Correction to: A real-world pharmacovigilance study of adverse events associated with esketamine: disproportionality analysis and detection of potential drug-drug interaction signals
Claudia Pisanu, Shungo Imai, Masami Tsuchiya, Mari Inoue, Keisuke Ikegami, Gianpaolo Zammarchi, Hayato Kizaki, Satoko Hori

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TopicsPharmacovigilance and Adverse Drug Reactions · Treatment of Major Depression · Drug-Induced Adverse Reactions
Correction to: European Journal of Clinical Pharmacology (2026) 82:13 10.1007/s00228-025-03954-z
At page 13, the correct version of “ 60 vs. 3 days, p < 0.001, Table 3” is “60 vs. 2 days, p < 0.001, Table 3).
Corrected Tables 2, 3, 4 and 5 are shown in this paper.
Table 2. Disproportionality estimates for the top 30 PTs based on RORAEEsketamine (7,790 cases)Non-esketamine (10,118,302 cases)ROR (95% CI)Dissociation1,217 (15.6%)1,713 (0.0%)1,093.46 (1,012.06-1,181.41)Sedation829 (10.6%)11,119 (0.1%)108.25 (100.50–116.61)Suicidal ideation753 (9.7%)41,145 (0.4%)26.21 (24.30–28.27)Nausea483 (6.2%)420,607 (4.2%)1.52 (1.39–1.67)Depression448 (5.8%)109,003 (1.1%)5.60 (5.09–6.17)Anxiety410 (5.3%)145,172 (1.4%)3.82 (3.45–4.22)Vomiting395 (5.1%)247,656 (2.4%)2.13 (1.92–2.36)Hypertension379 (4.9%)113,679 (1.1%)4.05 (4.06–4.99)Dizziness350 (4.5%)270,273 (2.7%)1.71 (1.54–1.91)Blood pressure increased345 (4.4%)87,692 (0.9%)5.30 (4.76–5.91)Hospitalisation292 (3.7%)74,056 (0.7%)5.28 (4.7–5.94)Product dose omission issue258 (3.3%)153,231 (1.5%)2.23 (1.97–2.52)Suicide attempt248 (3.2%)27,277 (0.3%)12.16 (10.71–13.81)Feeling abnormal226 (2.9%)132,892 (1.3%)2.25 (1.97–2.56)Completed suicide168 (2.2%)31,515 (0.3%)7.05 (6.05–8.22)Panic attack163 (2.1%)18,866 (0.2%)11.44 (9.79–13.37)Hallucination157 (2%)37,320 (0.4%)5.56 (4.74–6.51)Somnolence123 (1.6%)104,843 (1%)1.53 (1.28–1.83)Hallucination, visual98 (1.3%)10,251 (0.1%)12.56 (10.28–15.35)Device issue96 (1.2%)57,688 (0.6%)2.18 (1.78–2.66)Underdose91 (1.2%)45,000 (0.4%)2.65 (2.15–3.25)Seizure88 (1.1%)80,560 (0.8%)1.42 (1.15–1.76)Hypoaesthesia86 (1.1%)81,037 (0.8%)1.38 (1.12–1.71)Major depression84 (1.1%)3,758 (0%)29.34 (23.61–36.46)Surgery82 (1.1%)29,347 (0.3%)3.66 (2.94–4.55)Adverse event81 (1%)35,577 (0.4%)2.98 (2.39–3.71)Loss of consciousness76 (1%)65,154 (0.6%)1.52 (1.21–1.91)Euphoric mood74 (0.9%)5,087 (0.1%)19.07 (15.14–24.01)Crying68 (0.9%)18,601 (0.2%)4.78 (3.76–6.07)Agitation65 (0.8%)34,725 (0.3%)2.44 (1.91–3.12)
Table 3. Differences in demographic characteristics and frequency of AEs between serious and non-serious casesNon-serious cases(n = 1,527)Serious cases(n = 5,560)StatisticspAge, median years (IQR)^a^46.5 (24)48 (23)2,047,0590.08Sex distributionFemale, n (%)1,009 (66.1%)3,548 (63.8%)2.680.10Male, n (%)518 (33.9%)2,012 (36.2%)Weight, median Kg (IQR)^b^77.8 (32)79.1 (31.0)133,9010.89Time-to-onset*, median days (IQR) ^c^ 2 (40)
60 (227)
237,900
< 0.001 Data available for ^a ^926 not-serious and 4,590 serious cases; ^b^ 256 not-serious and 1,052 serious cases; ^c^ 375 not-serious and 2,224 serious cases. Abbreviations: IQR, interquartile range. Age, weight and time-to-onset were compared between serious and non-serious cases using Mann-Whitney U test, while sex and AEs with Pearson’s chi-squared test. Results in bold are statistically significant
Table 4. Sex differences in potential safety signalsPTN. reports femalesROR_females_ (95% CI)N. reports malesROR_males_ (95% CI)Relative ROR 95% CI) More likely to be reported in females Agitation443.22 (2.39–4.33)181.77 (1.12–2.82)1.81 (1.04–3.15)Sedation520135.82 (123.47–149.41)294104.46 (92.19–118.36)1.30 (1.11–1.52)Oxygen saturation decreased251.58 (1.06–2.34)50.56 (0.23–1.36)2.79 (1.07–7.30)Hallucination, auditory278.44 (5.77–12.34)83.44 (1.72–6.89)2.45 (1.11–5.42)Abnormal behaviour193.22 (2.05–5.06)61.02 (0.46–2.27)3.17 (1.26–7.95)Unresponsive to stimuli254.62 (3.11–6.85)82.01 (1.00–4.02)2.30 (1.04–5.11)Aggression182.61 (1.64–4.15)91.08 (0.56–2.08)2.42 (1.08–5.39) More likely to be reported in males Dissociation7591,113.28 (1,007.04–1,230.72)4271,405.53 (1,228.92–1,607.53)1.26 (1.07–1.49)Therapeutic product effect decreased221.90 (1.25–2.89)214.23 (2.75–6.50)2.23 (1.22–4.06)Completed suicide664.82 (3.78–6.15)859.48 (7.63–11.78)1.97 (1.42–2.73)Blood pressure increased1974.90 (4.25–5.65)1326.89 (5.78–8.21)1.41 (1.12–1.76)Anxiety2593.59 (3.17–4.07)1344.65 (3.91–5.54)1.30 (1.05–1.61)Dizziness2071.50 (1.30–1.72)1212.22 (1.85–2.66)1.48 (1.18–1.86)Nausea3111.35 (1.20–1.51)1412.00 (1.68–2.37)1.48 (1.21–1.82)Hypertension2144.10 (3.58–4.71)1455.75 (4.86–6.80)1.40 (1.13–1.74)Depression2825.23 (4.64–5.90)1436.52 (5.50–7.72)1.25 (1.01–1.53)Vomiting2531.99 (1.75–2.26)1232.66 (2.22–3.19)1.34 (1.07–1.67)Vision blurred290.76 (0.53–1.09)231.59 (1.05–2.40)2.10 (1.21–3.63)Spinal operation122.87 (1.63–5.06)147.70 (4.55–13.04)2.68 (1.24–5.81)Panic attack1009.91 (8.12–12.09)5817.02 (13.10–22.11)1.72 (1.24–2.39)Vertigo392.02 (1.47–2.77)213.62 (2.36–5.57)1.80 (1.05–3.06)Bradycardia70.66 (0.32–1.39)172.06 (1.28–3.32)3.11 (1.29–7.51)Hyperacusis65.40 (2.42–12.05)925.23 (13.04–48.83)4.67 (1.65–13.21)Relative ROR women (F/M) and men (M/F) are reported for AEs more likely to be reported in women or in men, respectively. Abbreviations: CI, confidence interval; ROR, reporting odds ratio
Table 5. Age differences in potential safety signalsPTN. reports older adultsROR_older adults_ (95% CI)N. reports adultsROR_adults_ (95% CI)Relative ROR (95% CI) More likely to be reported in older adults Drug ineffective621.69 (1.31–2.19)2480.92 (0.81–1.04)1.85 (1.38–2.46)Anxiety436.58 (4.84–8.94)2833.43 (3.04–3.86)1.92 (1.38–2.67)Feeling abnormal353.55 (2.53–4.99)1502.29 (1.94–2.69)1.56 (1.07–2.26)Sedation114198.48 (162.23–242.83)697138.40 (127.08–150.73)1.43 (1.15–1.79)Dissociation1663,569.21 (2,848.45–4,472.35)9711,054.53 (958.52–1,160.16)3.38 (2.65–4.32)Depression5210.77 (8.13–14.25)3014.96 (4.42–5.58)2.17 (1.60–2.94)Suicide attempt1828.59 (17.89–45.69)1639.39 (8.02–10.98)3.05 (1.86–4.99)Suicidal ideation5349.26 (37.24–65.16)57025.28 (23.13–27.62)1.95 (1.45–2.61)Panic attack1522.25 (13.33–37.14)1189.91 (8.25–11.91)2.25 (1.30–3.87)Nervousness62.46 (1.10–5.49)100.80 (0.43–1.49)3.08 (1.12–8.50)Catatonia530.39 (12.56–73.53)74.44 (2.11–9.34)6.85 (2.16–21.72)Euphoric mood742.56 (20.13–90.01)4816.79 (12.60–22.38)2.53 (1.14–5.65)Depressive symptom555.23 (22.75–134.08)76.13 (2.91–12.91)9.00 (2.83–28.66)Agitation114.69 (2.59–8.50)392.22 (1.62–3.04)2.12 (1.08–4.15)Diplopia65.90 (2.64–13.18)152.24 (1.35–3.72)2.64 (1.02–6.82)Dissociative disorder101,596.30 (740.13–3,442.90)38158.48 (111.80–224.64)10.07 (4.33–23.43)Migraine53.19 (1.32–7.68)340.92 (0.66–1.29)3.47 (1.35–8.89) More likely to be reported in adults Hospitalisation314.57 (3.20–6.55)2057.17 (6.23–8.25)1.57 (1.07–2.30)Hallucination224.74 (3.11–7.24)938.13 (6.61–9.99)1.71 (1.07–2.74)Relative ROR older adults (older adults/adults) and adults (adults/older adults) are reported for AEs more likely to be reported in older adults or in adults, respectively. Abbreviations: CI, confidence interval; ROR, reporting odds ratio
