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
ADVERSE REACTIONS
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…
