Analyses of oxycodone-induced adverse effects based on the Japanese Adverse Drug Event Report Database

ABSTRACT

　Recently, the amount of oxycodone used for palliative care in the medical setting has markedly increased in Japan. As the beneficial effects and pharmacokinetic profile of oxycodone are dependent on patient characteristics such as gender and age, it is important to understand the relationships between adverse effects and patient characteristics when administering oxycodone therapy to patients suffering from cancer-related pain. Therefore, we used the Japanese Adverse Drug Event Report Database administered by the Pharmaceuticals and Medical Devices Agency, Japan, to analyze the frequencies of adverse events associated with oxycodone therapy. Furthermore, the statistical significance of the associations between adverse effects and background parameters, such as age and gender, was determined using Fisher’s exact test and odds ratio. As a result, it was found that delirium, nausea, and vomiting are the most common adverse events seen after oxycodone administration. These symptoms are also caused by morphine and fentanyl. Nausea and diarrhea in female and interstitial lung disease in male reported more frequently. On the other hand, somnolence and delirium in elderly patients reported more often than in young patients. These findings might be helpful for managing the adverse effects of pain therapy on an individual basis.