Quetiapine During Pregnancy

Schizophrenia is a mental health condition that presents itself most commonly in individuals between 20 to 29 years of age. It appears more often in women, although it can affect both genders. Use of quetiapine during pregnancy is a common concern for women experiencing schizophrenia who want to maintain mental health without jeopardizing the health and wellness of their developing baby. However, there is not enough data on the safety of quetiapine, more commonly called Seroquel, during pregnancy. As such, it is imperative to discuss any medical condition and medication use with your health care provider.

Quetiapine and Pregnancy

  • Brand name: Seroquel
  • Manufacturer: AstraZeneca

Therapeutic Effect: Seroquel is used to treat schizophrenia and manic episodes associated with bipolar I disorder.
Pregnancy Safety Rating: Category C
Pregnancy Recommendation: There is limited human data. Animal data suggest risk.

Side Effects:

  • Frequent: (19-10%) Headache, dizziness, drowsiness.
  • Occasional: (9%-3%) Constipation, orthostatic hypotension, dyspepsia (heartburn, indigestion, epigastric pain), tachycardia, rash, rhinitis, dry mouth, asthenia (loss of strength, energy), abdominal pain.
  • Rare: (2%) Back pain, weight gain, fever.

Pregnancy/Lactation Considerations: It is unknown if quetiapine is distributed in breast milk. It is not recommended for breastfeeding mothers.

Pregnancy Summaries:

The following summaries are cited directly from the sources of Briggs, Freeman, & Yaffe, the Physicians’ Desk Reference, and the Reprotox Toxicology Center.

Briggs, Freeman, & Yaffe – Quetiapine is a potent atypical antipsychotic that may cause clinically significant improvements in the symptoms experienced by a schizophrenic patient. In certain situations, this improvement may result in an increased opportunity for conception and subsequent pregnancy.

Quetiapine was not teratogenic in two animal species, but only low doses have been evaluated. Administration of higher doses was prevented because of significant maternal, embryo, and fetal toxicity.
The human pregnancy experience is too limited for an assessment of the embryo-fetal risk. However, because of the very limited human pregnancy experience with atypical antipsychotics, the American College of Obstetricians and Gynecologists does not recommend the routine use of these agents in pregnancy, but a risk-benefit assessment may indicate that such use is appropriate(1).

However, because quetiapine is indicated for severe debilitating mental disease, the benefits to the mother appear to outweigh the unknown risk (2).

A 1996 review on the management of psychiatric illness concluded that patients with histories of chronic psychosis or severe bipolar illness represent a high-risk group (for both the mother and the fetus) and should be maintained on pharmacologic therapy before and during pregnancy(3). Folic acid (4mg/day) has been recommended for women taking atypical antipsychotics because they may have a higher risk of neural tube defects due to inadequate folate intake and obesity(4).

Physicians’ Desk Reference – There are no adequate and well-controlled studies in pregnant women and quetiapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. For further information, please refer to the Physicians’ Desk Reference or contact your Healthcare Provider.

Reprotox Toxicology Center – Based on experimental animal studies, quetiapine is not expected to increase the risk of congenital anomalies. Quetiapine in a small series of cases did not increase the risk of birth defects.
If you are pregnant and have questions related to medication use during pregnancy, this is Reprotox Toxicology Center is the most comprehensive resource on medication use during pregnancy.

Next Steps:

The American Pregnancy Association does not prescribe medication, nor do we serve as a consult for medication use during pregnancy.  It is imperative that you discuss the use of any medication during pregnancy with your health care provider.
The purpose of this document is to provide you with information to support discussions with your health care provider.


Hodgson, Barbara, and Kizior, Robert, Saunders Nursing Drug Handbook 2012, Elsevier, St. Louis, MO. ISBN: 978-1-4377-2334-2.
Briggs, Gerald, Freeman, Roger and Yaffe, Sumner, Drugs in Pregnancy and Lactation, 9th Ed., Wolters Kluwer/Lippincott Williams & 3. Wilkins, Philadelphia, PA. ISBN: 978-1-60831-708-0, 2011.
Physicians’ Desk Reference (PDR), PDR Network, LLC, Montvale, NJ 07645 ISBN: 978-1-56363-780-3
Reproductive Toxicology Center, https://www.reprotox.org, agent # 4099