Pioglitazone side effects

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-632-7753

List of side effects

Cardiac Failure and Other Cardiac Effects

Heart enlargement

Dyspnea & Edema

Hypoglycemia

Edema

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Cardiac Failure and Other Cardiac Effects

Pioglitazone , like other thiazolidinediones, can cause fluid retention when used alone or in combination with other antidiabetic agents, including insulin. Fluid retention may lead to or exacerbate heart failure. Patients should be observed for signs and symptoms of heart failure (see Information for Patients). Pioglitazone should be discontinued if any deterioration in cardiac status occurs. Patients with New York Heart Association (NYHA) Class III and IV cardiac status were not studied during clinical trials; therefore, Pioglitazone is not recommended in these patients. Return to top

Heart enlargement

Heart enlargement has been observed in mice (100 mg/kg), rats (4 mg/kg and above) and dogs (3 mg/kg) treated orally with pioglitazone HCl (approximately 11, 1, and 2 times the maximum recommended human oral dose for mice, rats, and dogs, respectively, based on mg/m2)In a one-year rat study, drug-related early death due to apparent heart dysfunction occurred at an oral dose of 160 mg/kg/day (approximately 35 times the maximum recommended human oral dose based on mg/m2). Heart enlargement was seen in a 13-week study in monkeys at oral doses of 8.9 mg/kg and above (approximately 4 times the maximum recommended human oral dose based on mg/m2), but not in a 52-week study at oral doses up to 32 mg/kg (approximately 13 times the maximum recommended human oral dose based on mg/m2). Return to top

Dyspnea & Edema

In the Pioglitazone plus insulin trial (n=379), 10 patients treated with Pioglitazone plus insulin developed dyspnea and also, at some point during their therapy, developed either weight change or edema. Seven of these 10 patients received diuretics to treat these symptoms. This was not reported in the insulin plus placebo group. Return to top

Hypoglycemia

Mild to moderate hypoglycemia was reported during combination therapy with sulfonylurea or insulin. Hypoglycemia was reported for 1% of placebo-treated patients and 2% of patients when Pioglitazone was used in combination with a sulfonylurea. In combination with insulin, hypoglycemia was reported for 5% of placebo-treated patients, 8% for patients treated with 15 mg of Pioglitazone , and 15% for patients treated with 30 mg of Pioglitazone . Return to top

Edema

In monotherapy studies, edema was reported for 4.8% of patients treated with ACTOS versus 1.2% of placebo-treated patients. In combination therapy studies, edema was reported for 7.2% of patients treated with Pioglitazone and sulfonylureas compared to 2.1% of patients on sulfonylureas alone. In combination therapy studies with metformin, edema was reported in 6.0% of patients on combination therapy compared to 2.5% of patients on metformin alone. Return to top

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The content of this page is taken from the FDA package insert for this drug and should not be edited.