Curated safety summary

Psilocybin for Substance Use Disorders (SUD): adverse events

Psilocybin safety reports for Substance Use Disorders (SUD) most often include headache, nausea, anxiety, insomnia among the source-backed named adverse events currently normalized in Blossom.

Papers with named AEs

Named AE rows

156

Source papers

Residual papers

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 →

Event	Aggregate count	Rate	Papers	Source terms
headache	196/638	30.7%	11	Headache, headaches lasting no more than 1-2 days, transient headache
nausea	109/618	17.6%	10	Nausea, mild and transient nausea, transient nausea
anxiety	79/618	12.8%	9	Anxiety, transient anxiety, transient anxiety lasting for minutes
insomnia	35/638	5.49%	9	Insomnia
vomiting	23/559	4.11%	10	Vomiting
fatigue	22/393	5.60%	8	Fatigue
dizziness	19/593	3.20%	7	Dizziness
abdominal discomfort	15/480	3.13%	5	Abdominal pain
diarrhea	13/269	4.83%	8	Diarrhea, Diarrhoea
confusion	13/49	26.5%	2	confusion, transient confusion or thought disorder
paresthesia	10/329	3.04%	6	Hypoesthesia, Paraesthesia
blood pressure increased	8/289	2.77%	6	Blood pressure increased, Hypertension

headache

headache was captured in 11 source papers (196/638). 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

Multidimensional Personality Changes Following Psilocybin-Assisted Therapy in Patients With Alcohol Use Disorder: Results From a Double-Blind, Placebo-Controlled Clinical Trial

registry:multidimensional-personality-changes-following-psilocybin-assisted-therapy-in-pa:NCT02061293:ctg-api

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

Psilocybin|21/48| 43.8%| during treatment

Psilocybin-induced changes in neural reactivity to alcohol and emotional cues in patients with alcohol use disorder: an fMRI pilot study

registry:psilocybin-induced-changes-in-neural-reactivity-to-alcohol-and-emotional-cues-in:NCT02061293:ctg-api

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

Psilocybin|21/48| 43.8%| during treatment

Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder

registry:percentage-of-heavy-drinking-days-following-psilocybin-assisted-psychotherapy-vs:NCT02061293:ctg-api

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

nausea

nausea was captured in 10 source papers (109/618). 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

Multidimensional Personality Changes Following Psilocybin-Assisted Therapy in Patients With Alcohol Use Disorder: Results From a Double-Blind, Placebo-Controlled Clinical Trial

registry:multidimensional-personality-changes-following-psilocybin-assisted-therapy-in-pa:NCT02061293:ctg-api

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

Psilocybin|10/48| 20.8%| during treatment

Psilocybin-induced changes in neural reactivity to alcohol and emotional cues in patients with alcohol use disorder: an fMRI pilot study

registry:psilocybin-induced-changes-in-neural-reactivity-to-alcohol-and-emotional-cues-in:NCT02061293:ctg-api

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

Psilocybin|10/48| 20.8%| during treatment

Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder

registry:percentage-of-heavy-drinking-days-following-psilocybin-assisted-psychotherapy-vs:NCT02061293:ctg-api

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

anxiety

anxiety was captured in 9 source papers (79/618). 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

Multidimensional Personality Changes Following Psilocybin-Assisted Therapy in Patients With Alcohol Use Disorder: Results From a Double-Blind, Placebo-Controlled Clinical Trial

registry:multidimensional-personality-changes-following-psilocybin-assisted-therapy-in-pa:NCT02061293:ctg-api

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

Psilocybin|7/48| 14.6%| during treatment

Psilocybin-induced changes in neural reactivity to alcohol and emotional cues in patients with alcohol use disorder: an fMRI pilot study

registry:psilocybin-induced-changes-in-neural-reactivity-to-alcohol-and-emotional-cues-in:NCT02061293:ctg-api

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

insomnia

insomnia was captured in 9 source papers (35/638). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Psilocybin|3/48| 6.30%| during treatment

Multidimensional Personality Changes Following Psilocybin-Assisted Therapy in Patients With Alcohol Use Disorder: Results From a Double-Blind, Placebo-Controlled Clinical Trial

registry:multidimensional-personality-changes-following-psilocybin-assisted-therapy-in-pa:NCT02061293:ctg-api

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

Psilocybin|3/48| 6.30%| during treatment

Psilocybin-induced changes in neural reactivity to alcohol and emotional cues in patients with alcohol use disorder: an fMRI pilot study

registry:psilocybin-induced-changes-in-neural-reactivity-to-alcohol-and-emotional-cues-in:NCT02061293:ctg-api

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

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

Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder

registry:percentage-of-heavy-drinking-days-following-psilocybin-assisted-psychotherapy-vs:NCT02061293:ctg-api

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

vomiting

vomiting was captured in 10 source papers (23/559). 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: Vomiting 3/50 (6%) in Psilocybin.

Arm not specified|n=2| 15.4%| during treatment

5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) for alcohol use disorder: An open-label, phase 2, proof-of-concept, clinical trial

paper full text

of participants 2 (15.4) Vomiting 2 (15.4)Nausea 1 (7.7)Cardiac disorders, total no.

Psilocybin|2/48| 4.20%| during treatment

Multidimensional Personality Changes Following Psilocybin-Assisted Therapy in Patients With Alcohol Use Disorder: Results From a Double-Blind, Placebo-Controlled Clinical Trial

registry:multidimensional-personality-changes-following-psilocybin-assisted-therapy-in-pa:NCT02061293:ctg-api

ClinicalTrials.gov adverse events: Vomiting 2/48 (4.2%) in Psilocybin.

Psilocybin|2/48| 4.20%| during treatment

Psilocybin-induced changes in neural reactivity to alcohol and emotional cues in patients with alcohol use disorder: an fMRI pilot study

registry:psilocybin-induced-changes-in-neural-reactivity-to-alcohol-and-emotional-cues-in:NCT02061293:ctg-api

ClinicalTrials.gov adverse events: Vomiting 2/48 (4.2%) in Psilocybin.

fatigue

fatigue was captured in 8 source papers (22/393). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Ketamine+Education|6/24| 25%| during treatment

Adjunctive Ketamine With Relapse Prevention-Based Psychological Therapy in the Treatment of Alcohol Use Disorder

registry:adjunctive-ketamine-with-relapse-prevention-based-psychological-therapy-in-the-t:NCT02649231:ctg-api

ClinicalTrials.gov adverse events: Fatigue 6/24 (25%) in Ketamine+Education.

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.

Placebo+Education|4/25| 16%| during treatment

Adjunctive Ketamine With Relapse Prevention-Based Psychological Therapy in the Treatment of Alcohol Use Disorder

registry:adjunctive-ketamine-with-relapse-prevention-based-psychological-therapy-in-the-t:NCT02649231:ctg-api

ClinicalTrials.gov adverse events: Fatigue 4/25 (16%) in Placebo+Education.

Arm not specified|n=1| 7.70%| during treatment

5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) for alcohol use disorder: An open-label, phase 2, proof-of-concept, clinical trial

paper full text

on site erythema 1 (7.7)Fatigue 1 (7.7)Investigations, total no. of participants 4 (30.8) Blood pressure increased 4 ( Nervous system disorders, total no. of participants 2 ( Paraesthesia 1 (7.7)Gastrointestinal disorders, total no. o

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.