Safety assessment and sub-group analysis (gender-based and age-based) of Rocuronium: A real-world pharmacovigilance study from the FAERS database.
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BACKGROUND: Most of the evidence for rocuronium-related adverse events came from clinical trials or case reports, with relatively small sample sizes. It is currently unclear whether rocuronium may cause other serious adverse reactions. This study aims to analysis adverse events related to rocuronium from FAERS database. METHODS: The adverse events data related to rocuronium from 2004 Q1 to 2024 Q2 were collected. After standardizing the data, signal quantification techniques (ROR, PRR, BCPNN and EBGM) were used for analysis. Gender-based and age-based differences were also conducted. RESULTS: Among the 3316 adverse event reports with rocuronium as the primary suspected drug, 191 preferred terms of adverse reactions spanning 23 different system organ classes were identified. Anaphylaxis, residual paralysis, myopathy and increased pulmonary vascular resistance were common adverse events of rocuronium. Some unexpected adverse reactions were also founded, such as acquired dysfibrinogenaemia, postresuscitation encephalopathy, hypersensitivity myocarditis, hyperthermia malignant and cardiac arrest. Gender-based differences were found, especially in Respiratory, thoracic and mediastinal disorders, Cardiac disorders, Nervous disorders, Musculoskeletal and connective tissue disorders, etc. And more life-threatening adverse reactions, such as cardiac failure acute and acute pulmonary oedema, were found in elderly patients. Anaphylactic shock, anaphylactic reaction and cardiac arrest were the three leading causes of death related to rocuronium. CONCLUSIONS: These findings advise medical professionals to exercise more caution when using rocuronium, especially in elderly people. This study provide guidance for early identification of rocuronium-related adverse reactions, and valuable references for more in-depth future studies and safety regulatory work.