Esketamine side effects: what 994 FDA adverse event reports show

Esketamine Hydrochloride · 856 reaction terms · 36,441 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

994 reports · 93% serious · 62 with death outcome · 64% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Reporting / coding artifact 8Lab value / disease marker 1No label text to screen 31

What the badges mean

Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 816 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Dissociation	3,733	1,174.1 1,124.7–1,225.7ROR 1,487.0 · χ² 2,180,566 / p <1e-300	583.8 EB05 568.3 · IC025 +9.0 3/3 methods agree	No label text to screen	–	no trial data cached
Physical examination abnormal	88	377.3 296.8–479.6ROR 379.2 · χ² 24,671 / p <1e-300	268.7 EB05 224.8 · IC025 +6.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Dissociative disorder	89	168.0 134.6–209.6ROR 168.8 · χ² 12,766 / p <1e-300	142.5 EB05 119.3 · IC025 +6.0 3/3 methods agree	No label text to screen	–	no trial data cached
Sedation	2,706	137.1 132.1–142.2ROR 161.6 · χ² 327,381 / p <1e-300	122.7 EB05 118.8 · IC025 +6.8 3/3 methods agree	No label text to screen	–	no trial data cached
Autoscopy	24	55.4 36.8–83.4ROR 55.5 · χ² 1,173 / p 2e-257	50.9 EB05 36.0 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Drug monitoring procedure incorrectly performed	28	51.8 35.5–75.5ROR 51.8 · χ² 1,286 / p 6e-282	48.1 EB05 34.9 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Self-destructive behaviour	31	51.1 35.6–73.1ROR 51.2 · χ² 1,410 / p <1e-300	47.6 EB05 35.1 · IC025 +4.2 3/3 methods agree	No label text to screen	–	no trial data cached
Flashback	19	40.2 25.5–63.5ROR 40.3 · χ² 665 / p 6e-147	37.6 EB05 25.4 · IC025 +3.5 3/3 methods agree	No label text to screen	–	no trial data cached
Oxygen saturation abnormal	82	35.6 28.6–44.4ROR 35.8 · χ² 2,646 / p <1e-300	34.4 EB05 28.6 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Psychogenic seizure	26	34.3 23.2–50.6ROR 34.3 · χ² 784 / p 1e-172	32.6 EB05 23.4 · IC025 +3.7 3/3 methods agree	No label text to screen	–	no trial data cached
Morbid thoughts	24	24.6 16.4–36.8ROR 24.6 · χ² 508 / p 8e-113	23.7 EB05 16.7 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Therapeutic product effect increased	21	22.2 14.4–34.1ROR 22.2 · χ² 396 / p 2e-88	21.4 EB05 14.7 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Major depression	120	19.7 16.4–23.6ROR 19.8 · χ² 2,075 / p <1e-300	19.3 EB05 16.6 · IC025 +3.9 3/3 methods agree	No label text to screen	–	no trial data cached
Suicidal ideation (thoughts of suicide)	1,351	17.7 16.8–18.6ROR 19.1 · χ² 21,023 / p <1e-300	17.4 EB05 16.7 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Drug monitoring procedure not performed	26	17.5 11.9–25.8ROR 17.5 · χ² 383 / p 1e-85	17.0 EB05 12.0 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Euphoric mood	145	16.9 14.3–19.9ROR 17.0 · χ² 2,119 / p <1e-300	16.6 EB05 14.4 · IC025 +3.7 3/3 methods agree	No label text to screen	–	no trial data cached
Illusion	22	15.8 10.4–24.0ROR 15.8 · χ² 286 / p 2e-64	15.1 EB05 10.2 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial data cached
Derealisation	28	15.7 10.8–22.8ROR 15.7 · χ² 365 / p 1e-81	15.2 EB05 10.8 · IC025 +3.0 3/3 methods agree	No label text to screen	–	no trial data cached
Product delivery mechanism issue	60	14.8 11.4–19.0ROR 14.8 · χ² 747 / p 1e-164	14.5 EB05 11.6 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Paternal exposure during pregnancy	10	13.9 7.5–26.0ROR 13.9 · χ² 106 / p 4e-25	11.9 EB05 5.9 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Substance use	16	12.4 7.6–20.3ROR 12.4 · χ² 155 / p 8e-36	11.2 EB05 6.7 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Depressive symptom	36	12.2 8.8–17.0ROR 12.3 · χ² 357 / p 8e-80	11.7 EB05 8.6 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial data cached
Feeling drunk	74	11.8 9.4–14.9ROR 11.9 · χ² 717 / p 4e-158	11.5 EB05 9.4 · IC025 +3.1 3/3 methods agree	No label text to screen	–	no trial data cached
Hallucination, visual	206	11.7 10.2–13.4ROR 11.8 · χ² 1,991 / p <1e-300	11.5 EB05 10.3 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Nasal discomfort	72	10.8 8.5–13.6ROR 10.8 · χ² 623 / p 7e-138	10.4 EB05 8.5 · IC025 +2.9 3/3 methods agree	No label text to screen	–	no trial data cached
Depersonalisation/derealisation disorder	14	10.4 6.1–17.5ROR 10.4 · χ² 108 / p 1e-25	8.8 EB05 5.2 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Panic attack	316	10.3 9.3–11.5ROR 10.5 · χ² 2,634 / p <1e-300	10.2 EB05 9.3 · IC025 +3.2 3/3 methods agree	No label text to screen	–	no trial data cached
Incorrect dose administered by device	202	9.5 8.3–10.9ROR 9.6 · χ² 1,512 / p <1e-300	9.3 EB05 8.3 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Panic disorder	29	8.9 6.2–12.8ROR 8.9 · χ² 194 / p 2e-44	8.1 EB05 5.8 · IC025 +2.3 3/3 methods agree	No label text to screen	–	no trial data cached
Negative thoughts	22	8.9 5.9–13.5ROR 8.9 · χ² 145 / p 8e-34	7.9 EB05 5.3 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Cystitis interstitial	12	8.9 5.0–15.7ROR 8.9 · χ² 76 / p 2e-18	7.2 EB05 4.2 · IC025 +1.8 3/3 methods agree	No label text to screen	–	no trial data cached
Psychotic symptom	15	8.8 5.3–14.5ROR 8.8 · χ² 95 / p 1e-22	7.4 EB05 4.6 · IC025 +1.9 3/3 methods agree	No label text to screen	–	no trial data cached
Self-injurious ideation	30	8.5 6.0–12.2ROR 8.6 · χ² 191 / p 1e-43	7.8 EB05 5.6 · IC025 +2.3 3/3 methods agree	No label text to screen	–	no trial data cached
Post-traumatic stress disorder	46	8.2 6.1–10.9ROR 8.2 · χ² 280 / p 5e-63	7.7 EB05 5.9 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Hyperacusis	24	7.6 5.1–11.4ROR 7.7 · χ² 131 / p 1e-30	6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Respiratory depression	74	7.2 5.7–9.0ROR 7.2 · χ² 385 / p 5e-86	6.9 EB05 5.6 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Alcoholism	26	7.2 4.9–10.5ROR 7.2 · χ² 131 / p 1e-30	6.4 EB05 4.6 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Rehabilitation therapy	23	7.1 4.7–10.7ROR 7.1 · χ² 114 / p 8e-27	6.3 EB05 4.4 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Conversion disorder	11	6.8 3.7–12.2ROR 6.8 · χ² 48 / p 2e-12	5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree	No label text to screen	–	no trial data cached
Drug delivery system malfunction	28	6.6 4.5–9.5ROR 6.6 · χ² 126 / p 1e-29	6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree	No label text to screen	–	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Dissociation	3,733	1,174.1 1,124.7–1,225.7ROR 1,487.0 · χ² 2,180,566 / p <1e-300	583.8 EB05 568.3 · IC025 +9.0 3/3 methods agree	No label text to screen	–	no trial data cached
Sedation	2,706	137.1 132.1–142.2ROR 161.6 · χ² 327,381 / p <1e-300	122.7 EB05 118.8 · IC025 +6.8 3/3 methods agree	No label text to screen	–	no trial data cached
Suicidal ideation (thoughts of suicide)	1,351	17.7 16.8–18.6ROR 19.1 · χ² 21,023 / p <1e-300	17.4 EB05 16.7 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Drug ineffective (drug did not work)	1,082	1.0 0.9–1.0ROR 1.0 · χ² 1 / p 0.171	1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached
Nausea	957	1.4 1.3–1.5ROR 1.5 · χ² 131 / p 1e-30	1.4 EB05 1.4 · IC025 +0.4	No label text to screen	–	no trial data cached
Depression	873	4.5 4.2–4.8ROR 4.7 · χ² 2,417 / p <1e-300	4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Hypertension (high blood pressure)	844	4.7 4.4–5.0ROR 4.9 · χ² 2,489 / p <1e-300	4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Product dose omission issue	792	3.3 3.1–3.5ROR 3.4 · χ² 1,279 / p 2e-280	3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Hospitalisation	787	6.1 5.7–6.6ROR 6.4 · χ² 3,385 / p <1e-300	6.1 EB05 5.7 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Anxiety	738	3.1 2.9–3.3ROR 3.2 · χ² 1,036 / p 1e-227	3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree	No label text to screen	–	no trial data cached
Vomiting	725	1.8 1.7–2.0ROR 1.9 · χ² 278 / p 1e-62	1.8 EB05 1.7 · IC025 +0.7	No label text to screen	–	no trial data cached
Dizziness	639	1.5 1.4–1.6ROR 1.5 · χ² 115 / p 3e-27	1.5 EB05 1.4 · IC025 +0.5	No label text to screen	–	no trial data cached
Blood pressure increased	558	4.3 4.0–4.7ROR 4.4 · χ² 1,426 / p <1e-300	4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Feeling abnormal	500	2.5 2.3–2.7ROR 2.5 · χ² 437 / p 3e-97	2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree	No label text to screen	–	no trial data cached
Off label use (used outside approved label)	421	0.6 0.5–0.6ROR 0.6 · χ² 139 / p 3e-32	0.6 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Esketamine?

In FDA FAERS, the most frequently co-reported reaction terms for Esketamine are dissociation, sedation, suicidal ideation, nausea, depression, hypertension. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Esketamine have an FDA boxed warning?

No validated FDA label could be retrieved for this product name, so this page cannot say.

Do FAERS signals prove that Esketamine causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

No FDA label passed the name-validation check for this product string, so label-based screening was skipped
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 856 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.