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

ABSTRACT

Background: 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. Aims and Objectives: To study the demographic details, clinical patterns, mucocutaneous involvement, causality, and the offending drugs causing ACDR. Materials and Methods: 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. Results: 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. Conclusion: Wide spectrum of drug reactions were observed in this study. Antimicrobials were the most common causative agents of ACDR.