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Label Changes for:

Durezol (difluprednate) 

July 2016

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

July 2016

ADVERSE REACTIONS (section revised)

The following serious reactions are found elsewhere in the labeling:

  • Elevated intraocular pressure
  • Posterior subcapsular cataract formation
  • Secondary ocular infection
  • Perforation of the globe