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U.S. Department of Health and Human Services

Safety

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Restasis (Cyclosporine Ophthalmic Emulsion)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2012

Summary View

 

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…