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Label Changes for:

Restasis (Cyclosporine Ophthalmic Emulsion)

December 2012

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) – December 2012



Post-marketing Experience
  • The following adverse reactions have been identified during post approval use of Restasis.  Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure…