This sheet is about exposure to atomoxetine in pregnancy and while breastfeeding. This information is based on published research studies. It should not take the place of medical care and advice from your healthcare provider.
What is atomoxetine?
Atomoxetine is a mediation that has been approved to treat attention deficit hyperactivity disorder (ADHD). It belongs to a class of medications known as norepinephrine reuptake inhibitors (NRIs). A brand name for atomoxetine is Strattera®.
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.
I take atomoxetine, and I was told that I am a poor/slow metabolizer. What does that mean for my pregnancy?
Some people’s bodies metabolize (process) atomoxetine slower than others. People who are slow metabolizers might have higher levels of the medication in their blood. It is not known if this could affect a pregnancy differently than people who metabolize the medication more quickly.
I take atomoxetine. Can it make it harder for me to get pregnant?
Studies have not been done in humans to see if atomoxetine could make it harder to get pregnant. Animal studies did not show a change in fertility (ability to get pregnant).
Does taking atomoxetine increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. Studies have not been done to see if atomoxetine could increase the chance of miscarriage.
Does taking atomoxetine 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 atomoxetine, might increase the chance of birth defects in a pregnancy.
Atomoxetine has not been well studied for use during pregnancy. Four human studies have not suggested an increased chance of birth defects. Most of these studies used a prescription database to see who had a prescription for atomoxetine during their pregnancy. Prescription-based studies cannot tell us if the person who filled the prescription took the medication during their pregnancy.
When looking at doses typically used by humans, animal studies did not suggest an increased chance of birth defects. With levels higher than those used with human treatment, there is some question of a higher chance for birth defects. It is not known if this information would apply to humans, especially those who are considered poor metabolizers.
Does taking atomoxetine in pregnancy increase the chance of other pregnancy-related problems?
It is not known if atomoxetine can increase the chance of other pregnancy-related problems such as low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth). One study of 453 people who filled a prescription for atomoxetine during the first 20 weeks of pregnancy showed no increased chance of placental abruption (when the placenta pulls away from the wall of the uterus before labor starts), being small for gestational age, preterm delivery (birth before week 37), or preeclampsia (high blood pressure and problems with organs, such as the kidneys), that can lead to seizures (called eclampsia). Prescription-based studies cannot tell us if the person who filled the prescription took the medication during their pregnancy.
Does taking atomoxetine in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if atomoxetine can increase the chance of behavior or learning issues for the child.
Breastfeeding while taking atomoxetine:
There are no studies on the use of atomoxetine while breastfeeding. If you suspect the baby has any symptoms (such as being too sleepy), contact the child’s healthcare provider. Be sure to talk to your healthcare providers about all your breastfeeding questions.
If a man takes atomoxetine, could it affect fertility or increase the chance of birth defects?
Studies have not been done to see if atomoxetine could affect men’s fertility (ability to get partner pregnant) or increase the chance of birth defects. In general, exposures that fathers or sperm donors have are unlikely to increase the risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.
Please click here to view references.
There is a pregnancy registry for women who take medications for ADHD, called The National Pregnancy Registry for ADHD Medications. For more information please visit their website: https://womensmentalhealth.org/adhd-medications/
