ICD Diagnoses for Risperidone Prescribing
FDA-Approved Indications
Risperidone has three FDA-approved indications in pediatric populations: irritability associated with autistic disorder (ages 5-16), schizophrenia in adolescents (ages 13-17), and acute manic or mixed episodes of bipolar I disorder in children and adolescents (ages 10-17). 1
Autism Spectrum Disorder (ICD-10: F84.0; ICD-11: 6A02)
- Risperidone is FDA-approved specifically for irritability associated with autistic disorder in children and adolescents aged 5-16 years. 1
- The target symptoms include aggression, self-injurious behavior, and severe tantrums—not the core social communication deficits of autism. 2
- Effective dose range is 0.5-3 mg/day, with most children achieving benefit at 1-2 mg/day. 2
- Clinical trials demonstrated 69% response rate versus 12% on placebo, with improvement typically beginning within 2 weeks. 2
Schizophrenia (ICD-10: F20.x; ICD-11: 6A20)
- Risperidone is FDA-approved for schizophrenia in adolescents aged 13-17 years. 1
- The medication addresses both positive symptoms (hallucinations, delusions) and negative symptoms (flat affect, social withdrawal). 3
- Dosing in adolescents typically ranges from 2-8 mg/day based on adult schizophrenia trials. 1
Bipolar I Disorder (ICD-10: F31.x; ICD-11: 6A60)
- Risperidone is FDA-approved as monotherapy for acute manic and mixed episodes in children and adolescents aged 10-17 years. 1
- The medication demonstrated significant improvement in mania symptoms, with mean dose of 4.7 mg/day in clinical trials. 4
- Risperidone may have both antipsychotic and mood-stabilizing properties when used in combination with mood stabilizers. 4
Off-Label Uses Supported by Guidelines
Delirium (ICD-10: F05; ICD-11: 6D70)
- Risperidone 0.5 mg orally as initial dose is recommended for delirium management in cancer patients and palliative care settings. 3
- Dosing may be given up to every 12 hours if scheduled dosing is required. 3
- The medication is less likely to cause extrapyramidal symptoms than haloperidol but may cause insomnia, agitation, anxiety, drowsiness, and orthostatic hypotension. 3
- Reduce dose in older patients and those with severe renal or hepatic impairment. 3
Intellectual Disability with Disruptive Behaviors (ICD-10: F70-F79; ICD-11: 6A00)
- Risperidone has demonstrated efficacy for irritability, aggression, and conduct problems in children with intellectual disability. 3
- Multiple studies showed significant improvement in behavior problems as measured by the Aberrant Behavior Checklist and other validated scales. 3
- Children with intellectual disability may be more sensitive to adverse effects, requiring conservative starting doses (0.5 mg) and slower titration. 2, 5
- Mean effective doses ranged from 1.16-2.9 mg/day in clinical trials. 3
Conduct Disorder and Oppositional Defiant Disorder (ICD-10: F91.x, F91.3; ICD-11: 6C90, 6C91)
- Risperidone improved symptoms of conduct disorder and oppositional defiant disorder in youth with intellectual disability. 3
- The medication is preferred over first-generation antipsychotics due to lower risk of extrapyramidal symptoms. 5
Schizoaffective Disorder (ICD-10: F25.x; ICD-11: 6A21)
- Risperidone demonstrated efficacy for both psychotic and mood symptoms in schizoaffective disorder, bipolar type. 4
- When added to mood stabilizers, risperidone produced significant improvements in mania, psychosis, and depression scores. 4
- Mean effective dose was 4.7 mg/day in a 6-week trial. 4
Tourette's Syndrome (ICD-10: F95.2; ICD-11: 6A05.0)
- Risperidone has been used for treatment of tics and behavioral symptoms associated with Tourette's syndrome. 6
- Evidence is primarily from open studies and case reports. 6
Obsessive-Compulsive Disorder (ICD-10: F42; ICD-11: 6B20)
- Risperidone may be used as augmentation therapy for treatment-refractory OCD without comorbid tic or delusional disorders. 7
- Five patients with refractory OCD showed significant improvement when risperidone was added to their existing medication regimen. 7
- This represents an off-label use with limited but positive evidence. 6, 7
Important Clinical Caveats
Age Restrictions
- For autism-related irritability: ages 5-16 years only. 1
- For schizophrenia: ages 13-17 years only. 1
- For bipolar disorder: ages 10-17 years only. 1
Contraindications and Warnings
- Avoid in patients with Parkinson's disease or dementia with Lewy bodies due to increased sensitivity to extrapyramidal symptoms. 3
- FDA black box warning: increased risk of death when used for behavioral problems in dementia. 3
- Risperidone should not be used to treat core autism symptoms (social communication deficits), only associated irritability and aggression. 2
Monitoring Requirements
- Baseline and ongoing monitoring must include weight, height, BMI, fasting glucose, lipid panel, blood pressure, prolactin levels, and assessment for extrapyramidal symptoms. 2, 8
- Weight gain averages 2.7 kg over 8 weeks in pediatric patients. 2
- Asymptomatic hyperprolactinemia is common and requires periodic monitoring. 3, 2, 5
Dosing Considerations
- Doses above 2.5 mg/day are associated with more adverse effects without improved efficacy in children with autism. 2
- Increased risk of extrapyramidal symptoms if dose exceeds 6 mg/24 hours. 3
- Conservative starting doses (0.5 mg) and slower titration are recommended, especially in children with intellectual disability. 2, 5