FDA label
What is Restasis used for?
Restasis contains cyclosporine. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “RESTASIS ® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.”
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Restasis, emulsion
Indications and Usage, quoted from the label by Allergan, Inc. (NDA050790). Cross-references to other label sections are left out.
RESTASIS ® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
Source: DailyMed label, set id 8e24af2b-bc1c-4849-94f2-6df950cdca89, version 19, effective September 9, 2024. NDC 0023-9163, one of 2 listings for this product.
Questions
What is Restasis used for?
The FDA label says: “RESTASIS ® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.”
What drug class is Restasis?
FDA lists cyclosporine in the Calcineurin Inhibitor Immunosuppressant established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Restasis
- Is Restasis a controlled substance?Federal schedule
- Generic for RestasisFDA Orange Book
- What is Cyclosporine used for?FDA label uses
- Is Cyclosporine a controlled substance?Federal schedule
- Generic for NeoralFDA Orange Book
- Generic for SandimmuneFDA Orange Book
- Generic for Restasis MultiDoseFDA Orange Book
- Generic for VerkaziaFDA Orange Book
- Generic for CequaFDA Orange Book
- Generic for VevyeFDA Orange Book
- Calcineurin Inhibitor Immunosuppressants listFDA drug class
- Restasis Medicare Part D coverageBy plan and state
- NDC 0023-9163Restasis NDC record
- NDC 50090-4476Restasis NDC record