What Is Cyclosporine Used For? Approved Uses, Per the Label

What cyclosporine is, in regulatory terms

Cyclosporine is a prescription medicine in the United States. It is a calcineurin inhibitor immunosuppressant that is marketed in several distinct dosage forms, including oral capsules and oral solution, an intravenous concentrate, and separate ophthalmic products applied to the eye. Each dosage form carries its own FDA-approved prescribing information, and the approved uses differ between them. A review of transplant pharmacotherapy described calcineurin inhibitors, the class that includes cyclosporine and tacrolimus, as central agents in maintenance immunosuppression after solid organ transplantation (PMID 23228138).

The phrase "approved use" on this page means an indication that appears in the Indications and Usage section of a current United States prescribing information. Anything else is described separately and labelled as not an approved indication. This page contains no dosing information and no instructions.

US label versions on DailyMed: Sandimmune (cyclosporine), DailyMed label version July 2026; Neoral (cyclosporine), DailyMed label version August 2026. The current label for the specific product governs.

Approved uses at a glance

Exact wording and the revision date vary between manufacturers and between generic and brand labels, so the current prescribing information for the specific product dispensed is the authoritative source.

Transplant rejection prophylaxis

The oldest and broadest cyclosporine indication is prophylaxis of organ rejection in kidney, liver and heart allogeneic transplantation, where the label specifies use together with adrenal corticosteroids. The non-modified oral and injectable label additionally carries treatment of chronic rejection in patients previously treated with other immunosuppressive agents. The modified oral formulation was developed to give more consistent absorption than the original formulation, and the two are not considered interchangeable on a milligram for milligram basis in the labeling, which is why the word MODIFIED appears in the established name.

The registration trials that supported these transplant indications are summarised inside the prescribing information itself rather than in the citation set used on this page. In later comparative literature, a 2013 review of tacrolimus in transplant rejection examined how the two calcineurin inhibitors have been positioned relative to one another in maintenance regimens (PMID 23228138).

Severe active rheumatoid arthritis

The modified oral cyclosporine label carries a rheumatology indication limited to severe active rheumatoid arthritis in patients whose disease has not adequately responded to methotrexate. The label frames cyclosporine as an option after an inadequate methotrexate response rather than as a first systemic agent, and it permits combined use with methotrexate in that setting. This is a narrow indication by design, and the same label restricts combination with other immunosuppressive agents outside what is specified.

Severe recalcitrant plaque psoriasis

The psoriasis indication on the modified oral label applies to adult non-immunocompromised patients with severe, recalcitrant plaque psoriasis who have failed at least one systemic therapy or who cannot use other systemic therapies. The label also flags that patients should not receive concomitant PUVA or UVB phototherapy, other radiation therapy, other immunosuppressive agents or coal tar while on cyclosporine for psoriasis. A 2012 review of cyclosporine in dermatology described the drug's established place among systemic agents for severe psoriasis and emphasised the monitoring that accompanies its dermatologic use (PMID 22859244).

Eye indications

Ophthalmic cyclosporine is a separate regulatory story from the systemic product. The approved ophthalmic indications concern tear production in keratoconjunctivitis sicca and, for one product, vernal keratoconjunctivitis. A 2022 note in a nursing journal reported the FDA approval of the first generic cyclosporine ophthalmic emulsion for dry eye, which opened the keratoconjunctivitis sicca indication to generic competition (PMID 35617559).

Formulating cyclosporine for the eye is technically demanding because the molecule is poorly water soluble, and a 2023 review examined ophthalmic cyclosporine delivery and the novel carrier systems that researchers have explored for ocular indications (PMID 37522548). That review is a formulation science survey rather than a regulatory document, so the approved wording for any given eye drop still comes from that product's own label.

Regulatory history of the indications

The sequence of approvals explains why the indication list looks fragmented across products:

1. The original oral and injectable cyclosporine formulation was approved first for prophylaxis of organ rejection in solid organ transplantation, and the chronic rejection wording sits on that same label.
2. A modified, microemulsion-based oral formulation was later approved with the same transplant prophylaxis indications, and subsequently carried the two non-transplant systemic indications, severe active rheumatoid arthritis after inadequate methotrexate response and severe recalcitrant plaque psoriasis.
3. Generic modified oral cyclosporine products entered the market referencing the modified formulation and carrying the same three systemic indications.
4. Ophthalmic cyclosporine emulsion was approved for increasing tear production in keratoconjunctivitis sicca, with later ophthalmic products adding a vernal keratoconjunctivitis indication; a 2022 report described approval of the first generic version of the dry eye emulsion (PMID 35617559).

What the cited literature covers, and what it does not

The published papers cited here are reviews, guidelines and consensus statements rather than the original registration trial reports that supported each indication. That distinction matters for anyone trying to trace an indication back to its pivotal evidence: the trial summaries for the transplant, rheumatoid arthritis and psoriasis indications appear within the prescribing information for the relevant product, and the clinical trial sections of those labels are the primary regulatory record. The reviews available in this citation set describe how cyclosporine has been used in transplantation (PMID 23228138), dermatology (PMID 22859244) and ophthalmology (PMID 37522548), which is useful context but is not a substitute for the label text.

A note on uses that are not approved indications

Cyclosporine appears in clinical literature well outside its approved indications, and those settings are not approved uses in the United States. In short: a 2019 review examined cyclosporine therapy in the management of inflammatory bowel disease (PMID 31620649); the 2024 American Academy of Dermatology guideline on phototherapy and systemic therapies addressed cyclosporine among systemic options discussed for atopic dermatitis in adults (PMID 37943240); a 2024 European expert consensus statement on systemic treatment of alopecia areata reviewed systemic agents including cyclosporine (PMID 38169088); a review of recent clinical trials in lupus nephritis surveyed calcineurin inhibitor strategies among the regimens studied (PMID 25034160); two 2018 reports on eltrombopag in severe aplastic anemia described a setting in which cyclosporine forms part of standard immunosuppressive therapy (PMID 30504345, PMID 30425070); and a 2008 review of myelodysplastic syndrome covered immunosuppressive approaches in that disease (PMID 18330027). Separately, cyclosporine holds veterinary approvals, and a 2013 review described its use in veterinary dermatology, including canine atopic dermatitis (PMID 23182330). None of these converts into a human label indication, and decisions about any of them rest with a prescribing clinician.

Label Warnings and Adverse Events: What Studies Report

United States cyclosporine labels carry boxed warnings covering administration by physicians experienced in immunosuppressive therapy, the increased susceptibility to infection and the possible development of lymphoma, and, for the psoriasis and rheumatoid arthritis indications, renal effects and hypertension. The ophthalmic labels are structured differently from the systemic labels because systemic exposure from eye drops is low.

In the published literature, a 2012 dermatology review reported that renal function and blood pressure monitoring were central to the safe use of systemic cyclosporine in skin disease (PMID 22859244). Researchers reviewing cyclosporine in inflammatory bowel disease similarly discussed the drug's narrow therapeutic window and the toxicity considerations that shape how it is monitored (PMID 31620649). The 2013 review of calcineurin inhibitors in transplantation described how adverse effect profiles have influenced the choice between cyclosporine and tacrolimus in maintenance regimens (PMID 23228138). None of this replaces the full warnings, precautions and adverse reactions sections of the applicable prescribing information.

Questions that belong with a prescribing clinician

• Whether an individual situation matches any approved indication on the specific product's label.
• Which cyclosporine formulation a prescription refers to, since modified and non-modified oral products are labelled differently.
• What monitoring a label requires for a given indication.
• How other medicines and medical conditions interact with an immunosuppressant.
• What the prescribing information says about use in a particular age group or during pregnancy.

This page is for educational purposes only and is not medical advice; consult a licensed physician or other qualified prescriber about any medical condition, medicine or treatment decision.

For a broader overview of this molecule, see the hub page at /learn/cyclosporine/.

References

• Tacrolimus in transplant rejection (Expert Opinion on Pharmacotherapy, 2013)
• The use of cyclosporine in dermatology (Journal of Drugs in Dermatology, 2012)
• First Generic Cyclosporine Drops for Dry Eye (The American Journal of Nursing, 2022)
• Exploring the Therapeutic Potential of Cyclosporine for Ophthalmic Indications by Novel Carrier Systems (Critical Reviews in Therapeutic Drug Carrier Systems, 2023)
• A novel player: cyclosporine therapy in the management of inflammatory bowel disease (Translational Gastroenterology and Hepatology, 2019)
• Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies (Journal of the American Academy of Dermatology, 2024)
• European expert consensus statement on the systemic treatment of alopecia areata (JEADV, 2024)
• Recent clinical trials in lupus nephritis (Rheumatic Disease Clinics of North America, 2014)
• Activity of eltrombopag in severe aplastic anemia (Hematology ASH Education Program, 2018)
• Activity of eltrombopag in severe aplastic anemia (Blood Advances, 2018)
• Myelodysplastic syndrome (Nihon Rinsho, 2008)
• Cyclosporine in veterinary dermatology (Veterinary Clinics of North America: Small Animal Practice, 2013)