Risperidone (Page 4 of 11)

6.1 Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials — Schizophrenia

Adult Patients with Schizophrenia

Table 1 lists the adverse reactions reported in 1% or more of risperidone-treated adult patients with schizophrenia in three 4- to 8-week, double-blind, placebo-controlled trials.

Table 1. Adverse Reactions in > 1% of Risperidone-Treated Adult Patients with Schizophrenia in Double-Blind, Placebo-Controlled Trials.

Percentage of Patients Reporting Event

Risperidone

System/Organ Class

2-8 mg per day

>8-16 mg per day

Placebo

Adverse Reaction

(N=366)

(N=198)

(N=225)

Blood and Lymphatic System Disorders
Anemia<110
Cardiac Disorders
Tachycardia130
Ear and Labyrinth Disorders
Ear pain<110
Eye Disorders
Vision blurred311
Gastrointestinal Disorders
Nausea944
Constipation896
Dyspepsia865
Vomiting757
Dry mouth401
Abdominal discomfort311
Salivary hypersecretion21<1
Diarrhea211
Abdominal pain110
Abdominal pain upper110
Stomach discomfort111
General Disorders
Fatigue310
Chest pain221
Asthenia21<1
Immune System Disorders
Hypersensitivity<110
Infections and Infestations
Nasopharyngitis343
Upper respiratory tract infection231
Sinusitis121
Urinary tract infection 130
Investigations
Weight increased110
Blood creatine phosphokinase increased12<1
Heart rate increased<120
Metabolism and Nutrition Disorders
Decreased appetite10<1
Musculoskeletal and Connective Tissue Disorders
Back pain411
Arthralgia23<1
Pain in extremity211
Joint stiffness110
Nervous System Disorders
Parkinsonism *14178
Akathisia *10103
Dizziness742
Somnolence721
Dystonia *342
Sedation331
Tremor *231
Dizziness postural200
Dyskinesia *122
Syncope110
Psychiatric Disorders
Insomnia322527
Anxiety 161111
Nervousness11<1
Renal and Urinary Disorders
Urinary incontinence110
Reproductive System and Breast Disorders
Ejaculation failure<110
Respiratory , Thoracic and Mediastinal Disorders
Nasal congestion462
Dyspnea120
Epistaxis<120
Skin and Subcutaneous Tissue Disorders
Rash141
Dry skin130
Dandruff110
Seborrheic dermatitis<110
Hyperkeratosis011
Vascular Disorders
Orthostatic hypotension210
Hypotension110
*Parkinsonism includes extrapyramidal disorder, musculoskeletal stiffness, parkinsonism, cogwheel rigidity, akinesia, bradykinesia, hypokinesia, masked facies, muscle rigidity, and Parkinson’s disease. Akathisia includes akathisia and restlessness. Dystonia includes dystonia, muscle spasms, muscle contractions involuntary, muscle contracture, oculogyration, tongue paralysis. Tremor includes tremor and parkinsonian rest tumor. Dyskinesia includes dyskinesia, muscle twitching, chorea, and choreoathetosis.

Pediatric Patients with Schizophrenia

Table 2 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.

Table 2. Adverse Reactions in > 5% of Risperidone-Treated Pediatric Patients with Schizophrenia in a Double-Blind Trial

Percentage of Patients Reporting Event

Risperidone

System/Organ Class

1-3 mg per day

4-6 mg per day

Placebo

Adverse Reaction

(N=55)

(N=51)

(N=54)

Gastrointestinal Disorders
Salivary hypersecretion 0102
Nervous System Disorders
Parkinsonism *162811
Sedation1382
Somnolence1142
Tremor11106
Akathisia *9104
Dizziness7142
Dystonia *260
Psychiatric Disorders
Anxiety760

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