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 Prescription; Discontinued
ATC Code L01BC02
DrugBank ID DB00544
KEGG ID D00584
MeSH ID D005472
PubChem ID 3385
TTD Drug ID D05LEO
NDC Product Code 63323-117; 0378-8078; 51672-4062; 16714-178; 70700-189; 51862-362; 51672-4118; 70700-186; 50090-4264; 38779-0025; 51672-4063; 0378-4791; 68001-524; 25021-215; 68001-266; 62049-185; 38779-3185; 16729-276; 68001-525; 0187-3204; 68083-269; 68083-293; 51927-1085; 68083-270; 66530-249; 28105-421; 16110-812; 68083-292; 70700-187; 0187-5200; 70700-188; 59348-0055; 12070-0002; 49452-3175; 16729-542; 0395-8080; 62991-1486
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
ApoptosisSoluble TNF receptor IIP68636Not Available14614330; 15546879; 10583368
Bone marrow toxicityDihydropyrimidine dehydrogenase [NADP(+)]Q12882T758909552051; 8955653; 10673535
Bone marrow toxicityDihydropyrimidine dehydrogenase [NADP(+)]Q12882T7589015228171; 9893619; 12525681
Bone marrow toxicityDihydropyrimidine dehydrogenase [NADP(+)]Q12882T758907882316; 8248211; 8137256
Drug effect decreasedDihydropyrimidine dehydrogenase [NADP(+)]Q12882T758907882316; 8248211; 8137256
Drug effect decreasedDihydropyrimidine dehydrogenase [NADP(+)]Q12882T758909552051; 8955653; 10673535
Drug effect decreasedDihydropyrimidine dehydrogenase [NADP(+)]Q12882T7589015228171; 9893619; 12525681
NeurotoxicityDihydropyrimidine dehydrogenase [NADP(+)]Q12882T758909552051; 8955653; 10673535
NeurotoxicityDihydropyrimidine dehydrogenase [NADP(+)]Q12882T7589015228171; 9893619; 12525681
NeurotoxicityDihydropyrimidine dehydrogenase [NADP(+)]Q12882T758907882316; 8248211; 8137256
Toxicity to various agentsDihydropyrimidine dehydrogenase [NADP(+)]Q12882T7589015228171; 9893619; 12525681
Toxicity to various agentsDihydropyrimidine dehydrogenase [NADP(+)]Q12882T758907882316; 8248211; 8137256
Toxicity to various agentsDihydropyrimidine dehydrogenase [NADP(+)]Q12882T758909552051; 8955653; 10673535
VomitingDihydropyrimidine dehydrogenase [NADP(+)]Q12882T7589015228171; 9893619; 12525681
VomitingDihydropyrimidine dehydrogenase [NADP(+)]Q12882T758907882316; 8248211; 8137256
VomitingDihydropyrimidine dehydrogenase [NADP(+)]Q12882T758909552051; 8955653; 10673535
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.004234%
Abdominal pain07.01.05.0020.008938%
Abdominal pain lower07.01.05.0100.001882%Not Available
Abdominal pain upper07.01.05.003--
Abdominal tenderness07.01.05.0040.001411%Not Available
Abortion spontaneous18.01.04.001--Not Available
Acute hepatic failure09.01.03.0010.000941%Not Available
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.001963%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.009408%Not Available
Acute promyelocytic leukaemia16.01.05.003; 01.10.05.0030.001411%Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.004--Not Available
Acute respiratory distress syndrome22.01.03.0010.000982%
Acute respiratory failure22.02.06.001; 14.01.04.0040.000736%Not Available
Agranulocytosis01.02.03.0010.004704%Not Available
Alanine aminotransferase increased13.03.01.0030.002823%
Alopecia23.02.02.0010.007527%
Altered state of consciousness19.07.01.003; 17.02.04.0010.001411%Not Available
Amnesia19.20.01.001; 17.03.02.001--
Anaemia01.03.02.0010.021169%
Anaphylactic reaction10.01.07.001; 24.06.03.0060.001882%
Anaphylactic shock10.01.07.002; 24.06.02.0040.001411%Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.0030.000941%Not Available
Angina pectoris24.04.04.002; 02.02.02.0020.004234%
Angioedema23.04.01.001; 10.01.05.009--Not Available
Aortic thrombosis24.01.09.0010.000941%Not Available
Aphasia19.21.01.001; 17.02.03.001--
Aphthous ulcer07.05.06.0020.000941%Not Available
Aplasia08.03.04.003; 03.02.01.0020.000736%Not Available
Aplastic anaemia01.03.03.0020.000245%Not Available
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