A disproportionality analysis of adverse events associated with omadacycline based on the FDA adverse event reporting system database

OBJECTIVE: Omadacycline, a novel aminomethylcycline antibiotic for community-acquired bacterial infections, lacks comprehensive real-world safety data. We evaluated its adverse drug reactions (ADRs) using the FDA Adverse Event Reporting System (FAERS). METHODS: A comprehensive analysis of post-marketing ADR reports submitted to FAERS between the first quarter of 2020 and the fourth quarter of 2024 was conducted. Disproportionality signals were assessed via four methods: reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network and multi-item gamma Poisson shrinker. RESULTS AND CONCLUSION: Among 4541 omadacycline-related reports, 577 distinct ADRs were identified. The most frequently reported ADRs were nausea (221 cases, 14.1%), vomiting (129), diarrhoea (93), dyspnoea (56) and rash (52). The strongest safety signals (ROR) included tooth discolouration (ROR = 184.33, 95% CI = 96.79-351.06), tongue discolouration (159.88, 101.76-251.25) and Mycobacterium avium complex infection (73.30, 40.15-133.78). Hepatic events (e.g. elevated transaminases) and mortality (49 cases) also demonstrated significant signals. Omadacycline is associated with gastrointestinal disturbances, dental discolouration and respiratory complications. Vigilance for hepatic injury and mortality is warranted, especially in elderly comorbid patients. Ongoing pharmacovigilance integrating real-world evidence is essential.