Animal studies have revealed evidence of embryotoxicity and teratogenicity (inducing stunted fetuses, malformations, resorptions, skeletal variations, and stillbirths) when oral doses were given during organogenesis. This drug may have the potential to produce fetal hypoxia related to maternal hypotension. There are no controlled data in human pregnancy.

Animal studies using male animal models have revealed evidence of impaired sperm function due to reversible changes in the head section of spermatozoa.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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: C
US FDA pregnancy category: C

See references

Use is not recommended and 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

Comment: The effects in the nursing infant are unknown.

See references