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Cyclosporine

Cyclosporine is an immune-suppressing medicine used to prevent organ rejection after kidney, liver and heart transplants, to treat severe rheumatoid arthritis and severe plaque psoriasis (oral forms), and to treat dry eye disease and vernal keratoconjunctivitis (eye products).

Brand names GengrafNeoralSandimmune CapsulesSandimmune Oral SolutionOptimmune +11 more
Drug class Calcineurin Inhibitor Immunosuppressant
Rx Forms 4
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 11 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Other forms & routes:
Cyclosporine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Cyclosporine is a powerful immune suppressant that calms the immune cells that drive rejection, a specialist medicine on the market since about 1983 and available generically; oral forms prevent rejection after kidney, liver and heart transplants and treat severe rheumatoid arthritis and plaque psoriasis, while eye drops treat dry eye and vernal keratoconjunctivitis (a severe allergic eye inflammation). Oral forms are demanding to take, and tremor, headache, stomach upset, extra hair growth and overgrown gums are common. Its boxed warning covers serious infections, cancers such as lymphoma, high blood pressure and kidney damage, so oral forms need regular checks of kidney function, blood pressure and blood levels; keep every lab appointment.

Clinical pearls

  • Take oral doses at the same times each day with the same relationship to meals, and skip grapefruit and grapefruit juice.
  • Neoral-type (modified) products and Sandimmune are not interchangeable, so never switch brands without your prescriber overseeing it.
  • St. John's Wort can sharply lower levels and has been linked to rejection, while clarithromycin or fluconazole push levels up.
  • Skip over-the-counter NSAIDs like ibuprofen and naproxen without checking first, since they add to cyclosporine's kidney strain.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Cyclosporine should be prescribed only by doctors experienced in managing immune-suppressing therapy. It weakens the immune system, so it can raise your risk of infection and of cancers such as lymphoma. This risk is higher in transplant patients taking several immune suppressants.

It can also cause high blood pressure and kidney damage, especially at higher doses and with longer treatment. Kidney function must be monitored. Psoriasis patients previously treated with PUVA and certain other therapies face a higher risk of skin cancer.

Modified cyclosporine (Neoral-type products) and Sandimmune are not bioequivalent and cannot be swapped without physician supervision. Blood levels need monitoring in transplant and rheumatoid arthritis patients to avoid toxicity from high levels, or rejection from low levels.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule, Eye drops, Oral solution +1
Earliest FDA record1983
Companies listing it with the FDA22
FDA label last updatedAug 10, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Cyclosporine, written from its FDA label.

What Cyclosporine is used for

▾

Cyclosporine is used for several conditions, depending on the product.

  • Gengraf, Neoral and modified generic cyclosporine (oral): preventing rejection in kidney, liver and heart transplants.
  • The same oral products: severe active rheumatoid arthritis not adequately helped by methotrexate.
  • The same oral products: severe, hard-to-treat plaque psoriasis in adults with normal immune systems who failed or cannot use other systemic therapy.
  • Sandimmune capsules and injection (with corticosteroids): preventing organ rejection and treating chronic rejection.
  • Restasis, Restasis MultiDose and generic cyclosporine eye emulsion: increasing tear production in dry eye tied to eye inflammation.
  • Cequa: increasing tear production in keratoconjunctivitis sicca (dry eye).
  • Vevye: signs and symptoms of dry eye disease.
  • Verkazia: vernal keratoconjunctivitis in children and adults.

How Cyclosporine works

▾

Cyclosporine quiets the immune system by reversibly blocking certain white blood cells called lymphocytes, mainly T-helper cells. It also reduces release of immune signals such as interleukin-2. This helps prevent the body from attacking a transplanted organ and calms immune-driven disease. It does not suppress the bone marrow.

Cyclosporine dosage

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Oral cyclosporine is generally taken twice a day, at consistent times and in a consistent way relative to meals. Avoid grapefruit. Eye products are given as drops, and the schedule depends on the brand. Your doctor will adjust oral doses based on blood levels. The label excerpts here do not give missed-dose advice for oral forms, so ask your pharmacist. Follow your prescriber's directions and the label.

  • Verkazia: if a dose is missed, continue as normal at the next scheduled dose.
  • Sandimmune injection: reserved for those who cannot take capsules.

Dosing details from the FDA-approved label

From the Cyclosporine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Newly transplanted patients (kidney, liver, heart)
    • Initial oral dose can be given 4 to 12 hours prior to transplantation or postoperatively
    • Same as the initial oral dose of Sandimmune
    • Survey mean ± SD initial doses were 9±3 mg/kg/day for renal, 8±4 mg/kg/day for liver, and 7±3 mg/kg/day for heart transplant patients, divided into two equal daily doses
    • Subsequently adjusted to achieve a pre-defined cyclosp
    • Always given in two divided doses (BID) on a consistent schedule with regard to time of day and relation to meals; avoid grapefruit and grapefruit juice
  • Conversion from Sandimmune to Gengraf in transplant patients
    • Start with the same daily dose as previously used with Sandimmune (1:1 dose conversion), then adjust to attain the pre-conversion cyclosporine blood trough concentration
    • Monitor trough concentration every 4 to 7 days after conversion; monitor serum creatinine and blood pressure every two weeks during the first two months
  • Transplant patients with poor absorption of Sandimmune
    • Titrate individually based on cyclosporine trough concentrations, tolerability, and clinical response
    • Measure trough concentration at least twice a week (daily, if initial dose exceeds 10 mg/kg/day) until it stabilizes within the desired range
    • Particular caution when converting at doses greater than 10 mg/kg/day
  • Rheumatoid arthritis
    • Initial dose 2.5 mg/kg/day, taken twice daily as a divided (BID) oral dose
    • If insufficient benefit and good tolerability (serum creatinine less than 30% above baseline), may be increased by 0.5 to 0.75 mg/kg/day after 8 weeks and again after 12 weeks
    • Maximum: 4 mg/kg/day
    • Onset of action generally between 4 and 8 weeks; patients with impaired renal function should not receive cyclosporine
  • Renal impairment in kidney, liver, and heart transplantation
    • Careful monitoring of renal function is recommended
    • Cyclosporine dosage should be reduced if indicated
    • Pharmacokinetics not significantly altered in end-stage renal disease patients on routine hemodialysis
  • Hepatic impairment
    • Dose reduction may be necessary in patients with severe liver impairment to maintain blood concentrations within the recommended target range
    • Clearance may be significantly reduced in severe liver disease
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Cyclosporine oral solution, USP MODIFIED has increased bioavailability in comparison to Sandimmune (cyclosporine oral solution, USP). Cyclosporine oral solution, USP MODIFIED and Sandimmune (cyclosporine oral solution, USP) are not bioequivalent and cannot be used interchangeably without physician supervision. The daily dose of cyclosporine oral solution, USP MODIFIED should always be given in two divided doses (BID). It is recommended that cyclosporine oral solution, USP MODIFIED be administered on a consistent schedule with regard to time of day and relation to meals. Grapefruit and grapefruit juice affect metabolism, increasing blood concentration of cyclosporine, thus should be avoided. Specific Populations Renal Impairment in Kidney, Liver, and Heart Transplantation Cyclosporine undergoes minimal renal elimination and its pharmacokinetics do not appear to be significantly altered in patients with end-stage renal disease who receive routine hemodialysis treatments (see CLINICAL PHARMACOLOGY ) . However, due to its nephrotoxic potential (see WARNINGS ) , careful monitoring of renal function is recommended; cyclosporine dosage should be reduced if indicated (see WARNINGS and PRECAUTIONS ) . Renal Impairment in Rheumatoid Arthritis and Psoriasis Patients with impaired renal function should not receive cyclosporine (see CONTRAINDICATIONS , WARNINGS and PRECAUTIONS ) . Hepatic Impairment The clearance of cyclosporine may be significantly reduced in severe liver disease patients (see CLINICAL PHARMACOLOGY ) . Dose reduction may be necessary in patients with severe liver impairment to maintain blood concentrations within the recommended target range (see WARNINGS and PRECAUTIONS ) . Newly Transplanted Patients The initial oral dose of cyclosporine oral solution, USP MODIFIED can be given 4 to 12 hours prior to transplantation or be given postoperatively. The initial dose of cyclosporine oral solution, USP MODIFIED varies depending on the transplanted organ and the other immunosuppressive agents included in the immunosuppressive protocol. In newly transplanted patients, the initial oral dose of cyclosporine oral solution, MODIFIED is the same as the initial oral dose of Sandimmune (cyclosporine oral solution, USP).

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Cyclosporine side effects

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Common side effects include:

Common side effects

  • Kidney problems (reduced kidney function)
  • High blood pressure
  • Tremor (shaking)
  • Excess hair growth
  • Gum overgrowth
  • Headache
  • Nausea, vomiting or diarrhea
  • Stomach pain

When to get medical help

  • Signs of serious infection, such as fever or feeling very unwell, since infections can be serious or fatal
  • Confusion, seizures, vision changes or loss of movement control, which can signal brain effects such as PRES
  • New neurological symptoms such as weakness on one side, confusion or loss of coordination, which can signal PML
  • Yellowing of skin or eyes or signs of liver injury
  • Muscle pain or weakness if you also take a statin
  • Reduced urine output or rising kidney lab results, which may signal kidney damage
  • Any new skin changes or lumps, since cyclosporine raises the risk of lymphoma and skin cancers
  • Severe allergic reaction (anaphylaxis), a risk with Sandimmune injection

Call your doctor about signs of infection, seizures, vision changes, confusion, yellow skin or eyes, or reduced urination.

Cyclosporine warnings and precautions

▾
  • Cyclosporine can harm the kidneys and raise blood pressure, more so at higher doses and with longer use.
  • It raises the risk of serious infections and cancers such as lymphoma and skin cancer.
  • It can cause liver injury, high potassium and nervous system problems, including seizures and PRES.
  • Rare brain and kidney infections from polyoma viruses (PML, PVAN) have been reported.
  • Blood levels should be monitored in transplant and rheumatoid arthritis patients.

Cyclosporine interactions

▾

Many medicines and foods change cyclosporine levels.

  • Grapefruit and grapefruit juice: raise levels.
  • St. John's Wort: can lower levels and cause organ rejection.
  • Diltiazem, verapamil, azole antifungals, macrolide antibiotics: can raise levels.
  • Rifampin, carbamazepine, phenytoin, phenobarbital, orlistat: can lower levels.
  • NSAIDs and other kidney-harming drugs: added kidney risk.
  • Digoxin, colchicine and statins: cyclosporine can raise their levels and cause toxicity.
  • Bosentan: should be avoided.

Interactions listed in the FDA-approved label

From the Cyclosporine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Grapefruit and grapefruit juice: Affect metabolism, increasing blood concentrations of cyclosporine. Should be avoided.
  • Bosentan: Decreases cyclosporine mean dose-normalized AUC, Cmax, and trough concentration by approximately 50%, 30%, and 60%, respectively. Coadministration should be avoided.
  • St. John's Wort: Marked reduction in cyclosporine blood concentrations, resulting in subtherapeutic levels, rejection of transplanted organs, and graft loss.
  • Digoxin: Severe digitalis toxicity has been seen within days of starting cyclosporine in several patients taking digoxin. Monitor serum digoxin concentrations if used concurrently.
  • Colchicine: Cyclosporine may enhance toxic effects of colchicine such as myopathy and neuropathy, with significant increases in colchicine plasma concentrations. Reduce the dosage of colchicine if used concurrently.
  • HMG-CoA reductase inhibitors (statins): Myotoxicity including muscle pain and weakness, myositis, and rhabdomyolysis has been reported with lovastatin, simvastatin, atorvastatin, pravastatin, and rarely fluvastatin. Dosage of these statins should be reduced when given concurrently.
  • Boceprevir: Increased mean AUC and Cmax of cyclosporine approximately 2.7-fold and 2-fold, respectively.
  • Telaprevir: Increased mean dose-normalized AUC and Cmax of cyclosporine approximately 4.5-fold and 1.3-fold, respectively.
  • HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir): Known to inhibit cytochrome P-450 3A and could potentially increase cyclosporine concentrations; no formal studies available. Care should be exercised when administered concomitantly.
  • Diclofenac or methotrexate: AUC of diclofenac and methotrexate each significantly increased when coadministered with cyclosporine in rheumatoid arthritis patients.
Read the label’s full interactions text

Drug Interactions (See PRECAUTIONS, Drug Interactions ) When diclofenac or methotrexate was coadministered with cyclosporine in rheumatoid arthritis patients, the AUC of diclofenac and methotrexate, each was significantly increased (see PRECAUTIONS, Drug Interactions ). No clinically significant pharmacokinetic interactions occurred between cyclosporine and aspirin, ketoprofen, piroxicam, or indomethacin. Specific Populations Renal Impairment In a study performed in 4 subjects with end-stage renal disease (creatinine clearance < 5 mL/min), an intravenous infusion of 3.5 mg/kg of cyclosporine over 4 hours administered at the end of a hemodialysis session resulted in a mean volume of distribution (Vdss) of 3.49 L/kg and systemic clearance (CL) of 0.369 L/hr/kg. This systemic CL (0.369 L/hr/kg) was approximately two thirds of the mean systemic CL (0.56 L/hr/kg) of cyclosporine in historical control subjects with normal renal function. In 5 liver transplant patients, the mean clearance of cyclosporine on and off hemodialysis was 463 mL/min and 398 mL/min, respectively. Less than 1% of the dose of cyclosporine was recovered in the dialysate. Hepatic Impairment Cyclosporine is extensively metabolized by the liver. Since severe hepatic impairment may result in significantly increased cyclosporine exposures, the dosage of cyclosporine may need to be reduced in these patients. Pediatric Population Pharmacokinetic data from pediatric patients administered cyclosporine capsules (modified) or Sandimmune ® are very limited. In 15 renal transplant patients aged 3 to 16 years, cyclosporine whole blood clearance after IV administration of Sandimmune ® was 10.6 ± 3.7 mL/min/kg (assay: Cyclo-trac specific RIA). In a study of 7 renal transplant patients aged 2 to 16, the cyclosporine clearance ranged from 9.8 to 15.5 mL/min/kg. In 9 liver transplant patients aged 0.6 to 5.6 years, clearance was 9.3 ± 5.4 mL/min/kg (assay: HPLC).

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Cyclosporine

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  • Do not use if allergic to cyclosporine or any ingredient.
  • With rheumatoid arthritis or psoriasis, abnormal kidney function, uncontrolled high blood pressure or cancer rules out oral Gengraf.
  • Psoriasis patients should not combine it with PUVA, UVB, methotrexate, other immune suppressants, coal tar or radiation.
  • Severe liver impairment may mean a lower dose.
  • Older adults need careful kidney monitoring.
  • Limit ultraviolet light exposure.

Cyclosporine overdose

▾

Experience with overdose is minimal. Large oral amounts have caused vomiting, drowsiness, headache, fast heartbeat and reversible kidney problems, and liver and kidney toxicity may occur. Treatment is supportive. If an overdose happens, contact Poison Help at 1-800-222-1222.

What Cyclosporine does in the body

▾

Cyclosporine suppresses some antibody-related immunity and, to a greater extent, cell-mediated immune reactions such as organ rejection. It reversibly inhibits lymphocytes, especially T-helper cells, and lowers production of signals like interleukin-2. It does not cause bone marrow suppression.

How your body processes Cyclosporine

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Absorption of oral cyclosporine is incomplete and varies by person and formulation. Modified products are absorbed better than Sandimmune. Food lowers absorption somewhat, and peak levels occur about 1.5 to 2 hours after a modified dose. Cyclosporine is broken down extensively by the liver and leaves mainly through bile, with only about 6% in urine. Its half-life is about 8.4 hours (range 5 to 18).

How to store Cyclosporine

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Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) 100 mg — Off-white, oblong, soft gelatin capsules. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) Store and Dispense In the original container at 20° to 25…

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

229

Supplements & herbs that interact with Cyclosporine

229 supplements and herbal products have documented interactions with Cyclosporine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 9
  • Moderate · 182
  • Minor · 38
Every supplement checked against Cyclosporine — ranked by severity The full interaction hub: 9 major · 182 moderate · 38 minor · every one linked to its full report. Check Cyclosporine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Cyclosporine has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Cyclosporine nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Cyclosporine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Cyclosporine — the kind of thing our pharmacy team would talk through with you at the counter.

What is cyclosporine for?

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It depends on the product. Oral forms help prevent organ rejection after kidney, liver or heart transplants. Some oral products also treat severe rheumatoid arthritis and severe plaque psoriasis. The eye versions treat dry eye and vernal keratoconjunctivitis.

How should I take it?

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Oral modified forms like Neoral and Gengraf are taken twice a day. Keep your timing and meal routine consistent from day to day. Follow your prescriber's directions and the label.

Can I have grapefruit?

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No, avoid grapefruit and grapefruit juice. They raise cyclosporine levels in your blood, which can increase side effects.

Can I switch between brands?

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Not on your own. Modified products such as Neoral and Gengraf are not interchangeable with Sandimmune, and switching needs your doctor's supervision and extra blood level checks.

What side effects should I expect?

▾
Common ones include kidney changes, high blood pressure, tremor, extra hair growth, gum overgrowth, headache and stomach upset. Call your doctor for signs of infection, seizures, vision changes, confusion, yellow skin or eyes, or reduced urination.

Do I need lab tests?

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Yes. Your kidney function, blood pressure and cyclosporine blood levels need regular checks. This helps avoid toxicity from high levels and, in transplant patients, rejection from low levels.

Is Cyclosporine available over the counter?

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No. Cyclosporine is a prescription medicine: every Cyclosporine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Cyclosporine first available?

▾
The earliest FDA record we hold for Cyclosporine is from 1983: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Cyclosporine was first used.

Who makes Cyclosporine?

▾
22 companies currently list Cyclosporine products in the FDA's NDC Directory, including Apotex Corp., Novartis Pharmaceuticals Corporation, Teva Pharmaceuticals USA, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Cyclosporine on HelloPharmacist

Detailed data & references for Cyclosporine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Cyclosporine forms and strengths (how it comes)

Cyclosporine is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Gengraf Neoral Sandimmune
How this form is used
What it may be used for
  • Gengraf capsules prevent organ rejection in kidney, liver and heart transplants, and treat severe rheumatoid arthritis and severe plaque psoriasis.
  • Neoral treats the same conditions: transplant rejection prevention, rheumatoid arthritis and plaque psoriasis.
  • Sandimmune capsules, with corticosteroids, prevent organ rejection and treat chronic rejection.
Important instructions
  • Gengraf is given in two divided daily doses on a consistent schedule with regard to time of day and meals.
  • Gengraf and Sandimmune are not bioequivalent and cannot be used interchangeably without physician supervision.
  • Neoral and Sandimmune capsules are not substituted mg-for-mg, and switching needs closer monitoring.
  • Gengraf and Neoral labels advise avoiding grapefruit and grapefruit juice.
Available strengths 3 strengths
78 FDA-listed product records ⓘ

Eye drops

In the eye · On the skin
Brands Cequa Restasis Restasis MultiDose Verkazia Vevye
How this form is used
What it may be used for
  • Restasis and Restasis MultiDose increase tear production when it is suppressed by eye inflammation from keratoconjunctivitis sicca.
  • Cequa increases tear production in keratoconjunctivitis sicca (dry eye).
  • Vevye treats signs and symptoms of dry eye disease.
  • Verkazia treats vernal keratoconjunctivitis in children and adults.
Important instructions
  • Restasis, Restasis MultiDose, Cequa and Vevye are used as one drop in each eye twice a day, about 12 hours apart.
  • Verkazia is used as one drop four times daily in each affected eye; remove contact lenses first and wait 15 minutes to reinsert.
  • Cequa and Restasis single-use vials should be discarded right after use.
  • Restasis, Cequa and Vevye can be used with other eye drops, leaving a 15-minute gap.
Available strengths 4 strengths
37 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Neoral
How this form is used
What it may be used for
  • Neoral oral solution prevents organ rejection in kidney, liver and heart transplants, and treats severe rheumatoid arthritis and severe plaque psoriasis.
  • Generic cyclosporine oral solution (modified) is used for the same transplant, rheumatoid arthritis and psoriasis conditions.
Important instructions
  • Neoral is given in two divided daily doses on a consistent schedule with regard to time of day and meals.
  • Neoral and Sandimmune are not bioequivalent and cannot be used interchangeably without physician supervision.
  • Neoral advice includes avoiding grapefruit and grapefruit juice.
Available strengths 1 strength
7 FDA-listed product records ⓘ

Injection

By injection · Into a vein
Brands Sandimmune
How this form is used
What it may be used for
  • Sandimmune injection, with corticosteroids, prevents organ rejection in kidney, liver and heart transplants and treats chronic rejection.
Important instructions
  • Sandimmune injection is reserved for patients unable to take Sandimmune capsules because of the risk of anaphylaxis.
Available strengths 1 strength
5 FDA-listed product records ⓘ

Cyclosporine on the U.S. market: products, makers and brands

How Cyclosporine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

22 companies list 47 Cyclosporine product records with the FDA, mostly as capsule, eye drops, oral solution; the earliest marketing or approval year on record is 1983. Brand names on the directory include Gengraf, Neoral, Sandimmune Capsules and 13 more; the rest are generics.

4
Dose forms ⓘ
22
Labelers (makers, repackagers, distributors)
11
Brand names
47
FDA-listed product records ⓘ
1983
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (23) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Apotex Corp.13%
Novartis Pharmaceuticals Corporation13%
Teva Pharmaceuticals USA, Inc.9%
Aurobindo Pharma Limited6%
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.6%
Strides Pharma Science Limited6%
Other makers47%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Cyclosporine is used (Medicaid data)

A general measure of how commonly Cyclosporine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Cyclosporine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

403,927
Medicaid prescriptions filled (Q1–Q4 2025)
$268.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cyclosporine prescribed? Of the 1,601 medications we measure, Cyclosporine ranks #287 by Medicaid prescriptions — more than 82% of them.

Where Cyclosporine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Cyclosporine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 0.4 mL / 0.5 mg/mL ophthalmic suspension is the most-dispensed Cyclosporine product — about 81% of these Medicaid prescriptions.

0.4 ML cyclosporine 0.5 MG/ML Ophthalmic Suspension Most dispensed

328,030 Medicaid prescriptions (Q1–Q4 2025) 81% of Cyclosporine prescriptions shown $226.6M gross reimbursement (before rebates) ≈ $691 per prescription (gross)

Summed across the 12 of 28 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2572292

cyclosporine 0.9 MG/ML Ophthalmic Solution

31,524 Medicaid prescriptions (Q1–Q4 2025) 8% of Cyclosporine prescriptions shown $23.3M gross reimbursement (before rebates) ≈ $740 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2055021

cyclosporine, modified 25 MG Oral Capsule

11,203 Medicaid prescriptions (Q1–Q4 2025) 3% of Cyclosporine prescriptions shown $950,603 gross reimbursement (before rebates) ≈ $85 per prescription (gross)

Summed across the 4 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835894

cyclosporine 1 MG/ML Ophthalmic Solution

9,829 Medicaid prescriptions (Q1–Q4 2025) 2% of Cyclosporine prescriptions shown $7.6M gross reimbursement (before rebates) ≈ $778 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2639936

cyclosporine, modified 100 MG Oral Capsule

7,570 Medicaid prescriptions (Q1–Q4 2025) 2% of Cyclosporine prescriptions shown $1.1M gross reimbursement (before rebates) ≈ $142 per prescription (gross)

Summed across the 5 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 241834

cyclosporine 0.5 MG/ML Ophthalmic Suspension

7,386 Medicaid prescriptions (Q1–Q4 2025) 2% of Cyclosporine prescriptions shown $4.8M gross reimbursement (before rebates) ≈ $644 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351291

cyclosporine 100 MG Oral Capsule

2,191 Medicaid prescriptions (Q1–Q4 2025) <1% of Cyclosporine prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $635 per prescription (gross)

Summed across the 2 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 328160

cyclosporine 25 MG Oral Capsule

2,025 Medicaid prescriptions (Q1–Q4 2025) <1% of Cyclosporine prescriptions shown $812,521 gross reimbursement (before rebates) ≈ $401 per prescription (gross)

Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197553

cyclosporine, modified 50 MG Oral Capsule

1,783 Medicaid prescriptions (Q1–Q4 2025) <1% of Cyclosporine prescriptions shown $185,843 gross reimbursement (before rebates) ≈ $104 per prescription (gross)

Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835925

cyclosporine, modified 100 MG/ML Oral Solution

1,604 Medicaid prescriptions (Q1–Q4 2025) <1% of Cyclosporine prescriptions shown $262,165 gross reimbursement (before rebates) ≈ $163 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835886

cyclosporine 1 MG/ML Ophthalmic Suspension

759 Medicaid prescriptions (Q1–Q4 2025) <1% of Cyclosporine prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $1,852 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2590608

Other Cyclosporine products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

23 Medicaid prescriptions (Q1–Q4 2025) <1% of Cyclosporine prescriptions shown $18,260 gross reimbursement (before rebates) ≈ $794 per prescription (gross)

Summed across the 1 of 45 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cyclosporine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 33 of 139 listed Cyclosporine NDCs with Medicaid activity.

Compare Cyclosporine products

A representative set of FDA-listed product records for Cyclosporine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 47 of 47 products — FDA National Drug Code Directory. See every product, package size and price: browse all 47 Cyclosporine NDCs →

Cyclosporine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 3 Cyclosporine recalls since July 2021. None of them is still listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class III Sep 7, 2023 · Terminated · SUN PHARMACEUTICAL INDUSTRIES INC
Subpotent: Out of Specification result observed for low assay
  • Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutance… Lots: Lot# 10026, Lot 10027, Exp. 09/2023. FDA record D-1172-2023 →
Class II Sep 16, 2022 · Terminated · Novartis Pharmaceuticals Corporation
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
  • Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 00… Lots: Lot # APCD162, Exp. 01/2023 FDA record D-1543-2022 →
Class III Apr 1, 2022 · Terminated · SUN PHARMACEUTICAL INDUSTRIES INC
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
  • Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-… Lots: Lot: 10014, 10016, Exp 08/2022 FDA record D-0770-2022 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Cyclosporine RxCUI 3008 6 dose forms · 16 strengths
  1. Dose form (SCDF) Injection RxCUI 1732364 In current FDA listings
    Clinical drug / strength (SCD) 5 ML cyclosporine 50 MG/ML RxCUI 205175
  2. Dose form (SCDF) Ophthalmic Ointment RxCUI 1093173 No current FDA listing
    Clinical drug / strength (SCD) 0.002 MG/MG RxCUI 1093174
  3. Dose form (SCDF) Ophthalmic Solution RxCUI 2055020 In current FDA listings
    Clinical drug / strength (SCD) 0.9 MG/ML RxCUI 2055021 1 MG/ML RxCUI 2639936
  4. Dose form (SCDF) Oral Capsule RxCUI 371666 In current FDA listings
    Clinical drug / strength (SCD) modified 10 MG RxCUI 835919 modified 100 MG RxCUI 241834 modified 25 MG RxCUI 835894 modified 50 MG RxCUI 835925 25 MG RxCUI 197553 50 MG RxCUI 205168 100 MG RxCUI 328160
  5. Dose form (SCDF) Oral Solution RxCUI 371667 In current FDA listings
    Clinical drug / strength (SCD) modified 100 MG/ML RxCUI 835886 100 MG/ML RxCUI 309632

Look up RxCUI 3008 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Cyclosporine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule, Liquid Filled · Oral 50 mg $0.765 per capsule NDC details & price history
Emulsion · Ophthalmic 0.5 mg/mL $112.32 per mL NDC details & price history
Capsule, Gelatin Coated · Oral 100 mg $7.51 per capsule NDC details & price history
Capsule, Gelatin Coated · Oral 25 mg $2.60 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Cyclosporine brand names

Cyclosporine is sold under 16 brand names in the FDA directory — Gengraf, Neoral, Sandimmune Capsules, Sandimmune Oral Solution and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Gengraf Neoral Sandimmune Capsules Sandimmune Oral Solution Optimmune Atopica Sandimmune Cequa Cyclavance Restasis Verkazia Vevye Sporimune Modulis Restasis MultiDose Cyclosporine Modified

Who makes Cyclosporine: manufacturers and labelers

22 companies list Cyclosporine products with the FDA. By number of product records, the largest are Apotex Corp., Novartis Pharmaceuticals Corporation, Teva Pharmaceuticals USA, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Apotex Corp. 6 Novartis Pharmaceuticals Corporation 6 Teva Pharmaceuticals USA, Inc. 4 Aurobindo Pharma Limited 3 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 3 Strides Pharma Science Limited 3 AbbVie Inc. 2 Allergan, Inc. 2 American Health Packaging 2 Dr. Reddy's Laboratories Inc 2 Harrow Eye, LLC 2 Sun Pharmaceutical Industries, Inc. 2 A-S Medication Solutions 1 Cipla USA Inc. 1 Devatis Inc. 1 Kvk-tech, Inc. 1 Lupin Pharmaceuticals, Inc. 1 Mylan Pharmaceuticals Inc. 1 Santen Incorporated 1 Saptalis Pharmaceuticals, LLC 1 Teva Pharmaceuticals, Inc. 1 Upsher-Smith Laboratories, LLC 1

Cyclosporine drug class (RxNorm)

Cyclosporine belongs to the Calcineurin Inhibitor Immunosuppressant class.

Pharmacologic class Calcineurin Inhibitor Immunosuppressant
Drug family (ATC) Calcineurin inhibitors, Other ophthalmologicals
How it works Calcineurin Inhibitors, Cytochrome P450 3A4 Inhibitors, P-Glycoprotein Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Cyclosporine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 10, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cyclosporine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Cyclosporine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
11
Finished products in the current FDA directory
47
Companies listing them (makers, repackagers, distributors)
22
FDA labeler codes behind them ⓘ
23
Linked representative label ⓘ
Novartis Pharmaceuticals Corporation
Linked label effective
Aug 10, 2026
Composite sections available
20
Linked SPL Set ID
94461af3-11f1-4670-95d4-2965b9538ae3
Linked SPL Document ID
47367e3d-2d79-49bd-849c-5557ef605b27
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →