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Mental Health

Psilocybin and side effects: A Meta-analysis of randomized controlled trials

(1186) Psilocybin and Side Effects: A Meta-analysis of Randomized Controlled Trials

Saturday, March 23, 2024
12:30 PM – 2:30 PM East Coast USA Time

    Primary (first) Author(s)

  • Akhila Yerubandi, PharmD

    Graduate Student
    University of Georgia, College of Pharmacy
    Athens, Georgia, United States

    • Presenting Author(s)

  • Akhila Yerubandi, PharmD

    Graduate Student
    University of Georgia, College of Pharmacy
    Athens, Georgia, United States

    • Co-Author(s)

  • NB

    N M Mahmudul Alam Bhuiya

    Graduate Student
    University of Georgia, College of Pharmacy
    Athens, Georgia, United States

  • JT

    Jennifer E. Thomas

    Assistant Professor
    Larkin University, College of Pharmacy, United States

  • CH

    Catherine Harrington

    Professor Emeritus
    Palm Beach Atlantic University, United States

  • JC

    Joshua Caballero

    Associate Professor, Limited Term
    University of Georgia, College of Pharmacy, United States

    • Faculty Advisor/Preceptor(s)

  • JC

    Joshua Caballero

    Associate Professor, Limited Term
    University of Georgia, College of Pharmacy, United States

Disclosure(s):
Akhila Yerubandi: No financial relationships to disclose


Objectives: Psilocybin has been studied in the treatment of depression and anxiety disorders. Clinical studies have primarily focused on efficacy with aggregate results showing favorable efficacy. Although there have been systematic reviews, none have focused on psilocybin safety. Therefore, the objective of this study was to provide a meta-analysis for psilocybin side effects.

Methods: A systematic review was conducted by searching Medline via PubMed, Web of Science, and ClinicalTrials.gov for publications available between January 01, 2012 and December 31, 2022. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Inclusion criteria included randomized controlled trials comparing psilocybin to placebo or other comparator (e.g., niacin, escitalopram, low-dose psilocybin) in the treatment of depression and anxiety. Dosing ranges of psilocybin were separated according to previous trials (low:1-3 mg; moderate:10-20 mg; high:20-30 mg). Descriptive statistics and relative risk were calculated using RevMan 5.4.1. Statistical significance was set at p < 0.05.

Results: Five of 30 studies met inclusion criteria. Seven side effects were reported in multiple studies and included in analysis. Among these, nausea (RR=9.02; 95% CI [3.22-25.30]), anxiety (RR=3.74; 95% CI [1.05-13.35]), and dizziness (RR=5.81; 95% CI [1.02-33.04]) were statistically significant. There was a non-statistical higher risk of headache (RR=1.78; 95% CI [0.96-3.32]), paranoia (RR=2.95; 95% CI [0.31-27.68]), transient thought disorder (RR=5.50; 95% CI [0.65-46.69]) and elevated blood pressure (RR=7.32; 95% CI [0.17-316.76]). The majority of the side effects lasted between 24-48 hours and none of them were reported serious.

Conclusions: The side effect profile of single-use psilocybin at this time appears to be tolerable and resolve within 48 hours. However, more studies are needed to evaluate if any dose related response exists and medication management of side effects.