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U.S. Department of Health and Human Services


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Lexapro (escitalopram oxalate) Tablets and Oral Solution October 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 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. Read about the new physician labeling format.


Summary View


Sections Modified


  • Events Reported Subsequent to the Marketing of Escitalopram
    • Cardiac Disorders
      • cardiac failure
    • Endocrine Disorders
      • diabetes mellitus
      • hyperprolactinemia
    • Gastrointestinal Disorder
      • rectal hemorrhage
    • Psychiatric Disorders
      • acute psychosis
    • Skin and Subcutaneous Tissue Disorders
      • urticaria
    • Vascular Disorders
      • deep vein thrombosis
      • phlebitis thrombosis


Label approved 10/11/2008 is not available on this site.