In rats, embryofetal toxicity has been demonstrated with doses approximately one-half of the maximum recommended human doses on a mg/m2 basis. Teratogenicity has not been demonstrated in the rat, rabbit, or dog. There are no controlled data in human pregnancy. Neonates exposed during the third trimester are at risk of developing severe and/or prolonged side effects (e.g., agitation, hyper/hypotonia, tremor, somnolence, respiratory distress, feeding disorder). The side effects have varied in severity and duration, with some neonates requiring intensive care support and prolonged hospitalization.

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.

Use is not recommended unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Comment: Exposed neonates should be monitored for the signs/symptoms of extrapyramidal syndrome and/or withdrawal.

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: Unknown
Excreted into animal milk: Yes

Comments:
-Some experts recommend that patients avoid breastfeeding for 48 hours and discard any milk produced during this interval.
-An alternate drug may be preferred, especially when breastfeeding a newborn or premature infant.

This drug is present in the milk of lactating dogs. There is no information available on the use of this drug during breastfeeding.

See references