This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Comments:
-A pregnancy exposure registry is available.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates exposed to antipsychotics during the third trimester of pregnancy; cases have varied widely in severity from self-limited to reports of neonates who have required intensive support and prolonged hospitalization. In animal studies in doses up to 25 mg/kg/day (rats) and 50 mg/kg/day (rabbits), corresponding to 1.5 and 5 times the maximal recommended human dose, respectively, teratogenicity was not observed. Studies in rats at doses up to 10 mg/kg/day did not show an effect on delivery or pup development when dosed from early gestation to weaning. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to atypical antipsychotics, a National Pregnancy Registry for Atypical Antipsychotics has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/atypicalantipsychotic/.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics considers other antipsychotics as agents whose effect on the nursing infant is unknown but may be of concern.
-Some experts state that an alternative drug may be preferred while nursing a newborn or preterm infant (e.g., haloperidol, olanzapine, risperidone).

See references