Animal studies showed that deferasirox was not teratogenic in rat or rabbits but caused increased frequency of skeletal variations and stillborn pups in rats at high doses that were severely toxic to the non-iron-overloaded mother. Deferasirox did not cause other effects on fertility or reproduction. The potential risk for humans is unknown.
No clinical data on exposed pregnancies are available for deferasirox. Studies in animals have shown some reproductive toxicity at maternally toxic doses. The potential risk for humans is unknown. As a precaution, it is recommended that deferasirox not be used during pregnancy unless clearly necessary.
It is not known if deferasirox is secreted into human milk. Deferasirox was found to be rapidly and extensively secreted into maternal milk. No effects on the offspring were noted at maternally non-toxic doses of deferasirox. Breast-feeding while taking deferasirox is not recommended.