Risperdal

[Risperidone]

Side Effects & Drug Interactions
ADVERSE REACTIONS

The following findings are based on the short-term, placebo-controlled, North American, premarketing trials for schizophrenia and acute bipolar mania. In patients with Bipolar I Disorder, treatment-emergent adverse events are presented separately for risperidone as monotherapy and as adjunctive therapy to mood stabilizers.
Certain portions of the discussion below relating to objective or numeric safety parameters, namely dose-dependent adverse events, vital sign changes, weight gain, laboratory changes, and ECG changes are derived from studies in patients with schizophrenia. However, this information is also generally applicable to bipolar mania.

Associated With Discontinuation of Treatment

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Schizophrenia

Approximately 9% ( 244/ 2607) of RISPERDAL ® ( risperidone) -treated patients in Phase 2 and 3 studies discontinued treatment due to an adverse event, compared with about 7% on placebo and 10% on active control drugs. The more common events ( 0.3% ) associated with discontinuation and considered to be possibly or probably drug-related included:

Suicide attempt was associated with discontinuation in 1.2% of RISPERDAL ® -treated patients compared to 0.6% of placebo patients, but, given the almost 40-fold greater exposure time in RISPERDAL ® compared to placebo patients, it is unlikely that suicide attempt is a RISPERDAL ® -related adverse event ( see PRECAUTIONS) . Discontinuation for extrapyramidal symptoms was 0% in placebo patients, but 3.8% in active-control patients in the Phase 2 and 3 trials.

Bipolar Mania

In the US placebo-controlled trial with risperidone as monotherapy, approximately 8% ( 10/ 134) of RISPERDAL ® -treated patients discontinued treatment due to an adverse event, compared with approximately 6% ( 7/ 125) of placebo-treated patients. The adverse events associated with discontinuation and considered to be possibly, probably, or very likely drug-related included paroniria, somnolence, dizziness, extrapyramidal disorder, and muscle contractions involuntary. Each of these events occurred in one RISPERDAL ® -treated patient ( 0.7% ) and in no placebo-treated patients ( 0% ) .

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