Objective  To evaluate the clinical safety of the new tetracycline drugs, omadacycline and eravacycline, by analyzing adverse events (ADE) reported in FDA Adverse Event Reporting System (FAERS), to provide reference for clinical safety.

Methods  Extract ADE report data submitted to FAERS from first quarter 2018 to second quarter 2024. Signals were categorized and analyzed using system organ class (SOC) and preferred terms (PT) of Medical Dictionary for Regulatory Activities (MedDRA). Signal detection methods included  the reporting odds ratio (ROR) method, Medicines and Healthcare products Regulatory Agency (MHRA) method, the Bayesian confidence interval propagation neural network (BCPNN) method and the multi-item gamma Poisson shrinker (MGPS) method.

Results  A total of 616 ADE cases were reported in which omadacycline was identified as the primary suspect drug, and the highest number of SOCs involved were reports of various types of injuries, poisonings, and surgical complications. While 85 cases were linked to eravacycline, and the SOCs were most frequent for systemic diseases and various reactions at the site of administration. Using the MHRA, ROR, BCPNN, and MGPS methods, omadacycline showed 32 positive signal PTs, while eravacycline showed 9. Omadacycline was frequently associated with ADE such as gastrointestinal disturbances and elevated liver enzyme levels. In contrast, eravacycline was commonly linked to increased lipase levels and pancreatitis. Notably, certain ADE were absent from the omadacycline prescribing information, including ototoxicity and tongue discoloration. Similarly, lactic acidosis and reduced fibrinogen levels were absent from the eravacycline preseribing information.

Conclusion  Using FAERS for ADE signal mining helps identify new side effects of tetracycline drugs. Omadacycline may cause ototoxicity and tongue discoloration, while eravacycline is linked to lactic acidosis and fibrinogen reduction, none of which are on product labels, and these effects should be monitored in clinical practice.

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