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)
Small intestinal perforation07.04.06.0060.000446%
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.003--Not Available
Spinal osteoarthritis15.01.04.0030.000297%Not Available
Splenic infarction24.04.08.024; 01.09.02.0040.000446%Not Available
Splenomegaly01.09.02.0010.001337%Not Available
Splinter haemorrhages24.07.01.039; 23.02.05.0140.000743%Not Available
Squamous cell carcinoma16.16.01.0020.005644%Not Available
Squamous cell carcinoma of lung16.19.01.006; 22.08.01.0140.000297%Not Available
Squamous cell carcinoma of skin23.08.02.005; 16.03.02.0050.002079%Not Available
Status epilepticus17.12.03.0050.002822%Not Available
Steroid withdrawal syndrome08.06.02.013; 19.04.02.014; 05.01.02.0070.000446%Not Available
Stevens-Johnson syndrome12.03.01.014; 11.07.01.005; 10.01.01.045; 23.03.01.007--
Stillbirth18.01.02.002; 08.04.01.0060.001040%Not Available
Stomatitis07.05.06.005--
Strabismus17.17.01.009; 06.05.02.0040.000891%Not Available
Stress19.06.02.004--Not Available
Stridor22.04.02.0030.000446%
Stupor19.02.05.004; 17.02.04.0070.000594%Not Available
Subarachnoid haemorrhage24.07.04.004; 17.08.01.010; 12.01.10.0110.002673%Not Available
Sunburn23.03.09.007; 12.05.02.001--Not Available
Supraventricular extrasystoles02.03.03.011--Not Available
Supraventricular tachycardia02.03.03.0120.001188%
Swelling08.01.03.015--Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.018--Not Available
Syncope24.06.02.012; 02.11.04.015; 17.02.04.008--
Systemic lupus erythematosus10.04.03.004; 23.03.02.006; 15.06.02.0030.000743%Not Available
T-cell lymphoma16.17.02.001; 11.05.17.006; 01.11.02.0010.000446%Not Available
Tachycardia02.03.02.007--Not Available
Tachypnoea22.02.01.0140.001545%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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