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U.S. Department of Health and Human Services

Safety

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Lamisil (terbinafine hydrochloride) Tablets and Oral Granules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2011 and April 2012

 

April 2012

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • Hearing Impairment and Vertigo.

 

November 2011

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • photosensitivity reactions
Drug-Drug Interactions
  • ...terbinafine may convert extensive CYP2D6 metabolizers to poor metabolizer status.

PATIENT COUNSELING INFORMATION

  • Photosensitivity reactions have been reported with the use of Lamisil. Patients should be advised to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) while using Lamisil