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# FDA Cautions About Compounded Ketamine
- URL: https://www.fdaweb.com/fda-cautions-about-compounded-ketamine/
- Published: 2023-10-10T12:00:00.000Z
- Updated: 2026-09-14T19:01:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155523

FDA says there is increased interest in compounded ketamine products, including oral formulations, for treating psychiatric disorders. An online [post](https://www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine?utm%5Fmedium=email&utm%5Fsource=govdelivery) says patients and healthcare providers should know:

- ketamine is not approved by the agency to treat any psychiatric disorder because it has not determined that the products are safe and effective for use to treat disorders such as depression, anxiety, post-traumatic stress disorder, and obsessive-compulsive disorder;
- compounded drugs are not FDA approved, meaning the agency has not evaluated their safety, effectiveness, or quality before marketing, and thus compounded drugs do not have any FDA-approved indications or routes of administration;
- using compounded ketamine products without monitoring by a healthcare provider for sedation, dissociation, and changes in vital signs may put patients at risk for serious adverse events;
- known safety concerns associated with using ketamine products include abuse and misuse, psychiatric events, increases in blood pressure, respiratory depression, and lower urinary tract and bladder symptoms;
- despite increased interest in using compounded ketamine, FDA is not aware of evidence to suggest that it is safer, is more effective, or works faster than medications that are FDA-approved to treat certain psychiatric disorders.