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KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

Table 4Adverse Reactions that Resulted in Discontinuation or Dose Reduction in Placebo-Controlled Studies in Adult Patients Experiencing Partial Onset Seizures.

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditionsbut the absolute risk differences were similar for the epilepsy and psychiatric indications.

The overall adverse reaction profile of KEPPRA was similar between females and malesThere are insufficient data to support a statement regarding the distribution of adverse reactions by age and race.

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