Association of antibiotics with Stevens-Johnson syndrome and toxic epidermal necrolysis: A real-world pharmacovigilance study.

BACKGROUND

Recent reports suggest antibiotics may cause severe allergic reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), exacerbating concerns about antibiotic safety.

OBJECTIVE

Given the limited real-world evidence, this study aims to analyse the FDA Adverse Event Reporting System to investigate the association between various antibiotics and SJS/TEN risk.

METHODS

Reports from infected patients (Q1 2014-Q4 2023) were extracted from the FDA Adverse Event Reporting System. Disproportionality analysis using information component identified risk signals of antibiotics associated with SJS/TEN. Subgroup analyses investigated the impact of age and gender on antibiotic-associated SJS/TEN. Also, a time of onset analysis was performed.

RESULTS

Among 78 593 infected patients, 1221 cases of SJS/TEN were identified from 30 369 antibiotic administrations. The median age of patients with SJS was 63 y, and with TEN was 60 y. Eleven positive signal drugs were detected through disproportionality analysis. Amoxicillin, piperacillin, ceftriaxone, cefuroxime, cefotaxime, azithromycin, sulfamethoxazole, trimethoprim, vancomycin, doxycycline, and gentamicin exhibited significant risk associations with SJS/TEN. Sulfamethoxazole had the highest risk. Patients with pneumonia, urinary tract infections, and sepsis had higher risks than those with respiratory tract infections. Male patients using specific antibiotics may have a higher risk than females, with no significant age difference.

CONCLUSIONS

Antibiotics including penicillins, cephalosporins, azithromycin, sulfamethoxazole, trimethoprim, vancomycin, doxycycline, and gentamicin are associated with an increased risk of SJS/TEN, with sulfamethoxazole presenting the highest risk. Patients with pneumonia, urinary tract infections, and sepsis are particularly vulnerable. These findings highlight the need for personalized antibiotic regimens based on infection site and patient gender.