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	<1	1	0
Cardiac Disorders
Tachycardia	1	3	0
Ear and Labyrinth Disorders
Ear pain	<1	1	0
Eye Disorders
Vision blurred	3	1	1
Gastrointestinal Disorders
Nausea	9	4	4
Constipation	8	9	6
Dyspepsia	8	6	5
Vomiting	7	5	7
Dry mouth	4	0	1
Abdominal discomfort	3	1	1
Salivary hypersecretion	2	1	<1
Diarrhea	2	1	1
Abdominal pain	1	1	0
Abdominal pain upper	1	1	0
Stomach discomfort	1	1	1
General Disorders
Fatigue	3	1	0
Chest pain	2	2	1
Asthenia	2	1	<1
Immune System Disorders
Hypersensitivity	<1	1	0
Infections and Infestations
Nasopharyngitis	3	4	3
Upper respiratory tract infection	2	3	1
Sinusitis	1	2	1
Urinary tract infection	1	3	0
Investigations
Weight increased	1	1	0
Blood creatine phosphokinase increased	1	2	<1
Heart rate increased	<1	2	0
Metabolism and Nutrition Disorders
Decreased appetite	1	0	<1
Musculoskeletal and Connective Tissue Disorders
Back pain	4	1	1
Arthralgia	2	3	<1
Pain in extremity	2	1	1
Joint stiffness	1	1	0
Nervous System Disorders
Parkinsonism *	14	17	8
Akathisia *	10	10	3
Dizziness	7	4	2
Somnolence	7	2	1
Dystonia *	3	4	2
Sedation	3	3	1
Tremor *	2	3	1
Dizziness postural	2	0	0
Dyskinesia *	1	2	2
Syncope	1	1	0
Psychiatric Disorders
Insomnia	32	25	27
Anxiety	16	11	11
Nervousness	1	1	<1
Renal and Urinary Disorders
Urinary incontinence	1	1	0
Reproductive System and Breast Disorders
Ejaculation failure	<1	1	0
Respiratory , Thoracic and Mediastinal Disorders
Nasal congestion	4	6	2
Dyspnea	1	2	0
Epistaxis	<1	2	0
Skin and Subcutaneous Tissue Disorders
Rash	1	4	1
Dry skin	1	3	0
Dandruff	1	1	0
Seborrheic dermatitis	<1	1	0
Hyperkeratosis	0	1	1
Vascular Disorders
Orthostatic hypotension	2	1	0
Hypotension	1	1	0

*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	0	10	2
Nervous System Disorders
Parkinsonism *	16	28	11
Sedation	13	8	2
Somnolence	11	4	2
Tremor	11	10	6
Akathisia *	9	10	4
Dizziness	7	14	2
Dystonia *	2	6	0
Psychiatric Disorders
Anxiety	7	6	0