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)
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.0010.001396%Not Available
Skin swelling23.03.03.0390.000653%Not Available
Application site swelling12.07.01.027; 08.02.01.0270.000297%Not Available
Growth retardation15.03.05.016; 14.03.02.031; 05.03.02.0070.000951%
Evans syndrome10.04.01.003; 01.06.01.0020.001188%Not Available
Nodule08.03.05.0020.000446%Not Available
Skin candida23.11.03.009; 11.03.03.010--Not Available
Affect lability19.04.01.001--Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.003267%Not Available
Metaplasia08.03.04.0040.000297%Not Available
Hepatic cancer metastatic16.07.02.002; 09.04.02.0060.000297%Not Available
Hypertensive nephropathy24.08.05.003; 20.01.08.004--Not Available
Foetal death18.01.02.003; 08.04.01.0110.000743%
Haemorrhage24.07.01.002--Not Available
Tinea versicolour23.11.03.013; 11.03.08.006--Not Available
Pulmonary mass22.02.07.0040.001040%Not Available
Food craving19.09.01.010; 14.03.01.0090.000297%Not Available
Vulvovaginal pruritus23.03.12.009; 21.08.02.0040.001010%Not Available
Gaze palsy17.02.05.044; 06.05.02.0140.000594%Not Available
Palpable purpura23.06.02.006; 10.02.02.019; 24.12.04.0180.000446%Not Available
Pneumatosis intestinalis07.11.01.0430.001485%Not Available
Temperature intolerance08.01.09.022--Not Available
Human polyomavirus infection11.05.05.005--Not Available
Bipolar disorder19.16.01.0030.001396%Not Available
Vascular dementia17.03.01.003; 24.04.06.017; 19.20.04.0010.000297%Not Available
Procedural complication12.02.05.005--
Metabolic disorder14.11.01.0010.000446%Not Available
Dyslipidaemia14.08.04.0150.000743%Not Available
Pulseless electrical activity02.03.04.0200.000446%Not Available
Dysplasia08.03.04.0070.000446%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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