Suspected Adverse Reactions to Medications and Food Supplements Containing Serenoa Repens: A Worldwide Analysis of Pharmacovigilance and Phytovigilance Spontaneous Reports

The study analyzed 1810 worldwide pharmacovigilance and phytovigilance reports on the safety profile of Serenoa repens (SR), commonly used in medications and dietary supplements. The majority of subjects were adult males with a median age of 69. SR-containing products were generally well tolerated, with most adverse effects related to the gastrointestinal system. However, there were anecdotal reports of a causal relationship with liver damage and pancreatitis, and potential interactions with anticoagulants. The study recommended avoiding use in children, adolescents, and women. Serious cases accounted for 26.19% of the reports, with 1.8% of the total cases resulting in death. The risk of serious suspected adverse reactions (SARs) was higher for those exposed to multiple SR-containing products, those reporting concomitant products, and for subjects exposed to SR for more than 14 days. The study concluded that while SR is generally considered safe, there are concerns about potential risks associated with its high dosages, especially when used in combination with other active compounds and for longer periods of time.