or plan to become pregnant. SYNJARDY or SYNJARDY XR may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking SYNJARDY or SYNJARDY XR
- are breastfeeding or plan to breastfeed. SYNJARDY or SYNJARDY XR may pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking SYNJARDY or SYNJARDY XR. Do not breastfeed while taking SYNJARDY
- are a person who has not gone through menopause (premenopausal), who does not have periods regularly or at all. SYNJARDY or SYNJARDY XR can cause the release of an egg from an ovary in a person (ovulation). This can increase your chance of getting pregnant
Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.
Please see Prescribing Information and Medication Guide for SYNJARDY and SYNJARDY XR.
CL-SY-100088 10.24.25