AU and UK: Use should be avoided
US: Use only if clearly needed

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

This drug was not teratogenic when administered to animals during organogenesis at doses up to 149 and 180 times the clinical dose. In addition, no harm to the developing embryo or adverse effects on the growth and development of offspring was observed when given to animals at approximately 95 times the clinical exposure. Placental transfer into the fetuses of pregnant rats has been observed. 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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

An alternate drug may be preferred, especially while nursing a newborn or preterm infant, as there is no information available on the use of this drug during breastfeeding,

AU and UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and breastfeeding to the child.
US: Caution is advised as there is no available data

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

The effects in the nursing infant are unknown.

See references