Risperidone Indications: FDA-Approved and Off-Label Uses

By Flavio Guzman, MD. Last updated: November 1, 2016

Risperidone is one of the oldest (and least expensive) second-generation antipsychotics. In 1993 the FDA approved it for the treatment of schizophrenia. Like most antipsychotics, risperidone is also effective for the treatment of manic and mixed episodes of bipolar I disorder. It is also one of the few antipsychotics approved for use in children [1].

FDA-Approved Indications

This table summarizes current approved uses and dosing, according to the product’s prescribing information [2].

IndicationInitial DoseTitrationTarget DoseEffective Dose Range
Adults2 mg/day1-2 mg/day
4-8 mg/day 4-16 mg/day
Adolescents0.5 mg/day 0.5-1 mg/day 3 mg/day 1-6 mg/day
Bipolar Disorder
Treatment of manic or mixed episodes
Bipolar Mania
2-3 mg/day 1 mg/day 1-6 mg/day 1-6 mg/day
Bipolar Mania
Children / Adolescents
0.5 mg/day 0.5-1 mg/day 2.5 mg/day 0.5-6 mg/day
Autism Spectrum Disorders
Irritability associated with autistic disorder.
Pediatric patients
0.25 mg/day (<20 kg), 0.5 mg/day ( ≥ 20kg)0.25-0.5 mg at ≥ 2 weeks0.5 mg/day (<20 kg), 1 mg/day ( ≥ 20kg)0.5-3 mg/day

Off-Label Uses

There is evidence supporting the efficacy of risperidone as adjunctive treatment for major depressive disorder and for the management of behavioral disturbances and psychosis in patients suffering from dementia [3]. However, the risk of side effects such as metabolic disturbances, weight gain, extrapyramidal symptoms and hyperprolactinemia should be kept in mind when prescribing antipsychotics as augmentation strategy.

In addition, there is a small but well-established increase in the risk of death and stroke when using second-generation antipsychotics in older adults with dementia [4]. This led the FDA to issue a black box warning for risperidone and other antipsychotics.

The list below is based on the comparative effectiveness review by the Agency for Healthcare Research and Quality [3].

Off-label UseEvidence
Generalized anxiety disorderLow or very low evidence of inefficacy
Social PhobiaNo trials
Attention-deficit hyperactivity disorder
No co-occuring disordersLow or very low evidence of efficacy
Bipolar ChildrenNo trials
Mentally retarded childrenLow or very low evidence of efficacy
OverallModerate or high evidence of efficacy
PsychosisModerate or high evidence of efficacy
AgitationModerate or high evidence of efficacy
Adjunctive treatmentModerate or high evidence of efficacy
Eating disordersNo trials
InsomniaNo trials
Obsessive-compulsive disorder
Augmentation with SSRIModerate or high evidence of efficacy
Augmentation of citalopramLow or very low evidence of efficacy
Personality disorder
Borderline personality disorderNo trials
Schizotypal personality disorderMixed results
Post-traumatic stress disorderModerate or high evidence of efficacy
Substance abuse
AlcoholNo trials
CocaineLow or very low evidence of inefficacy
Methamphetamine No trials
Methadone usersLow or very low evidence of inefficacy
Tourette's syndromeLow or very low evidence of efficacy

Related information


  1. Stahl, S M. The Prescriber’s Guide. 4th ed. New York: Cambrigde University Press; 2011
  2. Janssen Pharmaceuticals, Inc. Risperdal prescribing information. Retrieved from http://www.janssenpharmaceuticalsinc.com/assets/risperdal.pdf. [retrieval date: April 12, 2013]
  3. Maglione M, Ruelaz Maher A, Hu J, Wang Z, Shanman R, Shekelle PG, Roth B, Hilton L, Suttorp MJ, Ewing BA, Motala A, Perry T. Off-Label Use of Atypical Antipsychotics: An Update. Comparative Effectiveness Review No. 43. Rockville, MD: Agency for Healthcare Research and Quality. September 2011. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm
  4. Meeks TW, Jeste DV. Beyond the Black Box: What is The Role for Antipsychotics in Dementia? Current psychiatry. 2008;7(6):50-65.

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