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U.S. Department of Health and Human Services


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Pexeva (paroxetine mesylate) tablet

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2009, and April 2011


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. Read about the new physician labeling format.


April 2011

Summary View  



  • ...tamoxifen drug interaction...



Before starting Pexeva, tell your healthcare provider if you:
  • ...tamoxifen... added


January 2009

Summary View


Sections Modified

Summary of Changes to Contraindications and Warnings


  • Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions


  • The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including Pexeva treatment, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists.....