Reproductive studies in animals demonstrated no fetal anomalies or malformations at dosages approximately 14 times the human exposure. Embryolethality, reduced fetal weight, and increased incidence of fetal abnormalities were noted at dosages 20 to 25 fold higher than in humans. 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.

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

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A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Data not available
Excreted into animal milk: Yes

Animal studies have revealed slightly reduced body weight gain in nursing offspring. The offspring regained the weight during the maturation phase. There are no controlled data in humans; however, long-term use may reduce milk production or milk letdown.

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