Evaluation of Reported Adverse Drug Reactions in Antibiotic Usage: A Retrospective Study From a Tertiary Care Hospital, Malaysia.

Adverse drug reaction (ADR) primarily caused by many drugs including antibiotics. At present, the incidence and pattern of ADR caused by antibiotics have remained as neglected area in Malaysia. This study was conducted to determine the incidence and analyze the pattern of ADR caused by antibiotics among patients in a tertiary care hospital. It is a 2-year retrospective observational study conducted at Hospital Pulau Pinang, Malaysia. All eligible patients who had antibiotic prescribed belonging to any age group either from outpatient or inpatient that had experienced ADR was included in this study. The outcomes were measured with the aid of Naranjo's and Hartwig's scales. The incidence of the ADRs among patients prescribed with antibiotics in Hospital Pulau Pinang is about 1.1%. Vancomycin and Trimethoprim/Sulfamethoxazole both are considered to be the major contributors to ADR incidences. The skin was the most affected organ by ADRs followed by gastrointestinal system. Most of the severe ADRs were caused by Penicillin. The causality relationship of all the severe reactions was mostly probable. General Medicine unit had reported the highest number of ADRs caused by antibiotics. The common manifestations of ADRs are acute kidney injury and exanthem. In addition, majority of the ADRs caused by antibiotics were reversible. A large multicenter study is suggested to confirm the present findings.