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)
Bone marrow oedema15.02.01.005; 01.05.01.0190.000891%Not Available
Encephalomalacia17.11.01.0160.000297%Not Available
Intestinal adenocarcinoma16.13.04.004; 07.21.01.0140.000297%Not Available
Leukaemic infiltration pulmonary22.08.01.016; 16.01.03.007; 01.10.03.0070.000297%Not Available
Ocular neoplasm16.34.03.001; 06.12.03.0010.000446%Not Available
Secondary immunodeficiency10.03.03.0090.000446%Not Available
Autoimmune neutropenia10.04.01.010; 01.02.03.0130.000743%Not Available
Tracheomalacia22.04.07.011; 08.07.02.0020.000297%Not Available
Biliary dilatation09.02.03.0040.000446%Not Available
Cell death14.11.02.005; 08.03.03.0030.002525%Not Available
Eosinophilic colitis07.08.01.019; 01.02.04.0150.001040%Not Available
Balint's syndrome17.02.03.016; 06.08.03.0220.000446%Not Available
Right ventricular dysfunction02.04.02.0330.000594%
Acquired macroglossia07.14.01.0090.000743%Not Available
Acute myeloid leukaemia recurrent01.10.05.004; 16.01.05.0040.000743%Not Available
Biloma12.02.03.016; 09.01.08.0120.000297%Not Available
Small cell lung cancer metastatic22.08.01.012; 16.19.08.0020.000297%Not Available
Haemorrhagic ascites24.07.02.032; 09.01.05.007; 07.07.02.0030.000297%Not Available
Communication disorder19.19.01.0080.000653%Not Available
Foot deformity15.10.03.0050.000297%Not Available
Oesophageal squamous cell carcinoma16.13.06.004; 07.21.06.0040.000297%Not Available
Extranodal marginal zone B-cell lymphoma (MALT type)16.28.07.001; 01.15.07.0010.000297%Not Available
Pyelocaliectasis20.01.06.0110.000891%Not Available
Renal salt-wasting syndrome20.05.03.021; 14.05.01.0110.000297%Not Available
Hypercreatininaemia20.01.02.016; 14.11.01.0390.000446%Not Available
Dysplastic naevus23.10.01.011; 16.26.01.0110.000653%Not Available
Acute right ventricular failure02.05.03.0030.000297%Not Available
Metastatic squamous cell carcinoma16.16.01.0100.000594%Not Available
Eosinophilic oesophagitis01.02.04.016; 10.01.01.030; 07.08.05.0060.001040%Not Available
Graft versus host disease in skin12.02.09.031; 10.02.01.062; 23.07.04.0250.004069%Not Available
The 37th Page    First    Pre   37 38 39 40 41    Next   Last    Total 41 Pages
ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene