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Medicines are the most common medical interventions, primarily used to relieve sufferings. But medicines themselves can prove fatal so it is rightly said that medicines are double edged weapons. Adverse reaction monitoring and reporting are very important in identifying the adverse reaction trends and ensuring drug safely.

Aims and objectives

To monitor and analyze the suspected adverse drug reactions reported at tertiary care teaching hospital, to characterize nature and predictability of ADRs and identify most common medicines causing ADRs

Material and methods

A retrospective observational study was conducted between January 2014 to June 2016. Suspected ADRs submitted to National pharmacovigilance center. Following  parameters were studied, Age group-paediatric, adult, geriatric, Gender, Groupwise, systemwise classification of ADRs, Most common medicines causing ADRs, Causalty assessment of ADRs by using WHO-UMC causality assessment scale, Assessement of preventability criteria by Schumock and Thornton scale.


During the study period a total 1099 ADRs reported were analyzed. Male experienced a significantly higher percentage of ADRs (55.86 %).Highest percentage of ADRs was found in adult age group 31-40 yrs. All ADRs were probable. There was no any certain ADR we could find out. Maximum number of ADRs were in the age group 31-40 years i.e 377(34.30% ).Skin was the commonest organ showing highest no. of ADRs 41.87.Internal medicine was the commonest department 28.33% ADRs. Out of total antimicrobial agents causing ADRs, maximum number of ADRs were due to amoxicillin + clavulanic acid. Common symptoms due to ADRs of medicines were itching 174 (15.83%), skin rash 108 (9.82%).


There is urgent need of promotion of spontaneous reporting of ADRs. More awareness needs to be created to address these issues.


Adverse drug reactions Pharmacovigilance Causality assessment scale Thornton and Schumock scale

Article Details

How to Cite
Dr.Vandana Badar, Dr.Vidisha Parulekar, & Dr.Priti Garate. (2021). A surveillance study of adverse drug reactions in a tertiary care teaching hospital in India. International Journal of Research in Pharmacology & Pharmacotherapeutics, 7(2), 120-129. Retrieved from


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