Safety profiles of Tetracycline-class drugs: a pharmacovigilance analysis of the FAERS database

As synthesis technology advances, novel and efficient derivatives of tetracyclines are found. Three new antibiotics, tigecycline, omadacycline, and eravacycline, approved within the past 18 years, and represent a new era in the use of tetracyclines. To gain further insight into adverse events linked to tetracyclines and better protect pediatric patients, ongoing monitoring of safety data is crucial. The FAERS data from the first quarter of 2004 to the third quarter of 2023 in the AERSMine were extracted to conduct disproportionality analysis. The association between five tetracyclines and adverse events was evaluated using reporting odds ratio, and their risk factors were explored by multivariate logistic regression analysis. Our study showed that endocrine disorders had the strongest signal in children, especially thyroid gland disorders. Patients aged 12–18 and treatment with minocycline are risk factors for thyroid adverse events(12–18: OR = 10.727 [7.113–16.177], <i>p</i> &lt; 0.0001; minocycline: OR = 17.025 [10.475-27.678], <i>p</i> &lt; 0.0001).Second-generation tetracycline and third-generation tetracycline ADR patterns differed. Blood fibrinogen decreased and hypofibrinogenaemia were primarily reported with tigecycline and eravacycline. The potential effect of minocycline on thyroid function in adolescents should be of concern. This study investigated adverse events highly associated with tetracyclines treatment, which provided basic evidence for further research on tetracyclines-related adverse events for children. However, the safety of third-generation tetracycline in children requires additional validation through a large-scale prospective study.