pioglitazone, Actos (cont.)

Pharmacy Author:
Medical and Pharmacy Editor:

NURSING MOTHERS: It is unknown if pioglitazone is secreted in breast milk. Therefore, the effect of pioglitazone on the nursing infant whose mother is taking pioglitazone is unknown.

SIDE EFFECTS AND PRECAUTIONS: The most common side effects of pioglitazone alone or in combination with sulfonylureas, metformin, or insulin are upper respiratory tract infection, headache, sinusitis, muscle aches, tooth disorders, hypoglycemia, and sore throat.

In addition, dose related fluid accumulation (edema) can occur especially when combined with insulin. Fluid accumulation can worsen or lead to heart failure. Pioglitazone should not be used in patients with heart disease classified by the New York Heart Association (NYHA) as Class III and IV heart failure or symptomatic heart failure.

Fluid accumulation also may lead to macular edema, resulting in reduced vision. Pioglitazone also can reduce red blood cells.

Pioglitazone has been associated with liver injury. Periodic monitoring of liver-related side effects and liver tests should be conducted in patients taking pioglitazone. Side effects while taking pioglitazone which may be due to liver injury include nausea, vomiting, abdominal pain, fatigue, anorexia (loss of appetite), or dark urine. Liver blood tests also are recommended during pioglitazone therapy.

Pioglitazone may cause ovulation in women who have stopped ovulating if they are premenopausal and insulin resistant. This may lead to pregnancy. For women (but not men) taking pioglitazone, there is an increased risk of bone fractures of the distal bones of the arm and leg. Patients taking pioglitazone should maintain proper bone health.

Reference: FDA Prescribing Information

Last Editorial Review: 8/17/2012

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