This sheet is about exposure to risperidone 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 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 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.

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

In some people, risperidone may raise the levels of a hormone called 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 test 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. Risperidone use is not expected to 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. Some studies reported an increase chance of birth defects when risperidone is used in pregnancy. Other studies have not reported an increase chance. Overall, if there is an increased chance of birth defects with risperidone use, it is likely small.

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

Some studies have reported a higher chance for 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 in a person who is pregnant. This may increase the chance of developing gestational diabetes. More information about gestational diabetes can be found in our fact sheet https://mothertobaby.org/fact-sheets/diabetes-pregnancy/.

I need to take risperidone throughout my entire 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. 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?

One study which looked at risperidone in the 2^nd half of pregnancy did not find an increased chance of autism, attention deficit, or intellectual disability in the exposed children.

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 breastmilk in small amounts. Side effects were not reported in a small number of breastfed infants. If you suspect the baby has any symptoms (sleepiness, poor feeding, crankiness, or unusual movements) contact the child’s healthcare provider.

The product label for risperidone recommends people who using this medication should not breastfeed. But the benefit of using risperidone may outweigh the 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 male takes risperidone, could it affect fertility (or increase the chance of birth defects?

Using risperidone may raise a person’s levels of the hormone prolactin, which may affect fertility (ability to get partner pregnant). Studies have not been done to see if risperidone could increase the chance of birth defects above the background risk. 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/.

Selected References:

• Accessdata.fda.gov. (2009). Highlights of Prescribing Information – Risperidone. Retrieved from https://www​.accessdata​.fda.gov/drugsatfda_docs​/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf.
• Coppola D, et al. 2007. Evaluating the postmarketing experience of risperidone use during pregnancy: pregnancy and neonatal outcomes. Drug Saf; 30(3):247-64. [PubMed: 17343431]
• Damkier P and Videbech P. 2018. The Safety of Second-Generation Antipsychotics During Pregnancy: A Clinically Focused Review. CNS Drugs 32:351-366. [PubMed: 29637530]
• Eberhard J., et al. 2007. Prolactin level during 5 years of risperidone treatment in patients with psychotic disorders. Acta Psychiatrica Scandinavica. 115(4), 268-276. [PubMed: 17355517]
• Ennis ZN and Damkier P. 2014. Pregnancy Exposure to Olanzapine, Quetiapine, Risperidone, Aripiprazole and Risk of Congenital Malformation. A Systemic Review. Basic & Clinical Pharmacology & Toxicology 116:315-320. [PubMed: 25536446]
• Elstein Y, et al. 2004. Pregnancies in Gaucher disease: a 5 -year study. Am J Obstet Gynecol 190:435-441. [PubMed: 14981386]
• Habermann F, et al. 2013. Atypical Antipsychotic Drugs and Pregnancy Outcome: A Prospective, Cohort Study. J Clin Psychopharmacol 33:453-62. [PubMed: 23764684]
• Huybrechts KF, et al. 2016. Antipsychotic Use in Pregnancy and the Risk for Congenital Malformations. JAMA Psychiatry 73(9): 938-946. [PMC free article: PMC5321163] [PubMed: 27540849]
• McAllister-Williams RH, et al. 2017. British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum 2017. J Psychopharmacol; 31(5): 519-552. [PubMed: 28440103]
• Park Y, et al. 2018. Continuation of Atypical Antipsychotic Medication During Early Pregnancy and the Risk of Gestational Diabetes. Am J Psychiatry 175(6):564-574. [PMC free article: PMC5988929] [PubMed: 29730938]
• Petersen I, et al. 2016. Risks and Benefits of Psychotropic Medication in Pregnancy: Cohort Studies based on UK Electronic Primary Care Health Records. Health Technol Assess 20:1-176 [PMC free article: PMC4827034] [PubMed: 27029490]
• Straub L, et al. 2022. Association of antipsychotic drug exposure in pregnancy with risk of neurodevelopmental disorders: a national birth cohort study. JAMA Intern Med 182(5):522-533. [PMC free article: PMC8961398] [PubMed: 35343998]
• Uguz F. 2016. Second-Generation Antipsychotics During the Lactation Period. J Clin Psychopharmacol 36(3):244-252. [PubMed: 27028982]
• Uguz F. 2019. Adverse events in a breastfed infant exposed to risperidone and haloperidol. Breastfeed Med.;14:683–4. [PubMed: 31135176]
• Vigod SN, et al. 2015. Antipsychotic Drug Use In Pregnancy: High Dimensional, Propensity Matched, Population Based Cohort Study. BMJ 350:h2298. [PMC free article: PMC4430156] [PubMed: 25972273]