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)
Abdominal distension07.01.04.0010.001103%
Abdominal pain07.01.05.0020.002206%
Abdominal tenderness07.01.05.0040.000276%-
Abortion spontaneous18.01.04.001---
Acute hepatic failure09.01.03.0010.000276%-
Acute myeloid leukaemia01.10.05.001; 16.01.05.0010.001562%-
Acute myocardial infarction02.02.02.001; 24.04.04.0010.002206%-
Acute promyelocytic leukaemia01.10.05.003; 16.01.05.0030.000276%-
Acute pulmonary oedema02.05.02.004; 22.01.03.005---
Acute respiratory distress syndrome10.02.01.067; 22.01.03.001; 24.03.02.0340.000827%
Acute respiratory failure14.01.04.004; 22.02.06.0010.000551%-
Adenocarcinoma16.16.01.0040.000184%-
Agranulocytosis01.02.03.0010.001287%-
Alopecia23.02.02.0010.002518%
Altered state of consciousness17.02.04.001; 19.07.01.0030.000551%-
Amnesia17.03.02.001; 19.20.01.001--
Anaemia01.03.02.0010.005699%
Anaphylactic shock10.01.07.002; 24.06.02.0040.000551%-
Anaphylactoid reaction10.01.07.003; 24.06.03.0070.000368%-
Angina pectoris02.02.02.002; 24.04.04.0020.001287%
Angina unstable02.02.02.004; 24.04.04.0040.000184%-
Aortic thrombosis24.01.09.0010.000276%-
Aphasia17.02.03.001; 19.21.01.0010.000368%
Aphthous ulcer07.05.06.0020.000368%-
Aplastic anaemia01.03.03.0020.000184%-
Application site erythema08.02.01.001; 12.07.01.001; 23.03.06.0050.003309%-
Application site irritation08.02.01.003; 12.07.01.0030.001875%-
Application site pain08.02.01.004; 12.07.01.0040.003621%-
Application site pruritus08.02.01.005; 12.07.01.005; 23.03.12.0040.000625%-
Application site reaction08.02.01.006; 12.07.01.006---
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ADReCS-Target
Drug Name ADR Term Target
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