|
Side Effects & Drug Interactions
ADVERSE REACTIONS
Migraine Based on the results of one multicenter, randomized, double-blind, placebo-controlled clinical trial, DEPAKOTE ER was well tolerated in the prophylactic treatment of migraine headache. Of the 122 patients exposed to DEPAKOTE ER in the placebo-controlled study, 8% discontinued for adverse events, compared to 9% for the 115 placebo patients. Text Continues Below
Based on two placebo-controlled clinical trials and their long term extension, DEPAKOTE (divalproex sodium delayed-release tablets) was generally well tolerated with most adverse events rated as mild to moderate in severity. Of the 202 patients exposed to DEPAKOTE in the placebo-controlled trials, 17% discontinued for intolerance. This is compared to a rate of 5% for the 81 placebo patients. Including the long term extension study, the adverse events reported as the primary reason for discontinuation by 1% of 248 DEPAKOTE-treated patients were alopecia (6%),
nausea and/ or vomiting (5%),
weight gain (2%),
tremor (2%),
somnolence (1%),
elevated SGOT and/ or SGPT (1%),
depression (1%). Table 1 includes those adverse events reported for patients in the placebo-controlled trial where the incidence rate in the DEPAKOTE ER-treated group was greater than 5% and was greater than that for placebo patients. 
Epilepsy Based on a placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures, DEPAKOTE was generally well tolerated with most adverse events rated as mild to moderate in severity. Intolerance was the primary reason for discontinuation in the DEPAKOTE-treated patients (6%), compared to 1% of placebo-treated patients. Table 3 lists treatment-emergent adverse events which were reported by 5% of DEPAKOTE-treated patients and for which the incidence was greater than in the placebo group, in the placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures. Page: 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
