• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Ovidrel (choriogonadotropin alfa injection) prefilled syringe

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2010

Summary View

WARNINGS

The risks of gonadotropin treatment should be considered for women with risk factors of thromboembolic events such as prior medical or family history.

ADVERSE REACTIONS

  • Post-marketing Experience Cases of allergic reactions, including anaphylactic reactions and mild reversible skin rashes have been reported in patients treated with Ovidrel since market introduction. The causal relationship is unknown.
  • Thromboembolic events both in association with, and separate from, the Ovarian Hyperstimulation Syndrome