In the listings that follow, spontaneously reported adverse events were classified using World Health Organization ( WHO) preferred terms. The frequencies presented, therefore, represent the proportion of the 2607 patients exposed to multiple doses of RISPERDAL ® who experienced an event of the type cited on at least one occasion while receiving RISPERDAL ® . All reported events are included, except those already listed in Table 1, those events for which a drug cause was remote, and those event terms which were so general as to be uninformative. It is important to emphasize that, although the events reported occurred during treatment with RISPERDAL ® , they were not necessarily caused by it. Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/ 100 patients ( only those not already listed in the tabulated results from placebo-controlled trials appear in this listing) ; infrequent adverse events are those occurring in 1/ 100 to 1/ 1000 patients; rare events are those occurring in fewer than 1/ 1000 patients. Psychiatric Disorders Frequent increased dream activity* , diminished sexual desire* , nervousness. Infrequent impaired concentration, depression, apathy, catatonic reaction, euphoria, increased libido, amnesia. Rare emotional lability, nightmares, delirium, withdrawal syndrome, yawning. Central and Peripheral Nervous System Disorders Frequent increased sleep duration* . Infrequent dysarthria, vertigo, stupor, paraesthesia, confusion. Rare aphasia, cholinergic syndrome, hypoesthesia, tongue paralysis, leg cramps, torticollis, hypotonia, coma, migraine, hyperreflexia, choreoathetosis. Gastrointestinal Disorders Frequent anorexia, reduced salivation* . Infrequent flatulence, diarrhea, increased appetite, stomatitis, melena, dysphagia, hemorrhoids, gastritis. | ||||
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