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U.S. Department of Health and Human Services

Safety

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Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated estrogens plus medroxyprogesterone acetate) tablets

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

 

Summary View

CONTRAINDICATIONS

  • known anaphylactic reaction or angioedema and known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

WARNINGS AND PRECAUTIONS

  • anaphylactic reaction and angioedema
  • hereditary angioedema

ADVERSE REACTIONS

Postmarketing Experience
  • ischemic colitis
  • growth potentiation of benign meningioma

PATIENT PACKAGE INSERT

  • Revisions with the addition of have been diagnosed with a bleeding disorder

 

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