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)
Lupus nephritis20.05.02.003; 15.06.02.011; 10.04.03.0110.000297%Not Available
Lymphadenopathy mediastinal01.09.01.025; 22.09.03.0060.000594%Not Available
Malignant melanoma stage I23.08.01.005; 16.03.01.0050.001040%Not Available
Metastases to adrenals16.22.02.012; 05.01.04.0070.000446%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.000891%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.001040%Not Available
Milk allergy10.01.01.0320.001337%Not Available
Neonatal respiratory distress syndrome22.11.02.010; 18.04.10.0030.001931%Not Available
Neuroblastoma17.20.03.002; 16.30.03.002; 05.01.04.0010.000297%Not Available
Nodular vasculitis23.06.02.008; 24.12.04.017; 10.02.02.0260.000743%Not Available
Optic disc haemorrhage24.07.05.014; 06.07.03.0050.000446%Not Available
Peripheral T-cell lymphoma unspecified16.17.06.001; 01.11.06.0010.000594%Not Available
Pupil fixed06.05.03.012; 17.02.11.0080.000594%Not Available
Radiculitis brachial17.10.01.0170.000951%Not Available
Recurrent cancer16.16.01.0150.000297%Not Available
Renal arteriosclerosis20.01.07.012; 24.04.11.0040.000891%Not Available
Renal tubular atrophy20.05.03.0220.000891%Not Available
Small cell carcinoma16.16.01.0170.000297%Not Available
Small for dates baby18.04.02.0020.000594%Not Available
Splenic haemorrhage12.01.17.020; 24.07.01.080; 01.09.02.0150.000297%Not Available
Squamous cell carcinoma of the oral cavity16.13.07.006; 07.21.07.0090.000297%Not Available
Squamous cell carcinoma of the tongue16.13.07.007; 07.21.07.0100.000297%Not Available
Synovial sarcoma16.33.01.004; 15.09.03.0220.000446%Not Available
Toxic optic neuropathy06.02.08.003; 17.04.05.009; 12.03.01.0330.000297%Not Available
Ureteric stenosis20.06.01.0100.001188%Not Available
Wernicke's encephalopathy14.12.02.013; 17.13.01.0130.000446%Not Available
Multiple-drug resistance08.06.01.0320.000297%Not Available
Basilar artery occlusion24.04.06.030; 17.08.01.0420.000446%Not Available
Short-bowel syndrome12.02.03.024; 07.17.01.0100.000653%Not Available
Anti-neutrophil cytoplasmic antibody positive vasculitis24.12.04.002; 10.02.02.0230.000297%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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