Perinatal Safety of Quetiapine During Pregnancy: A Systematic Review, Meta-Analysis, ‎‎and ‎Evidence Gaps

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.

‎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.

‎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.

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.