Abstract: Objective To provide a reference for clinically safe use of omacycline and moxifloxacin in the treatment of community-acquired pneumonia. Methods Adverse Drug Event (ADE) reports concerning omadacycline and moxifloxacin and collected between the first quarter of 2004 and the first quarter of 2024 were retrieved from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. The Reporting Odds Ratio (ROR) method and the comprehensive criteria of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK were employed to mine and analyze ADE signals for both drugs. Results A total of 527 ADE reports about omadacycline and 16 614 ones about moxifloxacin were collected. Males outnumbered females in both groups. After signal screening, 45 ADE signals were identified for omadacycline and 607 for moxifloxacin. The three most frequent ADE signals for omadacycline were nausea (108 cases), vomiting (61 cases), and diarrhea (37 cases), all of which were specified in package inserts. For moxifloxacin, the three most frequent ADE signals were rash (1 198 cases), dizziness (1 157 cases), and hypersensitivity reactions (945 cases), among which dizziness was not documented in its package insert. When ranked by signal strength, infusion site phlebitis for omadacycline (with an ROR value of 635.83) and irideremia that tested positive for moxifloxacin (with an ROR value of 3 478.69) topped the list. The ADE signal was specified in the package insert of omadacycline, but not for moxifloxacin. Conclusion The ADEs of omadacycline usually involve various injuries, poisoning, procedural complications, and gastrointestinal system diseases while those of moxifloxacin are primarily related to neurological diseases, systemic diseases, and various reactions at the site of administration, with a relatively high number of signals of new suspicious high risks.

Key words: Omacycline, Moxifloxacin, Adverse Drug Events, Signal Mining, Reporting Odds Ratio Method(ROR), Comprehensive Criteria