Cutaneous Adverse Drug Reactions in a Tertiary Teaching Hospital: A Prospective, Observational Study

OBJECTIVE: To describe clinical patterns, identify associated drugs, and perform causality assessment of cutaneous adverse drug reactions. MATERIALS AND METHODS: In this prospective, observational study, patients with signs of cutaneous drug reaction from the department of dermatology of a tertiary teaching hospital were included. Patients with viral exanthemas were excluded. The patterns of cutaneous drug reactions, and associated drugs were noted. Naranjo scale was used for causality assessment of adverse drug reactions. RESULTS: Sixty-five patients (mean age 38.1 years) were included. Skin lesions were seen after 2 days of drug consumption in 25 (38.5%) patients. Pigmentation, fixed drug eruption, and maculo-papular rashes were seen in 13 (20%), 22 (33.8%), and 12 (18.5%) patients, respectively. Thirty-five (53.85%) patients had other associated symptoms. Fever was seen in 22 (33.8%) patients. Thirty-two (49.2%) cases had exposure to antibacterial agents. Most commonly associated drugs with reactions were nonsteroidal anti-inflammatory agents 14 (21.5%) followed by beta-lactam antibiotics 12 (18.5%), and fluroquinolones 7 (10.8%). Fifty-seven (87.7%) adverse drugs reactions had “probable” association with the drug.” CONCLUSION: Fixed drug eruption is the commonest presentation of cutaneous adverse drug reactions and antimicrobial agents are most commonly associated with it. According to the Naranjo scale, the majority of the cutaneous drug reactions have a “probable” association with the offending drugs.