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)
End stage renal disease20.01.03.0190.000442%Not Available
Tongue discomfort07.14.02.0190.000243%Not Available
Neuromyelitis optica spectrum disorder17.16.02.005; 10.04.10.015; 06.04.08.0030.000166%Not Available
Calcineurin inhibitor induced pain syndrome15.02.04.043; 12.02.09.033; 01.05.01.0240.000166%Not Available
Colon dysplasia07.11.03.0120.000111%Not Available
Cross sensitivity reaction10.01.01.0360.000111%Not Available
Cutaneous amyloidosis23.07.04.036; 10.02.05.0070.000111%Not Available
Cutaneous T-cell lymphoma16.17.03.002; 23.07.04.029; 01.11.03.0020.000166%Not Available
Disease complication08.01.03.0870.000166%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.0380.001934%Not Available
Engraftment syndrome01.05.01.025; 23.03.13.025; 22.01.02.030; 12.02.09.035; 10.02.01.0730.000111%Not Available
Fear of injection19.06.03.0160.000243%Not Available
Gait inability17.02.05.069; 08.01.02.011--Not Available
Glomerulonephritis chronic20.05.01.0210.000111%Not Available
Haemophagocytic lymphohistiocytosis16.32.03.038; 10.02.01.077; 01.05.01.0260.000553%Not Available
Hypertrophy of tongue papillae07.14.01.018--Not Available
Idiopathic angioedema23.04.01.023; 10.01.05.023--Not Available
Idiopathic intracranial hypertension17.07.02.011--Not Available
Illness08.01.03.091--Not Available
Immune thrombocytopenia10.02.01.083; 01.08.01.0130.000276%Not Available
Instillation site pruritus08.02.01.068; 23.03.12.014; 12.07.01.0680.000243%Not Available
Limb mass15.03.05.019--Not Available
Loss of therapeutic response08.06.01.0410.000276%Not Available
Lung carcinoma cell type unspecified stage I22.08.01.026; 16.19.02.0080.000111%Not Available
Lung opacity22.12.01.0060.000166%Not Available
Lung transplant rejection22.01.01.029; 12.02.07.015; 10.02.03.0110.000243%Not Available
Malignant neoplasm of conjunctiva16.34.05.001; 06.12.05.0010.000387%Not Available
Myelodysplastic syndrome with single lineage dysplasia01.10.04.013; 16.01.04.0130.000221%Not Available
Oral administration complication12.07.04.035; 08.02.04.0350.003227%Not Available
Self-consciousness19.05.01.025--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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