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Risperdal (risperidone)
Atypical antipsychotic that antagonizes dopamine D2 and serotonin 5-HT2A receptors for schizophrenia and bipolar disorder.
Risperidone (Risperdal) is an atypical antipsychotic developed by Janssen, approved in 1993. First-line for schizophrenia with oral and long-acting injectable formulations. Available generically.
At a glance
| Generic name | risperidone |
|---|---|
| Also known as | Risperdal, Risperdal Consta |
| Sponsor | Johnson & Johnson (Janssen) |
| Drug class | Atypical Antipsychotic [EPC] |
| Target | 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 5A, 5-hydroxytryptamine receptor 6 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1993-12-29 (United States) |
Mechanism of action
Risperidone was one of the first atypical antipsychotics, offering effective symptom control with fewer extrapyramidal side effects than first-generation antipsychotics at low doses. The long-acting injectable (Risperdal Consta) was the first long-acting atypical antipsychotic. Notable for hyperprolactinemia as a common side effect.
Approved indications
- Bipolar affective disorder, current episode manic
- Bipolar disorder in remission
- Infantile autism
- Mixed bipolar I disorder
- Schizophrenia
Boxed warnings
- WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone tablets are not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1) ] WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone tablets are not approved for use in patients with dementia-related psychosis. ( 5.1 )
Common side effects
- Nausea
- Constipation
- Dyspepsia
- Parkinsonism
- Akathisia
- Dystonia
- Tremor
- Sedation
- Dizziness
- Anxiety
- Blurred vision
- Vomiting
Key clinical trials
- A 2-year, Prospective, Blinded-rater, Open-label, Active-controlled, Multicenter, Randomized Study of Long-term Efficacy and Effectiveness Comparing Risperdal® Consta® and Abilify® (Aripiprazole) in A (Phase 4)
- A Study on the Preference of Risperidone Dosage Forms (N/A)
- Haloperidol vs Olanzapine for the Management of ICU Delirium: A Randomized Clinical Trial (NA)
- Is Premorbid Functioning a Predictor of Outcome in Patients With Early Onset Psychosis Treated With Risperdal Consta? (Phase 4)
- Risperidone in the Treatment of Psychotic-like and Deficit Symptoms of Schizotypal Personality Disorder (NA)
- The Efficacy And Safety Of Flexible Dosage Ranges Of Risperidone Versus Placebo In The Treatment Of Manic Or Mixed Episodes Associated With Bipolar I Disorder (Phase 3)
- A Study of the Safety and Efficacy of Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia (Phase 2)
- Six Week Double Blind, Randomized Trial of Escitalopram Add On for Treatment Resistant Bipolar Depression (Phase 1)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 9186413 | 2028-02-13 | Method of Use |
| 10058554 | 2026-09-26 | Method of Use |
| 10406160 | 2026-06-26 | Formulation |
| 10376590 | 2028-02-13 | Method of Use |
| 8221778 | 2027-11-12 | Formulation |
| 11712475 | 2028-02-13 | Method of Use |
| 11110093 | 2026-11-05 | Formulation |
| 10406161 | 2032-04-10 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |