Background: Antibioticsare currently the most commonly prescribed drugs in hospitals, worldwide. Detecting ADRs and establishing preventive measures is essential for patient safety.

Methods: A prospective, Cross-sectional, Observational study was conducted at inpatient and outpatient Department of Medicine in tertiary health care centre. 96 patient’s relevant medical history were obtained from ADR forms (CDSCO forms) and patients files from 1 October 2022 to 31 December 2022.

Results: A total of 96ADR forms and patients’ files were collected, analysed and assessed on WHO causality assessment scale. It was observed that male patients 58(60.41%) predominated over females 38 (39.58%) in ADR occurrence. Age wise distribution of the ADRs revealed that the Middle-aged patients were more accounted 41 (42.70 %), followed by geriatric28 (29.16 %), and Adult 23 (23.95 %). ADRs reported with Beta-Lactams were 37(38.54%) followed by Aminoglycosides19 (19.79%), and Quinolones 15(15.62%). GIT 29(30.20%) was the most affected organ system by Adverse Drug Reactions. The most common ADR was Abdominal pain 13(13.54%), Dyspnoea, Diarrhoea, Rashes 08 (8.33%), Vomiting, allergic reactions 6 (6.25%) and Cough. Severity assessment showed that out of 96 ADRs, mild reactions were high followed by moderate and severe reaction.

Conclusion: This study concluded the spontaneous reporting of Adverse Drug Reactions to antibiotics and other drugs, proper documentation and periodic reporting to regional pharmacovigilance centres should be promoted to ensure drug safety.