ADReCS

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)
Febrile bone marrow aplasia	01.03.03.007; 08.05.02.005	0.000919%		Not Available
Application site swelling	12.07.01.027; 08.02.01.027	0.000937%		Not Available
Infusion site pain	12.07.05.002; 08.02.05.014	0.000368%		Not Available
Evans syndrome	10.04.01.003; 01.06.01.002	0.000184%		Not Available
Cerebral haematoma	17.08.01.014; 24.07.04.006	0.000368%		Not Available
Infusion site oedema	12.07.05.013; 08.02.05.012	0.000184%		Not Available
Skin burning sensation	23.03.03.021; 17.02.06.009	0.001489%		Not Available
Scrotal erythema	23.03.06.013; 21.12.02.008	0.000404%		Not Available
Haemorrhage	24.07.01.002	-	-	Not Available
Varices oesophageal	09.01.06.009; 07.15.05.001; 24.10.02.004	0.000184%		Not Available
Cutaneous lupus erythematosus	10.04.03.007; 23.03.02.008; 15.06.02.007	0.000368%		Not Available
Peripheral sensorimotor neuropathy	17.09.03.009	0.000184%		Not Available
Gaze palsy	17.02.05.044; 06.05.02.014	0.000276%		Not Available
Gastrointestinal ulcer haemorrhage	24.07.02.023; 07.04.04.006	-	-	Not Available
Pneumatosis intestinalis	07.11.01.043	0.000643%		Not Available
Temperature intolerance	08.01.09.022	0.000184%		Not Available
Hypoaesthesia oral	17.02.06.021; 07.05.05.003	0.000496%		Not Available
Paraesthesia oral	07.05.05.035; 17.02.06.008	0.000276%		Not Available
Toxic skin eruption	23.03.05.003; 10.01.01.008; 12.03.01.073	0.000368%		Not Available
Haemobilia	24.07.01.049; 09.01.08.009	0.000276%		Not Available
Application site discolouration	23.03.03.023; 12.07.01.030; 08.02.01.030	0.000625%		Not Available
Gastrointestinal toxicity	12.03.01.019; 07.08.03.006	0.001599%		Not Available
Intestinal haemorrhage	24.07.02.031; 07.12.03.005	0.000551%		Not Available
Skin toxicity	23.03.03.032; 12.03.01.020	0.000276%		Not Available
Drug resistance	08.06.01.005	0.000368%		Not Available
Hot flush	21.02.02.001; 08.01.03.027; 24.03.01.005	0.000827%
Electrocardiogram change	13.14.05.014	-	-	Not Available
Ocular toxicity	12.03.01.031; 06.11.01.006	-	-	Not Available
Embolism	24.01.01.009	0.000460%
Haematotoxicity	12.03.01.025; 01.05.01.007	0.001746%		Not Available

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