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Introduction: Ayurveda, one of the world’s oldest medical sciences, has gained global recognition. However, concerns regarding the safety of Ayurvedic formulations, especially in the context of adverse drug reactions (ADRs), contamination, or improper use, have highlighted the importance of pharmacovigilance (PV). Traditionally, Ayurvedic pharmaceutics included safety measures like Shodhana (purification) and rational prescribing, but modern large-scale production and global usage necessitate systematic monitoring frameworks. Methods: A structured literature review was conducted through PubMed, Scopus, Web of Science, AYUSH Research Portal, and Google Scholar (2000–2025). Classical Ayurvedic texts (Charaka Samhita, Sushruta Samhita, Rasa Ratna Samucchaya) were reviewed to explore safety concepts. Research articles, policy reports, case studies, and reviews focusing on PV, ADR monitoring, and regulatory frameworks in Ayurveda were included. Results: Traditional texts mention adverse effects, contraindications, and the need for vigilance in prescribing. Modern pharmacovigilance systems in Ayurveda are still evolving. India’s Ministry of AYUSH launched the “Pharmacovigilance Program for ASU&H Drugs” in 2008, which has improved awareness but faces challenges like under-reporting, lack of trained manpower, and weak integration with healthcare systems. Studies show ADRs are often linked to poor manufacturing practices, self-medication, or non-adherence to classical guidelines rather than inherent flaws in Ayurveda. Integration of modern PV tools—such as digital reporting systems, standard terminology, and data-sharing platforms—has shown promise in improving safety monitoring. Discussion: Strengthening PV in Ayurveda requires blending classical knowledge with modern systems. Robust reporting networks, mandatory ADR monitoring in clinical trials, global harmonization, and public–practitioner awareness programs are needed for wider credibility. Conclusion: Pharmacovigilance in Ayurvedic formulations is essential for ensuring patient safety, sustaining trust, and promoting global acceptance. Proper implementation of PV systems can bridge traditional wisdom with modern pharmacology.

KEYWORDS: Adverse drug reactions, Ayurveda, herbal safety, pharmacovigilance, traditional medicine