Risperidone

The Basics

What is Risperidone?

Can treat schizophrenia, bipolar disorder, and irritability.

Brand names for Risperidone

Perseris

How Risperidone is classified

Antipsychotic Agents

Risperidone During Pregnancy

Risperidone pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Risperidone while pregnant

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including PERSERIS, during pregnancy. Healthcare professionals are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-researchprograms/ pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations). Overall available data from published epidemiologic studies of pregnant women exposed to risperidone have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). There are risks to the mother associated with untreated schizophrenia and with exposure to antipsychotics, including PERSERIS, during pregnancy (see Clinical Considerations). Oral administration of risperidone to pregnant mice caused cleft palate at doses 3 to 4 times the maximum recommended human dose (MRHD) of 16 mg/day with maternal toxicity observed at 4 times the MRHD based on mg/m2 body surface area. Risperidone was not teratogenic in rats or rabbits at doses up to 6 times the MRHD based on mg/m2 body surface area. Increased stillbirths and decreased birth weight occurred after oral risperidone administration to pregnant rats at 1.5 times the MRHD based on mg/m2 body surface area. Learning was impaired in offspring of rats when the dams were dosed at 0.6 times the MRHD and offspring mortality increased at doses 0.1 to 3 times the MRHD based on mg/m2 body surface area. Subcutaneous administration of the delivery system to pregnant rats and rabbits during the period of organogenesis caused developmental toxicity that included post-implantation loss, decreased number of live fetuses, decreased fetal weight and fetal malformations (external, skeletal, and visceral), at doses that are 52 (rat) and 43 (rabbit) times the delivery system amount present in 120 mg risperidone subcutaneous injectable suspension based on mg/m2 body surface area. These effects could be attributed to NMP an excipient in the delivery system based on information in the published literature (see Data). Subcutaneous administration of the delivery system to pregnant and lactating rats had no effect on embryo/fetal and postnatal development at doses up to 17 times the delivery system amount present in 120 mg risperidone subcutaneous injectable suspension based on mg/m2 body surface area. The estimated background risks of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Taking Risperidone While Breastfeeding

What are recommendations for lactation if you're taking Risperidone?

Limited information indicates that maternal risperidone doses of up to 6 mg daily produce low levels in milk. However, use with other antipsychotic drugs occasionally might negatively affect the infant. Because there is little published experience with risperidone during breastfeeding and little long-term follow-up data, other agents may be preferred, especially while nursing a newborn or preterm infant. Systematic reviews of second-generation antipsychotics concluded that risperidone seemed to be a second-line agent during breastfeeding because of the limited data available and higher excretion into milk relative to other agents.[1][2] Monitor the infant for drowsiness and developmental milestones, especially if other antipsychotics are used concurrently.

Maternal / infant drug levels

Limited information indicates that maternal risperidone doses of up to 6 mg daily produce low levels in milk. However, use with other antipsychotic drugs occasionally might negatively affect the infant. Because there is little published experience with risperidone during breastfeeding and little long-term follow-up data, other agents may be preferred, especially while nursing a newborn or preterm infant. Systematic reviews of second-generation antipsychotics concluded that risperidone seemed to be a second-line agent during breastfeeding because of the limited data available and higher excretion into milk relative to other agents.[1][2] Monitor the infant for drowsiness and developmental milestones, especially if other antipsychotics are used concurrently.

Possible effects of Risperidone on milk supply

Risperidone has caused elevated prolactin serum levels, gynecomastia, and galactorrhea in patients taking the drug.[10][11][12][13][14][15][16] In one case, euprolactinemic gynecomastia and galactorrhea occurred in a 19-year-old man who was also taking fluvoxamine.[17] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Possible alternatives to Risperidone

Haloperidol, Olanzapine, Quetiapine.