Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials Schizophrenia
Adult Patients with Schizophrenia
Table 8 lists the adverse reactions reported in 2% or more of Risperdal-treated adult patients with schizophrenia in three 4- to 8-week, double-blind, placebo-controlled trials.
Pediatric Patients with Schizophrenia
Table 9 lists the adverse reactions reported in 5% or more of Risperdal-treated pediatric patients with schizophrenia in a 6-week double-blind, placebo-controlled trial.
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 Risperdal-treated adult patients with bipolar mania in four 3-week, double-blind, placebo-controlled monotherapy trials.
Table 11 lists the adverse reactions reported in 2% or more of Risperdal-treated adult patients with bipolar mania in two 3-week, double-blind, placebo-controlled adjuvant therapy trials.
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Risperdal - FDA prescribing information, side effects and uses