Adverse reaction monitoring and reporting are very important in identifying the adverse reaction trends in the local population. This study was aimed to analyse the adverse effects due to antimicrobial agents reported to a regional pharmacovigilance centre. A study was conducted in a teaching hospital in Chennai for a period of one year. All ADR forms due to antimicrobial agents submitted to the regional pharmacovigilance centre between Jan 2014 to Dec 2014 were collected and analysed. The factors studied include age, gender, drug classification, departments from where reports were obtained, types of events reported, outcome of the reaction, causality assessment, preventability and severity of ADRs. The study revealed that ADRs were more common in male patients 33 (58%) and the age - wise distribution revealed that the Adult patients had more ADRs 25 (43.85%). Cephalosporins and fluroquinolones 19 (33.33%), were the most common causative antibiotics. Maximum number of ADRs were reported from the dermatology department 27 (47.36%) and Fixed drug eruption was the most reported event. The severity assessment revealed that most of them were mild (68.42%) followed by moderate and severe reactions. Of the reported ADRs, Type A 45 (78.94%) was more common compared to Type B 12 (21.05%) reactions. Preventability studies revealed that 12 (21.05%) of the ADRs are definitely preventable. Causality assessment showed 73.68% was “Possible” according to WHO scale. Most of the patients were medically treated and recovered from the event. When prescribing drugs in daily practice, clinicians should take antimicrobial-related ADRs into consideration, especially when patients receiving antimicrobial therapy have new clinical manifestations after initiation of antimicrobial therapy. Also, health system needs to promote spontaneous reporting of ADRs detected in clinical practice to regional pharmacovigilance centres.
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