Adverse Events of Saffron ( Crocus sativus L.): Systematic Review of Current Evidence

ABSTRACT Background Crocus sativus L., commonly known as saffron, is a widely used spice with a rich history of culinary and medicinal applications. This systematic review aims to compile human data from studies on monopreparations of C. sativus , including stigma powder and other extracts, to evaluate their safety. Methods Databases, including the Web of Science, Scopus, and PubMed Central, were searched up to August 2024 using the keywords “saffron” or “ Crocus sativus ” for clinical trials, case reports, and case series. Results A total of 102 clinical trials and a single case report were included in this review. Nearly 78% of the trials evaluating the monopreparation of C. sativus addressed safety concerns and reported the complications that occurred. Approximately 56% indicated that one or more adverse effects were experienced during the intervention period. The estimated incidence of adverse events related to C. sativus consumption is around 17.5%. The most frequently reported side effects were gastrointestinal problems, which were minor and self‐limiting in most cases. Conclusion The findings suggest that C. sativus is generally well tolerated. However, due to some potentially significant adverse events associated with its medicinal use at higher doses or prolonged administration, clinical monitoring should be considered.