Empagliflozin, linagliptin, and metformin (Trijardy XR) is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Trijardy XR 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.

Trijardy XR is not for treating type 1 diabetes.

Empagliflozin, linagliptin, and metformin may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to empagliflozin, linagliptin, or metformin, or if you have:

• severe kidney disease (or if you are on dialysis);
• a history of severe allergic or skin reaction after taking linagliptin; or
• metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking this medicine. Be sure your caregivers know ahead of time that you are using Trijardy XR.

Tell your doctor if you have ever had:

• liver or kidney disease;
• a bladder infection or urination problems;
• a pancreas disorder;
• congestive heart failure, a heart attack or stroke;
• gallstones;
• a genital infection (penis or vagina);
• alcoholism, or if you currently drink large amounts of alcohol;
• high cholesterol or triglycerides;
• if you are on a low salt diet; or
• if you are 65 or older.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Ask your doctor about your risk.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

You should not use Trijardy XR during the second or third trimester of pregnancy.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

Do not breastfeed.

Not approved for use by anyone younger than 18 years old.

Use Empagliflozin, Linagliptin, And Metformin (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, flaking or peeling skin; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a serious 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.

Stop taking this medicine and call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• severe or ongoing pain in your joints;
• lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired;
• serious skin reaction--itching, blisters, breakdown of the outer layer of skin;
• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;
• dehydration--dizziness, confusion, feeling very thirsty, less urination;
• signs of a bladder infection--pain or burning when you urinate, blood in your urine, pain in pelvis or back; or
• symptoms of heart failure--shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common side effects may include:

• stomach pain, diarrhea, constipation;
• a bladder infection;
• headache; or
• cold symptoms such as runny or stuffy nose, sneezing, sore throat.

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.

Avoid drinking alcohol. It may increase your risk of lactic acidosis.