Prescription Drug Information: Risperidone (Page 4 of 13)
Pediatric Patients with Schizophrenia
Table 9 lists the adverse reactions reported in 5% or more of risperidone-treated pediatric patients with schizophrenia in a 6 week double-blind, placebo-controlled trial.
*Parkinsonism includes extrapyramidal disorder, muscle rigidity, musculoskeletal stiffness, and hypokinesia. Akathisia includes akathisia and restlessness. Dystonia includes dystonia and oculogyration. | |||
Percentage of Patients Reporting Reaction | |||
Risperidone | |||
System/Organ Class Adverse Reaction | 1 to 3 mg per day (N=55) | 4 to 6 mg per day (N=51) | Placebo (N=54) |
Gastrointestinal Disorders | |||
Salivary hypersecretion | 0 | 10 | 2 |
Nervous System Disorders | |||
Sedation | 24 | 12 | 4 |
Parkinsonism * | 16 | 28 | 11 |
Tremor | 11 | 10 | 6 |
Akathisia * | 9 | 10 | 4 |
Dizziness | 7 | 14 | 2 |
Dystonia * | 2 | 6 | 0 |
Psychiatric Disorders | |||
Anxiety | 7 | 6 | 0 |
Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials – Bipolar Mania
Adult Patients with Bipolar Mania
Table 10 lists the adverse reactions reported in 2% or more of risperidone-treated adult patients with bipolar mania in four 3 week, double-blind, placebo-controlled monotherapy trials.
* Parkinsonism includes extrapyramidal disorder, parkinsonism, musculoskeletal stiffness, hypokinesia, muscle rigidity, muscle tightness, bradykinesia, cogwheel rigidity. Akathisia includes akathisia and restlessness. Tremor includes tremor and parkinsonian rest tremor. Dystonia includes dystonia, muscle spasms, oculogyration, torticollis. | ||
Percentage of Patients Reporting Reaction | ||
System/Organ Class | Risperidone 1 to 6 mg per day (N=448) | Placebo (N=424) |
Adverse Reaction | ||
Eye Disorders | ||
Vision blurred | 2 | 1 |
Gastrointestinal Disorders | ||
Nausea | 5 | 2 |
Diarrhea | 3 | 2 |
Salivary hypersecretion | 3 | 1 |
Stomach discomfort | 2 | <1 |
General Disorders | ||
Fatigue | 2 | 1 |
Nervous System Disorders | ||
Parkinsonism* | 25 | 9 |
Sedation | 11 | 4 |
Akathisia* | 9 | 3 |
Tremor* | 6 | 3 |
Dizziness | 6 | 5 |
Dystonia* | 5 | 1 |
Lethargy | 2 | 1 |
Table 11 lists the adverse reactions reported in 2% or more of risperidone-treated adult patients with bipolar mania in two 3 week, double-blind, placebo-controlled adjuvant therapy trials.
* Parkinsonism includes extrapyramidal disorder, hypokinesia and bradykinesia. Akathisia includes hyperkinesia and akathisia. | |||||
Percentage of Patients Reporting Reaction | |||||
System/Organ Class Adverse Reaction | Risperidone + Mood Stabilizer (N=127) | Placebo + Mood Stabilizer (N=126) | |||
Cardiac Disorders | |||||
Palpitations | 2 | 0 | |||
Gastrointestinal Disorders | |||||
Dyspepsia | 9 | 8 | |||
Nausea | 6 | 4 | |||
Diarrhea | 6 | 4 | |||
Salivary hypersecretion | 2 | 0 | |||
General Disorders | |||||
Chest pain | 2 | 1 | |||
Infections and Infestations | |||||
Urinary tract infection | 2 | 1 | |||
Nervous System Disorders | |||||
Parkinsonism * | 14 | 4 | |||
Sedation | 9 | 4 | |||
Akathisia * | 8 | 0 | |||
Dizziness | 7 | 2 | |||
Tremor | 6 | 2 | |||
Lethargy | 2 | 1 | |||
Psychiatric Disorders | |||||
Anxiety | 3 | 2 | |||
Respiratory,Thoracic and Mediastinal Disorders | |||||
Pharyngolaryngeal pain | 5 | 2 | |||
Cough | 2 | 0 |
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