Is Restasis safe for long-term use?
Yes, Restasis (cyclosporine ophthalmic emulsion) is safe for long-term use, and the potential side effects are the same regardless of how long the therapy is used. While some patients experience local side effects upon application, studies have found no serious adverse events with long-term or short-term use of Restasis.
Dry eye is a chronic condition that often requires lifelong therapy to manage symptoms and delay disease progression. Most studies have shown that Restasis must be used for 4 to 6 months to reach its maximum effect of significant symptom relief. After 6 months of twice daily application, a small minority of patients may be able to discontinue the therapy and remain symptom-free for some time.
However, after Restasis therapy ceases, most patients will eventually experience a relapse of their symptoms. In general, patients are advised to use Restasis for a minimum of 6 months, with the understanding that the vast majority will require lifelong treatment to remain symptom-free. Side effects were similar in 1-year and 3-year trials.
The potential side effects of long-term and short-term Restasis use all occur specifically in the eyes. These side effects include:
- de Oliveira RC, Wilson SE. Practical guidance for the use of cyclosporine ophthalmic solutions in the management of dry eye disease. Clin Ophthalmol. 2019;13:1115-1122. Published 2019 Jul 1. https://doi.org/10.2147/OPTH.S184412.
- U.S. Food and Drug Administration (FDA). RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%. November 2012. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050790s020lbl.pdf. [Accessed February 23, 2022].
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- Restasis Information for Consumers
- Restasis prescribing info & package insert (for Health Professionals)
- Side Effects of Restasis (detailed)