Clinical Spectrum and Drug Allergy Patterns in Children Presenting with Skin Rashes: A Hospital-Based Pharmacovigilance Study

Abstract

Background: Drug allergies are a significant cause of skin rashes in children, influencing treatment approaches and outcomes. However, data on causative agents and clinical patterns in the Middle East, particularly Iran, are limited. Objectives: This hospital-based cross-sectional study evaluated drug history and patterns of allergic reactions in children with suspected cutaneous adverse drug reactions (CADRs) at a hospital in Zahedan, Iran. Methods: In this cross-sectional study, 210 pediatric patients with suspected CADRs were enrolled between January 1 and December 31, 2023. Data on demographics, drug history, clinical manifestations, and family allergy history were collected using a structured questionnaire and medical record review. The Naranjo algorithm was applied for causality assessment. Data were analyzed using IBM SPSS Statistics for Windows, Version 26.0. Descriptive statistics and chi-square tests were used; a P-value < 0.05 was considered significant. Results: The mean age was 7.1 ± 4.3 years, with 51% males and 49% females. A history of drug exposure preceding rash onset was reported in 82.2% of cases. Antibiotics (32.2%) and anticonvulsants (27.8%) were the most common triggers, followed by nonsteroidal anti-inflammatory drugs (NSAIDs, 10%) and herbal medicines (12.2%). Urticaria/angioedema (45.5%) and maculopapular rash (30%) were the predominant clinical presentations. A family history of drug allergy was present in 43% of cases. Urticaria/angioedema was significantly more common in boys (P = 0.01), while maculopapular rash and anticonvulsant reactions were more frequent in girls (P = 0.03 and P < 0.001, respectively). Conclusions: Antibiotics and anticonvulsants are the principal causes of CADRs in children, with urticaria/angioedema being the most prevalent presentation. The high prevalence of herbal medicine reactions and family history of drug allergy underscores the need for meticulous evaluation and cautious prescribing. These findings highlight the importance of enhanced pediatric pharmacovigilance systems to improve drug safety.