Cyclosporine — uses, dosing, side effects & the brands that sell it · pharmaranks
Cyclosporine: uses, dosing, side effects & brands
Cyclosporine is a calcineurin inhibitor immunosuppressant sold in the U.S. under 9 brand and generic names, for rheumatoid arthritis, focal segmental glomerulosclerosis and systemic lupus erythematosus. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Calcineurin Inhibitor Immunosuppressant
Treats
Rheumatoid Arthritis, Focal Segmental Glomerulosclerosis and Systemic Lupus Erythematosus
From the FDA label for Gengraf (application ANDA065003). Other cyclosporine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Gengraf ® Capsules (cyclosporine capsules, USP [MODIFIED]) has increased bioavailability in comparison to Sandimmune ® Soft Gelatin Capsules (cyclosporine capsules, USP). Gengraf ® and Sandimmune ® are not bioequivalent and cannot be used interchangeably without physician supervision. The daily dose of Gengraf ® Capsules (cyclosporine capsules, USP [ MODIFIED ]) should always be given in two divided doses (BID). It is recommended that Gengraf ® 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…
Cyclosporine side effects
Kidney, Liver, and Heart Transplantation The principal adverse reactions of cyclosporine therapy are renal dysfunction, tremor, hirsutism, hypertension, and gum hyperplasia. Hypertension Hypertension, which is usually mild to moderate, may occur in approximately 50% of patients following renal transplantation and in most cardiac transplant patients. Glomerular Capillary Thrombosis Glomerular capillary thrombosis has been found in patients treated with cyclosporine and may progress to graft failure. The pathologic changes resembled those seen in the hemolytic-uremic syndrome and included thrombosis of the renal microvasculature, with platelet-fibrin thrombi occluding glomerular capillaries and afferent arterioles, microangiopathic hemolytic anemia, thrombocytopenia, and decreased renal function. Similar findings have been observed when other immunosuppressives have been employed post-transplantation. Hypomagnesemia Hypomagnesemia has been reported in some, but not all, patients exhibiting convulsions while on cyclosporine therapy. Although magnesium-depletion studies in normal subjects suggest that hypomagnesemia is associated with neurologic disorders, multiple factors, including hypertension, high dose methylprednisolone, hypocholesterolemia, and nephrotoxicity associated with high plasma concentrations of cyclosporine appear to be related to the neurological manifestations…
Cyclosporine and food
Grapefruit & grapefruit juice
Avoid grapefruit and grapefruit juice with this medicine unless your pharmacist or the label says it's fine — check, because not every drug in a class is affected the same way.
Gengraf ® Capsules (cyclosporine capsules, USP [ MODIFIED ]) is a modified oral formulation of cyclosporine that forms an aqueous dispersion in an aqueous environment. Cyclosporine, the active principle in Gengraf ® Capsules, is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Aphanocladium album . Chemically, cyclosporine is designated as [R-[R*,R*-(E)]]-cyclic-(L-alanyl-D-alanyl- N -methyl-L-leucyl- N -methyl-L-leucyl- N -methyl-L-valyl-3-hydroxy- N ,4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyryl- N -methylglycyl- N -methyl-L-leucyl-L-valyl- N -methyl-L-leucyl). Gengraf ® Capsules (cyclosporine capsules, USP [ MODIFIED ]) are available in 25 mg and 100 mg strengths. Each 25 mg capsule contains cyclosporine, 25 mg, alcohol, USP, absolute, 12.8% v/v (10.1% wt/vol.). Each 100 mg capsule contains cyclosporine, 100 mg, alcohol, USP, absolute, 12.8% v/v (10.1% wt/vol.). The chemical structure for cyclosporine USP is Inactive Ingredients FD&C Blue No. 2, gelatin NF, polyethylene glycol USP, polyoxyl 35 castor oil NF, polysorbate 80 NF, propylene glycol USP, sorbitan monooleate NF, titanium dioxide. The chemical structure for cyclosporine USP is:
What kind of drug is cyclosporine?
The FDA classifies cyclosporine as a calcineurin inhibitor immunosuppressant. Calcineurin inhibitors block an enzyme called calcineurin inside immune T-cells, which stops the cells from making interleukin-2 and other signaling chemicals. This keeps T-cells from activating and multiplying, dialing down the immune attack that drives organ rejection or autoimmune disease. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take cyclosporine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run cyclosporine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is cyclosporine sold under?
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take cyclosporine
General Gengraf ® Capsules (cyclosporine capsules, USP [ MODIFIED ]) is contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation. Rheumatoid Arthritis Rheumatoid arthritis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive Gengraf ® Capsules (cyclosporine capsules, USP [ MODIFIED ]). Psoriasis Psoriasis patients who are treated with Gengraf ® Capsules (cyclosporine capsules, USP [ MODIFIED ]) should not receive concomitant PUVA or UVB therapy, methotrexate or other immunosuppressive agents, coal tar or radiation therapy. Psoriasis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive Gengraf ® .
Cyclosporine drug interactions
A. Effect of Drugs and Other Agents on Cyclosporine Pharmacokinetics and/or Safety All of the individual drugs cited below are well substantiated to interact with cyclosporine. In addition, concomitant use of NSAIDs with cyclosporine, particularly in the setting of dehydration, may potentiate renal dysfunction. Caution should be exercised when using other drugs which are known to impair renal function (see WARNINGS , Nephrotoxicity ). Drugs That May Potentiate Renal Dysfunction Antibiotics Antineoplastics Anti-inflammatory Drugs Gastrointestinal Agents ciprofloxacin melphalan azapropazon cimetidine gentamicin colchicine ranitidine tobramycin Antifungals diclofenac vancomycin amphotericin B naproxen Immunosuppressives trimethoprim with sulfamethoxazole ketoconazole sulindac tacrolimus Other Drugs fibric acid derivatives (e.g.,bezafibrate, fenofibrate) methotrexate During the concomitant use of a drug that may exhibit additive or synergistic renal impairment with cyclosporine, close monitoring of renal function (in particular serum creatinine) should be performed. If a significant impairment of renal function occurs, the dosage of the coadministered drug should be reduced or an alternative treatment considered. Cyclosporine is extensively metabolized by CYP 3A isoenzymes, in particular CYP3A4, and is a substrate of the multidrug efflux transporter…
We track 9 cyclosporine-containing products in the U.S.: Gengraf, Restasis, Restasis Multidose, Neoral, Sandimmune, Cyclosporine, Cequa and Verkazia, and 1 more. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does cyclosporine come in?
Across the brands we track, cyclosporine is currently marketed as capsule, emulsion, solution, injectable and drops, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic cyclosporine?
Yes. Our catalog lists 2 generic cyclosporine products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has cyclosporine been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions cyclosporine. The most recent: Klarity-C Drops (Cyclosporine) 0.1% (Oct 20, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.