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. This sheet talks about whether exposure to duloxetine may increase the risk for birth defects over that background risk. This information should not take the place of medical care and advice from your health care provider.

What is duloxetine?


Duloxetine is a medication used to treat depression, anxiety, and chronic pain in adults. Duloxetine belongs to a group of antidepressant medications known as serotonin-norepinerphrine reuptake inhibitors (SNRIs). Duloxetine is marketed under the brand name Cymbalta®.

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

Individuals break down medicines at different rates. On average, it is thought to take around three to four days for most of the duloxetine to be gone from the body.

You should always speak with your health care provider before making any changes in your medication to discuss the benefits and risks. Women who suddenly stop taking their medications are at risk for physical and psychological symptoms such as dizziness, stomach upset, and nervousness or anxiety. If a woman plans to stop taking her duloxetine, it is recommended that this be done slowly over time.

Can taking duloxetine during my pregnancy increase the chance of miscarriage?

Two studies found that women taking duloxetine had a slight increase in their chances to miscarry in the first trimester. Other studies have found the chances of miscarriage to be similar to that of women taking other antidepressant medication. Depression itself may increase the risk for miscarriage, which makes it difficult to find out whether the medications used to treat depression can also cause miscarriage.

Will taking duloxetine during my pregnancy cause birth defects in my baby?

Studies have looked at over 800 babies born to women who took duloxetine during early pregnancy or throughout the pregnancy. These studies suggest that using duloxetine during pregnancy is unlikely to increase the chance to have a baby with a birth defect.

Does taking duloxetine during my pregnancy increase my risk of premature birth?

No. Studies have not found duloxetine to increase the chance for premature birth (born before 37 weeks). Depression itself may increase the risk of preterm birth, which makes it difficult to find out whether the medications used to treat depression can also cause prematurity. For more information on depression in pregnancy, please see our fact sheet at: https://mothertobaby.org/fact-sheets/depression-pregnancy/pdf/.

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

Yes, it can cause temporary withdrawal symptoms in the baby, more often when used near the time of delivery. Babies exposed in the third trimester to any of the antidepressant medications may have breathing problems, jitteriness, more or less muscle tone, irritability, problems sleeping, and difficulty feeding. While in rare cases some babies may need to stay in a special care nursery for a few days until these symptoms go away, most of the time the symptoms are mild and go away on their own in a few weeks. Not all babies exposed to duloxetine will have these symptoms.

Should I stop taking duloxetine during the pregnancy or wean off it before the third trimester?

Studies have shown that when depression is left untreated during pregnancy, there may be increased chances for miscarriage, preeclampsia (dangerously high blood pressure), preterm delivery, and low birth weight. Only you and your doctor know your medical history and can best determine whether or not you should stop taking duloxetine during pregnancy. Some women can gradually wean off duloxetine during pregnancy. For other women, the effects from stopping duloxetine may be more harmful than the possible risks to the baby if they continue to take it. The benefits of taking duloxetine for your specific situation and the potential small risks to the baby should be considered before a decision is made.

Will taking duloxetine have any long-term effect on my baby’s behavior and development?

Right now there is no evidence that taking duloxetine during pregnancy causes changes in the baby’s behavior and intellect. Long-term studies are needed to determine if duloxetine has any effects on a child’s learning or behavior.

Can I take duloxetine while breastfeeding?

Yes. Duloxetine is found in breast milk, usually only a very small amount. No reports have described harmful effects in breastfed infants. More studies are needed to determine if taking duloxetine while breastfeeding has any effects on children.

It is always wise to watch babies exposed through breastmilk for side effects such as sleepiness, especially in young, exclusively breastfed infants. Please talk to your health care provider for suggestions if you feel your baby is showing side effects due to your use of duloxetine.

What if the father of the baby takes duloxetine?

There are no studies looking at possible risks to a pregnancy when a father takes duloxetine. In general, medications that the father takes do not increase risk to a pregnancy because the father does not share a blood connection with the developing baby. For more information, please see the MotherToBaby fact sheet on Paternal Exposures and Pregnancy at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/pdf/.

References:

  • Bellantuono C, et al. 2015. The safety of serotonin-noradrenaline reuptake inhibitors (SNRIs) in pregnancy and breastfeeding: a comprehensive review. HumPsychopharmacol. 30(3), 143-51.
  • Hoog SL, et al. 2013. Duloxetine and pregnancy outcomes: safety surveillance findings. International Journal of Medical Sciences. 10(4). 413-419.
  • Kallen B, et al. 2013. The use of central nervous system active drugs during pregnancy. Pharmaceuticals. 6(10), 1221-1286.
  • Kjaersgaard MI, et al. 2013. Prenatal antidepressant exposure and risk of spontaneous abortion – a population-based study. PLoS One. 8(8). e72095.