A comprehensive pharmacovigilance study recently published in the Saudi Pharmaceutical Journal has provided critical real-world evidence regarding the association between three major antibiotic classes and the risk of drug eruptions. By analyzing data from the United States Food and Drug Administration (U.S. FDA) Adverse Event Reporting System (FAERS) from 2020 through the first quarter of 2025, the research quantifies the safety signals for tetracyclines, macrolides, and fluoroquinolones. Drug eruptions, which account for approximately 30% of all adverse skin-related drug reactions, can range from manageable rashes to life-threatening conditions such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
The study’s findings reveal that while all three antibiotic classes are significantly associated with drug eruption risks, tetracyclines and specifically doxycycline demonstrated the strongest safety signal. Notably, the risk associated with tetracyclines remained stable in the early years of the study but experienced a dramatic surge in 2024. Researchers suggest this sharp increase may be linked to the rising global utilization of doxycycline as post-exposure prophylaxis (PEP) for bacterial sexually transmitted diseases (STDs), following recent clinical trials and updated CDC guidelines.
The demographic analysis further highlights distinct patterns across the medication classes. Tetracycline-related eruptions were predominantly reported in males (74%) and individuals aged 18 to 39. In contrast, macrolide reactions were more common in females (56%) and younger patients under the age of 18. Fluoroquinolones showed a higher prevalence in the elderly population, particularly those aged 60 to 89. Furthermore, the severity of these reactions was evidenced by high hospitalization rates; approximately 41% of fluoroquinolone cases and 40% of macrolide cases required inpatient care.
Given that there is no specific treatment for drug eruptions other than supportive care and the immediate cessation of the causative agent, these findings underscore the necessity of clinical vigilance. As antibiotic usage patterns evolve particularly with the expanded use of doxycycline for prophylaxis healthcare providers must be aware of these escalating risks to ensure patient safety and early intervention in the event of adverse cutaneous reactions.
