Prescription medicine
Cyclosporine Brand names: Sandimmune, Neoral, Restasis, Cequa, Verkazia
Cyclosporine (Restasis) is a prescription medicine with an FDA approval on record since 1983. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $1.04 per unit (Cyclosporine 0.05% eye emulsion) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the cyclosporine FDA label on DailyMed (effective August 10, 2026, Novartis Pharmaceuticals Corporation); the NDA 50573 record on Drugs@FDA; every cyclosporine label on DailyMed.
Highlights of the record
FDA label of August 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Neoral. At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Neoral. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. Neoral, a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients Neoral may be administered with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients. Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED have increased bioavailability in comparison to Sandimmune Soft Gelatin Capsules (cyclosporine capsules, USP) and Sandimmune Oral Solution (cyclosporine oral solution, USP). […]
Used for
From the label: indications and usageKidney, Liver, and Heart Transplantation Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.
Forms and strengths
- 25 mg
- 50 mg
- 100 mg
- 0.0009 mg/ml
- 0.0009 g/ml
- 0.5 mg/ml
- 1 mg/ml
- 50 mg/ml
- 100 mg/ml
Liquid-filled capsule; emulsion; gelatin-coated capsule; solution/ drops; capsule.
On the market
- Earliest approval on file
- November 14, 1983 Sandimmune, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 24 first October 29, 1999; 17 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 23 of which 14 under generic applications, 6 under brand applications, repackagers included
- Last listed patent
- May 11, 2034 Restasis emulsion; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.04 per unit Cyclosporine 0.05% eye emulsion
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 7 since 2012 0 Class I among all firms' recalls; latest September 7, 2023; 6 more by firms not listed as its makers
- FAERS reports
- 115,545 through July 30, 2026
What is cyclosporine used for?
From the label: indications and usageKidney, Liver, and Heart Transplantation Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Neoral is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Neoral can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. […]
Conditions named in the indications of cyclosporine's FDA labels, with every medicine labeled for each:
From other cyclosporine labelsOrgan transplant rejection: INDICATIONS AND USAGE Kidney, Liver, and Heart Transplantation Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.
FDA pharmacologic class: Calcineurin Inhibitor Immunosuppressant.
Source: FDA drug label (Neoral), Novartis Pharmaceuticals Corporation, effective August 10, 2026 (SPL set 94461af3-11f1-4670-95d4-2965b9538ae3), via openFDA; the full label on DailyMed
Is there a generic for cyclosporine (Restasis)?
The FDA approved the first generic cyclosporine on October 29, 1999. 24 generic applications are approved; 17 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cyclosporine from 14 labelers under a generic (ANDA) application and from 6 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 4 patents for Restasis emulsion, the last expiring on May 11, 2034; a patent listed only for Vevye solution runs to April 1, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1983 earliest approval on file
- 1999 first generic approved
- 2034 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cyclosporine (Restasis)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.04 per unit (Cyclosporine 0.05% eye emulsion), down 49% from $2.05 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Cyclosporine 0.05% eye emulsion (generic)
- Restasis 0.05% eye emulsion (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cyclosporine 0.05% eye emulsion | Generic | $1.04 per unit | n/a | -49% |
| Cyclosporine 100 mg capsule | Generic | $7.51 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $225.20 | +2% |
| Cyclosporine 25 mg capsule | Generic | $2.60 per capsule | $77.87 | -5% |
| Cyclosporine modified 100 mg | Generic | $1.23 per unit | n/a | -28% |
| Cyclosporine modified 100 mg/mL | Generic | $2.04 per mL | n/a | -20% |
| Cyclosporine modified 25 mg | Generic | $0.314 per unit | n/a | -8% |
| Cyclosporine modified 50 mg | Generic | $0.765 per unit | n/a | -7% |
| Cequa 0.09% solution | Brand | $10.38 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +3% |
| Gengraf 25 mg capsule | Brand | $1.87 per capsule | $55.96 | +5% |
| Neoral 100 mg gelatin capsule | Brand | $11.77 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $353.19 | +4% |
| Neoral 25 mg gelatin capsule | Brand | $2.95 per capsule | $88.37 | +4% |
| Restasis 0.05% eye emulsion | Brand | $10.31 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | no change |
| Restasis multidose 0.05% eye | Brand | $112.32 per mL | n/a | -0.1% |
| Vevye 0.1% eye drop | Brand | $379.87 per mL | n/a | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cyclosporine been recalled?
The FDA's Enforcement Report lists 13 recalls naming cyclosporine since 2012: 0 Class I (the most serious), 9 Class II, 4 Class III; 0 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of cyclosporine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 7, 2023 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Subpotent: Out of Specification result observed for low assay |
| December 22, 2022 | Class II | Pharmacy Innovations not a listed maker | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. |
| September 16, 2022 | Class II | Novartis Pharmaceuticals Corporation | CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content. |
| April 1, 2022 | Class III | 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. |
| May 7, 2021 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Subpotent and Presence of Particulates . |
| February 22, 2021 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Subpotent |
| February 9, 2018 | Class II | American Pharmaceutical Ingredients LLC not a listed maker | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. |
| February 8, 2017 | Class II | Amerisource Health Services | Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cyclosporine label say about other medicines?
The cyclosporine label names 74 other medicines in its interaction, contraindication or warning sections. The labels of 43 other medicines name cyclosporine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetic acid | drug interactions | Pharmacodynamic interactions have been reported to occur between cyclosporine and both naproxen and sulindac, in that concomitant use is associated with additive decreases in renal function, as determined by 99m Tc-diethylenetriaminepenta acetic acid (DTPA) and p -aminohippuric acid (PAH) clearances. |
| Aliskiren | drug interactions | Cyclosporine may reduce the clearance of digoxin, colchicine, prednisolone, HMG-CoA reductase inhibitors (statins), aliskiren, bosentan, dabigatran, repaglinide, NSAIDs, sirolimus, etoposide, and other drugs. |
| Allopurinol | drug interactions | diltiazem; fluconazole; azithromycin; methylprednisolone; Allopurinol |
| Ambrisentan | drug interactions | Ambrisentan Coadministration of ambrisentan (5 mg daily) and cyclosporine (100 to 150 mg twice daily initially, then dosing to achieve C min 150 to 200 ng/mL) for 8 days in healthy subjects resulted in mean increases in ambrisentan AUC and C max of approximately 2-fold and 1.5–fold, respectively, compared to … |
| Amiodarone | drug interactions | nicardipine; itraconazole; clarithromycin; Amiodarone |
| Amphotericin b | drug interactions | ciprofloxacin; melphalan; amphotericin B; azapropazon; cimetidine; tacrolimus; fibric acid derivatives (e.g., bezafibrate, fenofibrate) |
| Aspirin | drug interactions | No clinically significant pharmacokinetic interactions occurred between cyclosporine and aspirin, ketoprofen, piroxicam, or indomethacin. |
| Atorvastatin | drug interactions | HMG-CoA Reductase Inhibitors (Statins) Literature and postmarketing cases of myotoxicity, including muscle pain and weakness, myositis, and rhabdomyolysis, have been reported with concomitant administration of cyclosporine with lovastatin, simvastatin, atorvastatin, pravastatin, and rarely fluvastatin. |
| Azithromycin | drug interactions | diltiazem; fluconazole; azithromycin; methylprednisolone; Allopurinol |
| Bosentan | drug interactions | nafcillin; carbamazepine; bosentan; St. John’s Wort |
| Bromocriptine | drug interactions | verapamil; ketoconazole; erythromycin; Bromocriptine |
| Carbamazepine | drug interactions | nafcillin; carbamazepine; bosentan; St. John’s Wort |
| Castor oil | contraindications | Sandimmune injection is also contraindicated in patients with a history of a hypersensitivity reaction to Cremophor ® EL (polyoxyethylated castor oil). |
| Cimetidine | drug interactions | ciprofloxacin; melphalan; amphotericin B; azapropazon; cimetidine; tacrolimus; fibric acid derivatives (e.g., bezafibrate, fenofibrate) |
Every other medicine the cyclosporine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ciprofloxacin | drug interactions | ciprofloxacin; melphalan; amphotericin B; azapropazon; cimetidine; tacrolimus; fibric acid derivatives (e.g., bezafibrate, fenofibrate) |
| Clarithromycin | drug interactions | nicardipine; itraconazole; clarithromycin; Amiodarone |
| Coal tar | boxed warning | … lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking Neoral. |
| Colchicine | drug interactions | gentamicin; ketoconazole; colchicine; ranitidine; methotrexate |
| Dabigatran | drug interactions | Cyclosporine may reduce the clearance of digoxin, colchicine, prednisolone, HMG-CoA reductase inhibitors (statins), aliskiren, bosentan, dabigatran, repaglinide, NSAIDs, sirolimus, etoposide, and … |
| Danazol | drug interactions | … erythromycin Bromocriptine voriconazole quinupristin/ dalfopristin colchicine danazol imatinib metoclopramide nefazodone oral contraceptives HIV Protease Inhibitors The HIV protease inhibitors (e.g. … |
| Daunorubicin | drug interactions | … exposure to anthracycline antibiotics (e.g., doxorubicin, mitoxantrone, daunorubicin) in cancer patients. |
| Diclofenac | drug interactions | tobramycin; diclofenac |
| Digoxin | drug interactions | Cyclosporine may reduce the clearance of digoxin, colchicine, prednisolone, HMG-CoA reductase inhibitors (statins), aliskiren, bosentan, dabigatran, repaglinide, NSAIDs, sirolimus, etoposide, and … |
| Diltiazem | drug interactions | diltiazem; fluconazole; azithromycin; methylprednisolone; Allopurinol |
| Doxorubicin | drug interactions | … mg/kg/day) may increase the exposure to anthracycline antibiotics (e.g., doxorubicin, mitoxantrone, daunorubicin) in cancer patients. |
| Erythromycin | drug interactions | verapamil; ketoconazole; erythromycin; Bromocriptine |
| Etoposide | drug interactions | … (statins), aliskiren, bosentan, dabigatran, repaglinide, NSAIDs, sirolimus, etoposide, and other drugs. |
| Fenofibrate | drug interactions | ciprofloxacin; melphalan; amphotericin B; azapropazon; cimetidine; tacrolimus; fibric acid derivatives (e.g., bezafibrate, fenofibrate) |
| Fluconazole | drug interactions | diltiazem; fluconazole; azithromycin; methylprednisolone; Allopurinol |
| Fluvastatin | drug interactions | … with lovastatin, simvastatin, atorvastatin, pravastatin, and rarely fluvastatin. |
| Gentamicin | drug interactions | gentamicin; ketoconazole; colchicine; ranitidine; methotrexate |
| Heparin | warnings | Though resolution has occurred after reduction or discontinuation of cyclosporine and 1) administration of streptokinase and heparin or 2) plasmapheresis, this appears to depend upon early detection … |
| Imatinib | drug interactions | … Bromocriptine voriconazole quinupristin/ dalfopristin colchicine danazol imatinib metoclopramide nefazodone oral contraceptives HIV Protease Inhibitors The HIV protease inhibitors (e.g., indinavir … |
| Indomethacin | drug interactions | No clinically significant pharmacokinetic interactions occurred between cyclosporine and aspirin, ketoprofen, piroxicam, or indomethacin. |
| Itraconazole | drug interactions | nicardipine; itraconazole; clarithromycin; Amiodarone |
| Ketoconazole | drug interactions | gentamicin; ketoconazole; colchicine; ranitidine; methotrexate |
| Ketoprofen | drug interactions | No clinically significant pharmacokinetic interactions occurred between cyclosporine and aspirin, ketoprofen, piroxicam, or indomethacin. |
| Lovastatin | drug interactions | … been reported with concomitant administration of cyclosporine with lovastatin, simvastatin, atorvastatin, pravastatin, and rarely fluvastatin. |
| Melphalan | drug interactions | ciprofloxacin; melphalan; amphotericin B; azapropazon; cimetidine; tacrolimus; fibric acid derivatives (e.g., bezafibrate, fenofibrate) |
| Methotrexate | boxed warning | For Psoriasis Patients (see also BOXED WARNING above) Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or … |
| Methylprednisolone | drug interactions | diltiazem; fluconazole; azithromycin; methylprednisolone; Allopurinol |
| Metoclopramide | drug interactions | … voriconazole quinupristin/ dalfopristin colchicine danazol imatinib metoclopramide nefazodone oral contraceptives HIV Protease Inhibitors The HIV protease inhibitors (e.g., indinavir, nelfinavir … |
| Mitoxantrone | drug interactions | … increase the exposure to anthracycline antibiotics (e.g., doxorubicin, mitoxantrone, daunorubicin) in cancer patients. |
| Mycophenolate mofetil | drug interactions | Concomitant administration of cyclosporine and mycophenolate mofetil or mycophenolate sodium in transplant patients may decrease the mean exposure of MPA by 20% - 50% when compared with other … |
| Mycophenolic acid | drug interactions | Interactions Resulting in Decrease of Other Drug Levels Cyclosporine inhibits the enterohepatic circulation of mycophenolic acid (MPA). |
| Nafcillin | drug interactions | nafcillin; carbamazepine; bosentan; St. John’s Wort |
| Naproxen | drug interactions | trimethoprim with sulfamethoxazole; naproxen |
| Nefazodone | drug interactions | … quinupristin/ dalfopristin colchicine danazol imatinib metoclopramide nefazodone oral contraceptives HIV Protease Inhibitors The HIV protease inhibitors (e.g., indinavir, nelfinavir, ritonavir, and … |
| Nelfinavir | drug interactions | … Protease Inhibitors The HIV protease inhibitors (e.g., indinavir, nelfinavir, ritonavir, and saquinavir) are known to inhibit cytochrome P-450 3A and thus could potentially increase the … |
| Nicardipine | drug interactions | nicardipine; itraconazole; clarithromycin; Amiodarone |
| Nifedipine | drug interactions | The concomitant use of nifedipine should be avoided in patients in whom gingival hyperplasia develops as a side effect of cyclosporine. |
| Octreotide | drug interactions | rifampin; oxcarbazepine; octreotide |
| Orlistat | drug interactions | Compounds that decrease cyclosporine absorption, such as orlistat, should be avoided. |
| Oxcarbazepine | drug interactions | rifampin; oxcarbazepine; octreotide |
| Phenobarbital | drug interactions | phenobarbital; orlistat |
| Phenytoin | drug interactions | phenytoin; sulfinpyrazone |
| Piroxicam | drug interactions | No clinically significant pharmacokinetic interactions occurred between cyclosporine and aspirin, ketoprofen, piroxicam, or indomethacin. |
| Pravastatin | drug interactions | … administration of cyclosporine with lovastatin, simvastatin, atorvastatin, pravastatin, and rarely fluvastatin. |
| Prednisolone | drug interactions | Cyclosporine may reduce the clearance of digoxin, colchicine, prednisolone, HMG-CoA reductase inhibitors (statins), aliskiren, bosentan, dabigatran, repaglinide, NSAIDs, sirolimus, etoposide, and … |
| Ranitidine | drug interactions | gentamicin; ketoconazole; colchicine; ranitidine; methotrexate |
| Repaglinide | drug interactions | Cyclosporine may reduce the clearance of digoxin, colchicine, prednisolone, HMG-CoA reductase inhibitors (statins), aliskiren, bosentan, dabigatran, repaglinide, NSAIDs, sirolimus, etoposide, and … |
| Rifabutin | drug interactions | Rifabutin Rifabutin is known to increase the metabolism of other drugs metabolized by the cytochrome P-450 system. |
| Rifampin | drug interactions | rifampin; oxcarbazepine; octreotide |
| Ritonavir | drug interactions | … Inhibitors The HIV protease inhibitors (e.g., indinavir, nelfinavir, ritonavir, and saquinavir) are known to inhibit cytochrome P-450 3A and thus could potentially increase the concentrations of … |
| Simvastatin | drug interactions | … reported with concomitant administration of cyclosporine with lovastatin, simvastatin, atorvastatin, pravastatin, and rarely fluvastatin. |
| Sirolimus | drug interactions | … inhibitors (statins), aliskiren, bosentan, dabigatran, repaglinide, NSAIDs, sirolimus, etoposide, and other drugs. |
| Sulindac | drug interactions | vancomycin; sulindac |
| Tacrolimus | drug interactions | ciprofloxacin; melphalan; amphotericin B; azapropazon; cimetidine; tacrolimus; fibric acid derivatives (e.g., bezafibrate, fenofibrate) |
| Terbinafine | drug interactions | … oxcarbazepine octreotide phenobarbital orlistat phenytoin sulfinpyrazone terbinafine ticlopidine Bosentan Coadministration of bosentan (250 to 1000 mg every 12 hours based on tolerability) and … |
| Tobramycin | drug interactions | tobramycin; diclofenac |
| Trimethoprim | drug interactions | trimethoprim with sulfamethoxazole; naproxen |
| Vancomycin | drug interactions | vancomycin; sulindac |
| Verapamil | drug interactions | verapamil; ketoconazole; erythromycin; Bromocriptine |
| Voriconazole | drug interactions | voriconazole; quinupristin/ dalfopristin; colchicine |
Other labels that name cyclosporine
- Adalimumab
- Adefovir dipivoxil
- Afatinib
- Amiloride
- Amlodipine
- Armodafinil
- Aspirin, butalbital, caffeine and codeine
- Atazanavir
- Belatacept
- Bempedoic acid
- Bimekizumab
- Blinatumomab
- Brincidofovir
- Brodalumab
- Budesonide
- Candesartan and hydrochlorothiazide
- Carvedilol
- Caspofungin
- Celecoxib
- Cholic acid
- Cladribine
- Cobicistat
- Colesevelam
- Cyclophosphamide
- Daraxonrasib
- Darunavir
- Deferasirox
- Dexamethasone
- Dibasic and monobasic
- Diflunisal
- Dronabinol
- Dronedarone
- Efavirenz
- Elbasvir and grazoprevir
- Eluxadoline
- Enzalutamide
- Ethinyl estradiol and ferrous bisglycinate and levonorgestrel
- Ethinyl estradiol and ferrous fumarate and levonorgestrel
- Ethinyl estradiol and levonorgestrel
- Ethinyl estradiol and norelgestromin
- Ethinyl estradiol and norgestimate
- Ethinyl estradiol and segesterone
- Etodolac
- Etonogestrel
- Etravirine
- Everolimus
- Ezetimibe
- Fenofibric acid
- Fenoprofen
- Fosamprenavir
- Foscarnet
- Fosphenytoin
- Furosemide
- Ganciclovir
- Glecaprevir and pibrentasvir
- Glyburide
- Golimumab
- Hydrochlorothiazide and valsartan
- Hydrocortisone
- Ibuprofen
- Infliximab
- Isavuconazonium
- Ivacaftor
- Ketorolac
- Lanreotide
- Letermovir
- Levamlodipine
- Magnesium sulfate
- Mannitol
- Maribavir
- Mefenamic acid
- Meloxicam
- Metreleptin
- Metronidazole
- Mifepristone
- Modafinil
- Naldemedine
- Natalizumab
- Nevirapine
- Norethindrone
- Ofloxacin
- Omeprazole
- Oxaprozin
- Palbociclib
- Paltusotine
- Pasireotide
- Perindopril
- Pitavastatin
- Posaconazole
- Potassium chloride
- Potassium phosphate dibasic and potassium phosphate monobasic
- Ranolazine
- Revefenacin
- Rifaximin
- Rimegepant
- Rosuvastatin
- Seladelpar lysine
- Sevelamer
- Silodosin
- Siltuximab
- Sofosbuvir and velpatasvir and voxilaprevir
- Streptomycin
- Sulfamethoxazole and trimethoprim
- Tigecycline
- Tinidazole
- Tocilizumab
- Tofacitinib
- Triamcinolone
- Ubrogepant
- Valganciclovir
Source: FDA drug label (Neoral), Novartis Pharmaceuticals Corporation, effective August 10, 2026 (SPL set 94461af3-11f1-4670-95d4-2965b9538ae3), via openFDA; the full label on DailyMed
What do FAERS reports show for cyclosporine?
The FDA Adverse Event Reporting System holds 115,545 reports that list cyclosporine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14,506 are coded as a death and 28,361 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cyclosporine?
5 other medicines are given the same way (oral) and in the same FDA class as cyclosporine or labeled mainly for the same use (organ transplant rejection), the same class first. Organ transplant rejection lists all 13 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tacrolimus | Organ transplant rejection | 30 labelers | $0.123 per capsule 0.5 mg capsule (immediate release) | No current entry |
| Mycophenolate mofetil | Organ transplant rejection | 30 labelers | $0.138 per capsule 250 mg capsule | No current entry |
| Mycophenolic acid | Organ transplant rejection | 16 labelers | $0.0996 per tablet 180 mg tablet | No current entry |
| Sirolimus | Organ transplant rejection | 18 labelers | $0.723 per tablet 1 mg tablet | No current entry |
| Azathioprine | Rheumatoid arthritis, Organ transplant rejection | 16 labelers | $0.124 per tablet 50 mg tablet | No current entry |
Every medicine labeled for the same conditions as cyclosporine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does cyclosporine compare with medicines for the same use?
2 side-by-side pages set cyclosporine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to cyclosporine
- 5 medicines for the same use
- Other calcineurin inhibitor immunosuppressants
- the pharmacologic class, with prices and generics
- Cyclosporine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other