This sheet is about exposure to paroxetine in pregnancy and while breastfeeding. This information is based on available published literature. It should not take the place of medical care and advice from your healthcare provider.
What is paroxetine?
Paroxetine is a medication that has been used to treat depression, general anxiety disorder, social anxiety disorder, obsessive compulsive disorder, premenstrual dysphoric disorder, post-traumatic stress disorder, and panic disorder. Paroxetine belongs to the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). Some brand names for paroxetine are Paxil®, Aropax®, Brisdelle®, Pexeva® and Seroxat®.
Sometimes when people find out they are pregnant, they think about changing how they take their medication, or stopping their medication altogether. However, it is important to talk with your healthcare providers before making any changes to how you take your medication. Your healthcare providers can talk with you about the benefits of treating your condition and the risks of untreated illness during pregnancy. Some people may have a return of symptoms (relapse) if they stop this medication.
Studies have shown that when depression is left untreated during pregnancy, there could be an increased chance for pregnancy complications. Please see our fact sheet on depression at https://mothertobaby.org/fact-sheets/depression-pregnancy/.
I take paroxetine. Can it make it harder for me to get pregnant?
In some people, paroxetine may raise the levels of a hormone called prolactin. High levels of prolactin can stop ovulation (part of the menstrual cycle when an ovary releases an egg). This can make it harder to get pregnant. Paroxetine has also been associated with changes in sexual function (such as less desire to have sex).
Does taking paroxetine increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. Some studies suggest that taking paroxetine may slightly increase the chance of miscarriage. However, research also shows that depression itself may increase the chance of miscarriage. This makes it hard to know if an increased chance of miscarriage is due to medication, the underlying condition, or other factors.
Does taking paroxetine increase the chance of birth defects?
Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Some studies suggest that exposure to paroxetine in the first trimester might be associated with a small increased chance for heart defects. Other studies did not find a possible increased risk. The background rate of heart defects for any pregnancy is about 1 in 100 (1%). If there is an increased chance of birth defects with paroxetine use in the first trimester, it is expected to be small. Paroxetine exposure in pregnancy has not been shown to increase the chance of other birth defects.
Does taking paroxetine in pregnancy increase the chance of other pregnancy-related problems?
Some studies suggest a higher chance for preterm delivery (birth before week 37) with the use of an SSRI such as paroxetine, while others do not. Conditions such as depression may increase the chance of pregnancy-related problems, such as preterm delivery. This makes it hard to know if it is the medication, the condition being treating, or other factors that are increasing the chance of pregnancy-related problems.
Some, but not all, studies have suggested that when people who are pregnant take SSRIs during the second half of the pregnancy, their babies might have a higher chance for a serious lung condition called persistent pulmonary hypertension. Persistent pulmonary hypertension happens in 1 or 2 out of 1,000 births. Among the studies looking at this, the overall chance for pulmonary hypertension when an SSRI was used in pregnancy was less than 1/100 (less than 1%).
I need to take paroxetine throughout my entire pregnancy. Will it cause withdrawal symptoms in my baby after birth?
The use of paroxetine during pregnancy can cause temporary symptoms in newborns soon after birth. These symptoms are sometimes referred to as withdrawal. Symptoms may include jitteriness, increased muscle tone, irritability, changes in sleep patterns, tremors, trouble eating, and trouble breathing. These symptoms are usually mild and go away on their own. Some babies may need to stay in a special care nursery for several days. Not all babies exposed to paroxetine will have these symptoms. It is important that your healthcare providers know you are taking paroxetine so that if symptoms occur your baby can get the care that’s best for them.
Does taking paroxetine in pregnancy affect future behavior or learning for the child?
It is not known if paroxetine can increase the chance for behavior or learning issues. One study looking at prescriptions for SSRIs including paroxetine suggested an increased chance of autism spectrum disorder. Studies based on filled prescriptions/prescription records cannot tell if a person took the medication, so it is hard to know if the outcomes are related to the medication or other factors. Also, this study did not look at factors such as other exposures, paternal mental illness, or other family history of autism. Another prescription study did not report an increased chance for autism spectrum disorder.
One study looking at pregnancies exposed at least during the third trimester to SSRIs including paroxetine reported no differences in developmental outcomes between the exposed 46 infants or the unexposed 23 infants at 2 and 8 months of age. A follow-up study on some of these children found no difference in behaviors such as emotional reactivity, withdrawal, irritability, depression, or anxiety in the exposed group (22 children) when compared to the group that was not exposed to paroxetine (14 children).
Breastfeeding while taking paroxetine:
Paroxetine passes into breastmilk in small amounts. In some cases, mild side effects have been reported. If you suspect the baby has any symptoms (trouble sleeping, restlessness, or increased crying), contact the child’s healthcare provider. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a male takes paroxetine, could it affect fertility or increase the chance of birth defects?
Using paroxetine may raise a person’s levels of the hormone prolactin, which may affect fertility (ability to get partner pregnant). It is not known if paroxetine could increase the chance of birth defects above the background risk. In general, exposures that fathers or sperm donors have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.
National Pregnancy for Psychiatric Medications: There is a pregnancy registry for women who take psychiatric medications, such as paroxetine. For more information you can look at their website: https://womensmetnalhealth.org/research/prenancyregistry/.
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OTIS/MotherToBaby encourages inclusive and person-centered language. While our name still contains a reference to mothers, we are updating our resources with more inclusive terms. Use of the term mother or maternal refers to a person who is pregnant. Use of the term father or paternal refers to a person who contributes sperm.