Is cyclosporine FDA-approved, and what does the research show?

What is cyclosporine?

Cyclosporine is an immunosuppressant, a drug that damps down the body's immune defenses ¹. It is a cyclic polypeptide, a ring of 11 amino acids, produced by a fungus as a metabolite, a substance the fungus makes ¹. The eye-drop labels call it a calcineurin inhibitor, after calcineurin, an enzyme inside immune cells that it blocks ⁴. The Sandimmune label also names it cyclosporin A ¹.

It is a hospital and specialist drug, used after organ transplants and for certain autoimmune and eye conditions ¹, ³, ⁴. Novartis sells the original forms as Sandimmune and the modified oral forms as Neoral ¹, ⁶. Generic versions exist, Apotex's modified capsules among them ³, ⁷.

Is cyclosporine FDA-approved?

Yes. Cyclosporine is approved by FDA as a prescription medicine in several forms, the first of them in 1983 ¹, ². Drugs@FDA lists Novartis's Sandimmune injection, NDA 050573, and Sandimmune oral solution, NDA 050574, both approved November 14, 1983, with marketing status "Prescription" ², ⁸. Sandimmune capsules followed under NDA 050625 on March 2, 1990 ⁹. The modified oral forms, Neoral capsules and oral solution, were approved July 14, 1995 ¹⁰.

The Sandimmune label approves the capsules and the injection, "in combination with adrenal corticosteroids," steroid medicines, for two uses ¹. The first is the "prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants," an allogeneic transplant being an organ from another person ¹. The second is the "treatment of chronic rejection in patients previously treated with other immunosuppressive agents" ¹. The injection "should be reserved for patients who are unable to take the Sandimmune capsules," because of the risk of anaphylaxis, a severe allergic reaction ¹.

The modified oral forms carry two more uses. Their label approves them for "severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate," another arthritis drug ³, ⁶. It also approves them for adult, nonimmunocompromised patients with "severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis" who have failed at least one systemic therapy, or cannot take one ³, ⁶. Neoral and Sandimmune "are not bioequivalent and cannot be used interchangeably without physician supervision," meaning they are not absorbed into the blood the same way ³, ⁶.

The eye drops carry the same molecule under separate approvals, for the eye only. Restasis, NDA 050790, approved December 23, 2002, is "indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca," the medical name for dry eye ⁴, ¹¹. Two later dry-eye products, Cequa (2018) and Vevye (2023), are approved for the same condition ¹², ¹³, ¹⁴, ¹⁵. Verkazia, approved June 23, 2021, treats vernal keratoconjunctivitis in children and adults, an inflammation of the eye's surface ¹⁶, ¹⁷.

The route to any of these is a licensed clinician's prescription: Drugs@FDA lists each product the page cites with marketing status "Prescription," and the Neoral label is marked "Rx only" ², ¹¹, ⁶. The modified-capsule label goes further: "only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe" the drug ³. None of the labels names a wellness, weight, muscle or anti-aging use ¹, ³, ⁴.

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How does cyclosporine work?

The labels say the exact mechanism is not known ¹, ⁴. Experimental evidence, in the Sandimmune label's words, "suggests that the effectiveness of cyclosporine is due to specific and reversible inhibition of immunocompetent lymphocytes in the G0- or G1-phase of the cell cycle" ¹. Those phases are the stages before a cell copies its DNA. Lymphocytes are the white blood cells that recognize foreign tissue, and T lymphocytes, the T-helper cell most of all, are "preferentially inhibited" ¹. Cyclosporine also blocks the production and release of interleukin-2, which the label calls "T-cell growth factor," a signal T cells need to multiply ¹.

In animals it suppresses cell-mediated immune reactions, such as graft rejection, more than antibody-based immunity ¹. It "does not cause bone marrow suppression in animal models or man" ³. In the eye, the Restasis label says the emulsion "is thought to act as a partial immunomodulator," a drug that adjusts the immune response, and blood levels stayed below the limit of quantitation over 12 months of drops ⁴. This account is the labels', for an approved drug, from animal studies and from use in transplant patients ¹.

What does the research show?

The evidence sits at the top tier: FDA approval, alongside randomized trials in transplant recipients and later trials in rheumatoid arthritis, psoriasis and dry eye ⁵, ³, ⁴. Studied in people for kidney transplants: a randomized multicenter trial published on October 6, 1983, enrolled 209 recipients of kidneys from deceased donors ⁵. They received either cyclosporine with prednisone or standard therapy with azathioprine and prednisone ⁵. Predicted graft survival at one year was 80.4 percent with cyclosporine and 64.0 percent with standard therapy (P = 0.003, a difference unlikely to be chance) ⁵. Predicted patient survival at one year was 96.6 percent against 86.4 ⁵.

The trial also recorded the drug's cost to the kidney. Serum creatinine, a blood measure of kidney function, was higher with cyclosporine at 90 days, 2.6 against 2.0 milligrams per deciliter ⁵. Lymphoma developed in one patient on cyclosporine ⁵. The authors concluded that cyclosporine "is preferable to azathioprine in preventing renal transplant rejection" and that further studies were needed to find the best regimen ⁵.

FDA's label pools the historical Sandimmune trials, 892 patients in kidney, heart and liver transplant trials ³. The label also reports a randomized comparison of 227 kidney recipients on cyclosporine against 228 on azathioprine ³. In controlled studies of the modified form, adverse events in 493 transplant patients were "comparable" with those in 208 on Sandimmune when doses were adjusted to the same blood levels ³.

Studied in people for rheumatoid arthritis: the label summarizes five clinical studies of 728 cyclosporine-treated patients and 273 on placebo ³. They had active disease that earlier arthritis drugs had not controlled ³. A responder was defined by a 20 percent improvement in tender and swollen joint counts plus other measures ³. One of the five randomized 148 patients whose arthritis stayed active on the highest methotrexate dose they could tolerate to add cyclosporine or placebo for 24 weeks ³.

Studied in people for psoriasis: the label reports a dose-titration trial, one in which the dose was raised step by step, finding that "an improvement of psoriasis by 75% or more (based on PASI) was achieved in 51% of the patients after 8 weeks and in 79% of the patients after 16 weeks" ³. PASI, the Psoriasis Area and Severity Index, scores how much skin is affected and how badly ³. The label gives neither that trial's size nor a comparison group, and it adds that most patients relapse when treatment stops ³.

Studied in people for dry eye: four randomized studies enrolled about 1,200 patients with moderate to severe keratoconjunctivitis sicca ⁴. They tested the Restasis emulsion against its vehicle, the drops without the drug ⁴. At six months, an increase of 10 millimeters in Schirmer wetting, a paper-strip test of tear flow, was seen in about 15 percent against about 5 percent on vehicle ⁴. The increase was not seen in patients using topical anti-inflammatory drops or punctal plugs ⁴. No source on this page reports a trial of cyclosporine for weight, muscle, longevity or athletic performance, as of November 10, 2026 ⁵, ³, ¹, ⁴.

What are the side effects?

The label names the principal adverse reactions in transplant patients: "renal dysfunction, tremor, hirsutism, hypertension, and gum hyperplasia" ³. Hirsutism is excess hair growth, and gum hyperplasia is overgrowth of the gums ³. In the randomized kidney trials, renal dysfunction occurred in 32 percent of 227 patients on cyclosporine against 6 percent of 228 on azathioprine ³. Hypertension occurred in 26 percent against 18, hirsutism in 21 against under 1, and tremor in 12 against 0 ³. Infection rates were lower on cyclosporine in several categories, among them cytomegalovirus at 4.8 percent against 12.3 ³.

Across 705 kidney, 112 heart and 75 liver recipients on Sandimmune, renal dysfunction was reported in 25, 38 and 37 percent ³. Tremor was reported in 21, 31 and 55 percent, and lymphoma in 1, 6 and 1 percent ³. Among the 705 kidney recipients, 5.4 percent stopped treatment for renal toxicity ³. The label's adverse-reactions section puts it higher: hypertension, "usually mild to moderate, may occur in approximately 50% of patients following renal transplantation and in most cardiac transplant patients" ³.

The systemic labels open with a boxed warning, FDA's strongest label warning. It says only physicians experienced in immunosuppressive therapy should prescribe the drug, and that patients "should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources" ³, ¹. It warns that cyclosporine "may increase the susceptibility to infection and the development of neoplasia," and that "the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients" ³. Neoplasia is new tissue growth, including cancers ³. For psoriasis, it adds that patients previously treated with PUVA, a light therapy using psoralen and ultraviolet A, "are at an increased risk of developing skin malignancies" ³.

The warnings cover kidney damage, "including structural kidney damage," so that "renal function must be monitored during therapy" ³. They cover liver injury, "including cholestasis, jaundice, hepatitis, and liver failure," with fatal outcomes reported mainly in transplant patients ³. They cover serious infections, among them polyoma virus infections, which can cost a kidney graft, and progressive multifocal leukoencephalopathy, a brain infection that is "sometimes fatal" ³. They cover neurotoxicity: convulsions, and an encephalopathy, a brain disorder, with "impaired consciousness, convulsions, visual disturbances (including blindness), loss of motor function, movement disorders and psychiatric disturbances" ³.

The label counts the kidney harm outside transplantation too. Kidney biopsies showed cyclosporine nephropathy in 6 of 60 rheumatoid arthritis patients after an average of 19 months ³. They showed it in 18 of 86 psoriasis patients after a mean of 23 months ³.

In arthritis trials, within the recommended dose range, 5.3 percent stopped for hypertension and 7 percent for a rise in creatinine ³. In psoriasis trials, hypertension was reported in 27.5 percent of 182 patients on the modified capsules and increased creatinine in 19.8 percent ³. One death of a psoriasis patient, with progressive kidney failure, is reported in the label ³.

Both systemic labels contraindicate the drug in people with hypersensitivity to cyclosporine ³, ¹, and the modified-capsule label adds hypersensitivity to any ingredient ³. The injection is also contraindicated after a hypersensitivity reaction to Cremophor EL, its castor-oil carrier ¹. Rheumatoid arthritis and psoriasis patients "with abnormal renal function, uncontrolled hypertension, or malignancies should not receive" it ³. Psoriasis patients on the drug "should not receive concomitant PUVA or UVB therapy, methotrexate or other immunosuppressive agents, coal tar or radiation therapy" ³. The label adds that vaccination "may be less effective" and live vaccines "should be avoided," and that grapefruit raises blood levels of the drug ³.

The eye drops carry a shorter list. The most common adverse reaction with the Restasis emulsion was ocular burning, in 17 percent ⁴. Conjunctival redness, discharge, watering, eye pain, foreign-body sensation, itching, stinging and visual disturbance, most often blurring, were each reported in 1 to 5 percent ⁴. Post-marketing reports include hypersensitivity with eye, face and tongue swelling, rare severe angioedema, and injury from the bottle tip touching the eye ⁴. The drops are contraindicated in known or suspected hypersensitivity to any ingredient, and the label says not to use them while wearing contact lenses ⁴.

In sport

Cyclosporine is not named on WADA's 2026 Prohibited List, and immunosuppressants are not a listed class ¹⁸. WADA, the World Anti-Doping Agency, publishes the list of substances and methods prohibited in sport ¹⁸. Cyclosporine holds FDA approval, granted in 1983 ².

One method rule can reach it, because Sandimmune injection is given intravenously ¹. M2.2 prohibits "Intravenous infusions and/or injections of more than a total of 100 mL per 12-hour period except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations" ¹⁸.

What JumpstartMD offers

JumpstartMD does not prescribe cyclosporine. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.