PATTERN OF ADVERSE DRUG REACTIONS REPORTED AT THE ADVERSE DRUG REACTION MONITORING CENTRE (AMC-RIPER) AT A TERTIARY CARE TEACHING HOSPITAL IN INDIA: A RETROSPECTIVE OBSERVATIONAL STUDY

Abstract

Adverse drug reactions (ADRs) are an important cause of morbidity and may adversely affect patient safet. To analyze the demographic and clinical characteristics of reported ADRs and assess their distribution according to reporting source, seriousness, and annual reporting pattern over the study period. A retrospective observational study was conducted at AMC-RIPER, ADR reports documented over a five-year period from January 2021 to December 2025 were reviewed. Descriptive statistics were used for analysis. The VigiFlow export analyzed in the results contained 1,059 ADR report records. Among the 1,059 ADR reports analyzed, females accounted for 583 (55.05%) reports and males for 463 (43.72%), while sex was not reported in 13 (1.23%) reports. The mean age of patients with available age data was 37.25 ± 21.25 years, with a median age of 38 years and a range of 1–93 years. Regarding seriousness, 931 (87.91%) ADRs were classified as non-serious and 128 (12.09%) as serious. ADR reporting increased substantially during the later years of the available dataset, with the highest number of reports recorded in 2025.The study demonstrated a broad spectrum of suspected ADRs reported at AMC-RIPER, with a slight female predominance and adults representing the largest age group among reports with known age classification. Pharmacists made a major contribution to ADR reporting. Although most reported ADRs were non-serious, the presence of serious reactions emphasizes the need for continuous monitoring and timely intervention. The increase in reporting during the later years may reflect improved pharmacovigilance awareness, reporting practices, and documentation. Strengthening multidisciplinary participation, continuous ADR monitoring, timely reporting, and proper documentation may further improve medicine safety and promote rational use of medicines in the hospital setting.