OBJECTIVE: To assess the pattern of occurrence, causality, and severity of ADRs related to antibiotics

METHODS: A retrospective analysis of spontaneously reported ARDs pertaining to antibiotics from January 2021 to December 2021 was carried. Each reported ADR was assessed for its causality using the WHO Probability scale. The criterion developed by Hartwig et al. was adapted to assess the severity of the ADR. The data obtained were assessed categorically and represented as [n (%)].

RESULTS: A total of 1071 ADRs were reported during the calendar year 2021, of which 79 were associated with antibiotics. The majority of ADRs reported were among males [46 (58.2%)]. Patients of adult age were most affected, under the age groups 19- 29 years [16 (20.3%)], followed by 40- 49 years [11 (12.4%)]. Skin and subcutaneous tissue disorders [38 (48.1%)] was the most affected system organ class, followed by gastrointestinal disorders [22 (27.8%)]. Rash [21 (25%)] and diarrhoea [20 (23.8%)] were the most reported ADRs, followed by itching [11 (13.1%)]. Ceftriaxone [17 (21.5%)] was the most implicated antibiotic, followed by piperacillin and tazobactam [8 (10.1%)]. The causality of most reactions was probable [52 (65.8%)] and the severity was found to be moderate [45 (57.0%)] in nature.

CONCLUSION: Antibiotics are widely used, necessitating active surveillance for detection, reporting, and monitoring the ADRs associated with this class of drugs, which can be carried out effectively by a clinical pharmacist, thereby promoting patient safety and reducing the healthcare cost. Further, evaluation of predisposing factors is required to predict the early ADR occurrence among the risk population.