Skip to Content

Label Changes for:

Zyflo (zileuton) Tablets

June 2012

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2012




Pediatric Use
  • Due to the risk of hepatoxicity, use of Zyflo in pediatric patients under 12 years is not recommended