Quetiapine
MedicationSeroquel, Seroquel XR
Atypical antipsychotic
Research strength: 4 / 5
MotherToBaby reports that most studies found no miscarriage difference between people taking quetiapine and those using similar medicines; one Danish registry study found a higher rate among quetiapine-exposed pregnancies, but the authors thought the antipsychotic-class result was likely due to other factors. The National Pregnancy Registry for Psychiatric Medications reported major birth defects in 1.85% of 264 quetiapine-exposed pregnancies and 1.77% of 886 controls, with wide uncertainty. A 2026 quetiapine review reported a 4.1% major-malformation rate among 13,090 pregnancies, and a correction to a network meta-analysis changed its estimate to OR 1.13 (95% CrI 0.81 to 1.44), not a significant difference. The FDA label says available human studies have not established a quetiapine-related risk, while EMA product information says use only when expected benefits justify risks because the data remain inconclusive; the FDA label also lists a National Pregnancy Registry. The Seroquel boxed warnings state that elderly patients with dementia-related psychosis treated with antipsychotic drugs have an increased risk of death, and that children, adolescents, and young adults taking antidepressants have an increased risk of suicidal thoughts and behavior. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- MotherToBaby: Quetiapine fact sheetTeratology service
- DailyMed: SEROQUEL (quetiapine) tablets labelDrug company label
- Cohen et al., National Pregnancy Registry update, 2023US government
- Alem et al., Quetiapine perinatal safety review, 2026US government
- Wang et al., corrected network meta-analysis, 2026US government
- EMA: Seroquel and Seroquel XR product information, Annex IIIEU agencyEuropean guidance
Research strength: 4 / 5
MotherToBaby says quetiapine might raise gestational-diabetes risk, though psychiatric illness and other factors can also affect pregnancy outcomes. In a US cohort of 4,533 women prescribed quetiapine before pregnancy, continuing treatment in the first half was linked to an adjusted risk ratio of 1.28 (95% CI 1.01 to 1.62) for gestational diabetes; a Swedish study found higher risks in a group combining quetiapine with olanzapine and clozapine. A 2026 quetiapine review reports dose-related gestational-diabetes findings, and MotherToBaby notes that a provider can check blood sugar during pregnancy. The FDA label says available studies have not established an overall drug-associated risk of adverse maternal or fetal outcomes. The Seroquel boxed warnings state that elderly patients with dementia-related psychosis treated with antipsychotic drugs have an increased risk of death, and that children, adolescents, and young adults taking antidepressants have an increased risk of suicidal thoughts and behavior. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- MotherToBaby: Quetiapine fact sheetTeratology service
- DailyMed: SEROQUEL (quetiapine) tablets labelDrug company label
- Park et al., Medicaid cohort on gestational diabetes, 2018US government
- Heinonen et al., Swedish register cohort, 2022US government
- Alem et al., Quetiapine perinatal safety review, 2026US government
Research strength: 3 / 5
MotherToBaby reports that late-pregnancy quetiapine may be followed by temporary newborn symptoms, including unusual muscle tone, sleepiness, agitation, breathing or feeding problems, or tremors; not every newborn has symptoms. The FDA label warns that third-trimester exposure to antipsychotics, including Seroquel, can cause extrapyramidal or withdrawal symptoms after birth, with severity varying. The EMA product information lists similar symptoms and says newborns should be monitored carefully. The Seroquel boxed warnings state that elderly patients with dementia-related psychosis treated with antipsychotic drugs have an increased risk of death, and that children, adolescents, and young adults taking antidepressants have an increased risk of suicidal thoughts and behavior. Ask your provider about your situation.
Last reviewed: 2026-10-16
Quetiapine — Breastfeeding
Research strength: 4 / 5
LactMed reports that maternal doses up to 400 mg daily produce less than 1% of the maternal weight-adjusted dose in milk and places quetiapine among first- or second-choice antipsychotics during breastfeeding, with infant monitoring. MotherToBaby says infant blood levels are very low or undetectable and limited studies do not suggest an effect on development, but advises watching for unusual sleepiness. A nine-mother milk study estimated infant exposure at 0.16% of the maternal weight-adjusted dose; evidence about infant outcomes remains limited. EMA product information says the evidence is not robust and an individualized decision is needed, while the FDA label reports no consistent infant adverse events. The Seroquel boxed warnings state that elderly patients with dementia-related psychosis treated with antipsychotic drugs have an increased risk of death, and that children, adolescents, and young adults taking antidepressants have an increased risk of suicidal thoughts and behavior. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- LactMed: QuetiapineUS government
- MotherToBaby: Quetiapine fact sheetTeratology service
- DailyMed: SEROQUEL (quetiapine) tablets labelDrug company label
- Yazdani-Brojeni et al., quetiapine in human milk, 2018US government
- Sinha et al., infant outcomes during antipsychotic breastfeeding exposure, 2021US government
- EMA: Seroquel and Seroquel XR product information, Annex IIIEU agencyEuropean guidance
Pregnancy
Miscarriage: MotherToBaby reports that most studies found no difference with quetiapine versus similar medicines, while it cites one study with a higher estimate compared with no exposure. Sørensen et al. (2015) used Danish national registers covering 1,005,319 clinically recognized pregnancies from 1997 to 2008. In the quetiapine subgroup, 42 of 174 pregnancies ended in spontaneous abortion (24.1%; adjusted relative risk 1.65, 95% CI 1.28 to 2.15, compared with unexposed pregnancies). This subgroup figure is not a medication-caused risk estimate: the study's overall antipsychotic association was considered likely to reflect confounding, and the within-woman analysis of antipsychotic exposure overall found no increased spontaneous-abortion risk. The absolute subgroup figure is therefore kept out of the public summary. Major malformations: The 2023 National Pregnancy Registry report included 264 quetiapine-exposed women and 886 controls who completed postpartum follow-up. Major-malformation rates were 1.85% and 1.77%, respectively; the odds ratio was 1.04 (95% CI 0.38 to 2.85), so the estimate was imprecise. Huybrechts et al. (2023) included 11,065 first-trimester quetiapine exposures within a Nordic and US cohort; common exposure-outcome adjusted estimates were generally close to the null. Alem et al. (2026) reviewed 33 studies through February 2025 and reported 13,090 quetiapine-exposed pregnancies with malformation outcomes, with a 4.1% major-malformation rate that the authors considered comparable to background. A 2025 network meta-analysis initially reported a small statistically significant quetiapine association, but its May 2026 correction removed overlapping study data and revised the estimate to OR 1.13 (95% CrI 0.81 to 1.44), which did not show a significant difference. The correction is described in the disagreements section. Metabolic and growth outcomes: Park et al. (2018) studied 4,533 women with quetiapine prescriptions before pregnancy; continuing treatment in the first half of pregnancy was associated with an adjusted gestational-diabetes risk ratio of 1.28 (95% CI 1.01 to 1.62) compared with no dispensings during that period. Heinonen et al. (2022) found higher gestational-diabetes and large-for-gestational-age risks in a combined group of quetiapine, olanzapine, and clozapine, so its results do not isolate quetiapine. The 2026 quetiapine review reported dose-related gestational-diabetes findings. MotherToBaby also mentions possible low birth weight, but the saved source did not identify a quetiapine-specific primary estimate that could be verified; that claim is not repeated in the public summary. Later pregnancy: The Seroquel label states that epidemiologic studies have not established a drug-associated risk of adverse maternal or fetal outcomes, and separately warns of a class risk of extrapyramidal or withdrawal symptoms in newborns after third-trimester antipsychotic exposure. The available sources do not provide a precise quetiapine-specific rate for these newborn symptoms.
Breastfeeding
LactMed reports that maternal quetiapine doses up to 400 mg daily yield milk exposure below 1% of the maternal weight-adjusted dose and describes limited long-term follow-up in which infants generally developed normally. Yazdani-Brojeni et al. (2018) measured milk concentrations in nine women taking fast-release quetiapine at a mean dose of 41 mg daily; the estimated mean relative infant dose was 0.16% (range 0.04% to 0.35%). Sinha et al. (2021) followed a hospital-based group of 28 infants exposed to several atypical antipsychotics, with 17 attending follow-up; only two infants were exposed to quetiapine through milk. Developmental delay in one infant occurred with maternal quetiapine use during pregnancy and other risk factors, so the study cannot identify a milk-only effect. The small samples, frequent supplementary feeding, polytherapy, and short follow-up limit conclusions about infant outcomes. MotherToBaby reports very low or undetectable infant blood levels and recommends watching for unusual sleepiness. The EMA product information describes the human milk evidence as very limited, while LactMed, MotherToBaby, and the FDA label provide a more reassuring account with monitoring.
Quetiapine is the active medicine in Seroquel and Seroquel XR, which are atypical antipsychotics. The Seroquel label lists treatment indications including schizophrenia and bipolar disorder, and the extended-release label also lists adjunctive treatment for major depressive disorder. This audit concerns the active ingredient quetiapine, not a comparison of tablet release forms.
What was tested
Pregnancy evidence includes national registry cohorts, a prospective pregnancy registry, a large multinational malformation cohort, gestational-diabetes cohorts, and systematic reviews. Most pregnancy studies are observational and can be affected by illness severity, other medicines, and health differences between groups. The 2026 correction to the network meta-analysis states that the original analysis included overlapping study data. Third-trimester newborn concerns are mainly class-label warnings and clinical summaries; a precise quetiapine-specific rate was not verified. Breastfeeding evidence consists largely of small milk-level studies, case reports, and one small mixed-antipsychotic infant cohort. The milk-level studies estimate exposure, but they do not establish long-term infant outcomes.
Quetiapine and major congenital malformations in pregnancy
- Source A says
- The original 2025 network meta-analysis reported an odds ratio of 1.19 (95% CrI 1.01 to 1.39) and described a small increased risk compared with no exposure. (Wang et al., original network meta-analysis, 2025 version later corrected)
- Source B says
- The May 2026 correction removed overlapping data and revised the quetiapine estimate to OR 1.13 (95% CrI 0.81 to 1.44), with no significant difference from unexposed pregnancies. (Wang et al., correction to network meta-analysis, 2026)
- Why they differ
- The authors corrected the original analysis after identifying overlapping studies. The congenital-malformation network was reduced from 16 to 15 cohorts and from 3,040,761 to 1,698,670 participants; the corrected estimate has a confidence interval that includes no difference.
- Other sources
- A quetiapine-specific 2026 review reported a 4.1% malformation rate among 13,090 exposed pregnancies and judged it comparable to background. The 2023 registry and multinational cohort also did not identify a clear quetiapine malformation signal, though estimates remain limited. (Alem et al., Perinatal Safety of Quetiapine During Pregnancy, 2026, Cohen et al., National Pregnancy Registry for Psychiatric Medications, 2023, Huybrechts et al., Nordic and US cohort study, 2023)
- What the evidence shows overall
- The corrected analysis supersedes the original 2025 estimate. Current reviewed sources do not show a statistically significant increase in major malformations for quetiapine, but limited precision means a small effect cannot be excluded. The original uncorrected result should not be presented as a current confirmed signal.
How to describe the pregnancy evidence when the EMA product information is more cautious
- Source A says
- The EMA product information says available first-trimester data do not suggest an increased malformation risk but are not conclusive, and says quetiapine should be used only when expected benefits justify potential risks. (EMA: Seroquel and Seroquel XR product information, Annex III)
- Source B says
- MotherToBaby reports quetiapine is not thought to increase birth-defect chance based on studies reviewed, and the FDA label says available epidemiologic studies have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. (MotherToBaby: Quetiapine fact sheet, DailyMed: SEROQUEL (quetiapine) tablets label)
- Why they differ
- The EMA text uses a precaution because its cited human pregnancy data are limited, whereas the US label and MotherToBaby summarize later and broader observational evidence without identifying an established malformation risk. The EMA wording is not evidence that a malformation risk has been established.
- Other sources
- The corrected 2026 network analysis also did not find a statistically significant difference. (Wang et al., correction to network meta-analysis, 2026)
- What the evidence shows overall
- Under R1 and R2, the rating remains compatible because the EMA precaution is tied to uncertainty rather than established harm, while the main reviewed sources do not identify an increased malformation risk. The EMA advice is named in the trimester summary.
- MotherToBaby notes that a healthcare provider can monitor blood sugar levels during pregnancy. (MotherToBaby)
- LactMed says to monitor infants for drowsiness and developmental milestones, especially when other antipsychotics are also used. (LactMed)
- The Seroquel label encourages healthcare providers to register exposed patients with the National Pregnancy Registry for Atypical Antipsychotics. (DailyMed: SEROQUEL label)
General research, not specific to pregnancy.
Recent regulatory updates address general quetiapine effects and one narrowly scoped product recall, not a pregnancy-specific restriction.
- The Seroquel FDA boxed warnings address increased death risk in elderly patients with dementia-related psychosis and increased suicidal thoughts or behaviors in children, adolescents, and young adults taking antidepressants. (DailyMed: SEROQUEL (quetiapine) tablets label)
- FDA approved Seroquel and Seroquel XR label changes in January 2025 following a September 2024 safety notice about fecal incontinence and hyperprolactinemia. (FDA supplement approval letter for Seroquel and Seroquel XR)
- The EMA's 2024 quetiapine PSUSA added a warning about serotonin syndrome with other serotonergic medicines; the PRAC cited 10 spontaneous cases and considered the benefit-risk balance unchanged subject to label changes. (EMA CMDh scientific conclusions for quetiapine PSUSA/00002589/202307)
- The MHRA recalled all batches of Eaststone's unlicensed quetiapine oral suspension in January 2026 because the active content was twice the intended amount. The notice named 166 bottles manufactured from 26 October 2025 to 26 January 2026; this was a product-specific suspension recall and not a Seroquel tablet action. (MHRA recall notice for Eaststone unlicensed quetiapine oral suspension)
- MotherToBaby: Quetiapine fact sheetTeratology serviceSecondary
- LactMed: QuetiapineUS governmentSecondaryPage dated 2026-07-15
- DailyMed: SEROQUEL (quetiapine) tablets labelDrug company labelTertiaryPage dated 2026-04-10
- EMA: Seroquel and Seroquel XR product information, Annex IIIEU agencySecondaryIndependent checkEuropean guidance
- Sørensen et al., PLoS One, Danish pregnancy registry cohort, 2015US governmentPrimaryIndependent check
- Cohen et al., National Pregnancy Registry for Psychiatric Medications, 2023US governmentPrimaryIndependent check
- Huybrechts et al., Nordic and US cohort study, 2023US governmentPrimaryIndependent check
- Park et al., Medicaid cohort on gestational diabetes, 2018US governmentPrimaryIndependent check
- Heinonen et al., Swedish register cohort, 2022US governmentPrimaryIndependent check
- Alem et al., Perinatal Safety of Quetiapine During Pregnancy, 2026US governmentPrimaryIndependent check
- Wang et al., original network meta-analysis, 2025 version later correctedUS governmentPrimaryIndependent check
- Wang et al., correction to network meta-analysis, 2026US governmentPrimaryIndependent check
- Bruno et al., multinational neurodevelopment cohort, 2024US governmentPrimaryIndependent check
- Yazdani-Brojeni et al., quetiapine excretion into human breast milk, 2018US governmentPrimaryIndependent check
- Sinha et al., infant outcomes during antipsychotic breastfeeding exposure, 2021US governmentPrimaryIndependent check
- FDA supplement approval letter for Seroquel and Seroquel XRDrug company labelSecondaryPage dated 2025-01-22Independent check
- EMA CMDh scientific conclusions for quetiapine PSUSA/00002589/202307EU agencySecondaryPage dated 2024-05-03Independent checkEuropean guidance
- MHRA recall notice for Eaststone unlicensed quetiapine oral suspensionUK governmentSecondaryPage dated 2026-01-29Independent check
Last reviewed 2026-10-16
Independent check 2026-10-16
Not yet clinician-reviewed
Ask your provider about your situation.
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