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%-
Toxic leukoencephalopathy12.03.01.059; 17.13.02.0120.000297%-
Unmasking of previously unidentified disease08.01.03.0800.000297%-
Chronic papillomatous dermatitis12.02.16.002; 23.01.04.0050.000297%-
Meconium aspiration syndrome18.04.10.002; 22.11.01.0070.000297%-
Autoimmune hypothyroidism05.02.03.005; 10.04.08.009---
Soft tissue swelling15.03.02.0200.000297%-
Non-cirrhotic portal hypertension09.01.06.019; 24.08.06.0030.000891%-
End stage renal disease20.01.03.0190.005792%-
Abdominal rebound tenderness07.01.05.0130.000297%-
Acute macular neuroretinopathy06.10.02.008; 17.17.01.0260.000446%-
Allergy to animal10.01.03.0510.000297%-
Arterioenteric fistula07.11.05.018; 12.02.01.030; 24.02.02.0060.000891%-
Atypical haemolytic uraemic syndrome01.06.02.003; 07.11.01.032; 17.02.10.027; 20.01.03.0270.001485%-
Autoimmune enteropathy07.08.03.020; 10.04.04.0200.000297%-
Biliary obstruction09.02.02.0050.000446%-
Blood loss anaemia01.03.02.018; 24.07.01.0880.000446%-
Bone marrow transplant rejection01.05.01.023; 10.02.03.0080.000297%-
Calcineurin inhibitor induced pain syndrome01.05.01.024; 12.02.09.033; 15.02.04.0430.004753%-
Castleman's disease01.13.02.005; 16.21.02.0050.000594%-
Central nervous system vasculitis10.02.02.030; 17.08.02.029; 24.12.04.0050.001040%-
Conjunctival neoplasm06.12.03.002; 16.34.03.0020.000297%-
Cutaneous T-cell lymphoma01.11.03.002; 16.17.03.002; 23.07.04.0290.000743%-
Dilated cardiomyopathy02.04.01.0170.000594%-
Drug effective for unapproved indication08.06.01.037; 12.09.02.0010.002287%-
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.012030%-
Drug-disease interaction08.06.03.0120.001960%-
Dyschromatopsia06.02.09.0030.000594%-
Endocrine ophthalmopathy05.02.02.008; 06.09.04.008; 10.04.08.012; 14.11.01.051---
Epileptic encephalopathy17.12.03.033; 19.21.02.0150.000297%-
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ADReCS-Target
Drug Name ADR Term Target
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