• Rohit Bansal
• Anju Dhiman

The aim of the study is to analyze the adverse reactions reported with consumption of dietary supplements in United States safety database (CAERS) to understand their frequency and severity. Data from CAERS database was analyzed for the period between January 2004 and March 2020. The data retrieved from CAERS was presented for trend of adverse events reported with food and dietary supplements marketed in US including seriousness, frequently reported dietary supplements in this database, type of adverse events and patient demographic information. The analysis of the database revealed a total of 69,266 cases reporting 103,503 different food products/dietary supplements and a total of 190,694 adverse events. Most frequently reported adverse events were related to Gastrointestinal disorders and most frequently reported product category was Vit/Min/Pro/Unconv diet. Almost 90% of the reported adverse events were serious in nature and frequently reported in female population. CAERS database provide important information regarding safety of nutraceuticals. Regulatory bodies in countries with large nutraceutical market should employ such measures to collect the safety data along with spreading awareness to increase the reporting of the adverse events related to nutraceuticals.

Adverse reactions, CAERS, Dietary supplements, Nutraceuticals, Nutrivigilance, Pharmacovigilance

"Investigation of Adverse Reactions Reported with Dietary Supplements in United States Global Safety Database", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.9, Issue 1, page no.a402-a407, January-2022, Available :http://www.jetir.org/papers/JETIR2201054.pdf

"Investigation of Adverse Reactions Reported with Dietary Supplements in United States Global Safety Database", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.9, Issue 1, page no. ppa402-a407, January-2022, Available at : http://www.jetir.org/papers/JETIR2201054.pdf