Adverse drug reactions among inpatients in a north Indian referral hospital.

Abstract

Monitoring spontaneous adverse drug reactions is one of the epidemiological methods for assessing the safety of drugs in a hospital setting. Data on adverse drug reactions (ADRs) were collected over a 3-year period among inpatients in a north Indian referral hospital using the spontaneous ADR monitoring system. A total of 317 ADRs were reported. Cutaneous reactions (38.8%) and gastrointestinal disturbances (28.4%) made up a large proportion of reported ADRs. Antimicrobial agents, including those used for antituberculosis therapy, were responsible for 47.3% of the events. Radiocontrast dyes, and antineoplastic and psychoactive agents were the other important drugs causing ADRs. No age- or sex-related differences were found in the overall rate of ADRs, though toxic epidermal necrolysis was more frequent in the elderly. The pattern of ADRs and drugs involved were largely similar to those reported in the western literature.