Is Risperidone safe while breastfeeding?

Effects on the breastfed infant

One woman took risperidone 4 mg daily during breastfeeding. Her infant showed no developmental abnormalities on examinations up to 9 months of age. Another mother took risperidone 6 mg daily during breastfeeding. Her infant showed no developmental abnormalities on examinations up to 12 months of age.[ 10 ] Two women taking risperidone 4 mg and 1.5 mg daily breastfed their infants of 3.3 months and 6 weeks of age, respectively, were achieving normal developmental milestones and had no adverse effects reported.[ 6 ] A 1 week postpartum woman was started on risperidone 2 mg daily and increased after 10 days to a dosage of 3 mg daily. She breastfed her infant 6 times daily. The infant was observed for 5 weeks of inpatient therapy and judged normal by a pediatric neurologist. No sedation or other adverse effects were observed in the infant. After 3 months of treatment with risperidone, the mother and infant were judged to be well.[ 7 ] An infant had been exclusively breastfed for 3 months during maternal therapy with risperidone 1 mg daily. A pediatric examination found the infant to have no neurological or physical abnormalities, and appeared to interact appropriately.[ 8 ] In a telephone follow-up study, 124 mothers who took a benzodiazepine while nursing reported whether their infants had any signs of sedation. One mother who was taking 0.75 mg of risperidone daily, flurazepam 15 mg daily, clonazepam 0.25 mg twice daily, and 1 mg of bupropion daily reported sedation in her breastfed infant.[ 11 ] A woman diagnosed with schizophrenia was taking risperidone 1.5 mg daily during late pregnancy and postpartum while nursing (extent not stated) her full-term infant. At 2 weeks postpartum, haloperidol 0.8 mg daily was added because of a recurrence of symptoms. At these dosages, no adverse effects were seen in the infant. However, because of recurring symptoms, the dosage of haloperidol was increased to 1.5 mg daily. Three days later, the infant had excessive sedation, poor fe

Effects on milk supply

Risperidone has caused elevated prolactin serum levels, gynecomastia, and galactorrhea in patients taking the drug.[ 18 - 33 ] A single-center, retrospective cohort study over a 7-year period from January 2018 to January 2025 identified a total of 33 children aged 2 to 18 years who had drug-induced hyperprolactinemia. Risperidone was responsible for 27 of the cases. In all cases, prolactin levels normalized within a median time frame of 4 to 6 weeks after discontinuation of the drug or switching to an alternative medication.[ 34 ] In one case, euprolactinemic gynecomastia and galactorrhea occurred in a 19-year-old man who was also taking fluvoxamine.[ 35 ] A meta-analysis of 3 studies found that the risk of gynecomastia with risperidone is 4.3 times greater than that of quetiapine.[ 36 ] The prolactin level in a mother with established lactation may not affect her ability to breastfeed. Patients enlisted in the National Pregnancy Registry for Atypical Antipsychotics who were taking a second-generation antipsychotic drug while breastfeeding (n = 576) were compared to control breastfeeding patients who primarily had diagnoses of major depressive disorder and anxiety disorders, most often treated with SSRI or SNRI antidepressants, but not with a second-generation antipsychotic (n = 818). Among women on a second-generation antipsychotic, 60.4% were on more than one psychotropic compared with 24.4% among women in the control group. Of the women on a second-generation antipsychotic, 59.3% reported ever breastfeeding compared to 88.2% of women in the control group. At 3 months postpartum, 23% of women on a second-generation antipsychotic were exclusively breastfeeding compared to 47% of women in the control group.[ 15 ] The number of women taking risperidone was not reported. A review of the FDA s FAERS database analyzed 6,195 reports of drug-induced galactorrhea in all patient populations. Risperidone had the report count (3,378) of all drugs reported.[ 37 ]

Levels in milk

Risperidone is metabolized to the active metabolite 9-hydroxyrisperidone, which is known as and marketed as paliperidone. Maternal Levels. One mother taking risperidone 6 mg daily had milk and serum levels of risperidone and its active metabolite, 9-hydroxyrisperidone, measured over 24 hours. Results indicated that an exclusively breastfed infant would receive 0.84% of the maternal weight-adjusted dosage of risperidone and another 3.46% as 9-hydroxyrisperidone for a total of 4.3% of the maternal weight-adjusted dosage.[ 5 ] Two breastfeeding women taking 2 mg twice daily and 1.5 mg daily in 2 divided doses, respectively, and another with risperidone-induced galactorrhea taking 3 mg once daily were studied. Both risperidone and 9-hydroxyrisperidone were measured in milk. Milk levels of the drugs were rather flat during the 12 to 24 hours after the dose. The mean dose that an exclusively breastfed infant would receive was calculated to be 3.3% (range 2.2 to 4.7%) of the maternal weight-adjusted dosage.[ 6 ] A woman who was 1 week postpartum was started on oral risperidone 2 mg daily and increased to 3 mg once daily. On day 6 of therapy (dosage 2 mg daily) average milk levels at 3 hours after a dose were risperidone 2.5 mcg/L and 9-hydroxyrisperidone 10 mcg/L. On day 10 (dosage 2 mg daily) at 15 hours after a dose 9-hydroxyrisperidone averaged 1.2 mcg/L and risperidone was undetectable. On day 20 of therapy (dosage 3 mg daily) average milk levels at 16 hours after a dose were risperidone 0.1 mcg/L and 9-hydroxyrisperidone 2.5 mcg/L.[ 7 ] A woman took risperidone during pregnancy and breastfeeding. At 3 months postpartum, she provided 6 foremilk samples over a 24-hour period after her daily dose while she was taking a dose of 1 mg daily. Milk was analyzed for risperidone and 9-hydroxyrisperidone by HPLC. Risperidone could not be detected in milk (assay limit not specified). Breastmilk 9-hydroxyrisperidone was about 3 mcg/L at 1 and 24 hours later; its concentration was

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