Reported Cases of Serotonin Syndrome in MDMA Users in FAERS Database
Tigran Makunts, Lisa Jerome, Ruben Abagyan, Alberdina De Boer
Frontiers in Psychiatry January 24, 2022 DOI: 10.3389/fpsyt.2021.824288 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Retrospective database analysis Placebo-controlled Open-label Peer reviewed |
|---|---|
| Sample size | 20 |
| Population | People with adverse event reports involving MDMA in the FDA Adverse Event Reporting System |
| Topics | MDMA Serotonin |
| Keywords | Serotonin syndrome Faers database Surveillance system |
| Citations | 19 |
| Key points | All 20 cases of serotonin syndrome associated with MDMA involved co-use of other serotonergic substances; no cases occurred with MDMA alone. |
Abstract
3,4-Methylenedioxymethamphetamine (MDMA), is investigated as a treatment for post-traumatic stress disorder and other anxiety-related conditions in multiple placebo-controlled and open label studies. MDMA-assisted therapy is projected for approval by the United States Food and Drug Administration (FDA) and other regulatory agencies worldwide within the next few years. MDMA is a monoamine releaser and uptake inhibitor affecting serotonin, potentially increasing the risk of serotonin syndrome (SS). No instances of SS have occurred in clinical trials. The relatively small number of patients in controlled trials warranted a survey of FDA Adverse Event Reporting System data for the occurrence of SS in a larger database. We found 20 SS cases in people exposed to MDMA, all of which had also taken one or more substances with serotonergic properties in addition to MDMA, including amphetamines, stimulants, and opioids. There were no cases of SS associated with MDMA where MDMA was the sole reported compound taken.
Comparable studies
Other observational and cohort studies on MDMA, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Subjective Reports of the Effects of MDMA in a Clinical Setting Individuals who took MDMA in a clinical setting | 1986 | Observational study | |
| Memory impairment in abstinent MDMA ("Ecstasy") users Abstinent MDMA users | 1998 | Observational cohort | |
| Impaired cognitive performance in drug free users of recreational ecstasy (MDMA) Otherwise healthy young people | 2000 | Observational | |
| The Psychological and Physiological Effects of MDMA on Normal Volunteers Older, more educated, drug-experienced individuals | 1986 | Observational cohort | |
| Cognitive performance in recreational users of MDMA or 'ecstasy': evidence for memory deficits Young people who were regular or novice MDMA users, or non-users | 1998 | Observational cohort | n = 30 |
Citations in the library
Cited by 10
- MDMA and MDMA-Assisted Therapy. American Journal of Psychiatry 2025
- A Multidisciplinary Hypothesis about Serotonergic Psychedelics. Is it Possible that a Portion of Brain Serotonin Comes From the Gut? Journal of Integrative Neuroscience August 31, 2022
- Concomitant medications associated with ischemic, hypertensive, and arrhythmic events in MDMA users in FDA adverse event reporting system Frontiers in Psychiatry May 18, 2023
- The entactogen 3,4-methylenedioxymethamphetamine (MDMA; ecstasy) as a treatment aid in psychotherapy and its safety concerns. Archives of Toxicology August 1, 2024
- A thematic analysis of MDMA-related harm and harm reduction experiences and knowledge in Aotearoa New Zealand. Harm Reduction Journal May 23, 2024
and 5 more in the library
Cites 18
- MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine June 1, 2021
- MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology September 1, 2019
- MDMA enhances emotional empathy and prosocial behavior Social Cognitive and Affective Neuroscience October 4, 2013
- MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study Scientific Reports November 24, 2020
- Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials. Psychopharmacology August 1, 2020
and 13 more in the library