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Fertility: In animal toxicity studies, histopathological changes of testis in rats (12 weeks old) and young dogs (7 to 8 months old), and abnormal findings of sperm in mice (11 weeks old) have been reported. Recovery or tendency of recovery has been observed in those studies after the administration was suspended.
Pregnancy: Do not administer favipiravir to women known or suspected to be pregnant.
(Early embryonic deaths [rats] and teratogenicity have been observed in animal studies with exposure levels similar to or lower than the clinical exposure.)
Lactation: Do not administer to lactating women.
(The major metabolite of favipiravir, a hydroxylated form, was found to be distributed in breast milk.)
