Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Capecitabine
Drug ID BADD_D00349
Description Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. Capecitabine is a prodrug, that is enzymatically converted to fluorouracil (antimetabolite) in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.
Indications and Usage For the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen. May also be used in combination with docetaxel for the treatment of metastatic breast cancer in patients who have failed to respond to, or recurred or relasped during or following anthracycline-containing chemotherapy. Capecitabine is used alone as an adjuvant therapy following the complete resection of primary tumor in patients with stage III colon cancer when monotherapy with fluroprymidine is preferred. The use or capecitabine in combination regimens for advanced gastric cancer is currently being investigated.
Marketing Status approved; investigational
ATC Code L01BC06
DrugBank ID DB01101
KEGG ID D01223
MeSH ID D000069287
PubChem ID 60953
TTD Drug ID D00HCQ
NDC Product Code 55111-893; 82920-001; 72205-007; 72485-205; 62331-043; 16714-467; 51407-640; 55111-496; 55111-497; 61269-475; 65162-844; 15308-0714; 54893-0002; 59651-205; 64980-277; 70756-815; 68001-487; 69097-949; 72205-006; 63482-099; 72969-094; 16729-072; 59923-721; 61269-470; 0054-0271; 69539-019; 0093-7473; 64980-276; 0054-0272; 69097-948; 72606-554; 53104-7618; 55512-0015; 0004-1100; 51407-639; 67877-459; 68001-488; 69539-020; 35369-0010; 16729-073; 51407-096; 62756-238; 62756-239; 65162-843; 67877-458; 59651-204; 72485-204; 72606-555; 49452-1713; 68554-0033; 0004-1101; 0093-7474; 51407-095; 60687-149; 0378-2511; 70756-816; 53183-4009; 54245-7014; 65129-1241; 81955-0001; 16714-468; 59923-722
UNII 6804DJ8Z9U
Synonyms Capecitabine | N(4)-pentyloxycarbonyl-5'-deoxy-5-fluorocytidine | Xeloda
Chemical Information
Molecular Formula C15H22FN3O6
CAS Registry Number 154361-50-9
SMILES CCCCCOC(=O)NC1=NC(=O)N(C=C1F)C2C(C(C(O2)C)O)O
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)
Infusion site pain12.07.05.002; 08.02.05.014--Not Available
IIIrd nerve disorder17.04.02.005; 06.05.02.0150.000112%
Cerebral haematoma17.08.01.014; 24.07.04.0060.000224%Not Available
Dacryostenosis acquired06.06.04.0030.000168%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.000851%Not Available
Mucosal discolouration08.01.06.0080.000112%Not Available
Hepatic cancer metastatic16.07.02.002; 09.04.02.0060.000112%Not Available
Necrotising enterocolitis neonatal18.04.11.002; 07.08.03.011--Not Available
Haemorrhage24.07.01.002--Not Available
Varices oesophageal09.01.06.009; 07.15.05.001; 24.10.02.0040.000224%Not Available
Fluid intake reduced14.05.10.0010.000548%Not Available
Pulmonary mass22.02.07.004--Not Available
Cutaneous lupus erythematosus23.03.02.008; 15.06.02.007; 10.04.03.0070.000112%Not Available
Pneumatosis intestinalis07.11.01.0430.000504%Not Available
Temperature intolerance08.01.09.0220.001556%Not Available
Rectal tenesmus15.05.03.011; 07.03.03.0010.000504%Not Available
Hypoaesthesia oral07.05.05.003; 17.02.06.021--Not Available
Paraesthesia oral17.02.06.008; 07.05.05.035--Not Available
Breast cancer female21.05.01.011; 16.10.01.0040.000795%Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000504%Not Available
Cancer pain16.32.03.0040.000302%Not Available
Post procedural complication12.02.05.018--Not Available
Pulseless electrical activity02.03.04.0200.000280%Not Available
Cystoid macular oedema12.02.02.005; 06.04.06.0100.000112%Not Available
Nail pigmentation23.02.05.0070.000381%Not Available
Oral toxicity12.03.01.051; 07.05.01.0120.000168%Not Available
Skin oedema23.06.04.0010.000112%Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Haemobilia24.07.01.049; 09.01.08.0090.000112%Not Available
Bicytopenia01.03.03.0100.000168%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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