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)
Internal haemorrhage24.07.01.0720.000743%Not Available
Toxic leukoencephalopathy17.13.02.012; 12.03.01.0590.000297%Not Available
Unmasking of previously unidentified disease08.01.03.0800.000297%Not Available
Chronic papillomatous dermatitis23.01.04.005; 12.02.16.0020.000297%Not Available
Meconium aspiration syndrome22.11.01.007; 18.04.10.0020.000297%Not Available
Autoimmune hypothyroidism10.04.08.009; 05.02.03.005--Not Available
Soft tissue swelling15.03.02.0200.000297%Not Available
Non-cirrhotic portal hypertension24.08.06.003; 09.01.06.0190.000891%Not Available
End stage renal disease20.01.03.0190.005792%Not Available
Abdominal rebound tenderness07.01.05.0130.000297%Not Available
Acute macular neuroretinopathy17.17.01.026; 06.10.02.0080.000446%Not Available
Allergy to animal10.01.03.0510.000297%Not Available
Arterioenteric fistula07.11.05.018; 24.02.02.006; 12.02.01.0300.000891%Not Available
Atypical haemolytic uraemic syndrome17.02.10.027; 20.01.03.027; 07.11.01.032; 01.06.02.0030.001485%Not Available
Autoimmune enteropathy10.04.04.020; 07.08.03.0200.000297%Not Available
Biliary obstruction09.02.02.0050.000446%Not Available
Blood loss anaemia24.07.01.088; 01.03.02.0180.000446%Not Available
Bone marrow transplant rejection10.02.03.008; 01.05.01.0230.000297%Not Available
Calcineurin inhibitor induced pain syndrome15.02.04.043; 12.02.09.033; 01.05.01.0240.004753%Not Available
Castleman's disease16.21.02.005; 01.13.02.0050.000594%Not Available
Central nervous system vasculitis17.08.02.029; 24.12.04.005; 10.02.02.0300.001040%Not Available
Conjunctival neoplasm16.34.03.002; 06.12.03.0020.000297%Not Available
Cutaneous T-cell lymphoma23.07.04.029; 16.17.03.002; 01.11.03.0020.000743%Not Available
Dilated cardiomyopathy02.04.01.0170.000594%Not Available
Drug effective for unapproved indication12.09.02.001; 08.06.01.0370.002287%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.0380.012030%Not Available
Drug-disease interaction08.06.03.0120.001960%Not Available
Dyschromatopsia06.02.09.0030.000594%Not Available
Endocrine ophthalmopathy06.09.04.008; 05.02.02.008; 14.11.01.051; 10.04.08.012--Not Available
Epileptic encephalopathy19.21.02.015; 17.12.03.0330.000297%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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