Baraclude (entecavir) Tablets and Oral Solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

Summary View

Sections Modified

ADVERSE REACTIONS

• Postmarketing Experience (new subsection)
  • Skin and subcutaneous tissue disorders
    • Rash

PATIENT PACKAGE INSERT

• What are the possible side effects of Baraclude?
  • There have also been occasional reports of rash (added)
• How should I store Baraclude?
  • Keep Baraclude and all medicines out of the reach of children and pets at all times. Do not keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place Baraclude in an unrecognizable closed container in the household trash.

 

Label approved 06/03/2008 is not available on Drugs@FDA