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Label Changes for:

Femring (estradiol acetate vaginal ring)

May 2009

Changes have been made to the PATIENT PACKAGE INSERT sections of the safety label.

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

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.



        Postmarketing Experience

  • toxic shock syndrome
  • ring adhesion to the vaginal wall making ring removal difficult
  • bowel obstruction

    "What are possible side effects to vaginal rings?" (Section Revision)

    "What can I do to lower my chances of getting a serious side effect with Femring?" (Section Revision)