Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cyclosporine
Drug ID BADD_D00551
Description Cyclosporine is a calcineurin inhibitor known for its immunomodulatory properties that prevent organ transplant rejection and treat various inflammatory and autoimmune conditions. It is isolated from the fungus _Beauveria nivea_.[A174049] Initially manufactured by Sandoz and approved for use by the FDA in 1983, cyclosporine is now available in various products by Novartis (previously known as Sandoz).[L11097,L3734,L11118]
Indications and Usage Cyclosporine is approved for a variety of conditions. Firstly, it is approved for the prophylaxis of organ rejection in allogeneic kidney, liver, and heart transplants. It is also used to prevent bone marrow transplant rejection. For the above indications, cyclosporine can be used in conjunction with azathioprine and corticosteroids. Finally, cyclosporine can be used in patients who have chronic transplant rejection and have received previous immunosuppressive therapy[L3002] and to prevent or treat graft-versus-host disease (GVHD).[L11097] Secondly, cyclosporine is used for the treatment of patients with severe active rheumatoid arthritis (RA) when they no longer respond to methotrexate alone.[L3734] It can be used for the treatment of adult non-immunocompromised patients with severe, recalcitrant, plaque psoriasis that have failed to respond to at least one systemic therapy or when systemic therapies are not tolerated or contraindicated.[L3734] The ophthalmic solution of cyclosporine is indicated to increase tear production in patients suffering from keratoconjunctivitis sicca.[L11097] In addition, cyclosporine is approved for the treatment of steroid dependent and steroid-resistant nephrotic syndrome due to glomerular diseases which may include minimal change nephropathy, focal and segmental glomerulosclerosis or membranous glomerulonephritis.[L11097] A cyclosporine ophthalmic emulsion is indicated in the treatment of vernal keratoconjunctivitis in adults and children.[L34694] Off-label, cyclosporine is commonly used for the treatment of various autoimmune and inflammatory conditions such as atopic dermatitis, blistering disorders, ulcerative colitis, juvenile rheumatoid arthritis, uveitis, connective tissue diseases, as well as idiopathic thrombocytopenic purpura.[A139,A174085,A189393,A189396,A189399]
Marketing Status approved; investigational; vet_approved
ATC Code S01XA18; L04AD01
DrugBank ID DB00091
KEGG ID D00184
MeSH ID D016572
PubChem ID 5280754
TTD Drug ID D0O3YF
NDC Product Code 10888-5040; 11014-0033; 11014-0034; 11014-0041; 51927-0160; 55361-0025; 55361-0023; 23155-838; 0172-7313; 64380-127; 64380-128; 68084-921; 51927-3196; 55486-1567; 55486-1604; 55500-0009; 0093-9020; 51862-460; 60505-0134; 64380-129; 65086-001; 0574-0866; 47848-004; 51552-0663; 59573-0001; 66507-0001; 0074-3108; 0078-0241; 23155-837; 23155-839; 47335-506; 60505-0133; 0378-8760; 65897-3008; 0078-0110; 60505-4630; 60505-4632; 63629-8640; 65897-1008; 0078-0246; 0078-0274; 0093-9019; 68084-879; 11014-0040; 51927-0213; 55361-0022; 55361-0026; 68254-2501; 0078-0248; 47335-507; 60505-4631; 60505-6202; 68180-214; 10888-5041; 52928-005; 52972-0027; 55486-1602; 10702-808; 68254-0008; 0074-3109; 0074-7269; 0078-0109; 0078-0240; 0023-5301; 0074-5503; 51862-458; 55486-1603; 0093-9018; 0023-9163
UNII 83HN0GTJ6D
Synonyms Cyclosporine | Cyclosporine A | Cyclosporin A | Ciclosporin | Cyclosporin | Neoral | Sandimmun Neoral | CyA-NOF | CyA NOF | Sandimmune | Sandimmun | CsA-Neoral | CsA Neoral | CsANeoral | OL 27-400 | OL 27 400 | OL 27400
Chemical Information
Molecular Formula C62H111N11O12
CAS Registry Number 59865-13-3
SMILES CCC1C(=O)N(CC(=O)N(C(C(=O)NC(C(=O)N(C(C(=O)NC(C(=O)NC(C(=O)N(C(C(=O)N(C(C(=O)N(C (C(=O)N(C(C(=O)N1)C(C(C)CC=CC)O)C)C(C)C)C)CC(C)C)C)CC(C)C)C)C)C)CC(C)C)C)C(C)C)C C(C)C)C)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Posterior reversible encephalopathy syndrome17.13.02.0070.002398%
Drug-induced liver injury12.03.01.044; 09.01.07.023--Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.0100.000497%Not Available
Reversible cerebral vasoconstriction syndrome24.04.06.026; 18.06.01.004; 17.08.02.0140.000221%Not Available
Candida infection11.03.03.021--
Renal transplant failure20.01.02.014; 12.02.09.017; 10.02.03.006--Not Available
Language disorder19.19.01.006; 17.02.08.0150.000111%Not Available
Mouth swelling23.04.01.020; 10.01.05.020; 07.05.04.007--Not Available
Multiple organ dysfunction syndrome08.01.03.0570.001050%
Acoustic neuroma17.18.02.002; 16.09.02.002; 04.04.04.0030.000111%Not Available
Alexia19.21.01.008; 17.02.03.0140.000111%Not Available
Anal ulcer07.04.01.0010.000111%
Bladder cancer recurrent20.03.04.005; 16.08.01.0030.000111%Not Available
Cardiac failure chronic02.05.01.0090.000111%Not Available
Concomitant disease aggravated08.01.03.0630.000829%Not Available
Dermatitis exfoliative generalised23.03.07.002; 10.01.01.0290.000111%Not Available
Dyslalia19.19.03.009; 17.02.08.0180.000166%Not Available
Enthesopathy15.07.01.011--Not Available
Hyperaldosteronism24.08.04.005; 14.05.04.006; 05.01.01.0060.000111%Not Available
IgA nephropathy20.05.01.016; 10.02.01.0630.000221%Not Available
Liposarcoma16.33.05.001; 15.09.03.005--Not Available
Lumbar spinal stenosis17.10.03.004; 15.10.04.0080.000276%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.000166%Not Available
Normal newborn18.08.06.0010.000111%Not Available
Peripheral T-cell lymphoma unspecified16.17.06.001; 01.11.06.0010.000111%Not Available
Renal atrophy20.01.06.0010.000111%Not Available
Renal tubular atrophy20.05.03.0220.000221%Not Available
Small for dates baby18.04.02.002--Not Available
Threatened labour18.07.01.0090.000111%Not Available
Concomitant disease progression08.01.03.0640.000497%Not Available
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ADReCS-Target
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