Label Changes for:

Estring (estradiol vaginal ring)

August 2008

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


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


Summary View

Sections Modified

ADVERSE REACTIONS

  • Postmarketing Experience
    • A few cases of toxic shock syndrome (TSS) have been reported...
    • A few cases of ring adherence to the vaginal wall, making ring removal difficult, have been reported...
    • A few cases of bowel obstruction and vaginal ring use have been reported...

PATIENT PACKAGE INSERT

  • Who should not use Estring?
    • Currently have or have had liver problems.
  • What are the possible side effects of Estring?
    • Initial Paragraph
  • What can I do to lower my chances of getting a serious side effect with Estring?
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