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)
Ventricular septal defect03.07.02.001; 02.04.02.007--Not Available
Ventricular tachycardia02.03.04.0100.000827%
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.0030.008033%
Xerophthalmia14.12.03.002; 06.06.03.0080.000184%Not Available
Xerosis08.01.03.0160.000184%Not Available
Cardiotoxicity02.11.01.009; 12.03.01.0070.002941%Not Available
Infusion site erythema23.03.06.016; 12.07.05.009; 08.02.05.0080.000276%Not Available
Application site vesicles12.07.01.009; 23.03.01.009; 08.02.01.0090.000625%Not Available
Brain oedema17.07.02.003; 12.01.10.0100.000184%
Application site inflammation12.07.01.024; 08.02.01.024--Not Available
Emotional distress19.04.02.008--Not Available
Neutropenic sepsis11.01.11.006; 01.02.03.007--Not Available
Onychomadesis23.02.05.0060.000276%
General physical health deterioration08.01.03.0180.002482%Not Available
Left ventricular dysfunction02.04.02.0110.000643%
Left ventricular hypertrophy02.04.02.0140.000184%Not Available
Muscle tightness15.05.03.0070.000184%Not Available
Balance disorder08.01.03.081; 17.02.02.007--Not Available
Subileus07.13.01.0040.000368%Not Available
Ventricular hypokinesia02.04.02.0130.000184%Not Available
Deep vein thrombosis24.01.02.003--Not Available
Bile duct stenosis09.02.02.0010.000184%
Systemic inflammatory response syndrome24.06.03.008; 10.02.01.008; 08.01.05.0050.000184%Not Available
Malignant neoplasm progression16.16.01.0050.001930%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.001103%Not Available
Application site discharge23.03.03.049; 12.07.01.039; 08.02.01.0390.000625%Not Available
Colorectal cancer metastatic16.13.01.005; 07.21.01.0050.000184%Not Available
Nasal discomfort22.12.03.012--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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