Overall, the incidence of discontinuation due to adverse events was 17% in clonazepam compared to 9% for placebo in the combined data of two 6- to 9-week trials. The most common events (≥ 1%) associated with discontinuation and a dropout rate twice or greater for clonazepam than that of placebo included the following:
|Adverse Event||Clonazepam (N = 574)||Placebo (N = 294)|
|Intellectual Ability Reduced||1%||0%|
Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of panic disorder from a pool of two 6- to 9-week trials. Events reported in 1% or more of patients treated with clonazepam (doses ranging from 0.5 to 4 mg/day) and for which the incidence was greater than that in placebo-treated patients are included.
The prescriber should be aware that the figures in Table 3 cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the population studied.
|Clonazepam Maximum Daily Dose|
|Adverse Event by Body System||< 1 mg n = 96 %||1- < 2 mg n = 129 %||2- < 3 mg n = 113 %||≥ 3 mg n = 235 %||All Clonazepam Groups N = 574 %||Placebo N = 294 %|
|Central & Peripheral Nervous System|
|Coordination Abnormal †||1||2||7||9||6||0|
|Intellectual Ability Reduced||0||2||4||3||2||0|
|Upper Respiratory Tract Infection †||10||10||7||6||8||4|
|Abdominal Pain †||2||2||2||0||1||1|
|Body as a Whole|
|Resistance Mechanism Disorders|
|Urinary Tract Infection †||0||0||2||2||1||0|
|Reproductive Disorders ‡|
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