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In controlled clinical studies in adults with partial onset seizuresthe most common adverse reactions in patients receiving KEPPRA in combination with other AEDsfor events with rates greater than placebowere somnolenceastheniainfectionand dizzinessOf the most common adverse reactions in adults experiencing partial onset seizuresastheniasomnolenceand dizziness occurred predominantly during the first 4 weeks of treatment with KEPPRA.

The physician should prescribe the most appropriate pharmaceutical formpresentation and strength according to ageweight and dose.

The following adverse reactions have been reported in patients receiving marketed KEPPRA worldwideThe listing is alphabetizedabnormal liver function testacute kidney injuryanaphylaxisangioedemaagranulocytosischoreoathetosisdrug reaction with eosinophilia and systemic symptomsDRESSdyskinesiaerythema multiformehepatic failurehepatitishyponatremiamuscular weaknesspancreatitispancytopeniawith bone marrow suppression identified in some of these casespanic attackthrombocytopeniaand weight lossAlopecia has been reported with KEPPRA userecovery was observed in majority of cases where KEPPRA was discontinued.

The following adverse reactions have been identified during postapproval use of KEPPRABecause these reactions are reported voluntarily from a population of uncertain sizeit is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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