Adverse Drug Reactions (ADRs) represent a major public health challenge, contributing to increased morbidity, prolonged hospitalization, and healthcare costs. This study aimed to detect, assess, and report ADRs in a tertiary care hospital, while analyzing their prevalence, severity, causality, preventability, and management strategies.

A prospective observational study was conducted over six months at Prathima Institute of Medical Sciences, Telangana, involving 107 patients with suspected ADRs. Data were collected from patient case records, medication charts, and patient interviews. ADRs were evaluated using the Hartwig Severity Scale, WHO-UMC and Naranjo’s Causality Assessment Scales, and Schumock and Thornton’s Preventability Scale. Statistical tools were used to assess distribution patterns and contributing factors.

The majority of ADRs were reported in females (60%) compared to males (40%), with adults (85.98%) being the most affected group. The highest number of ADRs occurred in the gynecology department (21.4%), followed by general surgery (14%). Antibiotics (32.71%) were the most commonly implicated drug class, particularly Augmentin (7.47%) and Ceftriaxone (6.54%). Most ADRs were associated with oral (46.7%) and intravenous (45.7%) routes. Skin-related reactions (41.1%), especially rashes (15.88%), were the most frequently reported. The majority of ADRs were mild (52.3%) and had probable causality (57.1%). Management strategies included drug substitution (45.7%), additional therapy (42.05%), and drug withdrawal (8.4%). Most patients (77.5%) fully recovered.

The study concludes, active ADR monitoring and robust pharmacovigilance practices are essential to improving patient safety. Strengthening ADR reporting systems and enhancing awareness among healthcare professionals can significantly reduce drug-related risks.

Keywords: Adverse Drug Reactions, Pharmacovigilance, Causality Assessment, Drug Safety, Tertiary Care Hospital, WHO-UMC Scale.