Adverse event reporting and management in psilocybin therapy clinical trials: A systematic review to guide clinical and research protocol development
Progress in Neuro-Psychopharmacology and Biological Psychiatry October 23, 2025 Danielle Bukovsky, Aron Amaev, Jianmeng Song et al.
A systematic review of 42 clinical studies involving 1,068 participants found that psilocybin, when administered in controlled settings, has a favorable safety profile. Common adverse events included headache, transient increases in blood pressure, and nausea, which typically resolved on their own. Serious adverse events were reported infrequently, in only 2 of the 42 studies, and were limited to participants with underlying depressive disorders, such as suicidal behavior or hospitalization. All studies had a high risk of bias due to concerns regarding blinding. The review provides an outline of common and uncommon adverse events, serious adverse events, and considerations for future protocols.