Embryolethality and fetal abnormalities including malformations and variations has been demonstrated in reproductive toxicity studies in rats and rabbits at clinically relevant exposures. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

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Caution is recommended

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: Infant exposures should be minimized by avoiding breast-feeding for 24 hours after treatment.

In rats, oral dosing with this drug resulted in milk levels up to 4 times higher than in plasma. There are no published data on the presence of this drug in human breast milk or experiences with breastfeeding. If this drug is required by the mother, it is not a reason to discontinue breastfeeding; however, an alternate drug may be preferred, especially if nursing a newborn or preterm infant. Alternate drugs to consider may be sumatriptan or eletriptan.

See references