Real-world Pharmacovigilance Investigation and Pharmaceutical Care of Tetracycline antibiotics: Analysis of the FAERS Database

Abstract Background. Tetracyclines are widely used in clinical practice, particularly during the epidemics of Mycoplasma pneumoniae pneumonia. However, concerns regarding their associated drug safety have been raised. To address these concerns, we employed the FDA Adverse Event Reporting System (FAERS) database to conduct pharmacovigilance analyses for clinical reference. Methods. A disproportionality analysis based on the FAERS database from Q1 2004 to Q3 2024 using the reporting odds ratio (ROR) and information component (IC) methods. Results. A total of 21 964 448 reports associated with tetracyclines as the primary suspect were identified. The reports associated with doxycycline (n = 15 383), minocycline (n = 4 672), tigecycline (n = 2 434), tetracycline (n = 1 483), omadacycline (n = 586), sarecycline (n = 105), eravacycline (n = 85), and demeclocycline (n = 33) were extracted. After conducting data mining, there were 1 043 signals associated with tetracyclines. Among these, doxycycline and minocycline exhibited the highest signal frequencies. Gastrointestinal disorders and Skin and subcutaneous tissue disorders were the most commonly reported. Notably, significant signals related to thyroid disorders were observed in association with minocycline. Conclusion. AE signals for tetracyclines vary widely, with some newly identified and severe. Doxycycline has the highest number of signals, followed by minocycline. AEs that are closely monitored during medication must be accompanied by comprehensive patient education on the use of tetracyclines to ensure the safety and efficacy of treatment.