Comparative Safety Analysis of Hydromorphone and Morphone Sulfate: Evidence from the 2004–2024 FAERS

Xiaohong Chen, Chunli Yang, Zhiying Lin Jiangxi Provincial People’s Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang, Jiangxi Province, 330006, People’s Republic of ChinaCorrespondence: Zhiying Lin, Jiangxi Provincial People’s Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang, Jiangxi Province, People’s Republic of China, Tel +86 0791 86896209, Email [email protected]: Hydromorphone and morphine, as classic opioid drugs, are commonly used for postoperative analgesia and as adjuncts in the treatment of moderate to severe cancer pain and chronic pain. The lack of specific criteria and the complexity of their respective adverse events (AEs) make it difficult for clinical workers to make a decision.Methods: This study utilized the FAERS database to compare the baseline risk of AEs between hydromorphone and morphine sulfate. AEs of opioid drugs “morphine” and “hydromorphone” were extracted from FAERS from 2004 to 2024. Non-proportional signal mining is performed by calculating the ratio of reports (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and empirical Bayesian geometric mean. Then they were filtered and mapped to a total of 25 types of AEs, including primary preference term (PT) signals and systemic organ categories.Results: According to the FAERS database, Among totals of 44303 case reports related to two types of drug, 14902 reports were related to hydromorphone, 29401 reports were related to morphine sulfate. The statistical analysis results include 21890177 AEs reports in the FAERS database, of which 18282801 AEs reports are the “main analysis objects” of Hydromorphone and morphine. This study found that “psychological disorders” and “immune system disorders” are closely related to both drugs. But psychological disorders have the strongest correlation with Hydromorphone (ROR 6.33), while immune system disorders have the strongest correlation with morphine sulfate (ROR 8.41). The signal “General disorders and administrative site conditions” is more significantly associated with Hydromorphone. In addition, drug dependence is a common PT signal in both drugs, and prognosis should be closely monitored after treatment.Conclusion: Prescription decision-making should be a comprehensive and balanced process. Our study identified potential new and unexpected AEs for Hydromorphone and morphine, providing valuable evidence for the safety research of Hydromorphone and morphine. Especially for prescribers of hydromorphone, clinical vigilance should extend beyond its known opioid-class effects to particularly raise awareness of two unexpected adverse events: for the immune related disorders and administration site reactions.Keywords: hydromorphone, morphine, FAERS, adverse reactions, drug safety