RISPERDAL CONSTA (Page 6 of 14)

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

Table 4 lists the adverse reactions reported in 2% or more of RISPERDAL CONSTA® -treated patients with schizophrenia in one 12-week double-blind, placebo-controlled trial.

Table 4. Adverse Reactions in ≥2% of RISPERDAL CONSTA® -Treated Patients with Schizophrenia in a 12-Week Double-Blind, Placebo-Controlled Trial
Percentage of Patients Reporting Event
RISPERDAL CONSTA® Placebo
System/Organ Class 25 mg 50 mg
Adverse Reaction (N=99) (N=103) (N=98)
*
Fatigue includes fatigue and asthenia. Parkinsonism includes extrapyramidal disorder, musculoskeletal stiffness, muscle rigidity, and bradykinesia. Akathisia includes akathisia and restlessness. Sedation includes sedation and somnolence.
Eye disorders
Vision blurred 2 3 0
Gastrointestinal disorders
Constipation 5 7 1
Dry mouth 0 7 1
Dyspepsia 6 6 0
Nausea 3 4 5
Toothache 1 3 0
Salivary hypersecretion 4 1 0
General disorders and administration site conditions
Fatigue * 3 9 0
Edema peripheral 2 3 1
Pain 4 1 0
Pyrexia 2 1 0
Infections and infestations
Upper respiratory tract infection 2 0 1
Investigations
Weight increased 5 4 2
Weight decreased 4 1 1
Musculoskeletal and connective tissue disorders
Pain in extremity 6 2 1
Nervous system disorders
Headache 15 21 12
Parkinsonism * 8 15 9
Dizziness 7 11 6
Akathisia * 4 11 6
Sedation * 5 6 3
Tremor 0 3 0
Syncope 2 1 0
Hypoesthesia 2 0 0
Respiratory, thoracic and mediastinal disorders
Cough 4 2 3
Sinus congestion 2 0 0
Skin and subcutaneous tissue disorders
Acne 2 2 0
Dry skin 2 0 0

6.2 Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials – Bipolar Disorder

Table 5 lists the treatment-emergent adverse reactions reported in 2% or more of RISPERDAL CONSTA® -treated patients in the 24-month double-blind, placebo-controlled treatment period of the trial assessing the efficacy and safety of RISPERDAL CONSTA® when administered as monotherapy for maintenance treatment in patients with Bipolar I Disorder.

Table 5. Adverse Reactions in ≥2% of Patients with Bipolar I Disorder Treated with RISPERDAL CONSTA® as Monotherapy in a 24-Month Double-Blind, Placebo-Controlled Trial
Percentage of Patients Reporting Event
System/Organ Class Adverse Reaction RISPERDAL CONSTA® (N=154) Placebo(N=149)
Investigations
Weight increased 5 1
Nervous system disorders
Dizziness 3 1
Vascular disorders
Hypertension 3 1

Table 6 lists the treatment-emergent adverse reactions reported in 4% or more of patients in the 52-week double-blind, placebo-controlled treatment phase of a trial assessing the efficacy and safety of RISPERDAL CONSTA® when administered as adjunctive maintenance treatment in patients with bipolar disorder.

Table 6. Adverse Reactions in ≥ 4% of Patients with Bipolar Disorder Treated with RISPERDAL CONSTA® as Adjunctive Therapy in a 52-Week Double-Blind, Placebo-Controlled Trial
Percentage of Patients Reporting Event
System/Organ Class Adverse Reaction RISPERDAL CONSTA® + Treatment as Usual *(N=72) Placebo + Treatment as Usual *(N=67)
*
Patients received double-blind RISPERDAL CONSTA® or placebo in addition to continuing their treatment as usual, which included mood stabilizers, antidepressants, and/or anxiolytics.
Parkinsonism includes muscle rigidity, hypokinesia, cogwheel rigidity, and bradykinesia. Dyskinesia includes muscle twitching and dyskinesia.
Sedation includes sedation and somnolence.
General disorders and administration site conditions
Gait abnormal 4 0
Infections and infestations
Upper respiratory tract infection 6 3
Investigations
Weight increased 7 1
Metabolism and nutrition disorders
Decreased appetite 6 1
Increased appetite 4 0
Musculoskeletal and connective tissue disorders
Arthralgia 4 3
Nervous system disorders
Tremor 24 16
Parkinsonism 15 6
Dyskinesia 6 3
Sedation 7 1
Disturbance in attention 4 0
Reproductive system and breast disorders
Amenorrhea 4 1
Respiratory, thoracic and mediastinal disorders
Cough 4 1

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