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. |
PATIENT PACKAGE INSERT
ADVERSE REACTIONS
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)
