Ertugliflozin and sitagliptin 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 sitagliptin may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to ertugliflozin o sitagliptin, or if you have:

• severe kidney problems, end stage renal disease, or if you are on dialysis.

Tell your doctor if you have ever had:

• diabetic ketoacidosis;
• liver or kidney disease;
• a bladder infection or urination problems;
• problems with your pancreas, including surgery;
• a diabetic foot ulcer or amputation;
• heart problems, high or low blood pressure;
• blood circulation problems, especially in your legs;
• nerve damage in your legs;
• gallstones;
• high triglycerides (a type of fat in blood);
• alcoholism;
• type 1 diabetes; or
• if you are eating less, there is a change in your diet, or 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 ertugliflozin and sitagliptin during the second or third trimester of pregnancy.

You should not breastfeed while using this medicine.

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

Use Ertugliflozin And Sitagliptin (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 in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

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

Call your doctor at once if you have:

• severe autoimmune reaction--itching, blisters, breakdown of the outer layer of skin;
• new pain, tenderness, sores, ulcers, or infections in your legs or feet;
• severe or ongoing pain in your joints;
• little or no urination;
• 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);
• signs of a bladder infection--pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back;
• symptoms of heart failure--shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain; or
• symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, with or without nausea and vomiting.

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

Common side effects may include:

• urinating more than usual;
• upset stomach, diarrhea;
• headache; or
• cold symptoms such as 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.

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