ADReCS

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 ulcer	07.04.01.001	0.000168%
Brain neoplasm malignant	16.30.04.002; 17.20.04.002	0.000246%		-
Breast cancer recurrent	16.10.01.009; 21.05.01.017	0.000492%		-
Colon cancer recurrent	07.21.01.011; 16.13.01.013	0.000112%		-
Coombs negative haemolytic anaemia	01.06.03.001	0.000112%		-
Dermatitis exfoliative generalised	10.01.01.029; 23.03.07.002	0.000112%		-
Malignant ascites	07.07.01.004; 16.32.03.013	0.000168%		-
Malignant pleural effusion	16.32.03.014; 22.05.04.001	0.000168%		-
Metastases to bone	15.09.03.006; 16.22.02.005	0.001254%		-
Metastases to lymph nodes	01.09.01.015; 16.22.02.006	0.000448%		-
Metastases to pleura	16.22.02.022; 22.05.04.002	0.000280%		-
Metastases to skin	16.22.02.023; 23.07.04.026	0.000280%		-
Obstruction gastric	07.13.04.002	0.000280%
Pancreatic carcinoma metastatic	07.21.09.006; 16.13.10.003	0.000224%		-
Periportal sinus dilatation	09.01.06.020; 24.03.03.037	0.000112%		-
Rectal perforation	07.04.01.004	0.000168%
Recurrent cancer	16.16.01.015	0.000492%		-
Scleroderma-like reaction	10.04.07.005; 15.06.01.018; 23.03.02.019	0.000336%		-
Cardiomyopathy acute	02.04.01.008	0.000112%		-
Pericardial effusion malignant	02.06.01.009; 16.32.03.026	0.000112%		-
Short-bowel syndrome	07.17.01.010; 12.02.03.024	0.000224%		-
Mechanical ileus	07.13.01.014	0.000112%		-
Metastases to meninges	16.22.02.003; 17.02.10.012	0.000224%		-
Lip erosion	07.05.06.011	0.000112%		-
Small intestine carcinoma	07.21.01.016; 16.13.13.002	0.000112%		-
Peripheral paralysis	17.01.04.020	0.000168%		-
Genital erythema	21.10.01.015; 23.03.06.019	0.000280%		-
Rectal cancer metastatic	07.21.05.003; 16.13.01.007	0.000224%		-
Oesophageal cancer metastatic	07.21.06.003; 16.13.06.003	0.000168%		-
Breast cancer metastatic	16.10.01.008; 21.05.01.016	0.002093%		-

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