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.

Table 9. Adverse Reactions in ≥5% of Risperidone-Treated Pediatric Patients (and greater than placebo) with Schizophrenia in a Double-Blind 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.

Table 10. Adverse Reactions in ≥2% of Risperidone-Treated Adult Patients with Bipolar Mania in 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.

Table 11. Adverse Reactions in ≥2% of Risperidone-Treated Adult Patients (and greater than placebo) with Bipolar Mania in Double-Blind, Placebo-Controlled Adjunctive 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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