Quetiapine (Seroquel®)
Information last updated: September 2020
Most pregnancies result in healthy babies, but there are chances of complications and unexpected outcomes. These chances are called baseline risks. In Canada, the baseline risk of major birth defects is 3-5%. This means that 3-5 out of 100 babies born in the general population will be born with a major birth defect. There are also baseline risks for miscarriages (15-25 out of 100 pregnancies), premature birth and other outcomes. The information provided will summarize if taking this drug is likely to change these risks.
Summary:
Over 4500 pregnancies with exposure to quetiapine in the first trimester of pregnancy were included in published studies that examined the rates of birth defects. Based on this, taking quetiapine during pregnancy is not likely to lead to an increase in major birth defects above the baseline risk. Quetiapine belongs to the family of medications called the second-generation antipsychotics, sometimes also referred to as atypical antipsychotics. Some studies reported higher rates of some adverse pregnancy or newborn outcomes when pregnancies exposed to a second-generation antipsychotic medication were compared to unexposed pregnancies. Even if there are increases in the risks, the actual risk to any pregnancy would be small. However, these adverse outcomes were not found in the better designed studies, where it appears that the increased risks may be explained by other factors, such as additional medications used in pregnancy, or the underlying mental health condition that the medication was given to treat.
If quetiapine is used in late pregnancy, it is suggested to monitor the newborn for withdrawal-like symptoms after birth. If symptoms occur, they are usually short-lived.
To see more details please click on the tabs below. Any decisions concerning quetiapine treatment during pregnancy should be discussed with a healthcare provider, weighing the benefits of treatment against any possible risks.
Please consult with your health care provider if you are considering stopping or making any changes to your regular medications.
This information about quetiapine is of a general nature and about medical use and does not replace the medical care and advice of your healthcare provider. For questions on dose, timing, side effects, interactions, etc. please consult your healthcare provider. Additionally, please read the patient insert provided with your medication. If you are using quetiapine or other drugs or medications for non-medical reasons or beyond what was recommended by a healthcare provider, please see Harm Reduction section. In case of emergency, please go to the emergency room or call 911.
Although participants in the studies referenced below may have used quetiapine in various combinations, the studies usually do not provide detailed information on drug combinations. This makes it challenging to comment on the safety of using this medication in combination with others during pregnancy or lactation.
Pronunciation
Please check back. We are in the process of reviewing if there is available information on the pre-pregnancy effects of quetiapine.
Over 4500 pregnancies with exposure to quetiapine in the first trimester of pregnancy were included in published studies that examined the rates of birth defects. Based on this, it is not likely that taking quetiapine in pregnancy will increase the risk of babies being born with major birth defects beyond the baseline risk.
A small study reported a higher risk of miscarriage in pregnancies exposed to quetiapine. This study compared pregnancies with quetiapine exposure to unexposed pregnancies which included women both with and without mental health conditions.
Studies have also reported increased risks of prematurity (delivery before 37 weeks), low birth weight, pregnancy related high blood pressure conditions, placenta abruption (when the placenta separates from the wall of the womb before birth) and cesarean section in pregnancies exposed to second-generation antipsychotic medications when compared to an unexposed group of pregnancies which included women both with and without mental health conditions. Even if the increased risks are real, they are expected to be small.
However, when women who were treated with a second-generation antipsychotic medication during pregnancy were compared only to those who have a mental health condition but were not treated with a second-generation antipsychotic in pregnancy, no increased risks for the adverse outcomes mentioned above were reported. This suggests that the higher risks mentioned above might be associated with the woman’s mental health condition and related factors and not the medication itself.
A study that looked specifically at quetiapine found no increased risk of prematurity or of babies being born small or large for gestational age in the 566 pregnancies exposed to quetiapine.
Some studies have reported increased risks of gestational diabetes (diabetes that starts in pregnancy) in pregnancies exposed to quetiapine or second-generation antipsychotic medications as a group, while other studies have not. One of the better designed studies, from Ontario, compared over 1,000 pregnancies exposed to second-generation antipsychotic medications to pregnancies in women with a mental health condition who were not treated with a second-generation antipsychotic in pregnancy. They reported no increase in the risk of gestational diabetes in the exposed pregnancies. It is not clear if the increased risk of gestational diabetes reported in some studies is associated with the use of second-generation antipsychotic medications or can be explained by other risk factors such as obesity.
Please check back. We are in the process of reviewing if there is available information on the effects of paternal exposure to quetiapine.
There have been reports of newborns exposed to second-generation antipsychotic medications during the 3rd trimester having withdrawal-like symptoms after birth (e.g., unusual muscle movements, breathing and feeding issues, low blood sugar, agitation, etc.). In most of the cases the infants were also exposed to other medications in pregnancy. Some of these other medications are known to be associated with such withdrawal-like symptoms after birth. In addition, no increased risk of these symptoms was reported when infants of women who were treated with a second-generation antipsychotic medication for their condition during pregnancy were compared to infants of women who have a mental health condition but were not treated with a second-generation antipsychotic in pregnancy. This suggests that the reported increased risks may be associated with the women’s mental health condition, other related factors, and/or other medications used, and not the second-generation antipsychotic.
It is suggested to let the pregnancy health care provider know if quetiapine is used in late pregnancy so that the baby can be watched for withdrawal-like symptoms after birth. Not every exposed baby will have these symptoms. For those who will, the symptoms usually go away within hours or days and do not require specific treatment. In some cases, longer hospital stays may be needed.
Last updated September 2020
If you are taking medications and you notice any new health concerns or symptoms in your nursing infant, please contact their health care provider. In case of emergency, please go to the emergency room or call 911.
People who are taking a medication or substance while providing their breastmilk to an infant need to know how much of the medication or substance is passing into their milk. One of the commonly used measurements to estimate this is the Relative Infant Dose (RID). The RID is estimated by comparing the dose of drug taken in by the infant through breastmilk to the dose that the nursing parent takes. Most medications with an RID of less than 10% are usually compatible with nursing a healthy infant. The RID does not need to be calculated for each person because most of the time it is expected to be similar to what has been found in research studies. We will provide the RID in the information below, when available.
Quetiapine was reported to pass into breastmilk in small amounts based on breastmilk levels of 19 nursing women treated with 25-400 mg of quetiapine daily. The RID is estimated to be less than 1%.
According to the available information quetiapine is not expected to affect the nursing infant. Normal development and no adverse effects related to quetiapine were reported in a small number of infants (approximately 15) who were nursed by women taking 25-400mg of quetiapine daily. In some cases, the nursing woman was also taking other medications such as antidepressants or medications for sleep.
Although the levels in breastmilk are very low, out of an abundance of caution, some suggest to monitor the infant for sleepiness and developmental milestones if taking quetiapine while nursing, especially if also taking other medications.
We did not find information on whether taking quetiapine while nursing can affect breastmilk supply.
A study assessed the neurodevelopment of 76 infants exposed to a second-generation antipsychotic during pregnancy and compared them to unexposed infants. No differences were reported between the groups at 12 months of age. The number of infants included in the study was small and more studies are needed to confirm this finding before conclusions can be made regarding long term effects of quetiapine.
Costs of some medications are covered for eligible people under provincial or national Indigenous drug benefit plans. Please visit the Ontario Drug Benefit (ODB) program Check medication coverage or the Non-Insured Health Benefits (NIHB) program Drug Benefit List to check if quetiapine is covered for you.
Quetiapine, when used not as prescribed, has potential for problematic use.
Medications, if not taken as prescribed, if taken beyond the prescribed amount, or if taken in combination with certain other drugs, may cause harm to you and/or your pregnancy or your nursing child.
If you are using quetiapine or other drugs or medications for non-medical reasons or beyond what was recommended by a healthcare practitioner and you are pregnant, providing your breastmilk to an infant, or parenting please click Harm Reduction for additional information. In case of emergency, please go to the emergency room or call 911.
Using drugs beyond what your clinician prescribes during pregnancy or parenting in a way that harms you or your baby may result in a community member or care provider contacting child protective services.
Pregnancy:
Based on 4500 pregnancies with exposure to quetiapine in the first trimester of pregnancy, there does not appear to be an increased risk of major birth defects above the baseline risk.
A small study reported a higher risk of miscarriage in pregnancies exposed to quetiapine compared to an unexposed group of pregnancies. The unexposed group included pregnant women both with and without a mental health condition. Studies have also reported increased risks of prematurity, low birth weight, small for gestational age, pregnancy related hypertensive conditions, placenta abruption and cesarean section in pregnancies exposed to second-generation antipsychotic medications compared to unexposed group of pregnancies which included people both with and without mental health conditions. However, studies reported no increased risk for these outcomes when women exposed to second-generation antipsychotic medication(s) in pregnancy were compared to unexposed women with mental health conditions. This suggests that the reported increased risks may be confounded by the underlying mental health conditions and may not be related to the medication itself.
One study that looked specifically at quetiapine found no increased risk of prematurity or small or large for gestational age neonates in the 566 pregnancies exposed to quetiapine.
The research is conflicting on whether exposure to quetiapine or second-generation antipsychotic medications in pregnancy is associated with an increased risk of gestational diabetes. It has been suggested that other risk factors, such as obesity, may be confounding the association.
There have been reports of newborns exposed to second-generation antipsychotic medications during the 3rd trimester having withdrawal-like symptoms after birth (e.g., unusual muscle movements, respiratory and feeding issues, low blood sugar, agitation, etc.). In most cases, the infants were exposed to other medications during pregnancy, some of which are known to be associated with withdrawal symptoms after birth. In addition, studies that examined individuals with mental health conditions (in both the exposed and comparison groups) reported no increased risk for these outcomes in those exposed compared to those unexposed to second-generation antipsychotic(s) in pregnancy. This suggests that the reported increased risks may be confounded by indication, and/or concomitant medications used during pregnancy and not associated with the second-generation antipsychotic. It is suggested to monitor the newborn for withdrawal-like symptoms if quetiapine is used in late pregnancy. If symptoms occur, they are usually self-limiting, resolving within hours or days and do not require specific treatment. In some cases, however, longer hospital stays may be required.
The research on neurodevelopmental outcomes is limited to a study examining 76 infants exposed to a second-generation antipsychotic during pregnancy and comparing them to an unexposed group of infants. No differences were reported between the groups at 12 months of age. More studies are needed to confirm these findings.
Lactation:
One of the factors that helps to determine if a medication is compatible with nursing is the Relative Infant Dose (RID). The RID provides an estimate of infant’s exposure to a medication through breastmilk. It is the ratio between the infant’s and the nursing individual’s weight-adjusted doses. The infant weight adjusted dose is estimated based on the concentration of medication in breastmilk, and an assumption of infant daily milk consumption of 150 ml/kg/day. In general, for infants with normal growth and development, most medications with an RID of less than 10% are considered compatible with nursing. The RID does not account for infant’s drug metabolism, clearance, or infant blood levels. Although some variability may exist in the RID, in most cases the estimated RID is adequate for clinical purposes and does not need to be calculated for each individual. We will provide the RID in the information below, when available.
Based on breastmilk levels of 19 nursing women treated with 25-400mg of quetiapine daily, the RID is estimated to be less than 1%.
Normal development and no adverse effects related to quetiapine were reported in a small number of infants (approximately 15) who were nursed by women taking 25-400mg of quetiapine daily. In some cases, the nursing woman was also taking other psychotropic medications.
Based on this information quetiapine is not expected to affect the nursing infant. Despite the low concentrations in breastmilk, and out of an abundance of caution, some still suggest to monitor the infant for drowsiness and developmental milestones if taking quetiapine while nursing, especially if also taking other psychotropic medications.
We did not find information on whether taking quetiapine while nursing can affect breastmilk supply.
Harm Reduction:
Quetiapine, when used not as prescribed, has potential for problematic use.
If your patient may be using quetiapine or other drugs or medications not as indicated during pregnancy, while providing breastmilk to an infant, or parenting please click Harm Reduction for additional information. In case of emergency, please advise them to go to the emergency room or call 911.
For additional resources see Health Canada Drug and Natural Health Product Monographs, Making Sense of Risk and Statistics.
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Food and Drug Administration. SEROQUEL® (quetiapine) Highlights of prescribing information Washington, D.C.: Food and Drug Administration; 1997 [Date of Revision January, 2022] [updated January, 2022; cited 2024 July 25]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020639s072lbl.pdf.
Food and Drug Administration. FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns Washington, DC: U.S. Government Food and Drug Administration; [revised August 8, 2017] [updated August 4, 2017; cited 2024 January 24]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-antipsychotic-drug-labels-updated-use-during-pregnancy-and-risk.
Galbally M, Frayne J, Watson SJ, Morgan V, Snellen M. The association between gestational diabetes mellitus, antipsychotics and severe mental illness in pregnancy: A multicentre study. Aust N Z J Obstet Gynaecol. 2020;60(1):63-9. [PMID: 31141172].
Gentile S. Quetiapine-fluvoxamine combination during pregnancy and while breastfeeding. Arch Women Ment Health. 2006;9(3):158-9.[PMID: 16683078].
Gentile S. Pregnancy exposure to second-generation antipsychotics and the risk of gestational diabetes. Expert Opin Drug Saf. 2014;13(12):1583-90.[PMID: 25189088].
Disclaimer
First Exposure does not offer health care treatment. If you have an urgent question about your pregnancy or your baby’s health, you should contact your health care provider directly. If you don’t have a health care provider and you live in Ontario, you have a variety of health care options. In the case of an emergency, visit a hospital emergency room or call 911.