Ketamine and MDMA offerings: what to know

Ketamine and MDMA aren’t plant medicines, but they now turn up in the same places. There are ketamine clinics and at-home ketamine programs sold online, retreats that add a ketamine session to their schedule, and “heart opening” circles that serve MDMA. Some of these are run by doctors under medical rules. Others are run by people with no medical training and no legal basis at all, and the marketing can make the two look very similar.

This guide explains the legal status of each drug, what US health agencies say about the risks, and what to ask before you take part in anything that involves them. It was checked on 2026-10-08. This is not legal or medical advice. Regulatory decisions on both drugs are moving, and rules differ between countries. Talk to your own doctor about whether either is safe for you.

Ketamine: a legal medicine used off-label

Ketamine is an anesthetic. In the US it is a Schedule III controlled substance, which means it can be prescribed. The FDA has approved it as an injection for starting and maintaining general anesthesia. It is not FDA-approved for depression, anxiety, PTSD or any other psychiatric condition.

A related drug is approved. Esketamine, sold as Spravato, is one of the two mirror-image molecules that make up ketamine. The FDA has approved it as a nasal spray for adults with treatment-resistant depression, and for depressive symptoms in adults with major depressive disorder and suicidal thoughts or behavior, in both cases taken alongside an oral antidepressant. It comes with strict rules: it must be given in a certified health care setting, and patients must be monitored for at least two hours afterwards because of possible sedation, dissociation and misuse.

Many clinics offer ordinary ketamine for mental health conditions anyway, as infusions, injections, lozenges or nasal sprays, sometimes alongside talk therapy. A licensed prescriber may legally do that “off-label.” The US National Institute on Drug Abuse notes that dozens of clinics across the country offer it.

What the FDA and NIDA say about ketamine’s risks

In October 2023, the FDA warned patients about compounded ketamine products, including tablets and lozenges taken at home and obtained through telemedicine. It said it hadn’t established safe or effective dosing for any psychiatric use, and that using ketamine without monitoring by a health care provider for sedation, dissociation and changes in blood pressure and heart rate may put patients at risk of serious adverse events. It listed known safety concerns that include abuse and misuse, psychiatric events, raised blood pressure, slowed breathing (respiratory depression), and bladder and urinary tract problems.

The National Institute on Drug Abuse adds that short-term side effects can include dizziness, nausea, blurred vision and changes in heart rate and blood pressure. Calls to US poison control centers about ketamine rose 81 percent between 2019 and 2021 in one NIDA-funded study, and the most dangerous cases involved ketamine taken with other drugs, especially opioids or GHB. Long-term heavy use has been linked to memory problems, depression, anxiety and a bladder condition called ketamine-induced uropathy.

Ketamine in a ceremony or retreat

Because ketamine is a prescription drug, it matters a great deal who is giving it to you and on whose authority. If a facilitator without a medical license is handing it out, it’s being supplied outside the law, its source is unknown, and nobody is accountable for the dose or for your safety. Even at a legal clinic, the FDA’s concerns about monitoring still apply.

Watch out in particular for these situations:

Ketamine offered on the same day or night as another substance, such as ayahuasca or psilocybin. Combining drugs is where many serious problems happen.
Nobody checks your blood pressure, heart rate or breathing during the session.
You’re left alone during or after a session, or encouraged to go home or drive soon afterwards.
You’re told ketamine is “FDA-approved for depression.” Only esketamine is, and only under the conditions above.

MDMA: still Schedule I in the US

MDMA, sometimes called ecstasy or Molly, is a lab-made drug with effects similar to stimulants, and some researchers also class it as a psychedelic. Under US federal law it is in Schedule I, alongside DMT and psilocybin. Outside research authorized by the federal government, nobody in the US can legally give it to you, whatever setting or title they use.

Research on MDMA-assisted therapy for PTSD has been closely watched. In June 2024 an FDA advisory committee voted 9 to 2 against recommending it, and on 9 August 2024 the FDA declined to approve the drug company’s application and asked for another phase 3 trial. In August 2026 the company, now called Resilient Pharmaceuticals, resubmitted its application without a new trial, and at the time of checking the FDA hadn’t made a new decision.

Elsewhere, Australia has allowed authorized psychiatrists to prescribe MDMA for PTSD since 1 July 2023. That is a narrow medical program, run by specialist psychiatrists, and it doesn’t make MDMA legal in other settings there.

What NIDA says about MDMA’s risks

It can raise blood pressure and cause jaw clenching, nausea and vomiting.
It can cause a dangerous rise in body temperature, especially with physical activity or in a hot setting.
Taking it with alcohol or some prescription drugs, including SSRI antidepressants, may increase the risk of harm.
It has been linked to anxiety and panic attacks, and regular use to poor sleep, depression, paranoia and memory problems.
Drugs sold as MDMA are often mixed with other substances, such as methamphetamine, synthetic cathinones or ketamine, and fentanyl is increasingly found in the illicit drug supply.
Research suggests it is potentially addictive.

Any MDMA offered at a ceremony or retreat comes from the illicit supply, which means you can’t know for certain what it is or how strong it is.

Closeness, consent and touch

NIDA describes MDMA’s effects as including feeling warmer and closer to others, and more sensitive to touch. That makes clear boundaries more important, not less. Agree in advance, with a clear head, what kind of touch if any is acceptable, and treat any facilitator who suggests otherwise during a session as a serious red flag. Our guide to consent, touch and boundaries covers this in detail.

Questions to ask

Who prescribes the ketamine, and what is their license? Can I check it?
Will I have a medical assessment beforehand, including my blood pressure, heart health and every medicine I take?
Who monitors me during the session, what do they check, and are they trained to respond to slowed breathing or very high blood pressure?
Is anything else on the program on the same day or during the same stay?
How will I get home, and when am I allowed to leave?
If MDMA is offered: what is your legal basis? Is this a registered clinical trial?

If you’re interested in MDMA-assisted therapy specifically, the legal route in the US for now is a registered clinical study. An underground “MDMA therapy” session carries the drug’s risks without the screening, monitoring and accountability built into a study.

More guides

Past patients and participants can tell you how a clinic or retreat really handles screening and monitoring. You can search the Safe Ceremonies listings, including psychedelic-assisted therapy and integration and aftercare.