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However recently, there has been concern that the use of Dilantin can result in Stevens Johnson Syndrome (SJS) and the more severe version of it, Toxic Epidermal Necrosis Syndrome (TENS).

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Based on two placebo-controlled clinical trials and their long term extension, valproate was generally well tolerated with most adverse reactions rated as mild to moderate in severity.

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Prior to the initiation of Depakote ER therapy, evaluation for UCD should be considered in the following patients: 1) those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; 2) those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3) those with a family history of UCD or a family history of unexplained infant deaths (particularly males); 4) those with other signs or symptoms of UCD.

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The ultimate therapeutic dose should be achieved on the basis of both tolerability and clinical response (see WARNINGS).

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