Comparing the adverse effects of ketamine and esketamine between genders using FAERS data.
Frontiers in Pharmacology 2024 DOI: 10.3389/fphar.2024.1329436 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Retrospective pharmacovigilance analysis Peer reviewed |
|---|---|
| Sample size | 2,907 |
| Population | Patients with adverse drug event reports for ketamine or esketamine in the FAERS database |
| Interventions | Esketamine Ketamine |
| Topics | Esketamine Ketamine |
| Keywords | Adverse drug events Gender difference Signal mining Gender-specific medicine Drug safety Adverse reactions Psychopharmacology |
| Citations | 10 |
| Key points | Adverse events of esketamine and ketamine differ across genders, with men more prone to completed suicide, urinary retention, and hypertension on esketamine, and women more prone to suicidal ideation and certain organ toxicities on ketamine. |
Abstract
Ketamine was developed as an anesthetic. Esketamine is the isolated S-enantiomer of racemic ketamine. They provide new avenues for the treatment of depression, especially treatment-resistant depression. Considering differences in the pharmacokinetics and hormonal status of ketamine in patients of different genders, sex-based differences in esketamine adverse drug events (ADE) may also be observed. This study presents data mining and safety analysis of adverse events of ketamine and esketamine between genders, promoting the individualization of clinical practice. Adverse drug reactions to ketamine and esketamine reported between the first quarter of 2004 and the second quarter of 2023 in the U.S. Food and Drug Administration on Adverse Event Reporting System (FAERS) were extracted. Thereafter, the reporting odds ratio (ROR) with 95% confidence interval (CI) was calculated. A total of 2907 female reports and 1634 male reports on esketamine were included in the analysis. ROR mining showed that completed suicide, decreased therapeutic product effects, urinary retention, and hypertension were common in men. Additionally, 552 female and 653 male ketamine reports were recorded. ROR mining revealed that toxicity to various agents, bradycardia, cystitis and agitation, were more likely to occur in men, whereas women were more likely to develop suicidal ideation, increased transaminase levels, sclerosing cholangitis, and sterile pyuria. The adverse events of esketamine and ketamine differ across genders, which should be considered in clinical practice to provide individualized treatment.
Comparable studies
Other observational and cohort studies on esketamine, most cited first.
Citations in the library
Cited by 6
- Beyond NMDA Receptors: A Narrative Review of Ketamine's Rapid and Multifaceted Mechanisms in Depression Treatment. International Journal of Molecular Sciences December 20, 2024
- A real-world pharmacovigilance study of adverse events associated with esketamine: disproportionality analysis and detection of potential drug-drug interaction signals European Journal of Clinical Pharmacology December 22, 2025
- Inhibition Mechanism of Ketamine-Apatinib by CYP2C9 and 3A4: A Prediction of Possible Drug-Drug Interaction. Biopharmaceutics & drug disposition May 21, 2025
- Safety Profile and Suicidality Associated with the Use of Esketamine in the Treatment of Major Depressive Disorder in European Countries: An EudraVigilance Database Analysis. Pharmaceuticals May 9, 2025
- Adverse drug events and toxicological mechanisms of esketamine: a study based on US Food and Drug Administration Adverse Event Reporting System and network toxicology analysis. Naunyn-Schmiedeberg's Archives of Pharmacology February 26, 2026
and 1 more in the library
Cites 18
- R-ketamine: a rapid-onset and sustained antidepressant without psychotomimetic side effects Translational Psychiatry September 1, 2015
- Side-effects associated with ketamine use in depression: a systematic review. The Lancet Psychiatry 2018
- Intravenous Esketamine in Adult Treatment-Resistant Depression: A Double-Blind, Double-Randomization, Placebo-Controlled Study Biological Psychiatry November 4, 2015
- Esketamine Nasal Spray versus Quetiapine for Treatment-Resistant Depression New England Journal of Medicine October 4, 2023
- Association of Ketamine With Psychiatric Symptoms and Implications for Its Therapeutic Use and for Understanding Schizophrenia JAMA Network Open May 1, 2020
and 13 more in the library