Abstract

A COMPREHENSIVE REVIEW ON ADVERSE DRUG REACTIONS: MECHANISMS, MONITORING, REPORTING, AND MANAGEMENT

*Adi Kalavathi, Neeluru Sujatha, Dr. M. Sri Ramchandra

ABSTRACT

Adverse Drug Reactions (ADRs) remain a significant global health concern, contributing to patient morbidity, hospitalizations, and healthcare costs. Defined by the World Health Organization as harmful or unintended responses to drugs at normal doses, ADRs affect up to 20% of hospitalized patients and are among the leading causes of iatrogenic illness. Their occurrence is influenced by pharmacokinetic and pharmacodynamic variations, genetic susceptibility, immune mechanisms, drug interactions, and patient-specific factors such as age or comorbidities. Effective monitoring through spontaneous reporting, hospital-based surveillance, electronic health records, and advanced data-mining techniques is essential for early detection of safety signals. Reporting systems, including the Yellow Card Scheme, FDA MedWatch, EudraVigilance, and India’s Pharmacovigilance Programme, play a central role, though underreporting remains a challenge. Management requires early recognition, causality assessment, discontinuation or modification of therapy, supportive care, and preventive strategies such as rational prescribing and patient education. Strengthened pharmacovigilance and patient engagement are key to safer therapeutics.

Keywords: ADRs, Pharmacovigilance, Drug Safety, PvPI, Monitoring, Pharmacogenomics, CDSS.