Drug rash with eosinophilia and systemic symptoms: descriptive analysis of pharmacovigilance.

OBJECTIVES

Drug rash with eosinophilia and systemic symptoms (DRESS) is a rare but potentially fatal adverse drug reaction characterised by cutaneous and systemic involvement. This study aimed to analyse patients with DRESS reported through the US Food and Drug Administration Adverse Event Reporting System (FAERS).

METHODS

All DRESS reports submitted to FAERS between 1 January 2003 and 13 October 2025 were extracted. Patient characteristics were analysed descriptively according to severity, sex, age group and suspected drugs.

RESULTS

A total of 26 831 patients with DRESS were identified, of which 99.67% were classified as having a serious adverse reaction. Overall mortality was 6.9% (1846 deaths). Female patients were more frequently affected than male patients. Adults aged 18-64 years represented the largest group. Allopurinol, lamotrigine and vancomycin were the most frequently suspected drugs, accounting for over 30% of reports.

CONCLUSIONS

DRESS remains a severe adverse drug reaction. Early recognition and continuous pharmacovigilance are essential to reduce associated morbidity and mortality.