Animal models have failed to reveal evidence of teratogenicity at doses 2.1 to 4.2 times the maximum recommended human dose. When animal models were given intraperitoneal doses, fetal mortality occurred. There are no controlled data in human pregnancy.

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

Comments:
-Some experts recommend avoiding use 2 weeks prior to delivery due to reports of irritability, excitement, and inhibited platelet aggregation in exposed neonates.
-High doses given later in pregnancy have resulted in prolonged neurological/extrapyramidal disturbances in the neonate.

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:
-Breastfed infants exposed to this drug should be monitored for sedation, irritability, and excitement.

See references