Animal studies indicate the potential for placental perfusion and induction of fetal bradycardia. This drug may also exert a contractile effect on the pregnant uterus and lead to fetal asphyxia in late pregnancy. 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 recommended only if clearly needed and the benefit outweighs the risk.

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

See references

Caution is recommended.

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

Comments: The effects in the nursing infant are unknown.

Animal studies suggest this drug can decrease serum prolactin and reduce milk production, as well as inhibit the release of oxytocin which inhibits milk ejection. High IV doses may reduce milk production or milk letdown.

See references