Is Restasis safe for long-term use?

Q: 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: Burning Redness Discharge Watering Itching Stinging Blurring

Medically reviewed by Sally Chao, MD. Last updated on March 7, 2025.

Official Answer by Drugs.com

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:

Burning
Redness
Discharge
Watering
Itching
Stinging
Blurring

References

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].

What are the best eye drops for dry eyes? A pharmacist explains.

Dry eyes are a common condition that can cause symptoms like stinging, burning, itching, redness, and a gritty sensation. These symptoms occur when your eyes don’t produce enough tears or when the quality of your tears is poor. Choosing the right eye drops depends on how severe your symptoms are, the underlying cause of your dry eye, and your individual needs.

Is there a generic for Restasis eye drops?

The generic option for Restasis eye drops known as cyclosporine ophthalmic emulsion. The generic product contains the same active ingredient as the brand name product. It comes as a 0.05% strength in a package that contains 30 or 60 single-dose vials. Continue reading

Xiidra vs. Restasis: Which is better for dry eye?

Xiidra (lifitegrast) and Restasis (cyclosporine) are prescription eye drops used to treat dry eye disease, but they work differently and have distinct characteristics. Continue reading

Is Restasis safe for long-term use?

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