Sitagliptin Side Effects

Some side effects of sitagliptin 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 sitagliptin: oral tablet

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

Stop using sitagliptin and call your doctor at once if you have:

• pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, fast heart rate;

• little or no urinating;

• swelling, weight gain, feeling short of breath; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• runny or stuffy nose, sore throat;

• headache, back pain, joint or muscle pain; or

• nausea, stomach pain, diarrhea, constipation.

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 sitagliptin: oral tablet

Metabolic

Metabolic side effects have included hypoglycemia.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, nausea, and diarrhea. Postmarketing experience has included constipation, vomiting, acute pancreatitis, including fatal and nonfatal hemorrhagic and necrotizing pancreatitis.

Respiratory

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

Nervous system

Nervous system side effects have included headache.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Postmarketing hypersensitivity reactions have included rash, urticaria, and cutaneous vasculitis.

Hepatic

Hepatic side effects have included postmarketing reports of hepatic enzyme elevations.

Renal

Renal side effects have included postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis.

Musculoskeletal

Arthralgia, myalgia, pain in extremities, and back pain have been reported postmarketing.

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