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U.S. Department of Health and Human Services

Safety

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Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets

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

 

Summary View

 

ADVERSE REACTIONS 

Clinical Trials Experience
  • In Study 073, subjects with stable, virologic suppression on antiretroviral therapy and no history of virologic failure were randomized to receive ATRIPLA or to stay on their baseline regimen.  The adverse reactions observed in Study 073 were generally consistent with those seen in Study 934* and those seen with the individual components of Atirpla when each was administered in combination with other antiretroviral agents