Disproportionality Analysis of Safety Signals for a Wide Variety of Opioid-Related Adverse Events in Elderly Patients Using the Japanese Adverse Drug Event Report (JADER) Database

Opioids are widely used for the treatment of moderate/severe pain in cancer and noncancer patients. In this study, we searched safety signals a wide variety opioid-related adverse events (AEs) elderly patients by disproportionality analysis using Japanese Adverse Drug Event Report (JADER) database. Data from JADER database April 2004 to May 2018 were obtained Pharmaceuticals Medical Devices Agency website. Safety signal detection AEs was defined relative reporting odds ratio (ROR). Among analyzed AEs, opioid-induced neurotoxicity (OIN) assessed based on time onset Weibull shape parameter. The following detected patients: respiratory depression, somnolence, hallucinations, akathisia OIN. Fentanyl, tramadol, oxycodone morphine exhibited large ROR median OIN transdermal fentanyl, oral 13.5, 6, 9, 6 d, respectively. These opioids classified as early failure types distribution. Our results showed that who administered should be closely monitored such akathisia.