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)
Anal ulcer07.04.01.0010.000168%
Brain neoplasm malignant17.20.04.002; 16.30.04.0020.000246%Not Available
Breast cancer recurrent21.05.01.017; 16.10.01.0090.000492%Not Available
Colon cancer recurrent16.13.01.013; 07.21.01.0110.000112%Not Available
Coombs negative haemolytic anaemia01.06.03.0010.000112%Not Available
Dermatitis exfoliative generalised23.03.07.002; 10.01.01.0290.000112%Not Available
Malignant ascites07.07.01.004; 16.32.03.0130.000168%Not Available
Malignant pleural effusion22.05.04.001; 16.32.03.0140.000168%Not Available
Metastases to bone15.09.03.006; 16.22.02.0050.001254%Not Available
Metastases to lymph nodes01.09.01.015; 16.22.02.0060.000448%Not Available
Metastases to pleura22.05.04.002; 16.22.02.0220.000280%Not Available
Metastases to skin23.07.04.026; 16.22.02.0230.000280%Not Available
Obstruction gastric07.13.04.0020.000280%
Pancreatic carcinoma metastatic16.13.10.003; 07.21.09.0060.000224%Not Available
Periportal sinus dilatation24.03.03.037; 09.01.06.0200.000112%Not Available
Rectal perforation07.04.01.0040.000168%
Recurrent cancer16.16.01.0150.000492%Not Available
Scleroderma-like reaction15.06.01.018; 10.04.07.005; 23.03.02.0190.000336%Not Available
Cardiomyopathy acute02.04.01.0080.000112%Not Available
Pericardial effusion malignant16.32.03.026; 02.06.01.0090.000112%Not Available
Short-bowel syndrome12.02.03.024; 07.17.01.0100.000224%Not Available
Mechanical ileus07.13.01.0140.000112%Not Available
Metastases to meninges17.02.10.012; 16.22.02.0030.000224%Not Available
Lip erosion07.05.06.0110.000112%Not Available
Small intestine carcinoma16.13.13.002; 07.21.01.0160.000112%Not Available
Peripheral paralysis17.01.04.0200.000168%Not Available
Genital erythema21.10.01.015; 23.03.06.0190.000280%Not Available
Rectal cancer metastatic16.13.01.007; 07.21.05.0030.000224%Not Available
Oesophageal cancer metastatic16.13.06.003; 07.21.06.0030.000168%Not Available
Breast cancer metastatic21.05.01.016; 16.10.01.0080.002093%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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