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 syndrome07.05.05.013; 17.02.06.016---
Hypertransaminasaemia09.01.02.0050.000470%-
Anorectal discomfort07.03.03.0030.000168%-
Oropharyngeal discomfort07.05.05.008; 22.12.03.015---
Oropharyngeal pain07.05.05.004; 22.12.03.016--
Vulvovaginal pain21.08.02.009--
Kounis syndrome02.02.02.020; 10.01.03.037; 24.04.04.0200.000112%-
Acute kidney injury20.01.03.0160.005451%
Nail bed disorder23.02.05.0170.000437%-
Gastrointestinal tract irritation07.08.03.0080.000246%-
Functional gastrointestinal disorder07.11.01.0160.000224%-
Central nervous system haemorrhage17.08.01.035; 24.07.04.0160.000112%-
Drug-induced liver injury09.01.07.023; 12.03.01.0440.001287%-
Peripheral artery thrombosis24.01.02.0100.000336%-
White matter lesion17.11.01.009; 24.04.06.0270.000112%-
Diffuse alopecia23.02.02.0070.000280%-
Candida infection11.03.03.021--
Mesenteric vascular occlusion07.15.02.011; 24.04.08.0140.000168%-
Faeces soft07.01.03.0080.000224%-
Language disorder17.02.08.015; 19.19.01.0060.000168%-
Mouth swelling07.05.04.007; 10.01.05.020; 23.04.01.0200.000358%-
Sinus node dysfunction02.03.03.0170.000224%
Perforation08.01.03.0580.000280%-
Stenosis08.01.03.0600.000168%-
Multiple organ dysfunction syndrome08.01.03.0570.001847%
Anal incontinence07.01.06.029; 17.05.01.0210.000280%
Persistent depressive disorder19.15.01.0060.000112%-
Somatic symptom disorder19.24.01.006---
Adenocarcinoma of colon07.21.01.008; 16.13.01.0100.000168%-
Agraphia17.02.03.013; 19.21.01.0070.000112%-
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ADReCS-Target
Drug Name ADR Term Target
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