Perinatal Safety of Quetiapine During Pregnancy

PURPOSE: The reproductive safety profiles of quetiapine (QTP) during pregnancy are not fully understood. This review primarily assesses perinatal outcomes and major malformations following exposure to quetiapine. METHODS: ‎A comprehensive literature search identified 33 studies published through February 2025. Outcomes were synthesized for QTP using random-effects models and benchmarked against population surveillance and psychiatric controls when available. RESULTS: ‎Among 13,090 pregnancies exposed to QTP with malformation outcomes, the major malformation rate was 4.1%, which is comparable to background rates. Perinatal outcomes were similar to those of the controls for QTP. Several high-quality studies have shown a dose-response relationship between higher QTP doses and the risk of gestational diabetes. CONCLUSIONS: QTP is not associated with an increased risk of major malformations and does not significantly raise adverse perinatal outcomes compared with controls. The dose-related metabolic risks of QTP underscore the importance of minimizing dosage and closely monitoring metabolism during pregnancy.