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Potential Safety Risks Associated with Compounded Ketamine Products

Patients who receive compounded ketamine products from compounders and telemedicine platforms for the treatment of psychiatric disorders may not receive important information about the potential risks associated with the product. As previously noted, safety concerns that may be associated with ketamine products include, but are not limited to, risks of sedation, dissociation, psychiatric events or worsening of psychiatric disorders, abuse and misuse, increases in blood pressure, respiratory depression (breathing becomes slower and shallower and the lungs fail to exchange carbon dioxide and oxygen efficiently), and lower urinary tract and bladder symptoms. At-home administration of compounded ketamine presents additional risks because a health care provider is not available onsite to monitor for serious adverse outcomes resulting from sedation and dissociation.

In April 20-2025, FDA received an adverse event report of a patient who experienced respiratory depression after taking compounded oral ketamine outside of a healthcare setting for the treatment of PTSD. The patient’s ketamine blood level appeared to be twice the blood level typically obtained for anesthesia.

In addition to the potential risks associated with compounded ketamine products, patients and healthcare providers should be aware that information about use of these products is lacking. For example, the FDA has not established safe or effective dosing of ketamine for any psychiatric indication. Furthermore, the dosages of the sublingual and oral compounded ketamine products marketed by compounders and telemedicine platforms may vary, which makes it challenging to predict which potential risks may be associated with these products. In addition to the concerns regarding the short-term use of compounded ketamine, the overall benefit-risk profile of ketamine for the treatment of psychiatric disorders is unknown.