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U.S. Department of Health and Human Services

Safety

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Lamisil (terbinafine hydrochloride) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Serious Skin/Hypersensitivity Reactions
  • There have been postmarketing reports of serious skin/hypersensitivity reactions [e.g., Stevens-Johnson Syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome]. Manifestations of DRESS syndrome may include cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more organ complications such as hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. If progressive skin rash or signs/symptoms of the above drug reactions occur, treatment with Lamisil Tablets should be discontinued.
 

ADVERSE REACTIONS

Postmarketing Experience
  • Skin and subcutaneous tissue disorders:...drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome