Risperdal - Side Effects & Drug Interactions

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Other Adverse Events

Adverse event data elicited by a checklist for side effects from a large study comparing 5 fixed doses of RISPERDAL ® ( 1, 4, 8, 12, and 16 mg/ day) were explored for dose-relatedness of adverse events. A Cochran-Armitage Test for trend in these data revealed a positive trend ( p< 0.05) for the following adverse events: sleepiness, increased duration of sleep, accommodation disturbances, orthostatic dizziness, palpitations, weight gain, erectile dysfunction, ejaculatory dysfunction, orgastic dysfunction, asthenia/ lassitude/ increased fatigability, and increased pigmentation.

Vital Sign Changes

RISPERDAL ® is associated with orthostatic hypotension and tachycardia ( see PRECAUTIONS) .

Weight Changes

The proportions of RISPERDAL ® and placebo-treated patients meeting a weight gain criterion of 7% of body weight were compared in a pool of 6-to 8-week, placebo-controlled trials, revealing a statistically significantly greater ncidence of weight gain for RISPERDAL ® ( 18% ) compared to placebo ( 9%).

Laboratory Changes

A between-group comparison for 6-to 8-week placebo-controlled trials revealed no statistically significant RISPERDAL ® / placebo differences in the proportions of patients experiencing potentially important changes in routine serum chemistry, hematology, or urinalysis parameters. Similarly, there were no RISPERDAL ® / placebo differences in the incidence of discontinuations for changes in serum chemistry, hematology, or urinalysis. However, RISPERDAL ® administration was associated with increases in serum prolactin ( see PRECAUTIONS) .

ECG Changes

Between-group comparisons for pooled placebo-controlled trials revealed no statistically significant differences between risperidone and placebo in mean changes from baseline in ECG parameters, including QT, QTc, and PR intervals, and heart rate.

When all RISPERDAL ® doses were pooled from randomized controlled trials in several indications, there was a mean increase in heart rate of 1 beat per minute compared to no change for placebo patients. In short-term schizophrenia trials, higher doses of risperidone ( 8-16 mg/ day) were associated with a higher mean increase in heart rate compared to placebo ( 4-6 beats per minute) .