Label Changes for:
Estring (estradiol vaginal ring)
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.|
- 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?