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Is Paroxetine (Paxil) safe during pregnancy?

What the FDA-approved label for Paroxetine (Paxil) actually states in its Pregnancy Risk Summary — not a secondhand verdict. The decision is one to make with your prescriber.

By the pharmaranks editorial teamReviewed against the FDA drug label (§8.1) for Paroxetine sourcesUpdated Jul 21, 2026How we research

What the label’s pregnancy summary says

The label describes specific reported risks rather than reassurance. Based on published observational studies, first-trimester paroxetine use is associated with a less than 2-fold increase in cardiovascular malformations (meta-analyses report inconsistent overall findings but an increased risk for right ventricular outflow tract defects and atrial septal defect). It also cites risks of persistent pulmonary hypertension of the newborn (PPHN) and poor neonatal adaptation with SSRI exposure, complications in neonates exposed late in the third trimester (respiratory distress, feeding difficulty, jitteriness, seizures), and a less than 2-fold increased risk of postpartum hemorrhage when used in the month before delivery. The label states that for women who intend to become pregnant or who are in their first trimester, paroxetine should be initiated only after consideration of other available treatment options, and it also weighs the risk of untreated depression (relapse) in pregnancy. It does not tell patients to stop or start on their own — these decisions belong with the prescriber.

Frequently asked questions

Is Paroxetine safe to take during pregnancy?

The label flags a real concern for Paroxetine — see the summary above. This is not a drug to start or continue in pregnancy on your own; it needs a prescriber weighing the specific risks against the reason you would take it. The one universal rule: do not start or stop a medication in pregnancy without medical advice — an untreated condition can carry its own risk to a pregnancy.

What does the FDA label say about Paroxetine in pregnancy?

The summary above is transcribed from the label's Pregnancy Risk Summary (§8.1). Since 2015 FDA labels replaced the old A/B/C/D/X letter categories with a narrative that describes what human and animal data actually show, which is what you are reading here — not a single letter grade.

Is Paroxetine safe while breastfeeding?

That is a separate question the label answers in a different section (§8.2, Lactation), and it does not always match the pregnancy verdict. This page covers pregnancy only. For breastfeeding, ask your prescriber or pharmacist, or check the NIH LactMed database, which summarizes the drug-in-breast-milk evidence.

The questions people actually ask about paroxetine in pregnancy

Answered by MotherToBaby, the fact sheets written by the Organization of Teratology Information Specialists and published through the NIH. Quoted in full — we do not condense them.

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 have suggested that taking paroxetine might slightly increase the chance for miscarriage. However, research also shows that depression itself may increase the chance for miscarriage. This makes it hard to know if it is the medication, untreated or poorly treated depression, or other factors that is increasing the chance for miscarriage.

Does taking paroxetine increase the chance of birth defects?

Birth defects can happen in any pregnancy for different reasons. Out of all babies born each year, about 3 out of 100 (3%) will have a birth defect. We look at research studies to try to understand if an exposure, like paroxetine, might increase the chance of birth defects in a pregnancy. Some studies have suggested that exposure to paroxetine in the first trimester might be associated with a small increased chance for birth defects, especially heart defects. Other studies did not find an increased risk. The background rate for heart defects in 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.

Does taking paroxetine in pregnancy increase the chance of other pregnancy-related problems?

Some studies have suggested that taking paroxetine throughout pregnancy may increase the complications such as preterm delivery (birth before week 37). However, research has also shown that when depression is left untreated during pregnancy, there could be an increased chance for pregnancy complications. This makes it hard to know if it is the medication, untreated depression or factors that are increasing the chance for these problems.

Some, but not all, studies have suggested that when people 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%).

What screenings or tests are available to see if my pregnancy has birth defects or other issues?

Prenatal ultrasounds can be used to screen for some birth defects, such as heart defects. There is a special kind of ultrasound that focuses on the heart called a fetal echocardiogram. Ultrasound can also be used to monitor the growth of the pregnancy. Talk with your healthcare provider about any prenatal screenings or testing that are available to you. There are no tests available during pregnancy that can tell how much effect there could be on future behavior or learning.

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).

If a man takes paroxetine, could it affect fertility or increase the chance of birth defects?

Using paroxetine may raise a man’s levels of the hormone prolactin, which may affect fertility (ability to get a woman pregnant). Also, men with conditions such as depression can have a lower sex drive. An increased chance of birth defects is not expected when a man takes paroxetine. 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/ .

Quoted from MotherToBaby Fact Sheets — Paroxetine, published April 2025. MotherToBaby states its fact sheets should not take the place of medical care and advice from your healthcare providers.

Breastfeeding is a separate question — what LactMed says about paroxetine

More guides for Paroxetine

Source

Paroxetine tablets - DailyMed label (SPL)

Other drugs: Acetaminophen · Amitriptyline · Amlodipine · Amoxicillin · Aspirin · Azithromycin · Bupropion · Cephalexin · Ciprofloxacin · Citalopram · Diphenhydramine · Doxycycline · Duloxetine · Escitalopram · all drugs.

The pregnancy information is transcribed from the drug’s FDA-approved label (§8.1) and mirrors what the label states — “insufficient data” is never rounded up to “safe.” This is general reference information, not medical advice. Whether to take any medication in pregnancy is a decision for you and your prescriber; do not start or stop a drug on your own, because an untreated condition can also carry risk.