Janumet Side Effects

Generic name: metformin / sitagliptin

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

Some side effects of Janumet 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 / sitagliptin: oral tablet, 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 / sitagliptin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

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

• urinating less than usual or not at all;

• feeling short of breath (even with mild exertion) swelling or rapid weight gain; 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.

Less serious side effects of metformin / sitagliptin may include:

• diarrhea, constipation, mild nausea, upset stomach;

• headache, weakness, back pain, joint or mucle pain; 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 / sitagliptin: oral tablet, oral tablet extended release

Metabolic

Metabolic side effects have included hypoglycemia and lactic acidosis, which is a potentially fatal metabolic complication. The incidence of lactic acidosis has been about 1.5 cases per 10,000 patient years. The risk of lactic acidosis has been particularly high in patients with underlying renal insufficiency. Cases of lactic acidosis occurring in patients with normal renal function have been rarely reported. Concomitant cardiovascular or liver disease, sepsis, and hypoxia have also increased the risk of lactic acidosis.

Lactic acidosis is a medical emergency requiring immediate evaluation and treatment. The case fatality rate may be as high as 50.3%. Patients taking metformin who present with even vague medical illnesses such as myalgia, malaise, somnolence, abdominal discomfort, and so forth, should be evaluated for a metabolic etiology like lactic acidosis.

Signs and symptoms of severe acidosis may include vomiting, abdominal pain, nausea, dyspnea, hypothermia, hypotension, and bradycardia.

Laboratory evaluation of metformin induced lactic acidosis generally includes determination of the following: blood glucose concentration, lactic acid concentration, serum electrolytes, blood pH, metformin concentration, and exclusion of ketoacidosis.

If lactic acidosis is present, immediate institution of general supportive care is indicated. Prompt hemodialysis is also generally recommended in order to correct the acidosis and remove metformin. Hemodialysis often results in rapid improvement. Some investigators have suggested that dialysis with a bicarbonate buffered dialysate may be particularly effective.

Gastrointestinal

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

Nervous system

Nervous system side effects have included asthenia and headache.

Respiratory

Respiratory side effects have included nasopharyngitis.

Hematologic

Hematologic side effects have included malabsorption of vitamin B12, due to intrinsic factor deficiency and possibly other mechanisms, in as many as 30% of treated patients. Megaloblastic anemia has occurred. Discontinuation of metformin or supplementation with vitamin B12 has been necessary.

Hypersensitivity

Hypersensitivity side effects have included postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with sitagliptin such as 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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