OBJECTIVES: The aim of this study was to describe trends and patterns in spontaneous reporting data for Ketamine therapy in a real-world setting.

METHODS: A retrospective analysis was conducted to evaluate all reported adverse events in the US FDA Adverse Event Reporting System (FAERS) database between 2012 - 2021. Disproportionality analysis as secondary analysis was used to evaluate the association between ketamine and neurological adverse events. The total numbers of reports, cases, drug adverse reactions and outcomes were estimated.

RESULTS: Female were 66% compared to 42 % male. The average age was 41.71 years, SD 21.16, and the average weight was 45 KG, SD 41.6. Highest number of records were reported in 2020 and 2019.The United States had the highest of reports, France was the second highest, while Canada had the third highest. Majority of the outcomes were documented as other serious which represent around 75% of the total outcomes, while hospitalization comes second and represent approximately 41% of the total outcomes, and around 20% of the outcomes were classified as life-threatening, which makes the third highest outcomes. Death less than 10% and around only 2% of outcomes required intervention and finally, only 1% of the outcomes were classified as a disability. The drug being ineffective was the most common adverse event reported, as metabolic acidosis, blurred vision, and anaphylactic shock . The other most common adverse events were seizures and bradycardia. Most of the ketamine indications were reported as unknown and epileptics.

CONCLUSIONS: This study shows significant adverse events associated with ketamine, which deserves urgent clarification by means of further prospective studies. It is recommended to conduct a consolidated case/non-case approach to estimate the reporting odds ratio (ROR) and information component (IC) with relevant confidence intervals (95% CI) for ketamine-related AEs with ≥4 counts.