Evaluation of Adverse Drug Reactions in Outpatients and Inpatients in Department of Dermatology at Tertiary Care Hospital

Abstract Objective: The study aims to evaluate the clinical spectrum, morphology, and causative drugs responsible for CADRs in inpatients and outpatients attending the dermatology department of a tertiary care center. It also emphasizes the necessity of an effective pharmacovigilance system to improve drug safety and minimize CADR-related morbidity and mortality. Methods: A cross-sectional observational study was conducted at a tertiary care center in Jamnagar, Gujarat, from January 2023 to June 2024. A total of 150 patients presenting with CADRs at the dermatology outpatient department were included. Detailed clinical history, physical examination, and relevant laboratory investigations were performed. Causality was assessed using WHO-UMC and Naranjo criteria, while severity and preventability were evaluated using standard classification systems. Results: Out of 150 patients, 54% were male and 46% female, with the majority in the 25-44 age group. The most common CADRs were maculopapular rash (28%), urticaria (25%), and fixed drug eruptions (16%). Antimicrobials (45%), NSAIDs (32%), and antiepileptics (10%) were the most implicated drug classes. According to WHO-UMC criteria, 65% of reactions were probable, 28% possible, and 6.66% definite. Most reactions (90%) were mild to moderate, while 10% were severe and required hospitalization. Conclusion: Mild-to-moderate CADRs were more prevalent than severe reactions. Antimicrobials and NSAIDs were the most common culprits. Severe ADRs were mainly linked to antiepileptics. Physicians should exercise caution in prescribing drugs with known CADR risks and promote awareness to reduce self-medication and polypharmacy. Implementing a strong pharmacovigilance system is crucial for improving patient safety.