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)
Infestation23.11.01.002; 11.09.01.001--Not Available
Inflammation10.02.01.089; 08.01.05.0070.001011%Not Available
Ischaemia24.04.02.0040.000368%Not Available
Ischaemic stroke24.04.06.010; 17.08.01.0180.000735%Not Available
Optic nerve disorder17.04.05.004; 06.02.08.001--
Optic neuropathy17.04.05.005; 06.02.08.0020.000184%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.004173%
Disease progression08.01.03.0380.004007%
Disease recurrence08.01.03.0500.000276%Not Available
Pulmonary toxicity22.01.02.007; 12.03.01.0130.000368%Not Available
Immunosuppression10.03.02.0010.000184%Not Available
Pigmentation disorder23.05.03.0010.000551%Not Available
Metastasis16.22.01.0010.000368%Not Available
Hyperamylasaemia14.11.01.0030.000184%Not Available
Neutropenic colitis07.08.01.014; 01.02.03.0100.000276%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.000276%Not Available
Vascular stent thrombosis24.01.01.044; 08.07.05.0020.000276%Not Available
Gastrointestinal inflammation07.08.03.0070.000551%Not Available
Skin haemorrhage23.06.07.001; 24.07.01.1030.000625%Not Available
Application site exfoliation23.03.07.007; 12.07.01.022; 08.02.01.0220.000404%Not Available
Device related infection11.01.08.018; 08.07.01.005--
Infusion site extravasation12.07.05.008; 08.02.05.0070.000993%
Ulcerative keratitis10.02.01.021; 06.04.02.0040.000460%
Application site burn08.02.01.038; 23.03.11.013; 12.07.01.038--Not Available
Bone marrow failure01.03.03.0050.003125%
Application site erosion12.07.01.021; 08.02.01.021; 23.07.03.0110.000625%Not Available
Application site scab23.03.03.050; 12.07.01.042; 08.02.01.0420.000404%Not Available
Cytopenia01.03.03.0120.000368%Not Available
Liver injury12.01.17.012; 09.01.07.0220.000368%Not Available
Hyperammonaemic encephalopathy17.13.01.005; 14.10.01.0060.001287%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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