Animal studies have failed to reveal evidence of teratogenicity. Animal studies have reported reduced fetal weights, decreased fertility in offspring, and increased auditory startle response. 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.

Use is not recommended.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk Summary: Compared to women who smoke, available data have suggested that major malformative risks with the use of this drug in pregnant women is unlikely.

Comment: Some experts recommend timing treatment to be completed before conception in women of childbearing potential.

See references

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: Unknown
Excreted into animal milk: Yes

The effects in the nursing infant are unknown.

Animal models given 15 mg/kg orally during gestation and lactation resulted in nursing pup concentrations ranging from approximately 5% to 22% of maternal serum concentrations.

See references