Animal studies of up to 13 mg/kg (equivalent to the maximum human dose) during organogenesis showed embryotoxicity (minor skeletal abnormalities were seen in one animal model); embryofetal effects were associated with maternotoxicity at 5 times the maximum clinical dose; embryofetal survival was reduced at 4.2 times the maximum clinical dose. 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.

Use is contraindicated during the first trimester. (AU)
Use is recommended only if clearly needed and the benefit outweighs the risk.

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

See references

Caution is recommended.

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

See references