Risperidone (Page 5 of 11)

*Parkinsonism includes extrapyramidal disorder, muscle rigidity, musculoskeletal stiffness, and hypokinesia. Akathisia includes akathisia and restlessness. Dystonia includes dystonia and oculogyration.

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
Tachycardia1<1
Eye Disorders
Vision blurred21
Gastrointestinal Disorders
Nausea52
Diarrhea32
Salivary hypersecretion31
Dyspepsia22
Stomach discomfort2<1
General Disorders
Fatigue21
Asthenia11
Pyrexia11
Infections and Infestations
Nasopharyngitis11
Investigations
Aspartate aminotransferase increased1<1
Nervous System Disorders
Parkinsonism *259
Akathisia *93
Tremor*63
Dizziness65
Sedation62
Somnolence52
Dystonia*51
Lethargy21
Dyskinesia *1<1
Reproductive System and Breast Disorders
Galactorrhea10
Skin and Subcutaneous Tissue Disorders
Acne10
*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 tumor. Dystonia includes dystonia, muscle spasms, oculogyration, torticollis. Dyskinesia includes muscle twitching and dyskinesia.

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
Palpitations20
Gastrointestinal Disorders
Dyspepsia98
Nausea64
Diarrhea64
Dry mouth44
Vomiting46
Constipation33
Salivary hypersecretion20
General Disorders
Chest pain21
Fatigue22
Infections and Infestations
Nasopharyngitis23
Urinary tract infection21
Investigations
Weight increased22
Nervous System Disorders
Parkinsonism *144
Headache1415
Akathisia *80
Dizziness72
Sedation63
Tremor *62
Somnolence31
Lethargy21
Psychiatric Disorders
Insomnia48
Anxiety32
Respiratory , Thoracic and Mediastinal Disorders
Pharyngolaryngeal pain52
Cough20
*Parkinsonism includes extrapyramidal disorder, hypokinesia and bradykinesia. Akathisia includes hyperkinesia and akathisia.

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 blurred470
Gastrointestinal Disorders
Abdominal pain upper16135
Nausea16137
Vomiting10105
Diarrhea872
Dyspepsia1032
Stomach discomfort602
General Disorders
Fatigue18303
Metabolism and Nutrition Disorders
Increased appetite472
Nervous System Disorders
Somnolence223012
Sedation20237
Dizziness16135
Parkinsonism *6123
Dystonia *650
Akathisia *082
Psychiatric Disorders
Anxiety083
Respiratory , Thoracic and Mediastinal Disorders
Pharyngolaryngeal pain1035
Skin and Subcutaneous Tissue Disorders
Rash072

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