Animal studies have revealed evidence of teratogenicity including shortened digits of the thoracic extremity and incomplete ossification when this drug was administered IV. Increased embryofetal resorption was also observed. Increases in the number of nonviable fetuses at oral doses that also produced maternal toxicity were observed. 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.

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:
-Women with pulmonary arterial hypertension should avoid becoming pregnant as pregnancy may lead to life-threatening exacerbation of this disease.
-Use of adequate methods of contraception should be encouraged.

See references

Breastfeeding is not recommended during use of this drug.

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

Comments: The effects in the nursing infant are unknown.

See references