Use in Pregnancy: Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women.
Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms after delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.
Clozapine should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
Use in Lactation: Animal studies showed that clozapine is excreted in breast milk and has an effect on the breastfeeding infant; therefore, mothers under clozapine therapy should not breastfeed.