Zileuton Pregnancy and Breastfeeding Warnings
Medically reviewed by Drugs.com. Last updated on Dec 1, 2021.
Zileuton is also known as: Zyflo, Zyflo CR
Zileuton Pregnancy Warnings
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
US FDA pregnancy category: C
Developmental studies indicated adverse effects (reduced body weight and increased skeletal variations) in rats at an oral dose of 300 mg/kg/day. In rabbits receiving oral dose of 150 mg/kg/day, cleft palates were also reported. This drug and/or its metabolites cross the placental barrier of rats. There are no controlled data in human pregnancy.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Zileuton Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments: The effects in the nursing infant are unknown.
See also
References for pregnancy information
- "Product Information. Zyflo (zileuton)." Abbott Pharmaceutical
- "Product Information. Zyflo (zileuton)." Abbott Pharmaceutical (2016):
- "Product Information. Zyflo CR (zileuton)." Cornerstone Therapeutics (2016):
References for breastfeeding information
- "Product Information. Zyflo (zileuton)." Abbott Pharmaceutical
- "Product Information. Zyflo (zileuton)." Abbott Pharmaceutical (2016):
- "Product Information. Zyflo CR (zileuton)." Cornerstone Therapeutics (2016):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.