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U.S. Department of Health and Human Services

Safety

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Vagifem (Estradiol) Vaginal Tablet

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2012

Summary View

 

CONTRAINDICATIONS

Vagifem should not be used in women with any of the following conditions:
  • Known anaphylactic reaction or angioedema to Vagifem
  • Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
 

WARNINGS AND PRECAUTIONS

Hereditary Angioedema
  • Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema.

 

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