OBJECTIVES: This study was aimed to identify the agents involved in the occurrence of ADRs and to identify and monitor the ADRs occurred in in-patients of a tertiary care hospital.

METHODS: It was a prospective, observational study conducted for a period of two years at a tertiary care hospital in India. On a daily basis, data were collected from the patients’ case sheets. The ADRs were detected and monitored by interviewing patients, reviewing laboratory tests and medical charts. All the collected data were tabulated and analyzed by using Naranjo algorithm and Hartwig and Seigel’s severity assessment scale to identify the probability, severity and preventability of the reactions.

RESULTS: In this study, it is observed that majority of ADRs occurred in females. Patients belonging to the age group of 21-50 years old experienced a higher number of ADRs than the patients in other age groups. The most commonly reported ADRs were associated with antimicrobial agents and cardiovascular agents. The most commonly reported ADRs were elevated liver function test (12.2%) followed by diarrhea (9.5%). The Gastrointestinal system was the most commonly affected organ system followed by fluid and electrolytes. Majority of the ADRs (55.1%) were found to be probable. In addition, the majority of the reported ADRs (84.2%) were mild.

CONCLUSIONS: The results of this study provide a database of ADRs, which aid clinicians in optimized and safer use of medicines and this, in turn, might lead to an enhanced level of patient care.