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)
Arteritis24.12.02.0010.000743%Not Available
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Arthropathy15.01.01.003--Not Available
Ascites02.05.04.002; 09.01.05.003; 07.07.01.0010.006089%
Asterixis17.01.06.001; 09.01.03.0040.000297%Not Available
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.0100.002733%Not Available
Ataxia08.01.02.004; 17.02.02.0010.002436%
Atelectasis22.01.02.0010.000594%
Atrial fibrillation02.03.03.002--
Atrial flutter02.03.03.0030.000891%
Atrophy08.03.04.0010.000297%Not Available
Autoimmune hepatitis10.04.09.001; 09.01.07.0190.002376%Not Available
Azotaemia20.01.01.0010.001337%Not Available
B-cell lymphoma16.28.01.001; 01.15.01.0010.001040%Not Available
B-cell type acute leukaemia16.01.01.002; 01.10.01.0020.000297%Not Available
Back pain15.03.04.005--
Basal cell carcinoma23.08.02.001; 16.03.02.0010.004159%Not Available
Benign breast neoplasm21.05.01.009; 16.14.01.005--Not Available
Benign prostatic hyperplasia21.04.02.0010.000297%Not Available
Bezoar07.11.01.0080.000297%Not Available
Bile duct stone09.02.02.0030.001634%Not Available
Bladder cancer20.03.04.001; 16.08.01.001--Not Available
Bladder pain20.02.02.001--Not Available
Blepharitis23.03.04.012; 06.04.04.001--Not Available
Blepharospasm17.17.02.001; 06.05.01.0010.001010%Not Available
Blindness06.02.10.003; 17.17.01.0030.005198%Not Available
Blindness cortical06.02.10.004; 17.17.01.017--Not Available
Blindness unilateral06.02.10.007; 17.17.01.0160.000891%Not Available
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