ADVERSE DRUG REACTIONS ASSOCIATED WITH HERBAL MEDICINES: A REVIEW
Jansi Rani I
Assistant Professor, Department of Pharmacognosy, St.Mary’s Institute of Pharmacy, Chinthamani, Puliankudi. - 627855
Adverse Drug Reactions Associated with Herbal Medicines represents a critical dimension of botanical medicine science that bridges traditional plant-based medicine heritage with modern pharmaceutical standards for quality, safety, and regulatory compliance [1, 2]. The global significance of herbal medicines—used by approximately 80% of the world's population and representing a multi-billion dollar industry in high-income countries—underscores the public health importance of rigorous adverse drug reactions associated with herbal medicines science [3, 4]. Key advances in adverse drug reactions associated with herbal medicines include: application of ultra-high-performance liquid chromatography coupled with high-resolution mass spectrometry (UHPLC-HRMS) metabolomics for comprehensive botanical profiling and authentication; deployment of DNA barcoding for molecular species verification; implementation of WHO Good Agricultural and Collection Practices (GACP) standards for botanical supply chain quality; and development of pharmacovigilance frameworks specifically adapted for herbal medicine adverse event monitoring and causality assessment [5, 6, 7]. Critical challenges in adverse drug reactions associated with herbal medicines include: botanical identity verification and adulteration prevention; pyrrolizidine alkaloid and aristolochic acid contamination monitoring; herb-drug interaction characterisation (particularly CYP3A4/P-gp-mediated interactions involving St. John's wort); hepatotoxicity risk assessment for botanicals with hepatotoxic signal; heavy metal and pesticide contaminant control; and international regulatory harmonisation enabling global market access for quality botanical products [8, 9, 10]. Regulatory frameworks governing adverse drug reactions associated with herbal medicines have matured substantially: the FDA Botanical Drug Guidance (2016/2023) and EU THMPD (2004/24/EC) with EMA HMPC community herbal monographs provide the most comprehensive frameworks globally, supplemented by WHO traditional medicine strategy and guidance documents [5, 6]. This review consolidates current knowledge on adverse drug reactions associated with herbal medicines, examining scientific advances, regulatory developments, safety evidence, quality standards, and priorities for future research and regulatory harmonisation
16 , 2 , 2026
99 - 103