MDMA: Compound Guide

If someone is in danger right now

Very high body temperature, confusion, seizures, fainting or collapse after taking MDMA need emergency care: call 911 in the United States. For a mental health crisis call or text 988. US Poison Help is 1-800-222-1222. [1]

What MDMA is

MDMA is short for 3,4-methylenedioxymethamphetamine. It is also called "Molly" or "Ecstasy" in illicit markets. NIDA describes it as a lab-made (synthetic) drug with effects similar to stimulants such as methamphetamine. [1] It is not a plant or fungus product.

MDMA is usually called an entactogen (or empathogen), not a classic psychedelic. The FDA's 2026 guidance on psychedelic drugs lists classic psychedelics, "typically understood to be 5-HT2A receptor agonists", and separately names entactogens or empathogens such as MDMA. [2] NIDA explains the difference in how they work: MDMA mainly causes release of serotonin and also affects dopamine and norepinephrine, and only weakly activates serotonin receptors. Classic psychedelics mainly act on the serotonin 5-HT2A receptor. [3] Some researchers and organizations still call MDMA a psychedelic because it can mildly alter perception. [1] See Entactogens: Why MDMA Is Not a Classic Psychedelic and MDMA vs Classic Psychedelics.

Regulatory category

Evidence labels used on this page: approved medicine, promising but limited, mixed, insufficient evidence.

• United States (federal). MDMA is listed in Schedule I in the Drug Enforcement Administration's regulations (21 CFR 1308.11). [4] Read 2026-10-22. Laws change and this is not legal advice. Other countries: not verified here; see Psychedelic Legal Status by Country.
• Approved medicine: none found. NIDA says the FDA has not approved MDMA as a treatment for any medical condition, though it designated MDMA a breakthrough therapy to speed research for PTSD. [1]
• FDA decision, August 2024. The FDA issued a complete response letter for the new drug application for midomafetamine (MDMA) capsules for PTSD, meaning the application was not approved as submitted. [5] I did not find a later FDA approval in the sources I read. Check the FDA directly for current status.

What the FDA said and why it matters

The letter listed several problems with the two phase 3 trials (called MAPP1 and MAPP2). It said [5]:

• Safety reporting. Training told sites not to report "positive" or "favorable" effects as adverse events, which raised "substantial concerns about the reliability of the safety data".
• Durability. The trials did not show the effect lasted beyond the 18-week assessments; the long-term follow-up study had a single visit with timing from 6 months to 2 years.
• Bias. About 40% of enrolled participants reported prior MDMA use, which the FDA said raised the possibility of selection bias and of participants recognizing which group they were in (functional unblinding).
• Next step. The FDA suggested a new randomized, double-blind trial with blinded long-term follow-up.

What research shows (PTSD)

PTSD: promising but limited, and not accepted as sufficient by the FDA. The first phase 3 trial (2021) randomized 90 people with severe PTSD to manualized therapy with MDMA or with placebo, with three preparatory and nine integrative therapy sessions. At 2 months after the last experimental session, CAPS-5 scores (a clinician-rated PTSD scale) fell more with MDMA (mean change -24.4 in people who completed treatment) than with placebo (-13.9). [6] The second phase 3 trial (2023) randomized 104 people with moderate to severe PTSD; the average CAPS-5 change was -23.7 with MDMA-assisted therapy against -14.8 with placebo plus therapy. Severe treatment-emergent adverse events occurred in 5 of 53 people (9.4%) on MDMA and 2 of 51 (3.9%) on placebo; there were no deaths or serious events in that report. [7] Both trials combined the drug with intensive therapy, so the effect of the drug alone cannot be separated from the therapy. Funding and sponsor details are not shown in the abstracts I read.

The registry lists other MDMA trials, including one labeled phase 3 (NCT06394284) shown as recruiting when last verified in April 2024. [8] A registered trial is not a result. For more, see PTSD Research: MDMA and Other Substances.

Other conditions (depression, anxiety, pain, social anxiety): Proper evidence not found in the regulator and systematic-review sources I read. NIDA says MDMA is being studied for depression in supervised trials. [1]

Risks and adverse effects

• Body temperature. NIDA reports a dangerously steep rise in body temperature (hyperpyrexia), especially with heavy physical activity or a warm environment. Deaths are described as rare. [1]
• Body and mood. Higher blood pressure, jaw clenching, nausea and vomiting; anxiety and panic attacks. People who use it regularly may have poor sleep, depression, anxiety, paranoia, and memory or attention problems. [1]
• Long-term use. NIDA links long-term use to heart problems or liver damage. [1]
• Addiction. MDMA is potentially addictive, though more research is needed. [1]
• Abuse-related effects in trials. The FDA said the trials did not adequately capture abuse-related events and impairment. [5]

Special groups and interactions

Using MDMA with alcohol or some prescription drugs, including SSRI antidepressants, may increase the risk of harm. [1] Do not stop or change any medicine because of this page; talk with the prescriber. Limited studies suggest exposure during pregnancy is linked to birth defects, including heart problems, and motor delays. [1] See Pregnancy and Breastfeeding.

Quality and labeling

Chemical analyses of drugs sold as MDMA have found other substances, including ketamine, amphetamine, synthetic cathinones, MDA and methamphetamine, and fentanyl is increasingly found in the drug supply. [1] See Contamination and Adulteration in Psychoactive Products.