Animal models given doses of 0.4 to 0.9 times the maximum recommended human dose, have revealed no evidence of impaired fertility or harm to the fetus. There have been reports of extrapyramidal and withdrawal symptoms in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. These complications have varied in severity, from self-limited to needing intensive care unit support and prolonged hospitalization. Clinically, there is a risk of exacerbation of psychosis when discontinuing or changing antipsychotic therapy. There are no controlled data in human pregnancy.

Male animal models have revealed evidence of inhibited spermatogenesis and testicular atrophy when given long-term treatment at doses less than the maximum human dose.

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 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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is recommended only if clearly needed and if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: B

Comments:
-A pregnancy exposure registry is available.
-Adequate methods of contraception should be encouraged.
-Neonates exposed to this drug during the third trimester should be monitored for extrapyramidal and/or withdrawal symptoms following delivery.
-Patients should be advised to notify their physician if they are pregnant or plan to become pregnant during treatment.
-Women receiving antipsychotic medication during pregnancy should consider undergoing early screening for gestational diabetes.

See references

There is limited data regarding use of this drug during breastfeeding. Because sedation and adverse hematologic effects have been reported, other agents are preferred. In 4 breastfed infants, 1 experienced sedation and 1 agranulocytosis; specific details of these cases are not available.

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

Comments:
-If breastfeeding is undertaken, closely monitor breastfed infant for excessive sedation and periodically monitor WBC.
-The American Academy of Pediatrics classifies antipsychotics as drugs whose effect on the nursing infant is unknown but may be of concern.

See references