Clinical patterns and pharmacovigilance trends of cutaneous adverse drug reactions in India

Cutaneous adverse drug reactions (CADRs represent a significant proportion of adverse drug reactions in India, driven by widespread antimicrobial use, self-medication, and polypharmacy. Manifestations range from mild exanthems to life-threatening syndromes such as Stevens–Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. This review aims to synthesize Indian epidemiological evidence and pharmacovigilance data to highlight patterns, mechanisms, and management of CADRs. Data were collated from published Indian studies and alerts from the Pharmacovigilance Programme of India (2020–2025). Beta-lactam antibiotics, sulfonamides, non-steroidal anti-inflammatory drugs, and antiepileptics emerged as the most frequently implicated drug classes. Immunopathogenesis involves hapten and pharmacological interaction mechanisms, with genetic susceptibility mediated by HLA associations. Severe CADRs demonstrate distinct immune signatures, including CD8 + T-cell activation, Th17 responses, and granulysin-driven keratinocyte apoptosis. Diagnostic approaches encompass clinical scoring systems, histopathology, patch testing, and structured causality assessment. Management prioritizes prompt drug withdrawal, supportive care, and syndrome-specific immunomodulation. Emerging strategies—pharmacogenomic screening, AI-assisted signal detection, and digital patient engagement—offer promise for improving early recognition. Strengthening clinician participation in national pharmacovigilance systems is essential to enhance reporting, enable timely interventions, and improve patient safety in dermatological practice.