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)
Vulvovaginal burning sensation21.08.02.0070.001010%Not Available
Toxic neuropathy12.03.01.055; 17.09.03.0170.000297%Not Available
Focal segmental glomerulosclerosis20.05.01.0030.003119%Not Available
Upper airway obstruction22.12.03.0320.000891%Not Available
Skin mass23.07.04.0140.001040%Not Available
Brain injury17.11.01.003; 19.07.03.0070.000891%Not Available
Cholestatic liver injury09.01.07.0160.000297%Not Available
Hypertransaminasaemia09.01.02.0050.000594%Not Available
Fasting26.01.02.001--Not Available
X-linked lymphoproliferative syndrome16.21.02.003; 11.05.10.005; 10.03.01.003; 03.17.01.002; 01.13.02.003--Not Available
Epstein-Barr virus associated lymphoproliferative disorder16.21.02.002; 11.05.10.001; 01.13.02.0020.001188%Not Available
Acute kidney injury20.01.03.0160.042328%
Osmotic demyelination syndrome17.16.02.0040.004010%Not Available
Hypoxic-ischaemic encephalopathy24.04.06.021; 22.02.02.011; 17.13.02.0060.000297%Not Available
Foetal growth restriction18.03.01.0020.004307%
Gestational hypertension24.08.07.004; 18.02.03.0040.002436%Not Available
Skin sensitisation23.03.03.052; 10.02.01.0380.000653%Not Available
Prostatic dysplasia21.04.01.0070.000297%Not Available
Posterior reversible encephalopathy syndrome17.13.02.0070.027476%
Functional gastrointestinal disorder07.11.01.0160.000297%Not Available
Lower urinary tract symptoms20.02.02.0230.000297%Not Available
Slow speech19.19.02.004; 17.02.08.0160.000297%Not Available
Resting tremor17.01.06.0080.000743%Not Available
Peripheral artery thrombosis24.01.02.0100.000446%Not Available
Rheumatic disorder15.03.04.018; 10.02.01.0480.000653%Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.0100.003119%Not Available
Reversible cerebral vasoconstriction syndrome18.06.01.004; 17.08.02.014; 24.04.06.0260.002228%Not Available
Autoimmune haemolytic anaemia10.04.01.005; 01.06.01.0040.004159%Not Available
Candida infection11.03.03.021--
Transplant dysfunction12.02.09.019--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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