Animal studies have revealed evidence of teratogenicity. However, no evidence of structural alterations was observed at doses 15 and 20 times the recommended human daily dose, respectively. This drug and/or its metabolites were shown to cross the placenta in rats. Developmental toxicity studies in animals revealed delayed ossification of fetuses in rats (inhalation administration), and decreased fetal weight in rabbits (oral administration) at doses that resulted in maternal toxicity. There are no controlled data in human pregnancy.

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 benefit outweighs the risk to the fetus.

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

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UK, AU: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
US: Caution is recommended.

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

Comments: The effects in the nursing infant are unknown.

Excretion of small amounts of this drug and/or metabolites into the milk of lactating female rats, and decreased pup weights were observed. There are no human studies that have investigated the effects on breast-fed infants.

See references