Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Fluorouracil
Drug ID BADD_D00931
Description A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the thymidylate synthetase conversion of deoxyuridylic acid to thymidylic acid.
Indications and Usage For the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Fluorouracil injection is indicated in the palliative management of some types of cancer, including colon, esophageal, gastric, rectum, breast, biliary tract, stomach, head and neck, cervical, pancreas, renal cell, and carcinoid.
Marketing Status approved
ATC Code L01BC02
DrugBank ID DB00544
KEGG ID D00584; D07974
MeSH ID D005472
PubChem ID 3385
TTD Drug ID D05LEO
NDC Product Code 62049-185; 16110-812; 16729-276; 68001-266; 16714-178; 25021-215; 51672-4063; 63323-117; 68083-293; 70700-187; 51927-1085; 62332-751; 38779-3185; 0378-8078; 68071-2961; 68083-270; 70700-188; 28105-421; 0378-4791; 68001-524; 68001-525; 68083-269; 12070-0002; 38779-0025; 59348-0055; 16729-542; 46708-751; 51672-4118; 70700-186; 70700-189; 51862-362; 68083-292; 49452-3175; 0187-5200; 51672-4062; 62991-1486; 0187-3204
UNII U3P01618RT
Synonyms Fluorouracil | 5FU | 5-FU | 5-Fluorouracil | 5 Fluorouracil | Fluoruracil | 5-FU Lederle | 5 FU Lederle | 5-FU Medac | 5 FU Medac | 5-HU Hexal | 5 HU Hexal | Adrucil | Carac | Efudix | Fluoro-Uracile ICN | Fluoro Uracile ICN | Efudex | Fluoroplex | Flurodex | Fluorouracil Mononitrate | Fluorouracil Monopotassium Salt | Fluorouracil Monosodium Salt | Fluorouracil Potassium Salt | Fluorouracil-GRY | Fluorouracil GRY | Fluorouracile Dakota | Dakota, Fluorouracile | Fluorouracilo Ferrer Far | Fluracedyl | Haemato-FU | Haemato FU | Neofluor | Onkofluor | Ribofluor | 5-Fluorouracil-Biosyn | 5 Fluorouracil Biosyn
Chemical Information
Molecular Formula C4H3FN2O2
CAS Registry Number 51-21-8
SMILES C1=C(C(=O)NC(=O)N1)F
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)
Enterovesical fistula20.03.01.021; 07.11.05.0090.000184%
Hypercreatininaemia20.01.02.016; 14.11.01.0390.000276%Not Available
Tumour perforation16.32.03.0310.000184%Not Available
Stress cardiomyopathy02.04.01.012; 24.04.04.0260.001746%Not Available
Hypercreatinaemia15.05.03.021; 14.11.01.0240.000184%Not Available
Skin plaque23.03.03.0440.000368%Not Available
Hyperlipasaemia14.11.01.0230.000184%Not Available
Toxic leukoencephalopathy17.13.02.012; 12.03.01.0590.000919%Not Available
Administration site extravasation12.07.04.019; 08.02.04.0190.000368%Not Available
Administration site recall reaction12.07.04.030; 08.02.04.0300.000184%Not Available
Application site injury12.07.01.051; 08.02.01.0510.000404%Not Available
Cell-mediated cytotoxicity14.11.02.004; 12.03.01.0180.000276%Not Available
Cerebral venous sinus thrombosis24.01.04.021; 17.08.03.0060.000276%Not Available
Chronic villitis of unknown etiology18.05.02.007; 12.01.15.0110.000184%Not Available
Cytotoxic lesions of corpus callosum17.02.10.030; 12.03.01.0620.000184%Not Available
Dilated cardiomyopathy02.04.01.0170.000551%Not Available
Gingivitis ulcerative07.09.13.0150.000184%Not Available
Graves' disease05.02.02.009; 10.04.08.014; 06.09.04.0090.000184%Not Available
Haemophagocytic lymphohistiocytosis10.02.01.077; 01.05.01.026; 16.32.03.0380.000184%Not Available
Hepatic cytolysis09.01.07.0360.000276%Not Available
Immune thrombocytopenia10.02.01.083; 01.08.01.0130.000184%Not Available
Infusion site bruising12.07.05.022; 08.02.05.022; 24.07.06.030; 23.03.11.034--Not Available
Intestinal strangulation07.13.01.016; 24.04.08.0200.000460%Not Available
Myelosuppression01.03.03.0150.000551%Not Available
Myocardial injury02.04.02.0460.000184%Not Available
Myopericarditis02.04.03.0090.000827%Not Available
Pleural fistula22.05.03.0060.000368%Not Available
Scrotal irritation23.03.04.050; 21.12.02.0130.000404%Not Available
Splenic cyst16.21.05.001; 01.13.05.0010.000184%Not Available
Swelling of eyelid23.04.01.026; 10.01.05.026; 06.04.04.0180.000588%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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