Animal studies have failed to reveal evidence of teratogenicity although an increased incidence of fetal resorption has been demonstrated. There are limited controlled data in human pregnancy. This drug passes the placental barrier and may lower the heart rate of the fetus. A transient rise in blood pressure in the newborn cannot be excluded postpartum.

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

Comments:
-If this drug is used during pregnancy careful monitoring of mother and child is recommended.

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: Yes

Comments:
-Concentrations of this drug in human breast milk are approximately twice those found in maternal plasma.
-Other drugs may be preferred, especially while nursing a newborn or preterm infant, due to possible infant side effects and negative effects on lactation.

See references