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U.S. Department of Health and Human Services

Safety

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Actos (Pioglitazone) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

November 2013

Summary View

USE IN SPECIFIC POPULATIONS

Pediatric Use
  • Actos is not recommended for use in pediatric patients based on adverse effects observed in adults, including fluid retention and congestive heart failure, fractures, and urinary bladder tumors.