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

ABSTRACT

BACKGROUND: Monitoring spontaneous adverse drug reactions is one of the epidemiological methods for assessing the safety of drugs in a hospital setting. METHODS: 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. RESULTS: 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. CONCLUSION: The pattern of ADRs and drugs involved were largely similar to those reported in the western literature.