Topamax

[Topiramate]

Side Effects & Drug Interactions
ADVERSE REACTIONS

The data described in the following section were obtained using TOPAMAX ® (topiramate) Tablets. The most commonly observed adverse events associated with the use of topiramate at dosages of 200 to 400 mg/ day in controlled trials in adults with partial onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndrome, that were seen at greater frequency in topiramate-treated patients and did not appear to be dose-related were: somnolence, dizziness, ataxia, speech disorders and related speech problems, psychomotor slowing, abnormal vision, difficulty with memory, paresthesia and diplopia [see Table 4].

The most common dose-related adverse events at dosages of 200 to 1,000 mg/ day were: fatigue, nervousness, difficulty with concentration or attention, confusion, depression, anorexia, language problems, anxiety,mood problems, and weight decrease [see Table 6].

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Adverse events associated with the use of topiramate at dosages of 5 to 9 mg/ kg/ day in controlled trials in pediatric patients with partial onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndrome, that were seen at greater frequency in topiramate-treated patients were: fatigue, somnolence, anorexia, nervousness, difficulty with concentration/ attention, difficulty with memory, aggressive reaction, and weight decrease [see Table 7].

In controlled clinical trials in adults, 11% of patients receiving topiramate 200 to 400 mg/ day as adjunctive therapy discontinued due to adverse events. This rate appeared to increase at dosages above 400 mg/ day. Adverse events associated with discontinuing therapy included somnolence, dizziness, anxiety, difficulty with concentration or attention, fatigue, and paresthesia and increased at dosages above 400 mg/ day. None of the pediatric patients who received topiramate adjunctive therapy at 5 to 9 mg/ kg/ day in controlled clinical trials discontinued due to adverse events.

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