Quetiapine (Seroquel) During Pregnancy: What to Know

What does the evidence say about quetiapine during pregnancy?

1. MotherToBaby concludes that quetiapine is not thought to increase the overall chance of birth defects, notes possible gestational diabetes and low-birth-weight associations with confounding by the underlying illness, and advises against medication changes without prescriber review because psychiatric relapse can also affect pregnancy. 1
2. A prospective registry comparison found major malformations in 1.85 percent of 264 quetiapine-exposed pregnancies and 1.77 percent of 886 psychiatric controls, with odds ratio 1.04 and a wide 95 percent confidence interval from 0.38 to 2.85; this does not prove equal risk. 2
3. A Swedish national cohort of 1,307,487 singleton births grouped quetiapine with olanzapine and clozapine and found higher adjusted gestational diabetes and large-for-gestational-age risks than in unexposed pregnancies; grouping, prescription dispensing, and residual confounding reduce the chance of a quetiapine-only causal estimate. 3
4. The FDA Seroquel label warns that third-trimester antipsychotic exposure may be followed by newborn extrapyramidal or withdrawal symptoms including agitation, altered muscle tone, tremor, sleepiness, breathing distress, and feeding difficulty; reported severity and duration vary. 4
5. LactMed reports that maternal quetiapine doses up to 400 mg daily generally produce milk exposure below 1 percent of the maternal weight-adjusted dose and that limited follow-up is usually reassuring, while recommending infant monitoring for drowsiness and developmental progress because evidence remains limited. 5

Is quetiapine safe in each trimester?

• First trimester. Prospective registry data did not find a higher major-malformation rate among 264 quetiapine-exposed pregnancies than 886 psychiatric controls, but the confidence interval was wide and cannot rule out smaller increases or decreases. Review the reason for use, current dose, other medicines, and relapse history with the prescriber rather than changing quetiapine abruptly.
• Second trimester. Quetiapine is grouped with olanzapine and clozapine as a higher-metabolic-risk antipsychotic in a large Swedish study. The group had higher adjusted gestational diabetes and large-for-gestational-age rates, but the design could not isolate quetiapine's effect. Follow the obstetric team's glucose and fetal-growth plan without assuming the medicine must be stopped.
• Third trimester. Tell the delivery and newborn teams about quetiapine used near birth. The FDA label and MotherToBaby describe possible temporary newborn symptoms including unusual muscle tone, sleepiness or agitation, tremor, breathing difficulty, and feeding problems. Reports do not show that every exposed newborn is affected, but observation can identify symptoms promptly.