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)
Lethargy17.02.04.003; 08.01.01.008; 19.04.04.0040.001415%
Leukocytosis01.02.01.0020.000276%
Leukoencephalopathy17.13.02.0030.002298%
Leukopenia01.02.02.0010.005882%Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.001213%Not Available
Local reaction08.01.03.012--Not Available
Loss of consciousness17.02.04.0040.001875%Not Available
Lung disorder22.02.07.0010.000735%Not Available
Lymphadenopathy01.09.01.0020.000772%Not Available
Lymphopenia01.02.02.0020.000368%Not Available
Malaise08.01.01.003--
Melaena24.07.02.013; 07.12.02.0040.000368%Not Available
Metastases to liver16.22.02.001; 09.04.02.0040.000827%Not Available
Metastases to lung16.22.02.002; 22.08.01.0050.000368%Not Available
Mouth ulceration07.05.06.0040.000460%Not Available
Mucosal inflammation08.01.06.0020.007757%Not Available
Muscle spasms15.05.03.004--
Muscular weakness17.05.03.005; 15.05.06.001--
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.0070.001838%
Myocardial ischaemia24.04.04.010; 02.02.02.0080.000551%Not Available
Myocarditis02.04.03.0010.001562%
Nail discolouration23.02.05.0010.000404%
Nail disorder23.02.05.002--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.0010.012702%
Neck pain15.03.04.0090.000460%
Necrosis24.04.02.006; 08.03.03.001--Not Available
Nervous system disorder17.02.10.001--Not Available
Neuralgia17.02.07.0050.000276%
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ADReCS-Target
Drug Name ADR Term Target
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