Limited information indicates that maternal risperidone doses of up to 6 mg daily produce low levels in milk. Because there is little published experience with risperidone during breastfeeding and few long-term follow-up data, other agents may be preferred, especially while nursing a newborn or preterm infant.
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.
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.
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.
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 about 4 mcg/L at 2, 4, 8, 18 and 23 hours after the dose. The authors estimated that a fully breastfed infant would receive 4.7% of the maternal weight-adjusted dosage as 9-hydroxyrisperidone.
In 2 breastfed infants (6 weeks and 3.3 months old) whose mothers were taking 2 mg twice daily and 1.5 mg daily in 2 divided doses, respectively, risperidone and 9-hydroxyrisperidone were both undetectable (<1 mcg/L) in the serums of the infants.
An infant was breastfed 6 times daily during maternal therapy with risperidone 2 mg once daily. Fifteen hours after the mother's last dose, the infant's plasma levels of risperidone was undetectable and 9-hydroxyrisperidone was 0.1 mcg/L.
An infant was exclusively breastfed on demand during maternal therapy with risperidone 1 mg daily. At 3 months of age, risperidone was undetectable in the infant's serum 6 hours after a maternal dose.
Effects in Breastfed Infants:
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.
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.
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.
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.
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 ofbupropiondaily reported sedation in her breastfed infant.
Possible Effects on Lactation:
Risperidone has caused elevated prolactin serum levels, gynecomastia, and galactorrhea in patients taking the drug. In one case, euprolactinemic gynecomastia and galactorrhea occurred in a 19-year-old man who was also taking fluvoxamine. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
1. Hill RC, McIvor RJ, Wojnar-Horton RE, Dip G et al. Risperidone distribution and excretion into human milk: case report and estimated infant exposure during breast-feeding. J Clin Psychopharmacol. 2000;20:285-6. Letter. PMID:10770482 2. Ilett KF, Hackett LP, Kristensen JH, Vaddadi KS et al. Transfer of risperidone and 9-hydroxyrisperidone into human milk. Ann Pharmacother. 2004;38:273-6. PMID:14742766 3. Aichhorn W, Stuppaeck C, Whitworth AB. Risperidone and breast-feeding. J Psychopharmacol. 2005;19: 211-3. PMID:15728443 4. Weggelaar NM, Keijer WJ, Janssen PK. A case report of risperidone distribution and excretion into human milk: how to give good advice if you have not enough data available. J Clin Psychopharmacol. 2011 ;31:129-31. PMID:21192160 5. Ratnayake T, Libretto SE. No complications with risperidone treatment before and throughout pregnancy and during the nursing period. J Clin Psychiatry. 2002;63(1):76-7. PMID:11838633 6. Kelly LE, Poon S, Madadi P, Koren G. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr. 2012;161:448-51. PMID:22504099 7. Gupta S, Frank B, Madhusoodanan S. Risperidone-associated galactorrhea in a male teenager. J Am Acad Child Adolesc Psychiatry. 2001;40:504-5. Letter. PMID:11349691 8. Popli A, Gupta S, Rangwani SR. Risperidone-induced galactorrhea associated with prolactin elevation. Ann Clin Psychiatry. 1998;10:31-3. PMID:9622047 9. Madhusoodanan S, Moise D. Risperidone-induced hyperprolactinemia in adolescents: A case series. J Clin Psychiatry. 2006;67(7):1110-3. PMID:16889455 10. Afzal KI, Briones DF, DeVargas C. Risperidone-induced polydipsia and polyphagia associated with galactorrhea, abdominal pain, and rapid weight gain in an adolescent Hispanic female. CNS Spectr. 2007;12:818-20. PMID:17984854 11. Benazzi F. Gynecomastia with risperidone-fluoxetine combination. Pharmacopsychiatry. 1999;32:41. PMID:10071182 12. Schreiber S, Segman RH. Risperidone-induced galactorrhea. Psychopharmacology (Berl). 1997;130:300-1. PMID:9151366 13. Holzer L, Eap CB. Risperidone-induced symptomatic hyperprolactinaemia in adolescents. J Clin Psychopharmacol. 2006;26:167-71. PMID:16633146 14. Pratheesh PJ, Praharaj SK, Srivastava A. Euprolactinemic gynecomastia and galactorrhea with risperidone-fluvoxamine combination. Psychopharmacol Bull. 2011;44:70-3. PMID:22506441
CAS Registry Number:
LactMed Record Number:
Last Revision Date:
Disclaimer:Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.