A prospective study on adverse drug reactions reported in a tertiary referral hospital

Brahadeesh Mayathevar, Dhivya Thiyagarajan, Thamilarasi Soundararajan, Vallish B. N., Rizwan S. A.


Background: To determine the incidence of Adverse drug reactions in our hospital, to study the age wise distribution, the role of concurrent medication and the common drugs that are prone to cause adverse drug reactions and its seriousness.

Methods: After getting prior approval from Institutional ethical committee a prospective study was done where in cases attending OPD, ward, ICU were studied over a year. A complete history was taken regarding drug exposure (dosage, date started, duration and interruptions in use), initiation of drug use and onset of reaction, previous adverse drug reactions, improvement after decrease in dosage, disease states predisposing to eruptions, previous family and personal history of skin disease, environmental and occupational exposure to chemicals. Relevant laboratory test such as blood investigations, liver and renal function tests are carried out and results were analysed statistically by SPSS version 21 and interpretations done based on the results.

Results: Incidence of ADR among OPD =0.18, IPD=1.98, OPD+IPD=0.39 /1000cases.The highest incidence of Adverse drug reactions were found among the age group of 30-39 years (27.45%), 40-49 years (23.53%), with the highest among antibiotic group of drugs (35.29%) involving a maximum duration of 2-7 days. Drug reactions mostly occurred with the oral route 66.67) and most of it requiring hospitalization (47.06%), 60.78% of reactions were manifested in skin, 58.82% of patients with ADR had concomitant medications and 19.61% had Diabetes mellitus, 90% of reactions abated after drug withdrawal with regard to its outcome 94.12% of reactions recovered.

Conclusions: The study suggest the adverse drug reactions commonly occur in middle age, mostly manifesting in skin with oral route of administration ,associated with concomitant medications and it requires hospitalisation with a good recovery rate with diabetes being the common comorbid disorder.


Adverse drug reaction, Diabetes, Hospitalisation, Incidence, Oral route, Withdrawal

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