Eperon Adverse Reactions

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of risperidone based on the comprehensive assessment of the available adverse event information. A causal relationship with risperidone usually cannot be reliably established in individual cases. Further, 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.
Clinical Trial Data: The safety of risperidone was evaluated from a clinical trial database consisting of 9803 patients exposed to one or more doses of risperidone for the treatment of various psychiatric disorders in adults, elderly patients with dementia, and pediatrics.
Of these 9803 patients, 2687 were patients who received risperidone while participating in double-blind, placebo-controlled trials. The conditions and duration of treatment with risperidone varied greatly and included (in overlapping categories) double-blind, fixed- and flexible-dose, placebo- or active-controlled studies and open-label phases of studies, inpatients and outpatients, and short-term (up to 12 weeks) and longer-term (up to 3 years) exposures.
The majority of all adverse reactions were mild to moderate in severity.
Double-Blind, Placebo-Controlled Data - Adult Patients: Adverse reactions reported by ≥ 1% of risperidone-treated adult patients in nine 3- to 8-week double-blind, placebo-controlled trials are shown in Table 3. (See Table 3.)

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Double-Blind, Placebo-Controlled Data - Elderly Patients with Dementia: Adverse reactions reported by ≥ 1% of risperidone-treated elderly patients with dementia in six 4- to 12-week double-blind, placebo-controlled trials are shown in Table 4. Table 4 includes only those adverse reactions that are either not listed in Table 3 or those adverse reactions that occurred at ≥ 2 times the frequency of the adverse reactions listed in Table 3. (See Table 4.)

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Double-Blind, Placebo-Controlled Data - Pediatric Patients: Adverse reactions reported by > 1% of risperidone-treated pediatric patients in eight 3- to 8-week double-blind, placebo-controlled trials are shown in Table 5. Table 5 includes only those adverse reactions that are either not listed in Table 3 or those adverse reactions that occurred at ≥ 2 times the frequency of the adverse reactions listed in Table 3. (See Table 5.)

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Other Clinical Trial Data: Paliperidone is the active metabolite of risperidone, therefore the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another. Hence, a comprehensive listing of adverse reactions across paliperidone and risperidone products provides relevant safety information for these related products. Adverse reactions detected for one formulation of risperidone or paliperidone were considered as relevant safety information for the other formulation of the same compound unless the adverse reaction was unique to either the formulation or the route of administration. Adverse reactions for one compound that were not listed for the other compound were also added to the label for the other compound unless no meaningful new safety information could be derived from the additional adverse reactions (ie. the term was vague or the medical concept was already found in the current label). All adverse reactions and their frequencies of occurrence in patients on risperidone are reflected in the Adverse Reactions tables as follows. (See Table 6.)

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Adverse reactions reported with risperidone and/or paliperidone by < 1% of risperidone-treated subjects in a pooled dataset of 23 double-blind, placebo-controlled pivotal studies (9 in adults, 6 in elderly patients with dementia, and 8 in pediatric patients) are shown in Table 7. (See Table 7.)

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Adverse reactions reported with risperidone and/or paliperidone in other clinical trials but not reported by risperidone-treated subjects in a pooled dataset of 23 double-blind, placebo-controlled pivotal studies are shown in Table 8. (See Table 8.)

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Postmarketing Data: Adverse events first identified as adverse reactions during postmarketing experience with risperidone and/or paliperidone are included in Tables 9.
In each table, the frequencies are provided according to the following convention: Very common ≥ 1/10; Common ≥ 1/100 to <1/10; Uncommon ≥ 1/1000 to <1/100; Rare ≥ 1/10000 to <1/1000; Very rare <1/10000, including isolated reports.
In Table 9, adverse reactions are presented by frequency category based on spontaneous reporting rates. (See Table 9.)

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