Ertugliflozin and metformin is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. This medicine is not for treating type 1 diabetes.

Ertugliflozin 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 ertugliflozin or metformin, or if you have:

• severe kidney disease (or if you are on dialysis); or
• diabetic ketoacidosis (call your doctor for treatment).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking ertugliflozin and metformin.

Ertugliflozin may increase your risk of lower leg amputation, especially if you have had a prior amputation, a foot ulcer, heart disease, circulation problems, or nerve damage.

Tell your doctor if you have ever had:

• heart problems;
• a diabetic foot ulcer or amputation;
• circulation problems or nerve problems in your legs or feet;
• liver or kidney disease;
• high ketone levels in your blood or urine;
• bladder infections or other urination problems;
• low blood pressure;
• problems with your pancreas, including surgery;
• if you drink alcohol often; or
• if you are on a low salt diet.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. 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, and having high blood sugar may cause complications in both the mother and the baby.

You should not use this medicine 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.

You should not breastfeed while using this medicine.

Ertugliflozin and metformin is not approved for use by anyone younger than 18 years old.

Use Ertugliflozin 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; 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:

• new pain, tenderness, sores, ulcers, or infections in your legs or feet;
• little or no urination;
• lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired;
• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
• dehydration symptoms--dizziness, weakness, feeling light-headed (like you might pass out); 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.

Some side effects may be more likely to occur in older adults.

Common side effects may include:

• genital yeast infection;
• stomach discomfort;
• nausea, vomiting, diarrhea, gas;
• headache, weakness; or
• urinating more than usual.

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 lowers blood sugar and may increase your risk of lactic acidosis.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.