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)
Granuloma08.01.05.001; 23.03.15.0010.000112%Not Available
Haemangioma of liver24.03.06.006; 16.06.01.003; 09.04.01.0030.000168%Not Available
Haematemesis24.07.02.011; 07.12.02.0020.001198%Not Available
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Haematoma24.07.01.001--
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemolysis01.06.04.0020.000414%
Haemolytic anaemia01.06.03.0020.000672%Not Available
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.004--Not Available
Haemorrhoids24.10.02.002; 07.15.03.001--
Headache17.14.01.001--
Hemiplegia17.01.04.0020.000280%Not Available
Hepatic failure09.01.03.0020.001343%
Hepatic fibrosis24.08.06.002; 09.01.04.002--Not Available
Hepatic function abnormal09.01.02.0010.003235%Not Available
Hepatic necrosis09.01.07.0020.000112%
Hepatic neoplasm09.04.03.001; 16.07.03.0010.000548%Not Available
Hepatic pain09.01.05.0050.000302%
Hepatic steatosis14.08.04.005; 09.01.07.003--Not Available
Hepatitis09.01.07.004--Not Available
Hepatitis cholestatic09.01.01.002--Not Available
Hepatocellular injury09.01.07.0080.001175%Not Available
Hepatomegaly09.01.05.001--Not Available
Hepatorenal failure20.01.03.013; 09.01.03.0080.000224%Not Available
Hepatorenal syndrome20.01.03.012; 09.01.03.0070.000168%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.001310%Not Available
Herpes simplex11.05.02.001; 23.11.05.004--Not Available
Herpes virus infection11.05.02.008--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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