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)
Cystitis noninfective20.03.02.001--
Chronic allograft nephropathy12.02.10.005; 10.02.03.004; 20.01.02.0100.001634%Not Available
Cerebral artery stenosis17.08.02.010; 24.04.06.0230.000297%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.001782%Not Available
Gastrointestinal inflammation07.08.03.0070.000297%Not Available
Skin haemorrhage24.07.01.103; 23.06.07.0010.000446%Not Available
Complex regional pain syndrome17.02.07.010; 12.01.12.0040.000446%Not Available
Dactylitis15.03.03.0090.000297%Not Available
Chronic kidney disease20.01.03.0170.009802%
Procedural pain12.02.05.007; 08.01.08.009--Not Available
Vulvovaginal mycotic infection21.14.02.004; 11.03.05.004--Not Available
Immune reconstitution inflammatory syndrome10.02.01.043; 08.06.02.0140.002376%Not Available
Application site burn12.07.01.038; 23.03.11.013; 08.02.01.038--Not Available
Polyomavirus-associated nephropathy12.02.09.037; 20.01.09.003; 11.05.05.002--Not Available
Infusion site haemorrhage24.07.01.058; 12.07.05.018; 08.02.05.0180.000297%Not Available
Bone marrow failure01.03.03.0050.001782%
Acute graft versus host disease12.02.09.002; 10.02.01.0280.003713%Not Available
Chronic graft versus host disease12.02.09.003; 10.02.01.0290.004159%Not Available
Cytopenia01.03.03.0120.001485%Not Available
Treatment failure08.06.01.0170.006654%Not Available
Hepatosplenic T-cell lymphoma16.17.01.001; 01.11.01.001--Not Available
Liver injury12.01.17.012; 09.01.07.022--Not Available
Oral herpes11.05.02.005; 07.05.07.002--Not Available
Cytotoxic oedema17.07.02.0060.000594%Not Available
Hyperammonaemic encephalopathy17.13.01.005; 14.10.01.0060.000891%Not Available
Hepatic angiosarcoma24.03.06.007; 16.07.02.003; 09.04.02.0070.000297%Not Available
Organising pneumonia22.01.02.0080.002525%Not Available
Low birth weight baby18.04.02.0030.013842%Not Available
Type 1 diabetes mellitus05.06.01.010; 14.06.01.010; 10.04.08.0070.001040%Not Available
Oral disorder07.05.01.0050.000653%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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