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Research/MDMA for PTSD/Adverse events
Curated safety summary

MDMA for PTSD: adverse events

MDMA safety reports for PTSD most often include headache, insomnia, anxiety, fatigue among the source-backed named adverse events currently normalized in Blossom.

Papers with named AEs
11
Named AE rows
176
Source papers
34
Residual papers
23

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
headache232/35665.2%10Headache
insomnia139/34140.8%9Insomnia
anxiety114/35632%9Anxiety
fatigue110/35630.9%10Fatigue
dizziness98/65515%7Dizziness
nausea93/35626.1%9Nausea
abdominal discomfort74/65311.3%7Abdominal Discomfort, Abdominal Pain
paresthesia57/6768.43%9Hypoaesthesia, Paraesthesia
nasal discomfort54/32016.9%6Nasopharyngitis
tremor33/32010.3%6Tremor
dry mouth32/32010%6Dry Mouth
palpitations30/3209.38%6Palpitations

headache

headache was captured in 10 source papers (232/356). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

MDMA-assisted therapy|33/46| 71.7%| during treatment
Self-compassion mediates treatment effects in MDMA-assisted therapy for posttraumatic stress disorder
registry:self-compassion-mediates-treatment-effects-in-mdma-assisted-therapy-for-posttrau:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Headache 33/46 (71.7%) in MDMA-assisted Therapy.

MDMA-assisted therapy|33/46| 71.7%| during treatment
Effects of MDMA-assisted therapy for PTSD on self-experience
registry:self-experience-in-mdma-assisted-therapy-of-ptsd:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Headache 33/46 (71.7%) in MDMA-assisted Therapy.

MDMA-assisted therapy|33/46| 71.7%| during treatment
Pilot study suggests DNA methylation of the glucocorticoid receptor gene (NR3C1) is associated with MDMA-assisted therapy treatment response for severe PTSD
registry:pilot-study-suggests-dna-methylation-of-the-glucocorticoid-receptor-gene-nr3c1-i:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Headache 33/46 (71.7%) in MDMA-assisted Therapy.

MDMA-assisted therapy|33/46| 71.7%| during treatment
MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD
registry:mdma-assisted-therapy-significantly-reduces-eating-disorder-symptoms-in-a-random:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Headache 33/46 (71.7%) in MDMA-assisted Therapy.

insomnia

insomnia was captured in 9 source papers (139/341). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

MDMA-assisted therapy|20/46| 43.5%| during treatment
Self-compassion mediates treatment effects in MDMA-assisted therapy for posttraumatic stress disorder
registry:self-compassion-mediates-treatment-effects-in-mdma-assisted-therapy-for-posttrau:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Insomnia 20/46 (43.5%) in MDMA-assisted Therapy.

MDMA-assisted therapy|20/46| 43.5%| during treatment
Effects of MDMA-assisted therapy for PTSD on self-experience
registry:self-experience-in-mdma-assisted-therapy-of-ptsd:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Insomnia 20/46 (43.5%) in MDMA-assisted Therapy.

MDMA-assisted therapy|20/46| 43.5%| during treatment
Pilot study suggests DNA methylation of the glucocorticoid receptor gene (NR3C1) is associated with MDMA-assisted therapy treatment response for severe PTSD
registry:pilot-study-suggests-dna-methylation-of-the-glucocorticoid-receptor-gene-nr3c1-i:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Insomnia 20/46 (43.5%) in MDMA-assisted Therapy.

MDMA-assisted therapy|20/46| 43.5%| during treatment
MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD
registry:mdma-assisted-therapy-significantly-reduces-eating-disorder-symptoms-in-a-random:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Insomnia 20/46 (43.5%) in MDMA-assisted Therapy.

anxiety

anxiety was captured in 9 source papers (114/356). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Placebo with therapy|17/44| 38.6%| during treatment
Effects of MDMA-assisted therapy for PTSD on self-experience
registry:self-experience-in-mdma-assisted-therapy-of-ptsd:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Anxiety 17/44 (38.6%) in Placebo With Therapy.

MDMA-assisted therapy|15/46| 32.6%| during treatment
Self-compassion mediates treatment effects in MDMA-assisted therapy for posttraumatic stress disorder
registry:self-compassion-mediates-treatment-effects-in-mdma-assisted-therapy-for-posttrau:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Anxiety 15/46 (32.6%) in MDMA-assisted Therapy.

MDMA-assisted therapy|15/46| 32.6%| during treatment
Effects of MDMA-assisted therapy for PTSD on self-experience
registry:self-experience-in-mdma-assisted-therapy-of-ptsd:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Anxiety 15/46 (32.6%) in MDMA-assisted Therapy.

MDMA-assisted therapy|15/46| 32.6%| during treatment
Pilot study suggests DNA methylation of the glucocorticoid receptor gene (NR3C1) is associated with MDMA-assisted therapy treatment response for severe PTSD
registry:pilot-study-suggests-dna-methylation-of-the-glucocorticoid-receptor-gene-nr3c1-i:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Anxiety 15/46 (32.6%) in MDMA-assisted Therapy.

fatigue

fatigue was captured in 10 source papers (110/356). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

MDMA-assisted therapy|14/46| 30.4%| during treatment
Self-compassion mediates treatment effects in MDMA-assisted therapy for posttraumatic stress disorder
registry:self-compassion-mediates-treatment-effects-in-mdma-assisted-therapy-for-posttrau:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Fatigue 14/46 (30.4%) in MDMA-assisted Therapy.

MDMA-assisted therapy|14/46| 30.4%| during treatment
Effects of MDMA-assisted therapy for PTSD on self-experience
registry:self-experience-in-mdma-assisted-therapy-of-ptsd:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Fatigue 14/46 (30.4%) in MDMA-assisted Therapy.

Placebo with therapy|14/44| 31.8%| during treatment
Effects of MDMA-assisted therapy for PTSD on self-experience
registry:self-experience-in-mdma-assisted-therapy-of-ptsd:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Fatigue 14/44 (31.8%) in Placebo With Therapy.

MDMA-assisted therapy|14/46| 30.4%| during treatment
Pilot study suggests DNA methylation of the glucocorticoid receptor gene (NR3C1) is associated with MDMA-assisted therapy treatment response for severe PTSD
registry:pilot-study-suggests-dna-methylation-of-the-glucocorticoid-receptor-gene-nr3c1-i:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Fatigue 14/46 (30.4%) in MDMA-assisted Therapy.

dizziness

dizziness was captured in 7 source papers (98/655). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

MDMA-assisted therapy|9/46| 19.6%| during treatment
Self-compassion mediates treatment effects in MDMA-assisted therapy for posttraumatic stress disorder
registry:self-compassion-mediates-treatment-effects-in-mdma-assisted-therapy-for-posttrau:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Dizziness 9/46 (19.6%) in MDMA-assisted Therapy.

MDMA-assisted therapy|9/46| 19.6%| during treatment
Effects of MDMA-assisted therapy for PTSD on self-experience
registry:self-experience-in-mdma-assisted-therapy-of-ptsd:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Dizziness 9/46 (19.6%) in MDMA-assisted Therapy.

MDMA-assisted therapy|9/46| 19.6%| during treatment
Pilot study suggests DNA methylation of the glucocorticoid receptor gene (NR3C1) is associated with MDMA-assisted therapy treatment response for severe PTSD
registry:pilot-study-suggests-dna-methylation-of-the-glucocorticoid-receptor-gene-nr3c1-i:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Dizziness 9/46 (19.6%) in MDMA-assisted Therapy.

MDMA-assisted therapy|9/46| 19.6%| during treatment
MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD
registry:mdma-assisted-therapy-significantly-reduces-eating-disorder-symptoms-in-a-random:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Dizziness 9/46 (19.6%) in MDMA-assisted Therapy.

nausea

nausea was captured in 9 source papers (93/356). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

MDMA-assisted therapy|14/46| 30.4%| during treatment
Self-compassion mediates treatment effects in MDMA-assisted therapy for posttraumatic stress disorder
registry:self-compassion-mediates-treatment-effects-in-mdma-assisted-therapy-for-posttrau:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Nausea 14/46 (30.4%) in MDMA-assisted Therapy.

MDMA-assisted therapy|14/46| 30.4%| during treatment
Effects of MDMA-assisted therapy for PTSD on self-experience
registry:self-experience-in-mdma-assisted-therapy-of-ptsd:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Nausea 14/46 (30.4%) in MDMA-assisted Therapy.

MDMA-assisted therapy|14/46| 30.4%| during treatment
Pilot study suggests DNA methylation of the glucocorticoid receptor gene (NR3C1) is associated with MDMA-assisted therapy treatment response for severe PTSD
registry:pilot-study-suggests-dna-methylation-of-the-glucocorticoid-receptor-gene-nr3c1-i:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Nausea 14/46 (30.4%) in MDMA-assisted Therapy.

MDMA-assisted therapy|14/46| 30.4%| during treatment
MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD
registry:mdma-assisted-therapy-significantly-reduces-eating-disorder-symptoms-in-a-random:NCT03537014:ctg-api

ClinicalTrials.gov adverse events: Nausea 14/46 (30.4%) in MDMA-assisted Therapy.

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

Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD A Randomized Clinical Trial
JAMA Psychiatry | 2026
Self-compassion mediates treatment effects in MDMA-assisted therapy for posttraumatic stress disorder
European Journal of Psychotraumatology | 2025
Effects of MDMA-assisted therapy for PTSD on self-experience
PLOS ONE | 2024
MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial
Nature Medicine | 2023
Pilot study suggests DNA methylation of the glucocorticoid receptor gene (NR3C1) is associated with MDMA-assisted therapy treatment response for severe PTSD
Frontiers in Psychiatry | 2023
Facing death, returning to life: A qualitative analysis of MDMA-assisted therapy for anxiety associated with life-threatening illness
Frontiers in Psychiatry | 2022
MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD
Journal of Psychiatric Research | 2022
The Effects of MDMA-Assisted Therapy on Alcohol and Substance Use in a Phase 3 Trial for Treatment of Severe PTSD
Drug and Alcohol Dependence | 2022
Sleep Quality Improvements After MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder
Journal of Traumatic Stress | 2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study
Nature Medicine | 2021
Discontinuation of medications classified as reuptake inhibitors affects treatment response of MDMA-assisted psychotherapy
Psychopharmacology | 2020