Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There are no available data on Cariprazine use in pregnant women to inform any drug-associated risks for birth defects or miscarriage. Based on animal data Cariprazine may cause fetal harm. Administration of Cariprazine to rats during the period of organogenesis caused malformations, lower pup survival, and developmental delays at drug exposures less than the human exposure at the maximum recommended human dose (MRHD) of 6 mg/day. However, Cariprazine was not teratogenic in rabbits at doses up to 4.6 times the MRHD of 6 mg/day.
