Based on a placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures, divalproex sodium delayed-release tablets were generally well tolerated with most adverse reactions rated as mild to moderate in severity. Intolerance was the primary reason for discontinuation in the divalproex sodium delayed-release tablets -treated patients (6%), compared to 1% of placebo — treated patients.
Table 3 lists treatment-emergent adverse reactions which were reported by ≥ 5% of divalproex sodium delayed-release tablets -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. Since patients were also treated with other antiepilepsy drugs, it is not possible, in most cases, to determine whether the following adverse reactions can be ascribed to divalproex sodium delayed-release tablets alone, or the combination of divalproex sodium delayed-release tablets and other antiepilepsy drugs.
|Body System/Reaction||Divalproex Sodium Delayed-Release Tablets (n = 77) %||Placebo (n = 70) %|
|Body as a Whole|
Table 4 lists treatment-emergent adverse reactions which were reported by ≥ 5% of patients in the high dose valproate group, and for which the incidence was greater than in the low dose group, in a controlled trial of divalproex sodium delayed-release tablets monotherapy treatment of complex partial seizures. Since patients were being titrated off another antiepilepsy drug during the first portion of the trial, it is not possible, in many cases, to determine whether the following adverse reactions can be ascribed to divalproex sodium delayed-release tablets alone, or the combination of valproate and other antiepilepsy drugs.
1 Headache was the only adverse reaction that occurred in ≥ 5% of patients in the high dose group and at an equal or greater incidence in the low dose group.
|Body System/Reaction||High Dose (n = 131) %||Low Dose (n = 134) %|
|Body as a Whole|
|Skin and Appendages|
Body as a Whole
Back pain, chest pain, malaise.
Tachycardia, hypertension, palpitation.
Increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess.
Hemic and Lymphatic System
Metabolic and Nutritional Disorders
SGOT increased, SGPT increased.
Myalgia, twitching, arthralgia, leg cramps, myasthenia.
Anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder.
Sinusitis, cough increased, pneumonia, epistaxis.
Skin and Appendages
Rash, pruritus, dry skin.
Taste perversion, abnormal vision, deafness, otitis media.
Urinary incontinence, vaginitis, dysmenorrhea, amenorrhea, urinary frequency.
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