Nysa Anand
Abstract: The objective of this study was to examine the trends in adverse event reporting for methadone before, during, and after global health emergencies. This study highlights the most recent global health emergency of the COVID-19 pandemic. This study utilized the FDA Adverse Event Reporting System to analyze methadone adverse event reports and compare these trends with those of all medications. The study finds that 18.8% of all methadone-related adverse event reporting occurred in 2021, with 21,257 out of 22,447 adverse event cases classified as serious adverse events, and 10,109 resulting in death. There was a 320.9% increase in reported adverse events for methadone between 2012 and 2013, marking the first major uptick in methadone adverse event reports. Overall, there was a 1297% increase in reported adverse events for methadone across the decade of 2011 to 2021. The trend in adverse event reporting for methadone did not match the trend in adverse event reporting across all medicines. There was a 61.9% increase in reported adverse events for methadone between 2020 and 2021, while the increase in reported adverse events across all medicines was only 5.7% over this same period. The study additionally finds that 51.2% of reported cases for methadone adverse events were from men. Additionally, the greatest proportion of reported adverse events for methadone involved drug dependence, making up 21.8% of all reported adverse events for methadone. The results highlight that increases in reported adverse events for methadone during the COVID-19 pandemic are unique to methadone, and cannot be attributed to a general increase in reporting of adverse events across all pharmaceuticals. This indicates that opioids used to treat OUD are at risk for higher misuse during emergencies. Further research could examine trends in adverse event reporting in other substances used to treat opioid use disorder, and potential solutions to counteract increased opioid usage in times of widespread infectious disease.
Keywords: adverse events, COVID-19 pandemic, methadone, opioid use disorder
Date Published: November 25, 2025 DOI: 10.11159/jbeb.2025.009
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