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)
Burning mouth syndrome17.02.06.016; 07.05.05.013--Not Available
Hypertransaminasaemia09.01.02.0050.000470%Not Available
Anorectal discomfort07.03.03.0030.000168%Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.008--Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Vulvovaginal pain21.08.02.009--
Kounis syndrome24.04.04.020; 10.01.03.037; 02.02.02.0200.000112%Not Available
Acute kidney injury20.01.03.0160.005451%
Nail bed disorder23.02.05.0170.000437%Not Available
Gastrointestinal tract irritation07.08.03.0080.000246%Not Available
Functional gastrointestinal disorder07.11.01.0160.000224%Not Available
Central nervous system haemorrhage24.07.04.016; 17.08.01.0350.000112%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.001287%Not Available
Peripheral artery thrombosis24.01.02.0100.000336%Not Available
White matter lesion24.04.06.027; 17.11.01.0090.000112%Not Available
Diffuse alopecia23.02.02.0070.000280%Not Available
Candida infection11.03.03.021--
Mesenteric vascular occlusion24.04.08.014; 07.15.02.0110.000168%Not Available
Faeces soft07.01.03.0080.000224%Not Available
Language disorder19.19.01.006; 17.02.08.0150.000168%Not Available
Mouth swelling23.04.01.020; 10.01.05.020; 07.05.04.0070.000358%Not Available
Sinus node dysfunction02.03.03.0170.000224%
Perforation08.01.03.0580.000280%Not Available
Stenosis08.01.03.0600.000168%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.001847%
Anal incontinence17.05.01.021; 07.01.06.0290.000280%
Persistent depressive disorder19.15.01.0060.000112%Not Available
Somatic symptom disorder19.24.01.006--Not Available
Adenocarcinoma of colon16.13.01.010; 07.21.01.0080.000168%Not Available
Agraphia19.21.01.007; 17.02.03.0130.000112%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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