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3 keppra-treated adult patients were hospitalized and their treatment was discontinued due to psychosis.

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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.

Psychiatric Symptomssee WARNINGS AND PRECAUTIONSSuicidal Behavior and Ideationsee WARNINGS AND PRECAUTIONSSomnolence and Fatiguesee WARNINGS AND PRECAUTIONSAnaphylaxis and Angioedemasee WARNINGS AND PRECAUTIONSSerious Dermatological Reactionssee WARNINGS AND PRECAUTIONSCoordination Difficultiessee WARNINGS AND PRECAUTIONSHematologic Abnormalitiessee WARNINGS AND PRECAUTIONSIncrease in Blood Pressuresee WARNINGS AND PRECAUTIONS

No impact on fertility was detected in animal studiessee section 5.3No clinical data are availablepotential risk for human is unknown.

No impact on fertility was detected in animal studiessee section 5.3No clinical data are availablepotential risk for human is unknown.

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