175ADVERSE DRUG REACTIONS ASSOCIATED WITH HERBAL MEDICINES: A REVIEWAdverse 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 harmonisationgodsonrani12@gmail.comResearch1622026Adverse Drug Reactions; Herbal Medicines; Hepatotoxicity; Herb-Drug Interactions; Allergic Reactions; Cardiovascular Toxicity; Nephrotoxicity; Pharmacovigilance; Spontaneous ReportingJansi Rani IAssistant Professor, Department of Pharmacognosy, St.Mary’s Institute of Pharmacy, Chinthamani, Puliankudi. - 627855