AU: Use is contraindicated
US and UK: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

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

Comments: May cause fetal harm

In animal studies, this drug was shown to be teratogenic causing adverse effects on embryo-fetal development. In a perinatal/postnatal study in rats using 4 times the mg/m2 maximum recommended human dose, impaired growth and development of nursing offspring and altered neurological development of female offspring were observed. There are no adequate and well controlled studies in pregnant women.

AU TGA pregnancy category B 3: 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.

See references

Animal studies show that this drug is excreted in the milk of lactating rats. There is no information on use in nursing mothers. As this drug suppresses serum prolactin, it may interfere with breastfeeding. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

AU: Use is contraindicated
UK: Not recommended
US: Use caution

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

Comments: This drug inhibits prolactin secretion and could potentially inhibit lactation.

See references