PPAR Special Precautions

Hypoglycemia: Patients receiving Pioglitazone in combination with other oral hypoglycemic agents may be at risk for hypoglycemia, and a reduction in the dose of the concomitant agent may be necessary.
Cardiovascular: A small number of patients with a history of previously existing cardiac disease developed congestive heart failure when treated with Pioglitazone in combination with insulin. Pioglitazone is not indicated in patients with NYHA class III or IV cardiac status.
Edema: Pioglitazone should be used with caution in patients with edema.
Weight gain: Dose-related weight gain was seen with Pioglitazone and in combination with other hypoglycemic agents.
Ovulation: In premenopausal anovulatory patients with insulin resistance, treatment with thiazolidinediones, including Pioglitazone may result in resumption of ovulation. As a consequence of their improved insulin sensitivity, these patients may be at risk for pregnancy if adequate contraception is not used.
Hematologic: Patients treated with Pioglitazone may cause dose-dependent decreased in (2-4%) hemoglobin and hematocrit.
Hepatic effects: Rare reports of liver dysfunction. Monitor liver functions before treatment, and periodically thereafter; advice patient to seek immediate medical help if symptoms such as nausea, vomiting, abdominal pain, fatigue and dark urine develop; discontinue if jaundice occurs.