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)
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Metastatic neoplasm16.16.01.0070.000694%Not Available
Neoplasm progression16.16.02.005--Not Available
Optic nerve disorder17.04.05.004; 06.02.08.0010.000112%
White blood cell disorder01.02.05.0020.000280%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.019912%
Colorectal cancer16.13.01.002; 07.21.01.002--Not Available
Corneal disorder06.08.01.004--Not Available
Psychiatric symptom19.01.02.001--Not Available
Renal injury20.01.03.015; 12.01.05.0010.000694%Not Available
Ill-defined disorder08.01.03.0490.002608%Not Available
Inner ear disorder04.04.02.002--Not Available
Ulcer haemorrhage24.07.01.040; 08.03.06.0030.000246%Not Available
Blood disorder01.05.01.0040.000168%Not Available
Autonomic neuropathy17.05.01.0090.000280%Not Available
Bone marrow disorder01.05.01.0060.000112%Not Available
Disease progression08.01.03.0380.053020%
Disease recurrence08.01.03.0500.001030%Not Available
Neoplasm recurrence16.16.02.0040.000246%Not Available
Obstruction08.01.03.0230.000224%Not Available
Obstructive airways disorder22.03.01.0110.000246%Not Available
Pulmonary toxicity22.01.02.007; 12.03.01.0130.000336%Not Available
Food intolerance14.02.01.0050.000112%Not Available
Gastrointestinal obstruction07.13.01.0050.000168%Not Available
Hepatobiliary disease09.01.08.003--Not Available
Immunosuppression10.03.02.0010.000224%Not Available
Lung neoplasm22.08.01.006; 16.19.04.0010.000246%Not Available
Large intestinal obstruction07.13.03.0030.000280%
Pigmentation disorder23.05.03.0010.002127%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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