Cyclosporine (Sandimmune / Neoral / Gengraf)

Pronunciation: sy-kloh-SPOR-een.

Generic name
cyclosporine (ciclosporin)
Drug class
Calcineurin inhibitor immunosuppressant
Form
Capsules (10 mg, 25 mg, 50 mg, 100 mg depending on brand/market), oral solution, and IV concentrate for infusion
Route
Oral (capsule, oral solution) or intravenous infusion
Legal status
Prescription-only; only to be prescribed by physicians experienced in systemic immunosuppressive therapy and/or organ transplantation

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Neoral (5), Cyclosporin Sandoz (generic) (5) · Full directory

What cyclosporine (ciclosporin) is and how it works

Cyclosporine is a prescription immunosuppressant that reduces the activity of the immune system's T-cells. It is used mainly to help prevent the body from rejecting a transplanted organ, and to treat certain severe autoimmune or inflammatory conditions, such as rheumatoid arthritis and psoriasis, when other treatments have not worked. (1) (2)

Because cyclosporine suppresses the immune system, it carries a genuine, serious boxed warning: it should only be prescribed by physicians experienced in this type of therapy, and it increases the risk of serious infections and certain cancers, including lymphoma and skin cancer, the longer and more intensively it is used. It can also affect kidney function and blood pressure, so regular blood tests and monitoring are essential. Never switch between different cyclosporine brands (Sandimmune, Neoral, Gengraf) without your prescriber's explicit direction, and never stop or change your dose on your own.

Mechanism of action: how cyclosporine (ciclosporin) works

Cyclosporine is a calcineurin inhibitor that binds cyclophilin, blocking calcineurin phosphatase activity and thereby inhibiting T-lymphocyte activation and interleukin-2 production, producing its immunosuppressive effect. (1) (2)

What cyclosporine (ciclosporin) is used for

Prevention of organ transplant rejection

Used to help prevent the body's immune system from rejecting a transplanted kidney, liver, or heart (and other transplanted organs, depending on market), usually together with other immunosuppressant medicines. (1) (4)

Severe rheumatoid arthritis

Used to treat severe, active rheumatoid arthritis that has not responded adequately to methotrexate. (1)

Severe psoriasis

Used to treat severe, treatment-resistant plaque psoriasis in adults who are not immunocompromised and who have failed other systemic treatments. (1)

Other severe inflammatory/autoimmune conditions (market-dependent)

In some markets, also used for endogenous uveitis, nephrotic syndrome, and severe atopic dermatitis requiring systemic therapy, always under specialist supervision. (2) (6)

Before taking cyclosporine (ciclosporin)

Do not take / not appropriate for

  • Do not take if you have a known hypersensitivity to cyclosporine or the specific product's other ingredients. (all countries) (1) (2)
  • Do not take together with St. John's Wort. (United Kingdom, European Union) (2)
  • If being treated for rheumatoid arthritis or psoriasis: do not take if you have abnormal kidney function, uncontrolled high blood pressure, or a current or past malignancy (for rheumatoid arthritis specifically), or if you are receiving PUVA, UVB, methotrexate, other immunosuppressives, coal tar, or radiation therapy (for psoriasis specifically). (United States) (1)
  • Do not switch between cyclosporine brands (Sandimmune, Neoral, Gengraf) on your own -- they are not interchangeable without your physician's supervision. (all countries) (1)

Tell your clinician about

  • Any history of kidney or liver problems, high blood pressure, or cancer.
  • All other medicines, herbal products, and supplements you take, including grapefruit juice consumption.
  • Whether you have or have had any infection, or feel you may currently have one.
  • Whether you are pregnant, planning pregnancy, or breastfeeding.
  • Whether you have previously had light therapy (PUVA/UVB) for psoriasis, which affects your skin-cancer risk with this medicine.
(1) (2)

How to take cyclosporine (ciclosporin)

  • Take exactly as prescribed by your specialist physician; do not change your dose or stop taking cyclosporine without medical guidance.
  • Always take the same brand and formulation your prescriber has specified -- do not switch between Sandimmune, Neoral, and Gengraf on your own.
  • Avoid grapefruit and grapefruit juice, which can raise cyclosporine levels in your body.
  • Attend all scheduled blood tests and monitoring appointments -- these are essential for using this medicine safely.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

Contact your prescriber or transplant/specialist care team for guidance if you miss a dose. Do not double up or adjust your own dose or schedule -- consistent, correctly timed dosing is part of how this medicine's safety and effectiveness are maintained.

Overdose

Seek urgent medical attention if you think you or someone else has taken too much cyclosporine. Contact your transplant/specialist team or emergency services, especially if you develop signs of kidney problems, severe drowsiness, or jaundice (yellowing of the skin or eyes). (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

High blood pressure.

What to notice: High blood pressure.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Kidney function changes (raised creatinine/BUN).

What to notice: Kidney function changes (raised creatinine/BUN).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Tremor, headache.

What to notice: Tremor, headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Excess hair growth (hirsutism) and gum overgrowth.

What to notice: Excess hair growth (hirsutism) and gum overgrowth.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Nausea and gastrointestinal discomfort.

What to notice: Nausea and gastrointestinal discomfort.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

Serious infection — boxed_warning

Symptoms: Fever, chills, sore throat, cough, unusual tiredness, or any signs of a new infection.

Action: Contact your clinician promptly. Cyclosporine increases susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections, because of its immunosuppressive effect -- this risk should be monitored for throughout treatment. (1)

Lymphoma or other cancers, including skin cancer — boxed_warning

Symptoms: New lumps, swollen glands, unexplained weight loss, night sweats, or new or changing skin lesions.

Action: Contact your clinician for prompt assessment. Chronic immunosuppression with cyclosporine increases the risk of lymphoma and other malignancies, particularly of the skin; use sun protection and attend recommended skin checks, especially if you have previously had light therapy (PUVA/UVB). (1) (2)

Kidney damage (nephrotoxicity) — high caution

Symptoms: Reduced urination, swelling, or simply abnormal results on scheduled blood tests (creatinine/BUN) -- often without obvious symptoms.

Action: Attend every scheduled blood test. Cyclosporine can cause dose-dependent, potentially structural kidney damage; your prescriber will adjust your dose based on kidney function results. (1) (2)

Signs of liver problems — high caution

Symptoms: Yellowing of the skin or eyes (jaundice), dark urine, or unusual tiredness.

Action: Contact your clinician promptly -- hepatotoxicity, including cholestasis, jaundice, hepatitis, and liver failure, has been reported with cyclosporine. (1) (2)

Interactions

  • Grapefruit juice, calcium channel blockers (diltiazem, verapamil), certain macrolide antibiotics (erythromycin, clarithromycin, azithromycin), and azole antifungals (ketoconazole, itraconazole) can raise cyclosporine levels and increase the risk of side effects. (1) (2)
  • Rifampin/rifampicin, phenytoin, carbamazepine, and St. John's Wort can lower cyclosporine levels and reduce its effectiveness. (1) (2)
  • NSAIDs, aminoglycoside antibiotics, amphotericin B, vancomycin, and methotrexate can increase the risk of kidney damage when combined with cyclosporine. (2)
  • Cyclosporine significantly raises blood levels of certain statins (for example, up to 8-10 times higher exposure with atorvastatin), as well as digoxin, colchicine, repaglinide, and sirolimus -- dose adjustments to these other medicines are often needed. (1) (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Discuss with your specialist -- cyclosporine may be continued in pregnancy when the benefit for organ-transplant recipients outweighs the risk, but this decision requires individualised specialist assessment; specific dosing/monitoring adjustments may be needed. (1) (2) (3) (4) (5) (6)

Breastfeeding

Cyclosporine passes into breast milk; discuss the risks and benefits with your specialist before breastfeeding. (1) (2) (3) (4) (5) (6)

Children

Used in children for certain indications (e.g. nephrotic syndrome, transplant) under specialist paediatric supervision, with dosing individualised to the child. (1) (2) (3) (4) (5) (6)

Elderly

Particular care with kidney function monitoring is recommended in older adults, per the UK SmPC. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Use with caution and closer monitoring; hepatotoxicity is a recognised risk of cyclosporine itself. (1) (2) (3) (4) (5) (6)

Renal_impairment

Requires especially close monitoring, since nephrotoxicity is one of cyclosporine's principal dose-related risks; dose adjustments are made based on kidney function results. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Baseline kidney function (creatinine, BUN/urea)
  • Baseline blood pressure
  • Baseline liver function tests
  • Baseline lipids, potassium, magnesium, uric acid
  • Screening for current infection or malignancy where relevant to the indication

During treatment

  • Serum creatinine and blood pressure: baseline and every 2 weeks for the first 3 months, then monthly (transplant/RA/psoriasis schedule per US label).
  • Routine cyclosporine blood trough levels, especially in transplant patients.
  • Liver function tests, electrolytes, and lipids periodically.
  • Skin checks for malignancy, particularly with a history of light therapy (PUVA/UVB).
  • Ongoing assessment for signs of infection.
(1) (2)

Storage

Store according to the specific product's instructions (capsules and oral solution typically at room temperature, protected from light; some formulations require refrigeration or have specific expiry-after-opening rules) -- check your product's leaflet, and keep out of reach of children.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and UK SmPC; verify against the current full label before prescribing.

United States / United Kingdom / European Union / Canada / Australia / New Zealand

Indication: Transplant rejection prophylaxis

Dose summary: Initial oral dosing approximately 10-15 mg/kg/day (or IV 3-5 mg/kg/day for a limited peri-transplant period per some sources), transitioned to individualised maintenance based on trough levels, renal function, and clinical response.

Renal context: Nephrotoxicity is dose-limiting; dose is adjusted based on serum creatinine and cyclosporine trough levels, with especially close monitoring in renal impairment. (2) (4)

United States

Indication: Rheumatoid arthritis / psoriasis

Dose summary: Lower, individualised doses than transplant use; contraindicated in RA/psoriasis patients with abnormal renal function, uncontrolled hypertension, or (for RA) malignancy.

Renal context: Contraindicated with abnormal baseline renal function in these non-transplant indications. (1)

Mechanism of action

Hepatic guidance

Hepatotoxicity, including cholestasis, jaundice, hepatitis, and liver failure, has been reported; monitor liver function periodically during treatment.

Overdose note

No specific antidote; manage with supportive care, monitoring of renal function, blood pressure, and cyclosporine blood levels. (1) (2)

Frequently asked questions

Is cyclosporine available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes. It is authorised in all of these regions, marketed under brand names including Sandimmune, Neoral, and Gengraf (US), Neoral and Sandimmun (UK, EU, Canada, Australia, New Zealand), alongside generic equivalents in several markets. (1) (2) (3) (4) (5) (6)

Why does cyclosporine have a boxed warning?

Because it is a systemic immunosuppressant, cyclosporine should only be prescribed by physicians experienced in this type of therapy. It increases the risk of serious infections and certain cancers, including lymphoma and skin cancer, due to the overall degree of immunosuppression. The different brand formulations (Sandimmune, Neoral, Gengraf) are also not interchangeable with one another without physician supervision. (1)

Can I switch from one cyclosporine brand to another on my own?

No. Sandimmune, Neoral, and Gengraf are not bioequivalent, meaning the same dose can result in different amounts of cyclosporine in your body depending on the formulation. Switching without your physician's supervision can change your cyclosporine exposure and increase the risk of side effects or reduced effectiveness. (1)

Why do I need so many blood tests while taking cyclosporine?

Cyclosporine can affect kidney function, blood pressure, liver function, and electrolyte levels, often without obvious symptoms. Regular blood tests and blood pressure checks let your care team detect and manage these effects early, and help set the right dose for you. (1) (2)

What is the mechanism of action of cyclosporine (ciclosporin)?

Cyclosporine is a calcineurin inhibitor that binds cyclophilin, blocking calcineurin phosphatase activity and thereby inhibiting T-lymphocyte activation and interleukin-2 production, producing its immunosuppressive effect. (1) (2)

What is the generic name of Cyclosporine (Sandimmune / Neoral / Gengraf)?

The generic name is cyclosporine (ciclosporin). (1) (2)

What class of drug is cyclosporine (ciclosporin)?

Cyclosporine (Sandimmune / Neoral / Gengraf) is classed as: Calcineurin inhibitor immunosuppressant. (1) (2)

References

  1. GENGRAF (cyclosporine) capsules -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, AbbVie (Gengraf) · United States · accessed 2026-07-31 · source 1
  2. Neoral Soft Gelatin Capsules -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom -- Novartis Pharmaceuticals UK Ltd · United Kingdom · accessed 2026-07-31 · source 2
  3. Sandimmun Neoral and associated names -- referral (CHMP harmonisation, completed 2013-06-27)European Medicines Agency (EMA) -- Article 30 referral harmonising Sandimmun/Sandimmun Neoral prescribing information across the EU · European Union · accessed 2026-07-31 · source 3
  4. NEORAL (cyclosporine capsules and oral solution) -- Product MonographHealth Canada product monograph, Novartis Pharmaceuticals Canada Inc. · Canada · accessed 2026-07-31 · source 4
  5. NEORAL ciclosporin -- ARTG entries 49723/49724/49725 (capsules and oral liquid)Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-31 · source 5
  6. NEORAL (ciclosporin capsules and oral solution) -- New Zealand Data SheetMedsafe (New Zealand regulator) -- Neoral (ciclosporin) New Zealand Data Sheet · New Zealand · accessed 2026-07-31 · source 6

Brand names by country

Single-ingredient cyclosporine (ciclosporin) names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • RESTASIS.5 mg/mL · allergan, inc.
  • Verkazia1 mg/mL · santen incorporated
  • Neoral100 mg/mL, 25 mg, 100 mg · novartis pharmaceuticals corporation
  • Sandimmune50 mg/mL, 100 mg, 25 mg · novartis pharmaceuticals corporation
  • CycloSPORINE, Modfied25 mg, 100 mg, 50 mg · apotex corp.
  • CEQUA.0009 mg/mL, .0009 g/mL · sun pharmaceutical industries, inc.
  • Gengraf25 mg, 100 mg · abbvie inc.
  • VEVYE1 mg/mL · harrow eye, llc
  • Restasis MultiDose.5 mg/mL · allergan, inc.

United Kingdom

  • Neoral (2)MHRA licensed emc smpc confirmed · 10 mg, 25 mg, 50 mg, 100 mg, oral solution · Novartis Pharmaceuticals UK Ltd
  • Sandimmun (concentrate for infusion) (2)MHRA licensed confirmed · 50 mg/mL · Novartis Pharmaceuticals UK Ltd

Canada

  • NEORAL
  • SANDIMMUNE IV
  • RESTASIS

Australia

  • Neoral (5)TGA ARTG registered 1995-08-28 confirmed · 50 mg, 100 mg capsules, 100 mg/mL oral liquid · Novartis Pharmaceuticals Australia Pty Ltd
  • Cyclosporin Sandoz (generic) (5)TGA ARTG registered confirmed · 100 mg · Sandoz

New Zealand

  • Neoral (6)Medsafe registered confirmed · capsules, 100 mg/mL oral solution · Novartis New Zealand
View brands in additional countries.

European Union

Sandimmun / Sandimmun Neoral (3)

This page provides general reference information about cyclosporine and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions should be made with the specialist physician or transplant team managing your care.

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