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Research/Psilocybin for Anxiety Disorders/Adverse events
Curated safety summary

Psilocybin for Anxiety Disorders: adverse events

Psilocybin safety reports for Anxiety Disorders most often include headache, nausea, anxiety, fatigue among the source-backed named adverse events currently normalized in Blossom.

Papers with named AEs
17
Named AE rows
80
Source papers
79
Residual papers
62

How to read this summary

This page summarizes named adverse-event rows extracted from published paper, supplement, and registry evidence. It is intended as an evidence navigation aid and should not be read as a formal pharmacovigilance estimate or direct cross-trial comparison.

Most commonly reported named events

Counts are aggregated from source-backed named adverse-event rows. Denominators are shown only where the source row reported or clearly inherited one.

Back to evidence set →
EventAggregate countRatePapersSource terms
headache120/28941.5%11Headache, headache, headaches lasting no more than 1-2 days, transient headache
nausea58/24423.8%7Nausea, mild and transient nausea, nausea, transient nausea
anxiety57/44112.9%11Anxiety, transient anxiety, transient anxiety lasting for minutes
fatigue15/1649.15%4Fatigue, fatigue
insomnia11/2195.02%4Insomnia, insomnia
blood pressure increased10/6515.4%4Blood pressure increased, Hypertension, hypertension
dizziness10/1975.08%2Dizziness
paresthesia9/1844.89%3Hypoesthesia, Paraesthesia, Paresthesia
confusionn=9Not calculated1transient confusion or thought disorder
vomiting7/1534.58%3Vomiting
diarrhea5/559.09%3Diarrhea, Diarrhoea, diarrhea
abdominal discomfort3/963.13%1Abdominal pain

headache

headache was captured in 11 source papers (120/289). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Psilocybin|33/50| 66%| during treatment
Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial
registry:single-dose-psilocybin-treatment-for-major-depressive-disorder-a-randomized-clin:NCT03866174:ctg-api

ClinicalTrials.gov adverse events: Headache 33/50 (66%) in Psilocybin.

Psilocybin|21/48| 43.8%| during treatment
Spiritual experiences in psychedelic-assisted psychotherapy: Case reports of communion with the divine, the departed, and saints in research using psilocybin for the treatment of alcohol dependence
registry:spiritual-experiences-in-psychedelic-assisted-psychotherapy-case-reports-of-comm:NCT02061293:ctg-api

ClinicalTrials.gov adverse events: Headache 21/48 (43.8%) in Psilocybin.

Niacin|14/54| 25.9%| during treatment
Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial
registry:single-dose-psilocybin-treatment-for-major-depressive-disorder-a-randomized-clin:NCT03866174:ctg-api

ClinicalTrials.gov adverse events: Headache 14/54 (25.9%) in Niacin.

Psilocybin|8/17| 47.1%| Dosing
Short-Term and Late-Term Effects of Psilocybin on Symptoms in Major Depression: A Randomized Clinical Trial.
supplement:short-term-and-late-term-effects-of-psilocybin-on-symptoms-in-major-depression-a-randomized-clin:Sup2

Psilocybin 25 mg N=17 | Niacin 100 mg N=18; , No. 5 5 Related SAEs – study medication 0 0 Related SAEs – study procedures 3 3 Total severe adverse events, No. 5 3 Related severe adverse events – study medication 3 2 Related severe adverse events, study procedures 1 0 Dosing Any adverse event, No. 37 10 Headache, No. (%) 8 (47.1) 4 (22.2) Hallucination, No. (%) 5 (29.4) – Agitation, No. (%) 3 (17.6) – Anxiety, No. (%) 3 (17.6) 1 (5.6) * Hypertension, No. (%) 3 (17.6) – Nausea, No. (%) 2 (11.8) 1

nausea

nausea was captured in 7 source papers (58/244). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Psilocybin|24/50| 48%| during treatment
Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial
registry:single-dose-psilocybin-treatment-for-major-depressive-disorder-a-randomized-clin:NCT03866174:ctg-api

ClinicalTrials.gov adverse events: Nausea 24/50 (48%) in Psilocybin.

Psilocybin|10/48| 20.8%| during treatment
Spiritual experiences in psychedelic-assisted psychotherapy: Case reports of communion with the divine, the departed, and saints in research using psilocybin for the treatment of alcohol dependence
registry:spiritual-experiences-in-psychedelic-assisted-psychotherapy-case-reports-of-comm:NCT02061293:ctg-api

ClinicalTrials.gov adverse events: Nausea 10/48 (20.8%) in Psilocybin.

Psilocybin|n=5| during treatment
Psilocybin with psychological support for treatment-resistant depression: six-month follow-up
paper results text

Consistent with our earlier report on the initial 12 patients from this trial, transient anxiety lasting for minutes (n = 15) and headaches lasting no more than 1-2 days (n = 8) were the most common side effects. Five reported transient nausea but there were no cases of vomiting.

Diphenhydramine|4/45| 8.90%| during treatment
Spiritual experiences in psychedelic-assisted psychotherapy: Case reports of communion with the divine, the departed, and saints in research using psilocybin for the treatment of alcohol dependence
registry:spiritual-experiences-in-psychedelic-assisted-psychotherapy-case-reports-of-comm:NCT02061293:ctg-api

ClinicalTrials.gov adverse events: Nausea 4/45 (8.9%) in Diphenhydramine.

anxiety

anxiety was captured in 11 source papers (57/441). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Psilocybin|n=15| during treatment
Psilocybin with psychological support for treatment-resistant depression: six-month follow-up
paper results text

Consistent with our earlier report on the initial 12 patients from this trial, transient anxiety lasting for minutes (n = 15) and headaches lasting no more than 1-2 days (n = 8) were the most common side effects. Five reported transient nausea but there were no cases of vomiting.

Psilocybin|n=12| during treatment
Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study
paper results text

The most common adverse events were transient anxiety (mostly mild) during drug onset (n=12), transient confusion or thought disorder (n=9), mild and transient nausea (n=4), and transient headache (n=4; table).

Psilocybin|7/48| 14.6%| during treatment
Spiritual experiences in psychedelic-assisted psychotherapy: Case reports of communion with the divine, the departed, and saints in research using psilocybin for the treatment of alcohol dependence
registry:spiritual-experiences-in-psychedelic-assisted-psychotherapy-case-reports-of-comm:NCT02061293:ctg-api

ClinicalTrials.gov adverse events: Anxiety 7/48 (14.6%) in Psilocybin.

Psilocybin|5/50| 10%| during treatment
Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial
registry:single-dose-psilocybin-treatment-for-major-depressive-disorder-a-randomized-clin:NCT03866174:ctg-api

ClinicalTrials.gov adverse events: Anxiety 5/50 (10%) in Psilocybin.

fatigue

fatigue was captured in 4 source papers (15/164). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Psilocybin|5/50| 10%| during treatment
Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial
registry:single-dose-psilocybin-treatment-for-major-depressive-disorder-a-randomized-clin:NCT03866174:ctg-api

ClinicalTrials.gov adverse events: Fatigue 5/50 (10%) in Psilocybin.

Psilocybin|5/12| 41.7%| during treatment
Pilot study of single-dose psilocybin for serotonin reuptake inhibitor-resistant body dysmorphic disorder
registry:pilot-study-of-single-dose-psilocybin-for-serotonin-reuptake-inhibitor-resistant:NCT04656301:ctg-api

ClinicalTrials.gov adverse events: fatigue 5/12 (41.7%) in Psilocybin.

TSND-201|n=3| 21.4%| during treatment
Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD A Randomized Clinical Trial
supplement:efficacy-and-safety-of-the-neuroplastogen-tsnd-201-for-the-treatment-of-ptsd-a-randomized:Supplement 7

Part A) Preferred Term TSND-201 (150mg + 100mg) (N=14) n (%) At least one TEAE 11 (78.6) Headache 6 (42.9) Decreased appetite 4 (28.6) Non-cardiac chest pain 3 (21.4) Fatigue 3 (21.4) Bruxism 2 (14.3) Dizziness 2 (14.

Niacin|1/54| 1.90%| during treatment
Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial
registry:single-dose-psilocybin-treatment-for-major-depressive-disorder-a-randomized-clin:NCT03866174:ctg-api

ClinicalTrials.gov adverse events: Fatigue 1/54 (1.9%) in Niacin.

insomnia

insomnia was captured in 4 source papers (11/219). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Psilocybin|3/50| 6%| during treatment
Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial
registry:single-dose-psilocybin-treatment-for-major-depressive-disorder-a-randomized-clin:NCT03866174:ctg-api

ClinicalTrials.gov adverse events: Insomnia 3/50 (6%) in Psilocybin.

Psilocybin|3/48| 6.30%| during treatment
Spiritual experiences in psychedelic-assisted psychotherapy: Case reports of communion with the divine, the departed, and saints in research using psilocybin for the treatment of alcohol dependence
registry:spiritual-experiences-in-psychedelic-assisted-psychotherapy-case-reports-of-comm:NCT02061293:ctg-api

ClinicalTrials.gov adverse events: Insomnia 3/48 (6.3%) in Psilocybin.

Diphenhydramine|2/45| 4.40%| during treatment
Spiritual experiences in psychedelic-assisted psychotherapy: Case reports of communion with the divine, the departed, and saints in research using psilocybin for the treatment of alcohol dependence
registry:spiritual-experiences-in-psychedelic-assisted-psychotherapy-case-reports-of-comm:NCT02061293:ctg-api

ClinicalTrials.gov adverse events: Insomnia 2/45 (4.4%) in Diphenhydramine.

Niacin|1/54| 1.90%| during treatment
Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial
registry:single-dose-psilocybin-treatment-for-major-depressive-disorder-a-randomized-clin:NCT03866174:ctg-api

ClinicalTrials.gov adverse events: Insomnia 1/54 (1.9%) in Niacin.

blood pressure increased

blood pressure increased was captured in 4 source papers (10/65). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Arm not specified|n=4| during treatment
A phase 1 study of a second experience with Group Retreat Psilocybin Therapy for partial responders after a first experience
paper full text

No serious adverse events occurred; mild adverse events included transient hypertension (n = 4), nausea (n = 3), and headache (n = 1).

Psilocybin|3/17| 17.6%| Dosing
Short-Term and Late-Term Effects of Psilocybin on Symptoms in Major Depression: A Randomized Clinical Trial.
supplement:short-term-and-late-term-effects-of-psilocybin-on-symptoms-in-major-depression-a-randomized-clin:Sup2

Psilocybin 25 mg N=17 | Niacin 100 mg N=18; verse events – study medication 3 2 Related severe adverse events, study procedures 1 0 Dosing Any adverse event, No. 37 10 Headache, No. (%) 8 (47.1) 4 (22.2) Hallucination, No. (%) 5 (29.4) – Agitation, No. (%) 3 (17.6) – Anxiety, No. (%) 3 (17.6) 1 (5.6) * Hypertension, No. (%) 3 (17.6) – Nausea, No. (%) 2 (11.8) 1 (5.6) * Paresthesia, No. (%) 2 (11.8) 1 (5.6) * Serious adverse events, No. 0 0 Severe adverse events, No. 1 0 Day 15 Any adverse event,

Arm not specified|n=2| during treatment
Exploratory study of the dose-related safety, tolerability, and efficacy of dimethyltryptamine (DMT) in healthy volunteers and major depressive disorder
paper full text

The most common AEs were transient anxiety prior to administration and drug onset (n = 6), transient headache (n = 2) during onset and after resolution of drug effects, and transient hypertension (n = 2) before dose and during onset of effects (Table).

Psilocybin|1/48| 2.10%| during treatment
Spiritual experiences in psychedelic-assisted psychotherapy: Case reports of communion with the divine, the departed, and saints in research using psilocybin for the treatment of alcohol dependence
registry:spiritual-experiences-in-psychedelic-assisted-psychotherapy-case-reports-of-comm:NCT02061293:ctg-api

ClinicalTrials.gov adverse events: Blood pressure increased 1/48 (2.1%) in Psilocybin.

Limitations

  • Counts are aggregated from source-backed named adverse-event rows and may mix event windows, arms, and safety populations when papers report them differently.
  • Papers still in the named-AE residual blocker queue are not interpreted as event absence.
  • Denominators are included only when the source row reported or clearly inherited one.
  • This summary is a curated navigation layer, not a substitute for paper-level safety review.

Source papers

Short-Term and Late-Term Effects of Psilocybin on Symptoms in Major Depression: A Randomized Clinical Trial.
JAMA Network Open | 2026
A phase 1 study of a second experience with Group Retreat Psilocybin Therapy for partial responders after a first experience
2026
Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD A Randomized Clinical Trial
JAMA Psychiatry | 2026
Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: An open-label, proof-of-concept clinical trial
Frontiers in Pain Research | 2025
Psilocybin-assisted psychotherapy improves psychiatric symptoms across multiple dimensions in patients with cancer
Nature Mental Health | 2024
Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial
JAMA | 2023
Pilot study of single-dose psilocybin for serotonin reuptake inhibitor-resistant body dysmorphic disorder
Journal of Psychiatric Research | 2023
Exploratory study of the dose-related safety, tolerability, and efficacy of dimethyltryptamine (DMT) in healthy volunteers and major depressive disorder
Neuropsychopharmacology | 2022
Spiritual experiences in psychedelic-assisted psychotherapy: Case reports of communion with the divine, the departed, and saints in research using psilocybin for the treatment of alcohol dependence
Spirituality in Clinical Practice | 2021
Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer
Journal of Psychopharmacology | 2020
Individual Experiences in Four Cancer Patients Following Psilocybin-Assisted Psychotherapy
Frontiers in Pharmacology | 2018
Psilocybin with psychological support for treatment-resistant depression: six-month follow-up
Psychopharmacology | 2017