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U.S. Department of Health and Human Services

Safety

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NuvaRing (etonogestrel/ethinyl estradiol vaginal ring)

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

 

June 2014

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • Reproductive system and breast disorders: galactorrhea 

 

October 2013

Summary View

WARNINGS AND PRECAUTIONS

Thromboembolic Disorders and Other Vascular Problems
  • Stop NuvaRing use if an arterial thrombotic or venous thromboembolic event (VTE) occurs. Stop NuvaRing use if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. [See Adverse Reactions (6).]
  • If feasible, stop NuvaRing at least four weeks before and through two weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism, and during and following prolonged immobilization.