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Label Changes for:

Baraclude (entecavir) Tablets and Oral Solution

June 2008

Changes have been made to the ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

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


Warnings and Precautions

Lactic Acidosis and Severe Hepatomegaly with Steatosis
  • Lactic acidosis with Baraclude use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. Treatment with Baraclude should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).


Postmarketing Experience
  • Metabolism and nutrition disorders: lactic acidosis
  • Hepatobiliary disorders: increased transaminases

Patient Package Insert

Baraclude can cause serious Side effects including
  • Lactic Acidosis...Reports of lactic acidosis with Baraclude generally involved patients who were seriously ill due to their liver disease or other medical condition.


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


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


  • 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 Do not keep medicine that is out of date or that you no longer need.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