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)
Graft versus host disease in liver12.02.09.029; 10.02.01.060; 09.01.07.0330.000594%Not Available
Plasmablastic lymphoma16.35.01.004; 01.17.01.0040.000594%Not Available
Acute graft versus host disease in skin23.07.04.020; 12.02.09.022; 10.02.01.0530.001485%Not Available
Acute graft versus host disease in liver10.02.01.052; 12.02.09.021; 09.01.07.0300.000891%Not Available
Acute graft versus host disease in intestine12.02.09.020; 10.02.01.051; 07.11.01.0190.001337%Not Available
Stress cardiomyopathy24.04.04.026; 02.04.01.0120.000891%Not Available
Oral mucosal erythema07.05.05.0230.000297%Not Available
Segmented hyalinising vasculitis24.12.04.023; 23.06.02.009; 10.02.02.0270.000743%Not Available
Skin plaque23.03.03.0440.000446%Not Available
Graft versus host disease in lung22.01.01.021; 12.02.09.030; 10.02.01.0610.000446%Not Available
Oral allergy syndrome10.01.01.0330.001485%Not Available
Capillaritis24.12.04.004; 23.06.02.0070.000743%Not Available
Gastrointestinal vascular malformation07.15.04.007; 24.03.03.0310.000594%Not Available
Superficial siderosis of central nervous system17.08.02.024; 14.13.03.007; 04.02.01.0160.000297%Not Available
Epstein-Barr virus associated lymphoma01.15.01.003; 16.28.01.003; 11.05.10.0070.000446%Not Available
Neuroendocrine carcinoma metastatic16.24.01.008; 05.08.01.0120.000297%Not Available
Chronic graft versus host disease in intestine12.02.09.023; 10.02.01.055; 07.11.01.0220.000743%Not Available
Chronic graft versus host disease in skin23.07.04.022; 12.02.09.025; 10.02.01.0570.001188%Not Available
Chronic graft versus host disease in liver12.02.09.024; 10.02.01.056; 09.01.07.0320.000891%Not Available
Trichodysplasia spinulosa10.03.02.004; 23.03.08.0150.001248%Not Available
Prerenal failure24.06.02.025; 20.01.03.0220.000297%Not Available
Encephalitis autoimmune17.06.05.002; 16.32.01.006; 10.04.10.0120.001040%Not Available
Preterm premature rupture of membranes18.02.02.0160.000297%Not Available
Clear cell renal cell carcinoma20.01.04.008; 16.08.02.0040.000297%Not Available
Decerebrate posture15.03.05.008; 17.02.05.0540.000297%Not Available
Abdominal lymphadenopathy07.11.01.018; 01.09.01.0200.000297%Not Available
Diabetic metabolic decompensation14.07.03.003; 05.07.03.0030.000446%Not Available
Nonreassuring foetal heart rate pattern18.03.02.017; 02.03.02.0270.000297%Not Available
Graft versus host disease in gastrointestinal tract12.02.09.028; 10.02.01.059; 07.11.01.0270.003416%Not Available
Purtscher retinopathy24.04.10.007; 12.01.04.029; 06.10.02.0060.001485%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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