Doxylamine succinate-pyridoxine hydrochloride (Diclegis®)

This sheet is about exposure to doxylamine succinate-pyridoxine hydrochloride in pregnancy and while breastfeeding. This information is based on research studies. It should not take the place of medical care and advice from your healthcare provider.

What is doxylamine succinate-pyridoxine hydrochloride?

The combination of doxylamine succinate and pyridoxine hydrochloride is a medication that has been used to treat nausea and vomiting in pregnancy (NVP), also called “morning sickness.” For more information on NVP, please see the MotherToBaby fact sheet at https://mothertobaby.org/fact-sheets/nausea-vomiting-pregnancy-nvp/.

Doxylamine succinate is an antihistamine. Antihistamines lessen the symptoms of allergic reactions and colds and help to treat insomnia (trouble sleeping). Pyridoxine hydrochloride is a form of vitamin B6.  In the United States, the combination of doxylamine and pyridoxine can be found under the brand name Diclegis®. In Canada, it can be found under the brand name Diclectin®. Doxylamine succinate and/or pyridoxine hydrochloride are also available as over-the-counter medications.

Sometimes when women 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 doxylamine succinate-pyridoxine hydrochloride. Can it make it harder for me to get pregnant?

It is not known if doxylamine succinate-pyridoxine hydrochloride can make it harder to get pregnant.

Does taking doxylamine succinate-pyridoxine hydrochloride increase the chance of miscarriage?

Miscarriage is common and can occur in any pregnancy for many different reasons. Doxylamine succinate-pyridoxine hydrochloride has not been shown to increase the chance of miscarriage.

Does taking doxylamine succinate-pyridoxine hydrochloride 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 doxylamine succinate-pyridoxine hydrochloride, might increase the chance of birth defects in a pregnancy.

Studies of hundreds of thousands of women have shown that taking doxylamine succinate-pyridoxine hydrochloride during pregnancy does not increase the chance of birth defects. Doxylamine succinate-pyridoxine hydrochloride has been recommended as a first-line treatment for NVP by the American College of Obstetricians and Gynecologists (ACOG) and by several medical organizations in Canada.

Does taking doxylamine succinate-pyridoxine hydrochloride in pregnancy increase the chance of other pregnancy-related problems?

Studies have found that taking doxylamine succinate-pyridoxine hydrochloride does not increase the chance of pregnancy-related problems such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth).

Does taking doxylamine succinate-pyridoxine hydrochloride in pregnancy affect future behavior or learning for the child? 

Studies that have followed children from ages 2 to 7 years have not found a higher chance of behavior or learning problems after exposure to doxylamine succinate-pyridoxine hydrochloride during pregnancy.

Breastfeeding while taking doxylamine succinate-pyridoxine hydrochloride: 

There are no studies looking at the combination of doxylamine succinate-pyridoxine hydrochloride while breastfeeding.

Antihistamines such as doxylamine can make people drowsy. It could cause drowsiness or irritability in a breastfeeding infant. If you suspect the baby has any symptoms (such as drowsiness or poor feeding), contact the child’s healthcare provider.

The product label for Diclegis® recommends people who are breastfeeding not use this medication. However, the benefit of breastfeeding and using this medication might outweigh possible risks. Your healthcare providers can talk with you about using doxylamine succinate-pyridoxine hydrochloride and what treatment is best for you. Be sure to talk to your healthcare provider about all your breastfeeding questions.

If a man takes doxylamine succinate-pyridoxine hydrochloride, could it affect fertility or increase the chance of birth defects?   

Studies have not been done to see if doxylamine-pyridoxine could affect men’s fertility (ability to get a woman pregnant) or increase the chance of birth defects in humans. 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 https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.

Please click here for references.


Doxylamine succinate-pyridoxine hydrochloride (Diclegis®)

This sheet is about exposure to risperidone 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 risperidone? 

Risperidone is a medication that has been used to treat mental health conditions such as schizophrenia, bipolar disorder, and depression. It can be taken by mouth or given as an injection. Risperidone belongs to a group of medications called atypical or second-generation antipsychotics. Brand names for risperidone include Risperdal®, Risperdal Consta®, and Perseris®. 

Sometimes when women 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. 

MotherToBaby has a fact sheet on depression here: https://mothertobaby.org/fact-sheets/depression-pregnancy/ 

I take risperidone. Can it make it harder for me to get pregnant?  

In some women, risperidone may raise the levels of the hormone prolactin. High levels of prolactin can stop ovulation (part of the menstrual cycle when an ovary releases an egg). This would make it harder to get pregnant. Your healthcare provider can monitor your levels of prolactin if there is concern. 

Does taking risperidone increase the chance of miscarriage?  

Miscarriage is common and can occur in any pregnancy for many different reasons. Some studies have linked risperidone to a higher chance of miscarriage. However, the evidence is conflicting and does not clearly prove that risperidone is the cause of this outcome. Other factors, such as the underlying condition being treated, may also increase the chance of miscarriage. 

Does taking risperidone 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 risperidone, might increase the chance of birth defects in a pregnancy.  

Studies and case reports show mixed outcomes in babies exposed to risperidone before birth. Overall, reviews reported that the rate of birth defects was not higher than the background risk. If there is an increased chance of birth defects with risperidone use, it is likely to be small. 

Does taking risperidone in pregnancy increase the chance of other pregnancy-related problems? 

Some studies have reported a higher chance of pregnancy-related problems, and other studies have not. One study found no increase in preterm delivery (birth before week 37). Another suggested that risperidone may increase the chance of low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth).  

Risperidone may cause weight gain and problems with blood sugar, which can increase the chance of gestational diabetes. Gestational diabetes can increase the chance of other complications such as preterm delivery or the fetus being larger than expected (called macrosomia). Talk with your healthcare provider about your risk for gestational diabetes. If needed, they can monitor your blood sugar levels before and during pregnancy. More information about gestational diabetes can be found in our fact sheet at https://mothertobaby.org/fact-sheets/diabetes-pregnancy/.    

I need to take risperidone during my pregnancy. Will it cause withdrawal symptoms in my baby after birth?  

The use of some medications during pregnancy may cause temporary symptoms in newborns soon after birth. These symptoms are sometimes referred to as withdrawal. Babies exposed to risperidone near the time of delivery should be watched for stiff or floppy muscles, drowsiness, agitation, tremors, trouble breathing, and problems with feeding. In most cases, symptoms would be expected to go away in a few days without any long-term health effects. Not all babies exposed to risperidone will have these symptoms. It is important that your healthcare providers know you are taking risperidone so that if symptoms occur, your baby can get the care that is best for them. 

Does taking risperidone in pregnancy affect future behavior or learning for the child?   

Studies to see if risperidone can increase the chance of behavior or learning issues for a child are limited. One study that looked at the filling of at least one prescription for risperidone after 18 weeks of pregnancy did not find an increased risk of developmental or behavioral disorders (autism, ADHD, learning or speech problems) in children followed up to age 14. Studies based on filled prescriptions cannot tell if the medication was taken as directed. This makes it hard to know if the study outcomes are related to medication or other factors. 

Breastfeeding while taking risperidone: 

Information on the use of risperidone during breastfeeding is limited. When taken in doses of up to 6 mg a day, risperidone was found in breast milk in small amounts. Side effects were not reported in a small number of breastfed infants. If you suspect the baby has any symptoms (being more sleepy than usual, jitteriness, poor feeding, crankiness, or unusual movements) contact the child’s healthcare provider.  

An older product label for risperidone recommends women using this medication should not breastfeed. Newer labels suggest weighing the benefit of using risperidone against possible risks. Your healthcare providers can talk with you about using risperidone and what treatment is best for you. Be sure to talk to your healthcare provider about all your breastfeeding questions.  

If a man takes risperidone, could it affect his fertility or increase the chance of birth defects? 

Using risperidone may raise a man’s levels of the hormone prolactin, which might affect fertility (ability to make healthy sperm). Studies have not been done to see if risperidone could increase the chance of birth defects. In general, exposures that men 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 for references. 


Doxylamine succinate-pyridoxine hydrochloride (Diclegis®)

This sheet is about exposure to leflunomide in pregnancy and while breastfeeding. This information is based on available published literature. It should not take the place of medical care and advice from your healthcare provider.

What is leflunomide?

Leflunomide is a medication that has been used to treat rheumatoid arthritis. It is in the class of medications known as DMARDs (disease modifying anti-rheumatic drugs). Leflunomide can reduce arthritis symptoms and slow down joint damage. A brand name of leflunomide is Arava®.

The product label for leflunomide recommends that women who are pregnant or trying to get pregnant not use this medication. However, the benefit of using leflunomide may outweigh possible risks. Your healthcare provider can talk with you about using leflunomide and what treatment is best for you.

I am taking leflunomide, but I would like to stop taking it before getting pregnant. How long does the drug stay in my body?

People eliminate medication at different rates. In healthy adults, it takes about 10 weeks (2 and 1/2 months), on average, for most of the leflunomide to be gone from the body. However, the manufacturer of Arava® says that for some people it could take up to 2 years for the drug to completely leave the body. Talk with your healthcare providers about checking your blood levels of leflunomide and, if needed, what treatments are available to help remove the medication from your body faster (washout treatment).

I take leflunomide. Can it make it harder for me to get pregnant?

It is not known if leflunomide can make it harder to get pregnant.

Does taking leflunomide increase the chance of miscarriage?

Miscarriage is common and can occur in any pregnancy for many different reasons. Small studies and case reports of women who became pregnant while taking leflunomide have not suggested an increased chance of miscarriage.

Does taking leflunomide 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. Animal studies have suggested that leflunomide can increase the chance of birth defects.

Case reports and studies on leflunomide exposure in human pregnancy have not found an increased chance of birth defects. Most women in these studies and reports stopped taking leflunomide very early in pregnancy once they found out they were pregnant and received washout treatment to remove the medication from the body more quickly. It is hard to know from these studies and reports how longer exposure to leflunomide may affect a pregnancy. Case reports and two small studies of women with longer exposures to leflunomide in pregnancy have not suggested an increased chance of birth defects.

Does taking leflunomide in pregnancy increase the chance of other pregnancy-related problems?

Limited information about the use of leflunomide later in pregnancy does not suggest an increased chance of other pregnancy-related problems, such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth).

Does taking leflunomide in pregnancy affect future behavior or learning for the child?

Studies have not been done to see if leflunomide can cause behavior or learning issues for the child.

Breastfeeding while taking leflunomide:

Studies have not been done on the use of leflunomide in breastfeeding. Leflunomide stays in the body for a long time, which means it could build up in the breast milk in higher amounts over time. Since leflunomide can weaken the immune system of adults who take it, there is concern that amounts of this medication in the milk might affect the immune system of a nursing child.

The product label for leflunomide recommends women who are breastfeeding not use this medication. Your healthcare providers can talk with you about using leflunomide and what treatment is best for you. Be sure to talk to your healthcare provider about all your breastfeeding questions.

If a man takes leflunomide, could it affect fertility or increase the chance of birth defects?

Studies have not been done to see if leflunomide could affect a man’s fertility (ability to get a woman pregnant). One study that included a small number of men who received prescriptions for leflunomide to treat rheumatoid arthritis did not find an increased chance of birth defects. In general, exposures that men have are unlikely to increase 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 for references.

MotherToBaby is currently conducting a study looking at leflunomide and other medications used to treat rheumatoid arthritis in pregnancy. If you are interested in taking part in this study, please call 1-877-311-8972 or sign up at https://mothertobaby.org/join-study/.


Doxylamine succinate-pyridoxine hydrochloride (Diclegis®)

This sheet is about exposure to verapamil in pregnancy and while breastfeeding. This information is based on research studies. It should not take the place of medical care and advice from your healthcare providers.

What is verapamil?

Verapamil is a medication that has been used to treat high blood pressure (hypertension), abnormal heart rhythm (arrythmia), and chest pain (angina). It has also been used to treat headaches and migraines, coronary arteriosclerosis (thick and stiff blood vessels near the heart), and kidney disease. Verapamil is in a class of medications called calcium channel blockers. Some brand names for verapamil include Calan®, Covera®, Isoptin®, and Verelan®.

Sometimes when women 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.

Women who are pregnant and have high blood pressure have a greater chance of developing pre-eclampsia (high blood pressure and problems with organs, such as the kidneys) that can lead to seizures (called eclampsia). High blood pressure can increase the chance for medical complications for the woman who is pregnant and for the pregnancy.

I take verapamil. Can it make it harder for me to get pregnant?

Studies have not been done to see if verapamil can make it harder to get pregnant. In some people, verapamil might raise the levels of a hormone called prolactin. When prolactin levels are too high, it can cause the body to make milk even if the woman is not breastfeeding (galactorrhea). Those who have this side effect might have a harder time becoming pregnant.

Does taking verapamil 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 verapamil can increase the chance of miscarriage. One study looking at 78 women who took calcium channel blockers, 32 of which took verapamil, did not find a higher chance for miscarriage.

Does taking verapamil 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 verapamil, might increase the chance of birth defects in a pregnancy. There is not a lot of information about using verapamil during pregnancy. However, most studies looking at women who took verapamil, as well as other calcium channel blockers, did not find a higher chance of birth defects.

Does taking verapamil in pregnancy increase the chance of other pregnancy-related problems?

Some studies have reported a greater chance for preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth) with the use of calcium channel blockers, including verapamil. However, it is not known if these issues are caused by verapamil, the condition being treated, other medications, or other factors.  Uncontrolled high blood pressure during pregnancy has been associated with a greater chance of preterm delivery and low birth weight.

Two studies did not find long term effects in heart function of 40 newborns after prenatal exposure to verapamil later in pregnancy to treat high blood pressure or premature labor.

People with high blood pressure have a greater chance of developing pre-eclampsia (high blood pressure and problems with organs, such as the kidneys) that can lead to seizures (called eclampsia).

Does taking verapamil in pregnancy affect future behavior or learning for the child? 

Studies have not been done to see if verapamil can increase the chance of behavior or learning issues for the child.

Breastfeeding while taking verapamil:

Verapamil passes into breast milk in small amounts. Three babies (ages 13 days, 8 weeks, and 3 months) who were exposed to verapamil through breast milk did not have any problems.

The product label for verapamil recommends women who are breastfeeding not use this medication if breastfeeding. This is because there is not enough information on how the verapamil in breast milk might affect a nursing infant. But the benefits of using verapamil and breastfeeding might outweigh possible risks. Your healthcare providers can talk with you about using verapamil and what treatment is best for you. Be sure to talk to your healthcare provider about all your breastfeeding questions.

If a man takes verapamil, could it affect his fertility or increase the chance of birth defects?

Some men who took verapamil had problems like getting or keeping an erection and lower interest in sex (low sex drive) which may affect male fertility (ability to get a woman pregnant). These problems went away after they stopped taking the medication. Other men who took verapamil did not have these issues. 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 for references.


Doxylamine succinate-pyridoxine hydrochloride (Diclegis®)

This sheet is about exposure to mifepristone in pregnancy and while breastfeeding. This information is based on available published literature. It should not take the place of medical care and advice from your healthcare provider.

What is mifepristone?

Some brand names for mifepristone are Korlym® and Mifeprex®.

The product label for mifepristone recommends people who are pregnant or planning to become pregnant not use this medication. 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 using mifepristone and what treatment is best for you.

I am taking mifepristone, but I would like to stop taking it before getting pregnant. How long does the drug stay in my body?

The time it takes the body to metabolize (to process) medication is not the same for everyone. In healthy non-pregnant adults, it takes between 5 and 20 days, on average, for most of the mifepristone to be gone from the body.

I take mifepristone. Can it make it harder for me to get pregnant?

While the medication is in the body, mifepristone can make it harder to get pregnant.

Does taking mifepristone increase the chance of miscarriage?

Miscarriage is common and can occur in any pregnancy for many different reasons. Mifepristone can cause the uterus to contract (get tight and then relax), which can increase the chance of miscarriage. The increased chance of miscarriage can depend on how much mifepristone is taken (dose), when in pregnancy it is taken (timing), the use of other medications, and other factors.

Does taking mifepristone 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. There are case reports of birth defects following the use of mifepristone during pregnancy. However, most infants born after exposure to mifepristone do not have birth defects. In early pregnancy, mifepristone is sometimes used in combination with another medication called misoprostol, which can increase the chance of birth defects. This makes it hard to know if the birth defects in these case reports are due to one of the medications, the combination of medications, or other factors.

Does taking mifepristone in pregnancy increase the chance of other pregnancy-related problems?

Studies have not been done to see if mifepristone increases the chance of pregnancy-related problems such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth).

Does taking mifepristone in pregnancy affect future behavior or learning for the child?

Studies have not been done to see if mifepristone can increase the chance of behavior or learning issues for the child.

What screenings or tests are available to see if my pregnancy has birth defects or other issues?

Prenatal ultrasounds can be used to screen for some birth defects. Ultrasound can also be used to track the growth of the pregnancy. Talk with your healthcare provider about any prenatal screenings or testing that are available to you. There are no tests available during pregnancy that can tell how much effect there could be on future behavior or learning.

Breastfeeding while taking mifepristone:

Mifepristone gets into breast milk in small amounts. In 1 study, no medication was found in the breast milk of 2 women who took a single 200 mg mifepristone pill. Based on the amount of medication found in the breast milk of 10 women who took a single 600 mg mifepristone pill, it was estimated that a fully breastfed infant would get a small amount (less than 1%) of the dose taken. The authors of this study have suggested that breastfeeding does not need to stop after taking a single dose of mifepristone. There is no information available about breastfeeding while taking mifepristone for longer periods of time, such as treating hyperglycemia. The manufacturer has recommended pumping and discarding milk during long-term therapy with mifepristone and for 18 to 21 days after the last dose. Be sure to talk to your healthcare provider about all your breastfeeding questions.

If a man takes mifepristone, could it affect fertility or increase the chance of birth defects?

Studies have not been done to see if mifepristone could affect a man’s fertility (ability to get a woman pregnant) or increase the chance of birth defects above the background risk. In general, exposures that men 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 for references.