Antimicrobial-induced Cutaneous Adverse Drug Reactions: A Prospective Study of 100 Cases in a Tertiary Care Centre
Birva Patel, Pranav Ladani, Riya Pandit, Bharti PatelBackground:
Cutaneous adverse drug reactions (CADRs) are a significant cause of morbidity, particularly in developing countries due to irrational prescribing, self-medication, and inadequate pharmacovigilance. Antimicrobials are the most frequently implicated drugs owing to their widespread use.
Objectives:
To evaluate the clinical patterns, causative antimicrobial agents, severity, outcomes, and emerging trends of CADRs relevant to clinical practice and pharmacovigilance.
Methods:
A prospective observational study was conducted over 3 years (from December 2022 to February 2026) at a tertiary care teaching hospital. A total of 100 patients with antimicrobial-induced CADRs were included. Data on drug exposure, latency, clinical features, and mucosal involvement were recorded. Severity was assessed using SCORTEN and RegiSCAR criteria, and causality using the Naranjo Adverse Drug Reaction Probability Scale. Data were analysed descriptively.
Results:
Most patients were aged 21–30 years (25%), with slight male predominance (52%). Reactions occurred within 1 week in 74% of cases. β-lactam antibiotics were most commonly implicated (41%), followed by fluoroquinolones (22%), while antifungal and anti-tubercular drugs each accounted for 13%. Morbilliform rash was the most frequent presentation (34%), followed by fixed drug eruption (25%) and urticaria (18%). Severe cutaneous adverse reactions occurred in 10%, with mucosal involvement in 37% and one mortality.
Conclusion:
Antimicrobials remain the leading cause of CADRs. Increasing involvement of antifungal and anti-tubercular drugs reflects evolving prescribing patterns. Early recognition and strengthened pharmacovigilance are essential to reduce morbidity and improve outcomes.