Monitoring of adverse drug reactions in medicine, paediatric and surgical departments of a tertiary care hospital: a prospective observational study


  • Sujatha Sowmyanarayan Department of Pharmacology, East Point College of Medical Science and Research Centre, Bangalore, Karnataka, India
  • Swati Banerjee Department of Pharmacology, East Point College of Medical Science and Research Centre, Bangalore, Karnataka, India



Adverse drug reaction, Causality, Drugs causing, Severity


Background: the aim of the study was to monitor all adverse drug reactions in the departments of Medicine, Paediatrics and Surgery in a Tertiary Care Hospital.

Methods: It was a prospective study undertaken in a 300 bedded tertiary care hospital. Patients presenting with adverse drug reactions in Medicine, Paediatrics and Surgery Departments were studied. Causality and severity of the adverse drug reactions were analysed Other parameters such as age wise and gender wise distribution of the ADRs, types of ADRs and drugs causing ADRs were studied.

Results: There were 33 cases of ADRs were enrolled for the study in the duration of Sept. 2016 to Aug. 2017. Female preponderance was seen. The largest number of ADRs were seen in the age group of 21-30 years (30.3%). The most common ADR was skin rash (30.3%) followed by periorbital edema (12%). There were two SAEs namely Anaphylaxis and Steven Johnson syndrome. The most offending class of drug was antibiotics (30.3%) followed by intravenous fluids (12.1%).

Conclusions: The maximum number of cases were reported from the Medicine Department which was 11 (33.33%). The highest number of ADRs fell in the probable category (63.6%). The number of cases of mild and moderate severity were equal (42.4%). The knowledge of these adverse drug reactions is necessary while prescribing drugs to patients as patient safety is absolutely essential. Also the healthcare provided by the institution will improve. This data has been collected with a view to establish an ADR monitoring centre at our hospital.


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How to Cite

Sowmyanarayan, S., & Banerjee, S. (2018). Monitoring of adverse drug reactions in medicine, paediatric and surgical departments of a tertiary care hospital: a prospective observational study. International Journal of Basic & Clinical Pharmacology, 7(4), 778–782.



Original Research Articles