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---
Mental disorder19.07.01.002---
Metastatic neoplasm16.16.01.0070.000694%-
Neoplasm progression16.16.02.005---
Optic nerve disorder06.02.08.001; 17.04.05.0040.000112%
White blood cell disorder01.02.05.0020.000280%-
Decreased appetite08.01.09.028; 14.03.01.0050.019912%
Colorectal cancer07.21.01.002; 16.13.01.002---
Corneal disorder06.08.01.004---
Psychiatric symptom19.01.02.001---
Renal injury12.01.05.001; 20.01.03.0150.000694%-
Ill-defined disorder08.01.03.0490.002608%-
Inner ear disorder04.04.02.002---
Ulcer haemorrhage08.03.06.003; 24.07.01.0400.000246%-
Blood disorder01.05.01.0040.000168%-
Autonomic neuropathy17.05.01.0090.000280%-
Bone marrow disorder01.05.01.0060.000112%-
Disease progression08.01.03.0380.053020%
Disease recurrence08.01.03.0500.001030%-
Neoplasm recurrence16.16.02.0040.000246%-
Obstruction08.01.03.0230.000224%-
Obstructive airways disorder22.03.01.0110.000246%-
Pulmonary toxicity12.03.01.013; 22.01.02.0070.000336%-
Food intolerance14.02.01.0050.000112%-
Gastrointestinal obstruction07.13.01.0050.000168%-
Hepatobiliary disease09.01.08.003---
Immunosuppression10.03.02.0010.000224%-
Lung neoplasm16.19.04.001; 22.08.01.0060.000246%-
Large intestinal obstruction07.13.03.0030.000280%
Pigmentation disorder23.05.03.0010.002127%-
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ADReCS-Target
Drug Name ADR Term Target
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