Abstract
The purpose of this study was to evaluate the adverse drug reactions (ADRs) and serious adverse events associated with capecitabine use in Korean patients by analyzing data from a comprehensive national database of adverse events. Data from all reports concerning capecitabine (Anatomical Therapeutic Chemical code: L01BC06) generated between January 2011 and December 2014 were collected from the Korean Adverse Event Reporting System database (KAERS). A total of 676 reports and 1069 capecitabine-related ADRs were identified. Ninety-nine cases (14.6%) were classified as serious adverse events. The most commonly reported capecitabine-related ADRs involved gastrointestinal system disorders (324, 30.3%), including diarrhea, nausea, vomiting, and stomatitis, followed by skin and appendage reactions (220, 20.6%), which included symptoms such as skin discoloration/disorder/dryness, itching, and rash. Patients need to be educated about the common ADRs associated with capecitabine intake in a clinical setting. Patient characteristics must be considered when determining the capecitabine dosage and risk of ADRs, and nursing intervention is critical for preventing exacerbation of these ADRs.
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