Ketamine has helped many people with depression and other conditions. It also carries real risks, and anyone considering treatment should understand them. In October 2023 the FDA issued a public warning about compounded ketamine. It is worth reading closely, including by patients of telehealth providers.
What the FDA said
- Ketamine is not FDA-approved for any psychiatric disorder. Using it for depression, anxiety, PTSD or OCD is off-label.
- Compounded drugs are not FDA-approved. The agency has not evaluated their safety, effectiveness or quality.
- No safe and effective dose has been established for any psychiatric use.
- The FDA said it is not aware of evidence that compounded ketamine is safer, more effective or faster than FDA-approved medicines.
The risks it listed
- Sedation and dissociation
- Changes in blood pressure and heart rate
- Slowed breathing
- Abuse and misuse
- Psychiatric events or worsening of a psychiatric condition
- Bladder and lower urinary tract symptoms
The agency also noted that doses of compounded oral and under-the-tongue products can vary, which makes their effects harder to predict.
Why at-home use got special attention
The FDA’s main concern was use outside a health care setting, where no clinician is present to respond if something goes wrong. It described a report received in April 2023 of a patient who developed slowed breathing after taking compounded oral ketamine at home for PTSD. The ketamine level in that patient’s blood appeared to be about twice what is typically seen during anaesthesia.
The agency contrasted this with Spravato (esketamine), which can only be given in a certified setting with at least two hours of monitoring after each dose.
What this means in practice
The warning is not a ban, and off-label prescribing by a licensed clinician is legal. But it sets out what careful treatment should look like. If you are considering at-home ketamine, ask your provider:
- Who evaluates me, and how? There should be a real medical and psychiatric assessment, including blood pressure, other medicines and any history of substance use or psychosis.
- What dose, and why? Low starting doses with slow adjustment are safer than a fixed high dose.
- Who do I contact if something goes wrong? You should have a direct line to a clinician, not a general inbox.
- Which pharmacy makes it? Ask whether it is state-licensed and how it checks the strength of each batch.
- What are the rules at home? No driving or hazardous activity until fully alert, no alcohol or sedatives alongside it, and ideally another adult present.
- How will we know it is working? Regular follow-up, and a plan to stop if it is not helping.
The FDA also asks patients and providers to report side effects to its MedWatch program, and says more clinical studies are needed. Both are reasonable requests.
Sources and further reading
This article is for education only and is not medical advice. Talk with a licensed provider about whether any treatment is right for you.
