Animal studies have reported an increase in stillbirths and an increase in pup deaths in the first 4 days of life. There is no controlled data in human pregnancy.

Cases have varied widely in severity from self-limited cases to reports of neonates who have required intensive support and prolonged hospitalization. One case of agenesis of the corpus callosum has been received in an infant exposed to risperidone in utero, although the relationship to drug is unknown.

Drug-induced hyperprolactinemia may impair reproductive function in both male and female patients. Hyperprolactinemia causes a reduction in the pituitary secretion of gonadotropin which, in turn, impairs gonadal steroidogenesis.

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 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 not be used during pregnancy unless the benefit outweighs the risk to the fetus.

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

Comments:
-A pregnancy exposure registry is available.
-Neonates exposed to this drug during the third trimester should be monitored for extrapyramidal and/or withdrawal symptoms following delivery.
-Some experts recommend that the dose and duration be as low and as short as possible.
-Patients should be advised to notify their physician if they are pregnant or plan to become pregnant during treatment.

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: Yes

Comments:
-Due to lack of published data and the potential for serious adverse reaction in nursing infants, other agents may be preferred, especially while nursing a newborn or preterm infant.
-Women should not breastfeed for at least 12 weeks after receiving a long-acting injection of the drug.
-Other antipsychotics are considered agents for which the effect on nursing infants is unknown but may be of concern, especially when given for long periods by the American Academy of Pediatrics.

An exclusively breastfed infant may expect to receive 4.3% of the maternal weight-adjusted drug dosage. This calculation is based on a study in 1 mother receiving risperidone 6 mg daily and having her milk and serum levels of risperidone and its active metabolite (9-hydroxyrisperidone) measured over 24 hours.

See references