This sheet is about exposure to cariprazine 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 cariprazine?
Cariprazine is a medication that has been used to treat schizophrenia, bipolar disorder, and depression. A brand name for cariprazine is Vraylar®.
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 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/. 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 where the animals were given higher doses of cariprazine than would be given to humans, there was a decrease in fertility (ability to get pregnant).
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 it was unclear if taking cariprazine increased the chances of miscarriage. However, because some mental health conditions can increase the chance of miscarriage, it is hard to know if a medication, the medical condition being treated, or other factors are the cause of a miscarriage.
Does taking cariprazine 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. Studies have not been done in humans to see if cariprazine increases 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. However, information from animal studies does not prove that a medication would affect human pregnancy in the same way.
Does taking cariprazine in pregnancy increase the chance of other pregnancy-related problems?
Studies have not been done in humans to see if cariprazine increases the chance for 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). 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 throughout my entire pregnancy. Will it cause withdrawal symptoms in my baby after birth?
The 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, some of which were higher than what would be given to humans, 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:
There is no information on the use of cariprazine while breastfeeding. It is important for your condition to be treated. Your healthcare providers can talk with you about using cariprazine and what treatment is best for you. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a male takes cariprazine, could it affect 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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OTIS/MotherToBaby encourages inclusive and person-centered language. While our name still contains a reference to mothers, we are updating our resources with more inclusive terms. Use of the term mother or maternal refers to a person who is pregnant. Use of the term father or paternal refers to a person who contributes sperm.
