This sheet is about exposure to atomoxetine in pregnancy and while breastfeeding. This information should not take the place of medical care and advice from your healthcare provider.
What is atomoxetine?
Atomoxetine is a mediation that has been used to treat attention deficit hyperactivity disorder (ADHD) and bed wetting. It belongs to a class of medications known as norepinephrine reuptake inhibitors. 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 this 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 metabolize 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.
Does taking atomoxetine increase the chance for miscarriage?
Miscarriage can occur in any pregnancy. Studies have not been done to see if atomoxetine could increase the chance of miscarriage.
Does taking atomoxetine 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. Atomoxetine has not been well studied for use during pregnancy. Two small human studies have not suggested a greater chance for birth defects. When looking at doses typically used by humans, animal studies did not suggest an increased chance for 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 people 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 cause other pregnancy-related problems. One study of 453 people who filled a prescription for atomoxetine during the first 20 weeks of pregnancy showed no increased chance for placental abruption (when the placenta pulls away from the wall of the uterus before labor starts), smallness for gestational age, preterm birth (birth before 37 weeks of pregnancy), or preeclampsia (dangerously high blood pressure).
Does taking atomoxetine in pregnancy cause long-term problems in behavior or learning for the baby?
Studies have not been done to see if atomoxetine can cause behavior or learning issues for the child.
Breastfeeding while taking atomoxetine:
There are no studies on the use of atomoxetine while breastfeeding. You and your healthcare providers should discuss the benefits and risks of staying on this medication. Be sure to talk to your healthcare providers about all your breastfeeding questions.
If a male takes atomoxetine, could it affect fertility (ability to get partner pregnant) or increase the chance of birth defects?
Atomoxetine can increase the chance of erectile dysfunction. Studies have not been done to see if atomoxetine could 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/.
Selected References:
- Bro SP, et al. 2015. Adverse pregnancy outcomes after exposure to methylphenidate or atomoxetine during pregnancy. Clin Epidemiol; 7:139-47.
- Brown JT, et al. 2019. Clinical Pharmacogenetics Implementation Consortium Guideline for Cytochrome P450 (CYP)2D6 Genotype and Atomoxetine Therapy. Clin Pharmacol Ther. ;106(1):94-102. doi: 10.1002/cpt.1409.
- Cohen JM, et al. 2017. Placental complications associated with psychostimulant use in pregnancy. Obstet Gynecol; 130(6):1192-201.
- Kallen B, et al. 2013. The Use of Central Nervous System Active Drugs During Pregnancy. Pharmaceuticals; 6(10):1221-86.
- Naguy A, et al. 2020. Atomoxetine in-focus! Asian J Psychiatr. ;49:101634. doi: 10.1016/j.ajp.2019.02.008.
- Perugi G, et al. 2015. The use of stimulants and atomoxetine in adults with comorbid ADHD and bipolar disorder. Expert Opin Pharmacother.;16(14):2193-204.
- Strattera Product Label. 2010. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0121363e-dcd9-4c24-940b-ea890ab762e7 [accessed 10/2019].
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/
OTIS/MotherToBaby recognizes that not all people identify as “men” or “women.” When using the term “mother,” we mean the source of the egg and/or uterus and by “father,” we mean the source of the sperm, regardless of the person’s gender identity.
