Adverse Cutaneous Drug Reactions at a Rural-Based Tertiary Health-Care Center in Gujarat: An Eleven Year Study.

Abstract

An adverse cutaneous drug reaction (ACDR) is an undesirable change in structure and function of the skin, its appendages, or mucous membranes due to drugs. To study the demographic details, clinical patterns, mucocutaneous involvement, causality, and the offending drugs causing ACDR. In this observational study, we have seen 2,96,544 patients in the skin department at a rural-based tertiary health-care hospital, out of which 728 cases were diagnosed to have ACDR from a time span of April 2010 to March 2021. The causality assessment system WHO-UMC (World Health Organization Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre), the Naranjo probability scale, and Hartwigs score were calculated for patients. Out of 728 cases, males were 371 (50.96%); most common age group was 21-30 years (25.13%). The most common presenting complaint was erythematous rash (21.29%). Antimicrobials (n = 345, 47.39%) were the most common drug group. Most common mucosa involved was oral mucosa and most common pattern of reaction seen was maculopapular rash (25%) among these patients. In the causality assessment using WHO guidelines, there were 66 (9.1%) certain, 224 (30.83%) probable, and 436 (60%) possible cases. Naranjo score showed 73 (10%) definite cases, 255 (35%) probable cases, and 400 (55%) possible cases, while Hartwigs score showed level 2 in 122 (16.7%) cases and level 3 in 412 (56.7%) cases. Wide spectrum of drug reactions were observed in this study. Antimicrobials were the most common causative agents of ACDR.