Cutaneous Adverse Drug Reactions on application of Nagaradi Lepa - A Retrospective analysis

Introduction: Cutaneous adverse drug reactions are among the most common types of drug hypersensitivity reactions. Although considered natural and safe, Ayurveda medicines can cause adverse reactions. This article highlights the cases of cutaneous adverse drug reactions possibly due to external application of Nagaradi lepa. Materials and Methods: This is an observational, retrospective and record based study conducted by analyzing the spontaneous reported ADR forms, caused by the external application of Nagaradi lepa, collected over a period of 12 months (April 2022 to March 2023) at Peripheral Pharmacovigilance Centre, VPSV Ayurveda College Kottakkal, Kerala. Results: During the period of one year, 3 cutaneous ADRs were reported due to external application of Nagaradi lepa. All the 3 cases fall under the category of Probable according to Naranjo’s ADR Probability scale. 2 cases were mild and 1 case was moderate in severity. All the 3 cases were recovered from ADR. Conclusion: Though under reporting, we may have to consider the possibility of Ayurvedic drugs to cause adverse drug reactions. Pharmacovigilance is an ongoing and continuous process. Reporting of ADR to Pharmacovigilance centers help to generate information on ADR related Ayurvedic formulations and also to prevent its recurrence.