Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

Safety

  • Share Share this page
-

Ortho Evra (norelgestromin / ethinyl estradiol) Transdermal system

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

 

Summary View

 

CONTRAINDICATIONS

  • The term “significant hypertension” was replaced with actual blood pressure values

WARNINGS

Elevated Blood Pressure
  • Providing more complete guidance to healthcare providers regarding use in women with hypertension

ADVERSE REACTIONS

Clinical Trial Experience, Postmarketing Experience
  • editorial revisions to provide for use of MedDRA terminology and a more user-friendly format
    
-
-
-
-
-