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)
Graves' disease10.04.08.014; 06.09.04.009; 05.02.02.009--Not Available
Haemophagocytic lymphohistiocytosis16.32.03.038; 10.02.01.077; 01.05.01.0260.003713%Not Available
Heart transplant rejection10.02.03.009; 02.11.01.015; 12.02.01.0390.001931%Not Available
Hyperglycaemic hyperosmolar nonketotic syndrome17.02.04.022; 14.07.04.009; 05.07.04.0090.002376%Not Available
Idiopathic intracranial hypertension17.07.02.0110.001040%Not Available
Illness08.01.03.091--Not Available
Immune thrombocytopenia10.02.01.083; 01.08.01.0130.005198%Not Available
Inferior vena cava dilatation24.03.04.0150.000297%Not Available
Inhibitory drug interaction08.06.03.0140.000594%Not Available
Intestinal metastasis16.22.02.029; 07.21.01.0210.000446%Not Available
Intestine transplant rejection12.02.03.027; 10.02.03.010; 07.11.01.0420.000446%Not Available
Intraductal papillary mucinous neoplasm16.13.11.007; 07.21.04.0150.000297%Not Available
Jejunal perforation07.04.06.0130.000446%
Lung transplant rejection10.02.03.011; 22.01.01.029; 12.02.07.0150.002376%Not Available
Malacoplakia11.07.01.023; 10.03.02.008; 08.01.05.0180.000891%Not Available
Neonatal respiratory distress22.11.02.015; 18.04.10.0040.000446%Not Available
Neuropsychological symptoms17.02.05.073; 19.07.03.0100.000297%Not Available
New onset diabetes after transplantation14.06.01.017; 12.02.15.002; 05.06.01.0170.001634%Not Available
Normocytic anaemia01.03.02.0220.000891%Not Available
Oligoarthritis15.01.01.0180.000594%Not Available
Oropharyngeal lymphoid hyperplasia07.05.01.022; 01.09.01.036; 22.04.05.0220.000446%Not Available
Pancreatic failure07.18.02.0110.000297%Not Available
Peripheral T-cell lymphoma unspecified stage IV16.17.06.003; 01.11.06.0030.000297%Not Available
Peritoneal lesion07.07.01.0160.000297%Not Available
Physical deconditioning08.01.03.0960.000297%Not Available
Post thrombotic retinopathy24.01.07.007; 06.10.02.0100.000297%Not Available
Primary biliary cholangitis10.04.09.004; 09.01.04.0100.000594%Not Available
Primary effusion lymphoma16.28.01.010; 01.15.01.0100.000446%Not Available
Pulmonary sensitisation22.01.01.032; 10.02.01.1010.000446%Not Available
Renal tubular dysfunction20.05.03.0280.000297%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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