Kombiglyze XR Side Effects

Generic name: metformin / saxagliptin

Note: This document contains side effect information about metformin / saxagliptin. Some of the dosage forms listed on this page may not apply to the brand name Kombiglyze XR.

Some side effects of Kombiglyze XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to metformin / saxagliptin: oral tablet extended release

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.

Get emergency medical help if you have any of these signs of an allergic reaction while taking metformin / saxagliptin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

• pain or burning when you urinate; or

• swelling or rapid weight gain.

Less serious side effects of metformin / saxagliptin may include:

• diarrhea, mild nausea;

• 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.

For Healthcare Professionals

Applies to metformin / saxagliptin: oral tablet extended release

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea, vomiting, abdominal pain, and gastroenteritis.

Metabolic

Metabolic side effects have included hypoglycemia.

Nervous system

Nervous system side effects have included headache.

Hypersensitivity

Hypersensitivity side effects have included urticaria and facial edema.

Respiratory

Respiratory side effects have included sinusitis, nasopharyngitis and upper respiratory tract infection.

Musculoskeletal

Musculoskeletal side effects have included fractures.

Hematologic

Hematologic side effects have included thrombocytopenia and lymphopenia.

Dermatologic

Dermatologic side effects have included rash.

General

General side effects have included infections, including tuberculosis.

Genitourinary

Genitourinary side effects have included urinary tract infection.

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