Ginkgo biloba extract safety: Insights from a real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events

• Published in: Journal of ethnopharmacology 2025-01, Vol.337 (Pt 3), p.119010, Article 119010
• Main Authors: Yao, Yinhui, Zhao, Jingyi, Li, Chen, Chen, Yan, Zhang, Tianci, Dong, Xianhui, Gao, Weijuan, Shang, Yazhen
• Format: Article
• Language: English
• Subjects: Adverse Drug Reaction Reporting Systems - statistics & numerical data; Data mining; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; FAERS; Ginkgo biloba; Ginkgo biloba extract; Ginkgo Extract; Humans; Pharmacovigilance; Plant Extracts - adverse effects; Signal; Spontaneous reporting; United States; United States Food and Drug Administration
• ISSN: 0378-8741; 1872-7573; 1872-7573
• DOI: 10.1016/j.jep.2024.119010

A traditional Chinese medicine extracted from the Ginkgophyta, Ginkgo biloba is commonly used to treat cardiac cerebral disease all over the world. Limited data exist regarding adverse drug reactions associated with Ginkgo biloba extract post-marketing. Currently, the drug safety profile of Ginkgo biloba extract is assessed using a substantial volume of case safety reports within the FDA Adverse Event Reporting System (FAERS) database. The study collected adverse events (AEs) data associated with Ginkgo biloba extract as the primary suspected drug from 2004 to 2023 from the FAERS database. A standardized mapping analysis of System Organ Class (SOC) and preferred term (PT) was conducted. Utilizing reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and empirical Bayes geometric mean (EBGM), significant disproportionate measurement signals of adverse drug reactions (ADR) were identified and high-intensity signals were analyzed. 700 reports of adverse events related to Ginkgo biloba extract were found in the FAERS database, affecting 23 organ systems. 88 significant mismatches were identified using four algorithms, leading to unexpected major adverse events like amaurosis fugax, fractional exhaled nitric oxide created, and obstructive sleep apnoea syndrome. The study observed a median onset time of AE associated with Ginkgo biloba extract at 7 days (interquartile interval [IQR] 0–109 days), with the majority of AE manifesting within the initial 7 days of drug treatment initiation. This investigation identified a noteworthy AE signal for Ginkgo biloba extract, underscoring the importance of clinical surveillance and risk assessment in its use. In clinical practice, this study provides a deeper and broader understanding of suspected adverse reactions associated with Ginkgo biloba extract. [Display omitted] •The real-world data shows that Ginkgo biloba extract is linked to 88 terms and 5,184 adverse reactions, raising global safety concerns.•Ginkgo biloba extract caution is needed when prescribing it to patients with drug interactions.•Ginkgo biloba extract is considered an early failure type due to its association with adverse drug events.