Metformin / pioglitazone Side Effects

Some side effects of metformin / pioglitazone 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 / pioglitazone: 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 / pioglitazone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any other serious side effects, such as:

• stomach pain, blood in your urine, painful urination;

• feeling short of breath, especially when lying down;

• swelling or rapid weight gain;

• pale skin, feeling light-headed, rapid heart rate, trouble concentrating;

• sudden unusual pain in your hand, arm, or foot; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of metformin / pioglitazone may include:

• headache;

• diarrhea, upset stomach; or

• sneezing, runny nose, cough or other signs of a cold.

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 / pioglitazone: oral tablet, oral tablet extended release

Cardiovascular

Cardiovascular side effects have included mild to moderate edema.

Gastrointestinal

Gastrointestinal side effects have included nausea and diarrhea.

Hematologic

Hematologic side effects have included decreases of previously normal levels of serum vitamin B12 to subnormal levels.

Metabolic

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.

Metabolic side effects of metformin have included lactic acidosis, which is a potentially fatal metabolic complication of biguanide therapy. The incidence of lactic acidosis appears to be about 1.5 cases per 10,000 patient years. The incidence may be lower with current recommended doses and less frequent use in the elderly. The risk of lactic acidosis is 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 may also increase the risk of lactic acidosis. Hypoglycemia occurs uncommonly in patients receiving metformin as monotherapy. Strenuous exercise, decreased caloric intake, general debilitation, adrenal insufficiency, pituitary insufficiency, and ethanol use may increase the risk of hypoglycemia. Metabolic side effects of rosiglitazone have included increases in total cholesterol, LDL, and HDL and decreases in free fatty acids. Dose related weight gain has been reported in patients treated with rosiglitazone alone and in combination with other hypoglycemic agents.

Respiratory

Respiratory side effects have included reports of upper respiratory tract infection and sinusitis.

Nervous system

Nervous system side effects have included headache and dizziness.

Genitourinary

Genitourinary side effects have included urinary tract infections.

Ocular

Ocular side effects have included postmarketing reports of new onset or worsening diabetic macular edema with decreased visual acuity.

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