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)
Mental status changes19.07.01.0010.006208%Not Available
Tubulointerstitial nephritis20.05.02.0020.003861%Not Available
Mobility decreased17.02.05.018; 08.01.03.030; 15.03.05.023--Not Available
Skin maceration23.03.03.0160.000297%Not Available
Lymphocele24.09.02.002; 01.09.01.0080.001634%
Pneumopericardium02.06.01.0070.000446%Not Available
Graft loss12.02.09.008--Not Available
Sebaceous hyperplasia23.02.07.0050.000297%Not Available
Deafness unilateral04.02.01.011--Not Available
Hypoacusis04.02.01.006--
Application site vesicles23.03.01.009; 12.07.01.009; 08.02.01.009--Not Available
Brain oedema17.07.02.003; 12.01.10.0100.001782%
Bladder spasm20.02.02.013--
Weight fluctuation14.03.02.002--Not Available
Brain death17.02.03.003; 08.04.01.0040.000297%Not Available
Osteopenia15.02.03.003; 14.04.04.004--Not Available
Oesophagitis ulcerative07.04.05.003--Not Available
Psychomotor skills impaired19.22.01.002; 17.02.10.005--Not Available
Erythropoiesis abnormal01.07.02.0100.000743%Not Available
Anal haemorrhage24.07.02.029; 07.12.03.0040.000297%
Muscle fatigue15.05.03.0060.000297%Not Available
Quadriparesis17.01.04.0120.000297%Not Available
Left ventricular dysfunction02.04.02.0110.000594%
Left ventricular hypertrophy02.04.02.0140.000743%Not Available
Idiosyncratic drug reaction08.06.01.0020.000446%Not Available
Bradyphrenia19.10.03.002; 17.03.03.0040.000802%Not Available
Abulia19.01.02.009; 17.02.05.0400.000297%Not Available
Application site paraesthesia17.02.06.012; 12.07.01.026; 08.02.01.026--Not Available
Intervertebral disc protrusion15.10.01.0040.000802%Not Available
Electrocardiogram T wave abnormal13.14.05.009--
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ADReCS-Target
Drug Name ADR Term Target
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