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-norepinephrine reuptake inhibitors (SNRIs). Duloxetine is marketed under the brand names Cymbalta® and Irenka®.

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. If you decide to go off of the medication, discuss how you should wean off with your healthcare provider. If this medication is stopped too quickly, it can cause physical and psychological symptoms such as dizziness, stomach upset, and nervousness or anxiety.

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 did not find a higher chance of birth defects.

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

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 newborn complications in my baby?

Maybe. When used near delivery, duloxetine may cause temporary (lasting a short time) symptoms in the baby. These symptoms are also referred to as withdrawal and/or toxicity. At this time, because of insufficient studies, we do not know how high the chance is that a baby would have withdrawal or toxicity from the medication. The symptoms may include breathing problems, jitteriness / tremors, more or less muscle tone, irritability, problems sleeping, and hard time eating or regulating their body temperature. 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. Symptoms usually go away within a few weeks. Not all babies exposed to duloxetine will have 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 healthcare provider 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?

There are no studies at this time looking at long-term effects. This does not mean that there is a risk or no risk and studies are needed.

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, or poor weight gain, especially in young, exclusively breastfed infants. Please talk to your healthcare 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/.

Selected References:

  • Bellantuono C, et al. 2015. The safety of serotonin-noradrenaline reuptake inhibitors (SNRIs) in pregnancy and breastfeeding: a comprehensive review.  Hum Psychopharmacol.  30(3), 143-51.
  • Hoog SL, et al. 2013. Duloxetine and pregnancy outcomes: safety surveillance findings. InternationalJournal 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.