What are the risks of Quetiapine (Seroquel) in pregnancy?

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Last updated: April 29, 2025View editorial policy

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From the FDA Drug Label

USE IN SPECIFIC POPULATIONS SECTION 8. 1 Pregnancy Pregnancy Category C: Risk Summary There are no adequate and well-controlled studies of quetiapine use in pregnant women. In limited published literature, there were no major malformations associated with quetiapine exposure during pregnancy. In animal studies, embryo-fetal toxicity occurred Quetiapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antipsychotic drugs (including quetiapine), during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery

Key Points:

  • There are no adequate and well-controlled studies of quetiapine use in pregnant women.
  • Quetiapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Neonates exposed to quetiapine during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Quetiapine use in pregnancy is associated with potential risks to the fetus, including embryo-fetal toxicity and extrapyramidal and/or withdrawal symptoms in neonates. The decision to use quetiapine during pregnancy should be made with caution, weighing the potential benefits against the potential risks 1.

From the Research

Seroquel (quetiapine) should be used during pregnancy only when the benefits clearly outweigh the risks, as it is classified as a Category C medication. If you have a serious mental health condition like bipolar disorder or schizophrenia, your doctor may recommend continuing Seroquel during pregnancy because untreated psychiatric illness can pose significant risks to both mother and baby 2. The typical dosage ranges from 150-800 mg daily depending on the condition being treated, but this should be individually determined by your healthcare provider 3. Some studies suggest a small increased risk of birth defects, particularly when used in the first trimester, though most pregnancies exposed to quetiapine result in normal outcomes 4. Babies exposed to antipsychotics like Seroquel near delivery may experience temporary withdrawal symptoms including irritability, abnormal muscle movements, or feeding difficulties 2. Regular prenatal care is essential if taking Seroquel during pregnancy, and any medication changes should only be made under medical supervision. Never stop taking Seroquel abruptly, as this could lead to a relapse of psychiatric symptoms that may be more harmful than the medication's potential risks.

Key considerations for the use of Seroquel during pregnancy include:

  • Monitoring for potential side effects such as gestational diabetes and neonatal respiratory distress 2
  • Regular prenatal care to minimize risks to the mother and baby
  • Avoiding abrupt discontinuation of the medication to prevent relapse of psychiatric symptoms
  • Weighing the benefits and risks of Seroquel use during pregnancy, particularly in the first trimester 4

It's essential to note that while Seroquel may be associated with some risks during pregnancy, the benefits of treating severe mental health conditions often outweigh these risks 2, 4. Therefore, the decision to use Seroquel during pregnancy should be made on a case-by-case basis, taking into account the individual patient's needs and medical history.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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