Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Tacrolimus
Drug ID BADD_D02105
Description Tacrolimus (also FK-506 or Fujimycin) is an immunosuppressive drug whose main use is after organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection. It is also used in a topical preparation in the treatment of severe atopic dermatitis, severe refractory uveitis after bone marrow transplants, and the skin condition vitiligo. It was discovered in 1984 from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis. Tacrolimus is chemically known as a macrolide. It reduces peptidyl-prolyl isomerase activity by binding to the immunophilin FKBP-12 (FK506 binding protein) creating a new complex. This FKBP12-FK506 complex inhibits calcineurin which inhibits T-lymphocyte signal transduction and IL-2 transcription.
Indications and Usage For use after allogenic organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection. It was given FDA approval in 1994 for use in liver transplantation. Since then, this indication has expanded to kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, and limb transplants. It has also been used in a topical preparation in the treatment of severe atopic dermatitis.
Marketing Status approved; investigational
ATC Code D11AH01; L04AD02
DrugBank ID DB00864
KEGG ID D00107; D08556
MeSH ID D016559
PubChem ID 445643
TTD Drug ID D06OMK
NDC Product Code 0904-6623; 51927-0092; 65897-3010; 68254-0020; 73377-010; 16729-041; 16729-421; 0093-3428; 63629-8726; 0378-2045; 67877-279; 67877-280; 68254-5006; 68992-3010; 68992-3075; 0469-1230; 70518-3216; 38779-2698; 47848-018; 49629-020; 51187-0006; 65050-0321; 68254-2502; 0093-3429; 43817-421; 50222-211; 55111-527; 63629-9325; 64380-721; 0378-2047; 68084-450; 68308-703; 70518-2996; 0904-6624; 0168-0416; 45802-390; 45802-700; 51079-028; 51079-818; 55111-526; 68462-686; 0469-0607; 70748-221; 60429-378; 68254-5005; 68462-534; 70377-014; 70748-220; 65897-1010; 16714-100; 0378-2046; 67877-278; 68462-687; 70377-015; 70518-3388; 49629-022; 52076-6222; 16729-042; 16729-422; 51079-817; 68084-449; 0469-1330; 69452-154; 69452-155; 72572-761; 82983-401; 82983-402; 16714-098; 55111-525; 60429-379; 63629-8725; 68084-451; 0469-0657; 71335-2189; 72572-760; 49629-021; 52928-006; 62991-3072; 50090-5596; 50222-203; 54288-135; 55154-4168; 68254-5004; 0469-0617; 0469-3016; 0781-2102; 0781-2103; 82983-400; 0168-0417; 43817-423; 55154-4080; 60429-377; 68992-3040; 70377-016; 82160-124; 55500-0010; 65727-009; 68254-0002; 43353-317; 43817-422; 62250-665; 63629-8723; 64380-720; 64380-722; 68462-685; 69452-153; 70748-219; 0781-2104; 0904-7097; 51552-1403; 52972-0040; 55486-1576; 16714-099; 16729-043
UNII WM0HAQ4WNM
Synonyms Tacrolimus | Prograf | Prograft | FR-900506 | FR 900506 | FR900506 | Anhydrous Tacrolimus | Tacrolimus, Anhydrous | Tacrolimus Anhydrous | Anhydrous, Tacrolimus | FK-506 | FK 506 | FK506
Chemical Information
Molecular Formula C44H69NO12
CAS Registry Number 104987-11-3
SMILES CC1CC(C2C(CC(C(O2)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C(CC(=O)C(C=C(C1)C)CC=C)O)C)C(=CC 4CCC(C(C4)OC)O)C)O)C)OC)OC
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)
Language disorder17.02.08.015; 19.19.01.006--Not Available
Encapsulating peritoneal sclerosis07.07.03.0040.000594%Not Available
Respiratory symptom22.12.02.0130.000297%Not Available
Varicella zoster virus infection11.05.02.023--Not Available
Acute motor-sensory axonal neuropathy17.09.01.002; 11.07.01.014; 10.04.10.0110.000297%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.009654%
Immune-mediated adverse reaction10.02.01.0440.002525%Not Available
Adenoidal hypertrophy22.04.05.0150.000594%Not Available
Adult T-cell lymphoma/leukaemia16.17.01.002; 01.11.01.0020.000594%Not Available
Anaemia of chronic disease01.03.04.0020.000446%Not Available
Angiosarcoma24.03.06.003; 16.16.03.0010.000594%Not Available
Antiphospholipid syndrome01.01.02.016; 24.01.01.029; 18.02.04.002; 10.04.01.0090.000297%Not Available
Biliary fistula09.02.03.0050.000446%
Burning sensation mucosal17.02.06.031; 08.01.06.0200.001010%Not Available
Cardiac failure chronic02.05.01.0090.000297%Not Available
Carotid artery aneurysm24.02.04.003; 17.08.06.0020.000594%Not Available
Central nervous system lymphoma18.04.04.013; 17.02.10.028; 16.20.01.005; 01.12.01.0050.000446%Not Available
Cervical spinal stenosis17.10.02.006; 15.10.04.006--Not Available
Chronic gastritis11.07.01.016; 10.04.04.011; 07.08.02.0050.000446%Not Available
Concomitant disease aggravated08.01.03.0630.000446%Not Available
Convulsive threshold lowered17.12.03.0230.000297%Not Available
Cryoglobulinaemia24.12.04.007; 10.04.04.0130.000743%Not Available
Dermatitis exfoliative generalised23.03.07.002; 10.01.01.0290.000446%Not Available
Diffuse large B-cell lymphoma stage IV16.28.02.004; 01.15.02.0040.000743%Not Available
Gastroenteritis eosinophilic07.08.03.014; 01.02.04.0180.001485%Not Available
Hepatic infarction09.01.06.017; 24.04.07.0070.000594%Not Available
Hypermetabolism14.11.01.0180.000594%Not Available
IgA nephropathy20.05.01.016; 10.02.01.0630.001485%Not Available
Locked-in syndrome17.01.04.0190.001782%Not Available
Lumbar spinal stenosis17.10.03.004; 15.10.04.0080.000297%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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