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)
Neuropathy peripheral17.09.03.0030.005993%Not Available
Neurotoxicity17.02.10.002; 12.03.01.0110.002298%Not Available
Neutropenia01.02.03.0040.017187%Not Available
Neutrophilia01.02.01.0050.000368%Not Available
Nystagmus17.02.02.006; 06.05.02.006--
Ocular hyperaemia06.04.05.0040.000809%Not Available
Odynophagia07.01.06.0360.000184%Not Available
Oedema14.05.06.010; 08.01.07.0060.000735%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.001195%
Oesophageal stenosis07.13.02.0010.000551%
Oesophagitis07.08.05.0010.000643%
Onycholysis23.02.05.0040.000184%Not Available
Oral discomfort07.05.05.0010.000496%Not Available
Osteoarthritis15.01.04.001--Not Available
Osteonecrosis24.04.05.004; 15.02.04.0070.000184%
Ovarian cancer21.11.01.003; 16.12.04.0010.000184%Not Available
Pain08.01.08.004--
Palmar-plantar erythrodysaesthesia syndrome23.03.05.009; 17.02.07.0090.003787%
Pancreatic pseudocyst07.18.03.0020.000184%Not Available
Pancreatitis acute07.18.01.0020.000460%Not Available
Pancytopenia01.03.03.0030.002114%Not Available
Paraesthesia23.03.03.094; 17.02.06.0050.002702%
Parkinsonism17.01.05.003--Not Available
Parosmia22.04.03.007; 17.04.04.0020.000184%Not Available
Pemphigoid23.03.01.004; 10.04.02.002--Not Available
Pericarditis02.06.02.0010.000460%
Peripheral motor neuropathy17.09.03.0040.000184%
Peripheral sensory neuropathy17.09.03.0050.000551%
Peritoneal adhesions12.02.03.008; 21.07.04.002; 07.07.03.0020.000460%Not Available
Petechiae24.07.06.004; 23.06.01.003; 01.01.03.0020.000184%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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