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).
🧬 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 →
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.
Patient information guide A plain-language walkthrough of Cyclosporine, written from its FDA label.
What Cyclosporine is used for
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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
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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
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- 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
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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
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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
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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 →
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.
- Major · 9
- Moderate · 182
- Minor · 38
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.
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.
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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How should I take it?
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Can I have grapefruit?
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Can I switch between brands?
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What side effects should I expect?
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Do I need lab tests?
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Is Cyclosporine available over the counter?
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When was Cyclosporine first available?
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Who makes Cyclosporine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Cyclosporine on HelloPharmacist
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
How this form is used
- 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.
- 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.
Eye drops
How this form is used
- 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.
- 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.
Oral solution
How this form is used
- 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.
- 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.
Injection
How this form is used
- Sandimmune injection, with corticosteroids, prevents organ rejection in kidney, liver and heart transplants and treats chronic rejection.
- Sandimmune injection is reserved for patients unable to take Sandimmune capsules because of the risk of anaphylaxis.
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.
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.
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.
How commonly is Cyclosporine prescribed? Of the 1,601 medications we measure, Cyclosporine ranks #287 by Medicaid prescriptions — more than 82% of them.
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.
0.4 ML cyclosporine 0.5 MG/ML Ophthalmic Suspension Most dispensed
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
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
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
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
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
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
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
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
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
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
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)
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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 25 mg | Oral | AbbVie Inc. | ANDA | View NDC → |
| 100 mg | Oral | AbbVie Inc. | ANDA | View NDC → |
| 25 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 100 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 25 mg | Oral | Apotex Corp. × 2 listings | ANDA | View NDC → |
| 50 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 100 mg | Oral | Apotex Corp. × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 50 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 100 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 25 mg | Oral | Dr. Reddy's Laboratories Inc | ANDA | View NDC → |
| 100 mg | Oral | Dr. Reddy's Laboratories Inc | ANDA | View NDC → |
| 25 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 50 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 100 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 25 mg | Oral | Novartis Pharmaceuticals Corporation × 2 listings | NDA | View NDC → |
| 100 mg | Oral | Novartis Pharmaceuticals Corporation × 2 listings | NDA | View NDC → |
| 25 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 50 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 100 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 25 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 50 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 💊Eye drops | ||||
| 0.5 mg/mL | Ophthalmic | A-S Medication Solutions | NDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Allergan, Inc. × 2 listings | NDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Apotex Corp | NDA AUTHORIZED GENERIC | View NDC → |
| 0.5 mg/mL | Ophthalmic | Cipla USA Inc. | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Devatis Inc. | ANDA | View NDC → |
| 1 mg/mL | Ophthalmic, Topical | Harrow Eye, LLC | NDA | View NDC → |
| 1 mg/mL | Ophthalmic | Harrow Eye, LLC | NDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Kvk-tech, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 0.5 mg/mL | Ophthalmic | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 0.5 mg/mL | Ophthalmic | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 1 mg/mL | Ophthalmic, Topical | Santen Incorporated | NDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Saptalis Pharmaceuticals, LLC | ANDA | View NDC → |
| 0.0009 mg/mL | Ophthalmic, Topical | Sun Pharmaceutical Industries, Inc. | NDA | View NDC → |
| 0.0009 g/mL | Ophthalmic, Topical | Sun Pharmaceutical Industries, Inc. | NDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Teva Pharmaceuticals, Inc. | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 💊Injection | ||||
| 50 mg/mL | Intravenous | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 💊Oral solution | ||||
| 100 mg/mL | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 100 mg/mL | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
Showing 47 of 47 products — FDA National Drug Code Directory. See every product, package size and price: browse all 47 Cyclosporine NDCs →
Cyclosporine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Cyclosporine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Cyclosporine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Cyclosporine FDA approval history
How Cyclosporine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
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.
- 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 →
- 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 →
- 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.
RxCUI 3008 6 dose forms · 16 strengths
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Dose form (SCDF) Injection RxCUI 1732364In current FDA listingsClinical drug / strength (SCD) 5 ML cyclosporine 50 MG/MLRxCUI 205175 -
Dose form (SCDF) Ophthalmic Ointment RxCUI 1093173No current FDA listingClinical drug / strength (SCD) 0.002 MG/MGRxCUI 1093174 -
Dose form (SCDF) Ophthalmic Solution RxCUI 2055020In current FDA listings -
Dose form (SCDF) Ophthalmic Suspension RxCUI 378766In current FDA listingsClinical drug / strength (SCD) 0.4 ML cyclosporine 0.5 MG/MLRxCUI 25722920.5 MG/MLRxCUI 3512911 MG/MLRxCUI 2590608 -
Dose form (SCDF) Oral Capsule RxCUI 371666In current FDA listingsClinical drug / strength (SCD) modified 10 MGRxCUI 835919modified 100 MGRxCUI 241834modified 25 MGRxCUI 835894modified 50 MGRxCUI 83592525 MGRxCUI 19755350 MGRxCUI 205168100 MGRxCUI 328160 -
Dose form (SCDF) Oral Solution RxCUI 371667In current FDA listings
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.
Cyclosporine supply and shortage status
Whether Cyclosporine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 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.
| Form | Strength | Pharmacy 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 |
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.
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.
Cyclosporine drug class (RxNorm)
Cyclosporine belongs to the Calcineurin Inhibitor Immunosuppressant class.
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.
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 →