Risperdal

[Risperidone]

In the US placebo-controlled trial with risperidone as adjunctive therapy to mood stabilizers, there was no overall difference in the incidence of discontinuation due to adverse events ( 4% for RISPERDAL ® vs. 4% for placebo) .

Incidence in Controlled Trials Commonly Observed Adverse Events in Controlled Clinical Trials

Schizophrenia

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In two 6-to 8-week placebo-controlled trials, spontaneously-reported, treatment-emergent adverse events with an incidence of 5% or greater in at least one of the RISPERDAL ® groups and at least twice that of placebo were anxiety, somnolence, extra-pyramidal symptoms, dizziness, constipation, nausea, dyspepsia, rhinitis, rash, and tachycardia. Adverse events were also elicited in one of these two trials ( i. e. , in the fixed-dose trial comparing RISPERDAL ® at doses of 2, 6, 10, and 16 mg/ day with placebo) utilizing a checklist for detecting adverse events, a method that is more sensitive than spontaneous reporting. By this method, the following additional common and drug-related adverse events occurred at an incidence of at least 5% and twice the rate of placebo: increased dream activity, increased duration of sleep, accommodation disturbances, reduced salivation, micturition disturbances, diarrhea, weight gain, menorrhagia, diminished sexual desire, erectile dysfunction, ejaculatory dysfunction, and orgastic dysfunction.

Bipolar Mania

In the US placebo-controlled trial with risperidone as monotherapy, the most commonly observed adverse events associated with the use of RISPERDAL ® ( incidence of 5% or greater and at least twice that of placebo) were somnolence, dystonia, akathisia, dyspepsia, nausea, parkinsonism, vision abnormal, and saliva increased. In the US placebo-controlled trial with risperidone as adjunctive therapy to mood stabilizers, the most commonly observed adverse events associated with the use of RISPERDAL ® were somnolence, dizziness, parkinsonism, saliva increased, akathisia, abdominal pain, and urinary incontinence.
Adverse Events Occurring at an Incidence of 1% or More Among RISPERDAL ® -Treated Patients -Schizophrenia

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