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This section is designed to inform professionals.

( Consumers, see Fact Sheet on Risperidone.)

Available as, Risperdal

  • Used in Schizophrenia and other Psychotic disorders.
  • Acute manic or mixed episodes of Bipolar Disorder as monotherapy or in combination with Lithium or Valproate.


Category C (Caution)

  • Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women.
  • Data are not sufficient to make definitive conclusions regarding the safety of Risperidone during pregnancy therefore it should be used only if the benefits outweigh the risks.
  • Animal studies indicate an increase in fetal mortality.
  • Although, in experimental animals, Risperidone did not show direct reproductive toxicity, some indirect prolactin and CNS mediated effects were observed.
  • Data of use of Risperidone in pregnancy is sparse, case reports have suggested a case of agenesis of corpus callosum, a case of oligohydramnios (10), 2 cases of spontaneous abortion and cases of 9 live births with no malformation.(9)
  • No teratogenic effect of Risperidone was noted in any study.
  • Reversible EPS symptoms were noted in neonates following use of Risperidone during the last trimester.
  • There is, however, growing number of reported cases of women completing their pregnancy while taking Risperidone without any detrimental effects to the newborn.(7,8,11,12)


Category L3

  • There are no controlled studies in breastfeeding women; however, the risk of untoward effects to a breastfed child is possible or controlled studies show only minimal non-threatening effects.
  • Risperidone and its metabolites are excreted in breast milk (2) and it has been found to be distributed in breast milk in greater than or equal to plasma concentrations in animal studies. It may thus also pass into human milk causing unwanted behavioural changes in breastfed babies.(9) Therefore, women receiving Risperidone should be advised not to breastfeed. (1)
  • There are , however, few studies show Risperidone-induced galactorrhea in one breast feeding woman and Risperidone and its metabolite were not detected in the plasma of 2 breastfed infants studied, and no adverse effects were noted.(5,)


1. MEDSAFE: Information for Health Professionals

2. Risperidone: Drug information provided by Lexi-comp: Merck Manual Professional.

3. Medline Plus: Trusted Health Information for you.

4.Salvatore Gentile (2004): Clinical utilization of Atypical Antipsychotics in Pregnancy and Lactation. The Annals of pharmacotherapy: vol. 38, No. 7 pp. 1265-1271.

5. Thomas W. Hale (2004): Medication and Mothers’ Milk – Eleventh Edition.

6. Committee on Drugs: Use of Psychoactive Medication During Pregnancy and Possible Effects on the Fetus and Newborn. American Academy of paediatrics: Vol. 105 No. 4 April 2000, pp. 880-887.

7. Dora Kohen: Psychotropic Medication in Pregnancy. Advances in Psychiatric Treatment (2004), Vol. 10, 59-66.

8. Matyas Trixler, Agnes Gati, Sandor Fekete and Tamas Tenyi, Department in Psychiatry, University Medical School of Pecs,Hungary. Use of Antipsychotics in the management of Schizophrenia during Pregnancy. Drugs 2005: 65 (9): 1193-1206.

9. Mohammad Masud Iqbal, Alka Aneja, James Megna, Atiq Rehman, Wanda Freemont, Mohammed Shiplo, Niki Nihilani and Kathy Lee. Evidence-Based Pharmacology: The Potential Risk of commonly prescribed Antipsychotics During Pregnancy and Lactation Psychiatry MMC Article(2008).

10. Sandeep Grover and Ajit Avasthi. Risperidone in Pregnancy: A case of Oligohydramnios. German Journal of Psychiatry(2004); 7: 56-57.

11. Debra Kennedy. Antipsychotic Drugs in Pregnancy and Breastfeeding. Australian Prescriber(2007); Vol. 30 No. 6.

12. Kate McKenna, Gideon Koren, Maria Tetelbaum, Lynda Wilton, Saad Shakir, Orna Diav-Citrin, Andrea Levinson, Robert B. Zipursky and Adrienne Einarson. Pregnancy Outcome of women Using Atypical Antipsychotic Drugs: A prospective Comparative Study. J Clin Psychiatry 66:4, April 2005.

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