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Somnolence and asthenia occurred most frequently within the first 4 weeks of treatmentIn generalthe incidences of somnolence and fatigue in the pediatric partial onset seizure studiesand in pediatric and adult myoclonic and primary generalized tonic-clonic seizure studies were comparable to those of the adult partial onset seizure studies.

Serious dermatological reactionsincluding Stevens-Johnson syndromeSJSand toxic epidermal necrolysisTENhave been reported in both pediatric and adult patients treated with KEPPRAThe median time of onset is reported to be 14 to 17 daysbut cases have been reported at least four months after initiation of treatmentRecurrence of the serious skin reactions following rechallenge with KEPPRA has also been reportedKEPPRA should be discontinued at the first sign of a rashunless the rash is clearly not drug-relatedIf signs or symptoms suggest SJS/TENuse of this drug should not be resumed and alternative therapy should be considered.

The following adverse reactions are discussed in more details in other sections of labeling:

Keppra injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.

The extent of absorption of levetiracetam was not altered by foodbut the rate of absorption was slightly reduced.

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