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U.S. Department of Health and Human Services

Safety

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Nuvigil (armodafinil) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2010

Summary View

 

WARNINGS

Psychiatric Symptoms
  • Postmarketing adverse events associated with the use of modafinil have included...aggression
Serious Rash, including Stevens-Johnson Syndrome
  • Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults in association with the use of modafinil and armodafinil and in children in association with the use of Modafinil.