Background: Adverse Drug Reactions (ADRs) are one of the leading causes of morbidity and mortality worldwide. They are important cause of hospitalization and rank fifth among all causes of death in developed countries. The present study was aimed to study the causality assessment and outcome of ADR related hospitalizations in the Medicine department of our tertiary care teaching hospital.

Methods: A prospective, observational study was conducted over a period of 10 months and included all adult patients with suspected ADR admitted to the Department of Medicine. Each patient of ADR was assessed for causality using the WHO Probability Scale.

Results: ADR related hospitalizations accounted for 0.24% of the total admissions to the Medicine department. The commonest ADR was hypoglycemia, followed by cutaneous drug reactions. Insulin and sulfonylureas were the most common suspected medications followed by antimicrobials. The most common predisposing factor was polytheapy. Causality assessment revealed that 36% of cases were certainly associated, 45% probably associated and 19% possibly associated with the respective suspected drugs. Death occurred in 2.2% of the ADR patients.

Keywords: pharmacovigilance, polytherapy, hypoglycaemia.

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Namita Mohapatra

UTKAL University