Use in Pregnancy: Adequate and well-controlled studies in humans have not been done.
Quetiapine showed no teratogenic potential in rats and rabbits, dosed at 0.3 to 2.4 and 0.6 to 2.4 times the MRHD on a mg/m2 basis, respectively, during the period of organogenesis. However, in rats, delays in skeletal ossification were seen in fetuses at all doses. Also, reduced fetal body weight and reduced maternal weight gain and/or increased maternal deaths were seen at all doses, delays in skeletal ossification in the fetuses, were seen at doses of 1.2 and 2.4 times the MRHD on a mg/m2 basis, and reduced fetal body weight and an increase incidence of minor soft tissue anomaly in the fetuses were seen at the highest dosage used. In a perinatal/postnatal study in rats receiving 0.01 to 0.24 times the MRHD on a mg/m2 basis, no drug-related effects were observed. However, in a preliminary perinatal/postnatal study in rats receiving three times the MRHD on a mg/m2 basis, increase in fetal and pup deaths and decreases in mean litter weight were found.
FDA Pregnancy Category C.
Use in Lactation: Quetiapine is distributed into the milk of animals. It is not known whether Quetiapine is distributed in breast milk, but breast-feeding while taking Quetiapine is not recommended.