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)
Organising pneumonia22.01.02.0080.000460%Not Available
Hypertransaminasaemia09.01.02.0050.000735%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Kounis syndrome24.04.04.020; 10.01.03.037; 02.02.02.0200.000184%Not Available
Acute kidney injury20.01.03.0160.003768%
Foetal growth restriction18.03.01.0020.000460%
Posterior reversible encephalopathy syndrome17.13.02.0070.002298%
Application site haemorrhage24.07.01.048; 08.02.01.040; 12.07.01.040--Not Available
White matter lesion24.04.06.027; 17.11.01.009--Not Available
Encapsulating peritoneal sclerosis07.07.03.0040.000184%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000643%
Anal incontinence07.01.06.029; 17.05.01.0210.000735%
Adenocarcinoma gastric07.21.02.002; 16.13.03.0020.000184%Not Available
Breast cancer recurrent21.05.01.017; 16.10.01.0090.000368%Not Available
Haemorrhagic infarction24.04.02.0080.000368%Not Available
Jugular vein thrombosis24.01.02.0070.000184%Not Available
Lymphadenopathy mediastinal22.09.03.006; 01.09.01.0250.000184%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.000184%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.000276%Not Available
Neonatal respiratory distress syndrome22.11.02.010; 18.04.10.0030.000184%Not Available
Recurrent cancer16.16.01.015--Not Available
Aneurysm ruptured24.02.01.0020.000276%Not Available
Pancreatic fistula07.11.05.0160.000460%
Focal nodular hyperplasia09.04.01.004; 16.06.01.0040.000184%Not Available
Non-alcoholic steatohepatitis14.08.04.024; 09.01.07.0350.000184%Not Available
Cardiac ventricular thrombosis24.01.05.006; 02.11.01.0080.000184%Not Available
Laryngeal discomfort22.12.03.0090.000184%Not Available
Colon cancer metastatic16.13.01.012; 07.21.01.0100.000184%Not Available
Subacute cutaneous lupus erythematosus15.06.02.012; 10.04.03.012; 23.03.02.0200.000368%Not Available
Diffuse alveolar damage22.01.01.0190.000643%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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