Pharmacovigilance of esketamine nasal spray: an analysis of the FDA adverse event reporting system database.
Ruixue Liu, Chunxiao Liu, Dianwei Feng, Tongxin Guo, Ying Wang
Frontiers in Pharmacology 2024 DOI: 10.3389/fphar.2024.1414703 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Observational pharmacovigilance study using FAERS database Peer reviewed |
|---|---|
| Sample size | 14,606 |
| Population | Patients with adverse events reported to the FDA where esketamine nasal spray was the primary suspected drug |
| Intervention | Esketamine nasal spray |
| Topics | Depression Esketamine |
| Keywords | Faers Adverse side effects Depression treatment Drug safety monitoring Psychiatric medicine Clinical data analysis Adverse drug reactions |
| Citations | 5 |
| Key findings | Dissociation was the most frequent and intense adverse event signal associated with esketamine nasal spray, and dissociative disorder, not listed in the product's summary of product characteristics, also showed a strong signal. |
Abstract
Esketamine nasal spray (ESK-NS) is a new drug for treatment-resistant depression, and we aimed to detect and characterize the adverse events (AEs) of ESK-NS using the Food and Drug Administration (FDA) adverse event reporting system (FAERS) database between 2019 Q1 and 2023 Q4. Reporting odds ratio (ROR), proportional reporting ratio (PRR), and multi-item gamma Poisson shrinker (MGPS) were performed to detect risk signals from the FAERS data to identify potential ESK-NS-AEs associations. A total of 14,606 reports on AEs with ESK-NS as the primary suspected drug were analyzed. A total of 518 preferred terms signals and 25 system organ classes mainly concentrated in psychiatric disorders (33.20%), nervous system disorders (16.67%), general disorders and administration site conditions (14.21%), and others were obtained. Notably, dissociation (n = 1,093, ROR 2,257.80, PRR 899.64, EBGM 876.86) exhibited highest occurrence rates and signal intensity. Moreover, uncommon but significantly strong AEs signals, such as hand-eye coordination impaired, feeling guilty, and feelings of worthlessness, were observed. Additionally, dissociative disorder (n = 57, ROR 510.92, PRR 506.70, EBGM 386.60) and sedation (n = 688, ROR 172.68, PRR 155.53, and EBGM 142.05) both presented strong AE signals, and the former is not recorded in the Summary of Product Characteristics (SmPC). In clinical applications, close attention should be paid to the psychiatric disorders and nervous system disorders, especially dissociation. Meanwhile, clinical professionals should be alert for the occurrence of AEs signals not mentioned in the SmPC and take preventive measures to ensure the safety of clinical use.
Comparable studies
Other observational and cohort studies on esketamine for depression, most cited first.
Citations in the library
Cited by 3
- 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
- Esketamine nasal spray for treatment-resistant depression: A retrospective multicenter real-world cohort study on effectiveness and suicidal outcomes. Journal of Psychopharmacology March 21, 2026
- Dextromethorphan-bupropion-associated pharmacovigilance signals based on the FAERS database: An observational study. Medicine June 26, 2026
Cites 15
- Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study American Journal of Psychiatry May 21, 2019
- Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study American Journal of Psychiatry April 16, 2018
- R-ketamine: a rapid-onset and sustained antidepressant without psychotomimetic side effects Translational Psychiatry September 1, 2015
- Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1) The International Journal of Neuropsychopharmacology July 9, 2019
- Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II) The International Journal of Neuropsychopharmacology August 26, 2020
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