This sheet is about exposure to cariprazine in pregnancy and while breastfeeding. This information is based on published research. It should not take the place of medical care and advice from your healthcare providers.
What is cariprazine?
Cariprazine is a medication that has been used to treat schizophrenia, bipolar 1 disorder, and major depressive disorder. A brand name for cariprazine is Vraylar®.
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 sheet on depression here: https://mothertobaby.org/fact-sheets/depression-pregnancy/. More information about mental health can be found here: https://mothertobaby.org/pregnancy-breastfeeding-exposures/mental-health/.
I take cariprazine. Can it make it harder for me to get pregnant?
Studies have not been done in humans to see if cariprazine can make it harder to get pregnant. In animal studies, reduced fertility (ability to get pregnant) was seen when animals were given doses of cariprazine that were higher than the doses used in humans.
Does taking cariprazine increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. Studies have not been done in humans to see if cariprazine increases the chance of miscarriage. In animal studies, cariprazine did not increase the chances of miscarriage. However, because some mental health conditions can also affect pregnancy, it is hard to know if a medication, the medical condition being treated, or other factors play a role. Talk to your doctor if you are pregnant or planning to become pregnant.
Does taking cariprazine 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 cariprazine, might increase the chance of birth defects in a pregnancy.
Studies have not been done in humans to see if cariprazine increases the chance of birth defects. There is 1 case report of a pregnancy with exposure to cariprazine, and the child is reported as doing well up to age 2 years. One case report is not enough to know if cariprazine could increase the chance of birth defects. Birth defects have been reported in some animal studies after the animals were given a range of cariprazine doses, some of which were higher than what would be given to humans. Results from animal studies do not always mean the same thing will happen in people.
Does taking cariprazine pregnancy increase the chance of other pregnancy-related problems?
Studies have not been done in humans to see if cariprazine can increase the chance of other pregnancy-related problems, such as preterm delivery (birth before week 37 of pregnancy) or low birth weight (weighing less than 5 pounds, 8 ounces [2,500 grams] at birth). In animals given lower doses of cariprazine than what would be given to humans, low birth weight and decreased survival after birth were seen. However, information from animal studies does not prove that a medication would affect human pregnancy in the same way. Some mental health conditions (such as depression) can increase the chance of preterm delivery, babies who are smaller than expected, and pre-eclampsia (dangerously high blood pressure in pregnancy). This makes it hard to know if a medication, the underlying condition, or other factors are increasing the chance of complications.
I need to take cariprazine during my pregnancy. Will it cause withdrawal symptoms in my baby after birth?
Use of cariprazine during pregnancy can cause temporary symptoms in the newborn soon after birth. These symptoms are sometimes referred to as withdrawal. Symptoms may include too much or too little muscle tone, excessive sleepiness, involuntary muscle movements, trouble breathing, and trouble eating. Not all babies exposed to cariprazine will have these symptoms. It is important that your healthcare providers know you are taking cariprazine so that if symptoms occur your baby can get the care that is best for them.
Does taking cariprazine in pregnancy affect future behavior or learning for the child?
Studies have not been done in humans to see if cariprazine can increase the chance of behavior or learning issues for the child. In animals given a range of cariprazine doses, developmental delays were reported. However, information from animal studies does not prove that a medication would affect human pregnancy in the same way. Some mental health conditions (such as depression) might affect a child’s behavior or development. This makes it hard to know if a medication, the underlying condition, or other factors are increasing the chance of learning and behavior issues.
Breastfeeding while taking cariprazine:
Cariprazine has not been well-studied for use while breastfeeding. According to 1 small study looking at 5 breastfeeding mothers taking 1.5 to 4.5 mg daily, cariprazine passes into breast milk in small amounts. 2 out of the 5 babies were reported to be more sleepy than usual, and 1 improved after the mother’s dose was lowered. Babies exposed to higher maternal doses, or younger babies may be more sensitive to effects. Because of these findings, more research is needed. If you suspect the baby is unusually sleepy, not feeding well, or hard to wake, contact the child’s healthcare provider.
The FDA label advises that the benefits of breastfeeding should be considered along with the mother’s need for cariprazine and any potential effects on the baby. It is important for your condition to be treated, and breastfeeding has many health benefits for both you and your baby. Your healthcare providers can talk with you about whether to use cariprazine while breastfeeding and what treatment is best for you. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a man takes cariprazine, could it affect his fertility or increase the chance of birth defects?
Studies have not been done in humans to see if cariprazine could affect male fertility (ability to get partner pregnant) or increase the chance of birth defects above the background risk. Animal studies have not shown an effect on male fertility. 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/.
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