This sheet talks about using fluoxetine in pregnancy and while breastfeeding. This information should not take the place of medical care and advice from your healthcare provider.

What is fluoxetine?

Fluoxetine is a medication commonly used to treat depression. Fluoxetine is also used to treat obsessive-compulsive disorders, Tourette’s syndrome, eating disorders (bulimia nervosa), panic disorder and premenstrual dysphoric disorder (PMDD). Some brand names for fluoxetine are Prozac® and Sarafem®. Fluoxetine belongs to the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

I am taking fluoxetine, but I would like to stop taking it before becoming pregnant. How long does fluoxetine stay in your body?

Every person’s ability to break down the medication is different. On average, in healthy adults, almost all of the fluoxetine would likely be gone from the body in a little over one month after stopping. However, it is important to discuss with your health care provider any risks and benefits of taking fluoxetine during pregnancy as compared to stopping fluoxetine. Studies have shown that when depression is left untreated during pregnancy, there can be a higher chance for pregnancy complications such as miscarriage, preeclampsia, preterm delivery, low birth weight, and/or postpartum depression. Only you and your health care team know your history and can best decide if you should continue or stop taking fluoxetine during pregnancy. Please see our fact sheet on Depression and Pregnancy at https://mothertobaby.org/fact-sheets/depression-pregnancy/pdf/

Can taking fluoxetine make it harder for me to become pregnant?

Animal studies have not shown any effect on fertility with the use of fluoxetine, but human pregnancy studies have not looked at fluoxetine’s effect on fertility.

Does fluoxetine use increase the chance for miscarriage?

Miscarriage can occur in any pregnancy. Several studies have not found a greater chance for miscarriage among women taking fluoxetine during pregnancy.

Can taking fluoxetine during my pregnancy cause birth defects?

In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect. This is called her background risk. Fluoxetine use in the first trimester is unlikely to increase the chance for birth defects. Fluoxetine is one of the better-studied antidepressants in pregnancy. There are reports on over 10,000 (ten thousand) pregnancies exposed to fluoxetine during the first trimester. No pattern of birth defects has been found and most studies have not found an increased chance for birth defects with fluoxetine use during pregnancy. Some studies have suggested an increased chance for heart defects or other birth defects. However, taking all the studies together, there is fortunately no proven risk for birth defects related to fluoxetine.

I need to take fluoxetine throughout my entire pregnancy. Will it cause withdrawal symptoms in my baby?

If you are taking an SSRI like fluoxetine during the third trimester, your baby could have some symptoms which are sometimes referred to as problems with neonatal adaptation. The symptoms include irritability, crying, jitteriness, increased muscle tone, harder time breathing, altered sleep patterns, tremors (shivers) and/or trouble eating. In most cases, these symptoms are mild and go away within weeks with no treatment or with only supportive care. However, most babies whose mothers took fluoxetine in late pregnancy do not have symptoms.

Are there any other problems with using fluoxetine in the third trimester?

It is not clear. Studies do not agree if there is an increased chance for preterm delivery (delivery before 37 weeks) or lower birth weight with fluoxetine use. These outcomes are hard to study because they are also associated with maternal depression.

Studies also do not agree whether babies whose mothers take SSRIs (like fluoxetine) during the second half of pregnancy might have a slightly higher chance for pulmonary hypertension, a serious lung problem at birth. For studies that have suggested an increased chance, the overall chance for this finding was low (likely less than 1%).

Will taking fluoxetine have any effect on my baby’s behavior and development?

A few studies have looked at the development of children from 16 months to 7 years of age and did not find differences between children whose mothers took fluoxetine during pregnancy and those whose mothers did not.

Most studies find no increase in attention deficit hyperactivity disorder (ADHD) in children whose mothers took SSRIs like fluoxetine during pregnancy. Most studies also find that SSRIs like fluoxetine do not appear to increase autism spectrum disorder (ASD) after considering the effects of maternal depression or other factors.

Can I take fluoxetine while breastfeeding?

Fluoxetine is found in breast milk. The amount of the medication that gets to the breastfed baby is usually less than ten percent of the amount found in the mother’s blood.

Most reports find no problems for breastfed babies. In a small number of cases, irritability, vomiting, diarrhea, and less sleep, have been reported. One study also noted slightly less weight gain in infants exposed to fluoxetine in breast milk; however, this would likely only be of clinical significance if the infant’s weight gain were already of concern.

One study showed that babies whose mothers took fluoxetine while breastfeeding scored no differently on neurodevelopmental tests than other babies.

In newborns less than two months of age, fluoxetine might have a higher chance of causing a side effect compared to older babies. If this medication is the one that works the best for the mother, breastfeeding should not be discouraged. Instead, observe the baby for side effects and report to the pediatrician. Discuss all of your breastfeeding questions with your healthcare providers.

What if the father of the baby takes fluoxetine?

One group looked at the rates of ADHD and ASD in children whose fathers redeemed a prescription for an unspecified SSRI prior to conception. The authors concluded that their data suggested the father’s diagnosis (or other factors), rather than the medicine itself, was associated with a small increase in these outcomes.

In general, exposures that fathers have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures and Pregnancy at http://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/pdf/.

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