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' disease05.02.02.009; 06.09.04.009; 10.04.08.014---
Haemophagocytic lymphohistiocytosis01.05.01.026; 10.02.01.077; 16.32.03.0380.003713%-
Heart transplant rejection02.11.01.015; 10.02.03.009; 12.02.01.0390.001931%-
Hyperglycaemic hyperosmolar nonketotic syndrome05.07.04.009; 14.07.04.009; 17.02.04.0220.002376%-
Idiopathic intracranial hypertension17.07.02.0110.001040%-
Illness08.01.03.091---
Immune thrombocytopenia01.08.01.013; 10.02.01.0830.005198%-
Inferior vena cava dilatation24.03.04.0150.000297%-
Inhibitory drug interaction08.06.03.0140.000594%-
Intestinal metastasis07.21.01.021; 16.22.02.0290.000446%-
Intestine transplant rejection07.11.01.042; 10.02.03.010; 12.02.03.0270.000446%-
Intraductal papillary mucinous neoplasm07.21.04.015; 16.13.11.0070.000297%-
Jejunal perforation07.04.06.0130.000446%
Lung transplant rejection10.02.03.011; 12.02.07.015; 22.01.01.0290.002376%-
Malacoplakia08.01.05.018; 10.03.02.008; 11.07.01.0230.000891%-
Neonatal respiratory distress18.04.10.004; 22.11.02.0150.000446%-
Neuropsychological symptoms17.02.05.073; 19.07.03.0100.000297%-
New onset diabetes after transplantation05.06.01.017; 12.02.15.002; 14.06.01.0170.001634%-
Normocytic anaemia01.03.02.0220.000891%-
Oligoarthritis15.01.01.0180.000594%-
Oropharyngeal lymphoid hyperplasia01.09.01.036; 07.05.01.022; 22.04.05.0220.000446%-
Pancreatic failure07.18.02.0110.000297%-
Peripheral T-cell lymphoma unspecified stage IV01.11.06.003; 16.17.06.0030.000297%-
Peritoneal lesion07.07.01.0160.000297%-
Physical deconditioning08.01.03.0960.000297%-
Post thrombotic retinopathy06.10.02.010; 24.01.07.0070.000297%-
Primary biliary cholangitis09.01.04.010; 10.04.09.0040.000594%-
Primary effusion lymphoma01.15.01.010; 16.28.01.0100.000446%-
Pulmonary sensitisation10.02.01.101; 22.01.01.0320.000446%-
Renal tubular dysfunction20.05.03.0280.000297%-
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ADReCS-Target
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