OBJECTIVES: To assess the frequency, causality, and severity of reported ADRs associated with skin and subcutaneous tissue disorders

METHODS: A retrospective analysis of spontaneously reported ARDs associated with the skin and subcutaneous tissue disorders 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 141 ADRs were reported during the calendar year 2021 related to skin and subcutaneous tissue disorders. Among the total reported ADRs, [71 (50.4%)] were females and [70 (49.6%)] were males. The ADRs were predominant among the age group 50-59 years [28 (19.9%)], followed by 40-49 years [27 (19.1%)], and 19-29 years [22 (15.6%)]. Rash [45 (31.9%)] was the most common ADR reported, followed by itching [27 (19.1%)], and urticaria [11 (7.8%)]. Ceftriaxone [11 (7.8%)] was the most implicated drug, followed by amlodipine and diclofenac [5 (3.8%)]. The causality of the ADRs was identified as certain [1 (0.7%)], possible [44 (31.2%)], probable [94 (66.7%)], and unlikely [2 (1.4%)] according to WHO probability scale. Majority [88 (62.4%)] of the reactions were ‘moderate’ in severity and [3 (2.1%)] were severe.

CONCLUSION: ADRs are amongst the leading causes of morbidity and mortality hence, it is important to identify, report, and prevent these reactions early on, to reduce patient suffering and reduce the healthcare cost in its management. Genetic predisposition may have a role in ADR occurrence. Therefore, a detailed study regarding the possible predisposing factors is essential, which will aid in the prevention and identification of ADR occurrence at the earliest occasion.