Risperdal

[Risperidone]

The table that follows enumerates adverse events that occurred at an incidence of 1% or more, and were more frequent among RISPERDAL ® -treated patients treated at doses of 10 mg/ day than among placebo-treated patients in the pooled results of two 6-to 8-week controlled trials. Patients received RISPERDAL ® doses of 2, 6, 10, or 16 mg/ day in the dose comparison trial, or up to a maximum dose of 10 mg/ day in the titration study. This table shows the percentage of patients in each dose group ( 10 mg/ day or 16 mg/ day) who spontaneously reported at least one episode of an event at some time during their treatment. Patients given doses of 2, 6, or 10 mg did not differ materially in these rates. Reported adverse events were classified using the World Health
Organization preferred terms.

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in this clinical trial. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical nvestigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the side effect incidence rate in the population studied.

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Adverse Events Occurring at an Incidence of 2% or More Among RISPERDAL ® -Treated Patients -Bipolar Mania

Tables 2 and 3 display adverse events that occurred at an incidence of 2% or more, and were more frequent among patients treated with flexible doses of RISPERDAL ® ( 1-6 mg daily as monotherapy and as adjunctive therapy to mood stabilizers, respectively) than among patients treated with placebo. Reported adverse events were classified using the World Health Organization preferred terms.

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