Antibiotics-related adverse drug reactions at a tertiary care hospital in North India

Background: Antibiotics are considered to be commonly used drugs in hospital setting due to higher prevalence of infectious diseases especially in India. So, the present study was conducted to assess the incidence of adverse drug reactions (ADRs) due to antibiotics and analyze for causality of adverse drug events reported.Methods: The present retrospective and observational, study was conducted in BPS GMC for women, Khanpur Kalan, Sonepat, Haryana which is a 500 bedded government medical hospital situated in rural area between March 2016 to February 2019 (i.e., 3 years). Patients of either sex or age who developed ADRs by any route were included in the study.Results: 300 (38.65%) cases were reported due to antibiotics out of total 776 ADR cases. 3% cases were serious. Adults (65%) were found to be most commonly affected by ADRs. Among antibiotics, cephalosporins and penicillins (15.98%) were the major culprit to cause adverse events followed by nitroimidazoles (15.2%) and antitubercular drugs and fluoro quinolones (13.16%). The most affected organ system was skin (49.33%) followed by the gastrointestinal system (33%). As per WHO scale of causality assessment, 33.33% and 67.67% reported cases were found to probably and possibly related to adverse events respectively.Conclusions: Antibiotics are most commonly prescribed drugs so its monitoring regarding ADRs may benefit the clinicians in early identification and management of ADRs so that quality of life of patient can be safeguarded at an earliest