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Suspected Cutaneous Adverse Reaction Due to Oral Consumption of Siddha Polyherbo-Mineral Formulation, Gandhaga Rasayanam: A Case Report

Subathra T, Chandan N, Barvaliya M, Shanmugapriya P, Senthilvel G

Current drug safety, 2026

Abstract

INTRODUCTION

The Siddha formulation Gandhaga Rasayanam (GRM) is a classical polyherbo-mineral medicine containing purified sulphur and other herbal ingredients, including Schedule E(1) drugs. It is traditionally used to manage chronic ailments and dermatological conditions. Limited safety data have been documented for Siddha medicines; this report highlights a suspected adverse cutaneous reaction probably associated with GRM.

CASE SUMMARY

A 36-year-old female treated for residual Padarthamarai (Tinea cruris) developed elevated plaque with ill-defined, diffuse borders over the neck and upper back on Day 3 of therapy with GRM in combination with other Siddha medicines. This lesion was inflamed, warm to the touch, and associated with pruritus, itching, and burning. The lesions subsided markedly upon GRM withdrawal and resolved completely after a short course of levocetirizine. The patient was advised to resume other internal medicines, excluding GRM, the most suspected drug, and no recurrence was observed. This implicates GRM as the probable cause of the adverse reaction.

CONCLUSION

This case highlights the potential for adverse reactions even with traditionally regarded safe Ayush formulations and emphasizes the need for vigilant pharmacovigilance and systematic documentation of adverse events to ensure patient safety.

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