A prospective study of clinical patterns and assessment of causality and severity of cutaneous adverse drug reactions in a tertiary care hospital

Abstract Background: There is a paucity of reliable published data from India regarding clinical patterns and assessment of causality and severity of cutaneous adverse drug reactions (CADRs). Methods: We prospectively studied 88 consecutive patients diagnosed with CADR during the period December 2021–July 2022 at our tertiary care teaching hospital. Results: Their median (interquartile range) age was 38.4 (24–51) years; there were 44 (50%) males. A history of similar complaints to the same drug was seen in 10 (12%) patients. Mucosal involvement was seen in 21 (24%) patients. Systemic involvement was seen in 21 (24%) patients. According to the World Health Organization-Uppsala Monitoring Centre system causality assessment, 23 (26%) were certain and 57 (65%) were probable CADR. CADR constituted 2.5% of patients attending the dermatology, venereology and leprosy outpatient department. Amongst them, 18 (20%) had severe CADR. The most common form of CADR were drug-induced acneiform eruption ( n = 28, 32%), followed by fixed drug eruption ( n = 9, 10%), and morbilliform drug eruption, drug-induced urticaria, drug-induced purpura (5 patients each). CADRs were most frequently seen with antimicrobials ( n = 28, 32%), followed by corticosteroids ( n = 22, 25%), anticancer drugs ( n = 10, 11%), anticonvulsants and non-steroidal anti-inflammatory drugs in 5 patients each. On multivariable analysis, older age was independently associated with the development of severe CADR. Conclusions: CADR should be considered in the differential diagnosis of any patient presenting with a new-onset rash.