This sheet is about exposure to 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 approved to treat depression, obsessive-compulsive disorder, Tourette’s syndrome, bulimia nervosa, panic disorder, and premenstrual dysphoric disorder (PMDD). Fluoxetine has also been used to treat body dysmorphic disorder, hot sweats, posttraumatic stress disorder (PTSD), and Raynaud’s phenomenon. Some brand names for fluoxetine are Prozac®, Prozac Weekly®, Rapuflux®, Selfemra®, and Sarafem®. Fluoxetine belongs to the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).
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 this 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 their symptoms (relapse) if they stop this medication during pregnancy. If you plan to stop this medication, your healthcare provider may suggest that you slowly lower the dose instead of stopping all at once. Stopping this medication suddenly can cause some people to have withdrawal symptoms.
I take fluoxetine. Can it make it harder for me to get pregnant?
In animal studies, fluoxetine did not have an effect on whether the animals could get pregnant. In people, fluoxetine has been studied in females having medical treatments because they were already having a hard time becoming pregnant. In these studies, those who took fluoxetine got pregnant at the same rate as those who did not take fluoxetine.
Does taking fluoxetine increase the chance for miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. A small number of studies did not find a greater chance for miscarriage when fluoxetine was used in pregnancy.
Does taking fluoxetine 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. Fluoxetine use is unlikely to increase the chance for birth defects.
There have been many studies looking at fluoxetine and pregnancy. There are reports on over 10,000 pregnancies exposed to fluoxetine in the first trimester. The first trimester is the time in pregnancy when major birth defects can happen. No pattern of birth defects has been found and most studies have not found an increased chance for birth defects related to fluoxetine use. Some studies have suggested an increased chance for heart defects or other birth defects. However, taking all the studies together, there is no proven risk for birth defects directly related to fluoxetine.
Does taking fluoxetine in pregnancy increase the chance of other pregnancy related problems?
Some complications have been reported more often if fluoxetine was used throughout the third trimester. Some studies saw a higher chance for preterm delivery (delivery before 37 weeks of pregnancy). Some studies also found babies to be a little more likely to have lower birthweight when fluoxetine was used throughout the third trimester. In some of the studies, the complications were seen more often when the medication dose used was high. Babies born early or with very low birthweight can develop health problems more easily than babies born at full term with a normal weight.
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 anxiety), or other factors that may be increasing the chance for these complications.
Studies also do not agree if fluoxetine use in the second half of pregnancy might increase the chance for a serious lung problem in the baby at birth, called pulmonary hypertension. Among the studies that suggested an increased chance for pulmonary hypertension, the overall chance for this lung problem was less than 1/100 (less than 1%).
For more information about depression or anxiety, please see our fact sheets at https://mothertobaby.org/fact-sheets/depression-pregnancy/ or at https://mothertobaby.org/fact-sheets/anxiety-fact/.
I need to take fluoxetine throughout my entire pregnancy. Will it cause withdrawal symptoms in my baby after birth?
Some medications taken during pregnancy can cause symptoms in a newborn after delivery. These symptoms are sometimes referred to as “withdrawal”.
Most babies exposed to fluoxetine in late pregnancy do not have withdrawal symptoms. However, when fluoxetine is used through the 3rd trimester, the baby could show some symptoms of withdrawal after birth. Symptoms might include: being irritable and/or jittery, crying, tight muscles, harder time breathing, unusual 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. There might be a higher chance for withdrawal symptoms if other psychiatric medications are also taken with fluoxetine through pregnancy.
Does taking fluoxetine in pregnancy affect future behavior or learning for the child?
A few studies have looked at the development of children from age 16 months to 7 years and did not find differences between children who were exposed to fluoxetine during pregnancy and those who were not. In addition, most studies found no increase in attention deficit hyperactivity disorder (ADHD) in children exposed to SSRIs like fluoxetine during pregnancy. Most studies also find that SSRIs like fluoxetine do not appear to increase the risk of autism spectrum disorder (ASD) after accounting for the effects of maternal depression or other factors.
Breastfeeding while taking fluoxetine:
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 noted slightly less weight gain in infants exposed to fluoxetine via breast milk; however, this would likely only be an issue if the infant’s weight gain were already a concern. One study showed that mental and physical development was normal for infants exposed to fluoxetine via breastmilk in their first year of life.
In newborns less than two months of age, fluoxetine might have a higher chance of causing a side effect compared to older babies. The product label for fluoxetine recommends people who are breastfeeding not use this medication. But, the benefit of using fluoxetine may outweigh the risks. Your healthcare providers can talk with you about using fluoxetine and what treatment is best for you. If fluoxetine is the medication that works the best for you, breastfeeding doesn’t always have to be stopped. Watch your child for any symptoms. Be sure to talk to your baby’s pediatrician about any concerns you have and all your breastfeeding questions.
If a male takes fluoxetine, could it affect fertility (ability to get partner pregnant) or increase the chance of birth defects in a partner’s pregnancy?
Fluoxetine and other SSRIs have been reported to cause some sexual side effects, such as lower sexual desire or problems with ejaculation. Studies looking at fluoxetine in a small number of males have seen that sperm quality can be affected with long-term fluoxetine use. The sperm quality was seen to improve when fluoxetine was stopped. However, while sperm quality was not as good with fluoxetine use, the level of quality was still within a normal range.
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 http://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.
National Pregnancy Registry for Psychiatric Medications: There is a pregnancy registry for people who take psychiatric medications, such as fluoxetine. For more information you can look at their website: https://womensmentalhealth.org/research/pregnancyregistry/.
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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.
