Risperidone (Page 5 of 11)
6.2 Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials – Bipolar Mania
Adult Patients with Bipolar Mania
Table 3 lists the adverse reactions reported in 1% or more of risperidone-treated adult patients with bipolar mania in four 3-week, double-blind, placebo-controlled monotherapy trials.
Table 3. Adverse Reactions in >1% Risperidone-Treated Adult Patients with Bipolar Mania in Double-Blind, Placebo-Controlled Monotherapy Trials.
| Percentage of Patients Reporting Event | |
| Risperidone | Placebo |
System/Organ Class | 1-6 mg per day | (N=424) |
Adverse Reaction | (N=448) | |
Cardiac Disorders | ||
Tachycardia | 1 | <1 |
Eye Disorders | ||
Vision blurred | 2 | 1 |
Gastrointestinal Disorders | ||
Nausea | 5 | 2 |
Diarrhea | 3 | 2 |
Salivary hypersecretion | 3 | 1 |
Dyspepsia | 2 | 2 |
Stomach discomfort | 2 | <1 |
General Disorders | ||
Fatigue | 2 | 1 |
Asthenia | 1 | 1 |
Pyrexia | 1 | 1 |
Infections and Infestations | ||
Nasopharyngitis | 1 | 1 |
Investigations | ||
Aspartate aminotransferase increased | 1 | <1 |
Nervous System Disorders | ||
Parkinsonism * | 25 | 9 |
Akathisia * | 9 | 3 |
Tremor* | 6 | 3 |
Dizziness | 6 | 5 |
Sedation | 6 | 2 |
Somnolence | 5 | 2 |
Dystonia* | 5 | 1 |
Lethargy | 2 | 1 |
Dyskinesia * | 1 | <1 |
Reproductive System and Breast Disorders | ||
Galactorrhea | 1 | 0 |
Skin and Subcutaneous Tissue Disorders | ||
Acne | 1 | 0 |
Table 4 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.
Table 4. Adverse Reactions in >2% of Risperidone-Treated Adult Patients with Bipolar Mania in Double-Blind, Placebo-Controlled Adjuvant Therapy Trials.
| Percentage of Patients Reporting Event | |
| Risperidone + | Placebo + |
System/Organ Class | Mood Stabilizer | Mood Stabilizer |
Adverse Reaction | (N=127) | (N=126) |
Cardiac Disorders | ||
Palpitations | 2 | 0 |
Gastrointestinal Disorders | ||
Dyspepsia | 9 | 8 |
Nausea | 6 | 4 |
Diarrhea | 6 | 4 |
Dry mouth | 4 | 4 |
Vomiting | 4 | 6 |
Constipation | 3 | 3 |
Salivary hypersecretion | 2 | 0 |
General Disorders | ||
Chest pain | 2 | 1 |
Fatigue | 2 | 2 |
Infections and Infestations | ||
Nasopharyngitis | 2 | 3 |
Urinary tract infection | 2 | 1 |
Investigations | ||
Weight increased | 2 | 2 |
Nervous System Disorders | ||
Parkinsonism * | 14 | 4 |
Headache | 14 | 15 |
Akathisia * | 8 | 0 |
Dizziness | 7 | 2 |
Sedation | 6 | 3 |
Tremor * | 6 | 2 |
Somnolence | 3 | 1 |
Lethargy | 2 | 1 |
Psychiatric Disorders | ||
Insomnia | 4 | 8 |
Anxiety | 3 | 2 |
Respiratory , Thoracic and Mediastinal Disorders | ||
Pharyngolaryngeal pain | 5 | 2 |
Cough | 2 | 0 |
Pediatric Patients with Bipolar Mania
Table 5 lists the adverse reactions reported in 5% or more of risperidone-treated pediatric patients with bipolar mania in a 3-week double-blind, placebo-controlled trial.
Table 5. Adverse Reactions in > 5% of Risperidone-Treated Pediatric Patients with Bipolar Mania in Double-Blind, Placebo-Controlled Trials
Percentage of Patients Reporting Event |
| ||
Risperidone |
|
| |
System/Organ Class | 0.5-2.5 mg per day | 3-6 mg per day | Placebo |
Adverse Reaction | (N=50) | (N=61) | (N=58) |
Eye Disorders | |||
Vision blurred | 4 | 7 | 0 |
Gastrointestinal Disorders | |||
Abdominal pain upper | 16 | 13 | 5 |
Nausea | 16 | 13 | 7 |
Vomiting | 10 | 10 | 5 |
Diarrhea | 8 | 7 | 2 |
Dyspepsia | 10 | 3 | 2 |
Stomach discomfort | 6 | 0 | 2 |
General Disorders | |||
Fatigue | 18 | 30 | 3 |
Metabolism and Nutrition Disorders | |||
Increased appetite | 4 | 7 | 2 |
Nervous System Disorders | |||
Somnolence | 22 | 30 | 12 |
Sedation | 20 | 23 | 7 |
Dizziness | 16 | 13 | 5 |
Parkinsonism * | 6 | 12 | 3 |
Dystonia * | 6 | 5 | 0 |
Akathisia * | 0 | 8 | 2 |
Psychiatric Disorders | |||
Anxiety | 0 | 8 | 3 |
Respiratory , Thoracic and Mediastinal Disorders | |||
Pharyngolaryngeal pain | 10 | 3 | 5 |
Skin and Subcutaneous Tissue Disorders | |||
Rash | 0 | 7 | 2 |
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