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U.S. Department of Health and Human Services


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Lamisil (terbinafine hydrochloride) Oral Granules

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

Summary View



Serious Skin/ Hypersensitivity Reactions
  • ...drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome] with oral terbinafine. 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 Oral Granules should be discontinued.


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