Introduction: Adverse drug reactions (ADRs), including cutaneous adverse drug reactions (CADRs), are significant global health concerns with India among the top affected countries. CADRs represent a significant concern in healthcare, impacting the skin, its appendages and mucous membranes ranging from mild rashes to severe, life threatening conditions like Stevens-Johnson syndrome and toxic epidermal necrolysis. Self- medication with over-the-counter drugs is a notable public health issue linked to CADRs. Clinical trials often miss long-term and rare CADRs making early detection and monitoring crucial. This study aims to evaluate CADRs by assessing their causality, severity and preventability; determining onset lag time; identifying morphological patterns; and investigating associations with different drug classes. It also explores the links between self-medication and CADRs and analyses related outcomes. This research addresses gaps in understanding CADRs' epidemiology, impact and management providing valuable insights for healthcare practitioners.

Material and methods: A 12-month prospective observational study conducted at a tertiary care hospital involved dermatology patients from both outpatient and inpatient units. Inclusion criteria comprised patients diagnosed with CADRs by physicians in the outpatient department (OPD) (active surveillance) and reported cases to pharmacovigilance unit (passive surveillance) while those unwilling to provide written consent were excluded.

Result: The majority (44.25%) of the patients were aged 18-39 years. Maculopapular rash (53.98%) and urticarial rash (9.73%) were the most common CADR types. Anti-bacterials (42.63%) were the primary suspected drug class. Serious CADRs were predominant (74.34%) with 1.77% resulting in fatalities. Severity was moderate in 79.65% and mild in 17.7% of the cases. Preventability was low (5.31%) with three CADRs attributed to self-medication. Recovery was seen in 46.9% of the patients with 42.48% still in recovery at discharge and a mortality rate of 1.77% due to Stevens-Johnson syndrome.

Conclusion: A comprehensive pharmacovigilance system for continuous monitoring of patients' health status can lead to opportunities to reduce the CADRs, lower drug-related morbidity and rationalize drug therapy.

Dr. Pravin Dhage is a dedicated healthcare professional with a passion for pharmacology and healthcare reform. After earning his MBBS and MD in Pharmacology from Lokmanya Tilak Municipal Medical College (LTMMC) in Mumbai, he continued to work there as a Senior Resident. Now, he’s sharing his expertise as an Assistant Professor in the Department of Pharmacology at LTMMC.

Throughout his career, Dr. Dhage has played a key role in clinical trials, working as a study physician for both COVID-19 and Rabies vaccines. He’s also heavily involved in academic and administrative work, including organizing the first-ever national online conference, "Advitiya," and various webinars.

His research spans several important topics, from cutaneous drug reactions to COVID-19 treatments, and he’s published in respected scientific journals. Beyond his academic achievements, Dr. Dhage is a State-Convener of the Indian Medical Association’s Junior Doctors Network and has held leadership positions, such as National Vice-President of the Federation of Resident Doctors Association India.

In addition to his academic pursuits, he is actively involved in physical activities like kickboxing and karate, and he also enjoys theater as a hobby. Dr. Dhage remains committed to advancing healthcare, education, and patient care.