Pregnancy: Pregnancy Category C. The safety in pregnant women has not been established. Fenofibrate has been shown to be embryocidal in rats when given in doses 7 to 10 times the maximum recommended human dose (MRHD) and in rabbits when given at 9 times the MHRD (on the basis of mg/m2 surface area). There are no adequate and well-controlled studies in pregnant women. Fenofibrate should not be administered during pregnancy.
Lactation: It is not known whether fenofibrate or its metabolites are excreted into human milk. Fenofibrate should not be administered to breastfeeding women.