Drug · FAERS side-effect profile with label screen
Ketamine side effects: what 4,820 FDA adverse event reports show
Drug class
General anesthetic
FDA label, Indications wording of the closest related product
Label matched
Ketamine Hydrochloride (Ketalar)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
4,820 reports · 71% serious · 539 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
KETALAR (ketamine hydrochloride) injection is indicated: as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. for the induction of anesthesia prior to the administration of other general anesthetic agents. as a supplement to other anesthetic agents.
FDA label, Indications and Usage
What it is
KETALAR (ketamine hydrochloride) injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C 13 H 16 ClNO•HCl and a molecular weight of 274.19.
FDA label, Description section
Boxed warning
None in the current label
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
Labeled adverse reaction 3Labeled (related wording) 5Reporting / coding artifact 11Lab value / disease marker 1Not in label — unassessed 20
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
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. 182 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Infusion site pain | 733 | 263.7 246.1–282.5ROR 310.5 · χ² 180,520 / p <1e-300 | 246.8 EB05 232.2 · IC025 +7.6 3/3 methods agree | Labeled (related wording) related wording | serious n=190 · 95% consumer | no trial data cached |
| Dermatitis contact | 96 | 36.9 30.2–45.0ROR 37.6 · χ² 3,290 / p <1e-300 | 36.3 EB05 30.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 80% (drug 60%) · 97% consumer | no trial data cached |
| Sedation | 210 | 35.1 30.8–40.1ROR 36.7 · χ² 6,883 / p <1e-300 | 34.8 EB05 31.0 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 38.7 · ♀ 8% (drug 60%) | no trial data cached |
| Device occlusion | 100 | 31.3 25.8–38.1ROR 32.0 · χ² 2,887 / p <1e-300 | 30.9 EB05 26.2 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=31 · 96% consumer | no trial data cached |
| Device failure | 104 | 29.9 24.7–36.1ROR 30.5 · χ² 2,855 / p <1e-300 | 29.5 EB05 25.1 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 17.0 · 88% consumer | no trial data cached |
| Nightmare | 195 | 24.4 21.3–28.0ROR 25.4 · χ² 4,337 / p <1e-300 | 24.2 EB05 21.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 33.2 · ♀ 3% (drug 60%) | no trial data cached |
| Bladder disorder | 49 | 21.4 16.2–28.3ROR 21.6 · χ² 929 / p 2e-204 | 21.2 EB05 16.6 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=49 · 98% clinician | no trial data cached |
| Anaphylactic shock | 99 | 16.8 13.8–20.4ROR 17.1 · χ² 1,449 / p <1e-300 | 16.7 EB05 14.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 · 94% clinician | no trial data cached |
| Nephrolithiasis (kidney stones) | 174 | 16.5 14.3–19.1ROR 17.1 · χ² 2,518 / p <1e-300 | 16.4 EB05 14.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 · ♀ 3% (drug 60%) | no trial data cached |
| Status epilepticus | 41 | 15.7 11.6–21.4ROR 15.9 · χ² 549 / p 9e-122 | 15.5 EB05 11.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · ♀ 92% (drug 60%) | no trial data cached |
| Drug abuse | 300 | 15.6 14.0–17.4ROR 16.5 · χ² 4,078 / p <1e-300 | 15.5 EB05 14.1 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 12.8 · ♀ 38% (drug 60%) · 98% clinician | no trial data cached |
| Unintentional medical device removal | 38 | 14.1 10.3–19.4ROR 14.2 · χ² 449 / p 7e-100 | 13.8 EB05 10.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 · 100% consumer | no trial data cached |
| Device dislocation | 133 | 13.3 11.2–15.7ROR 13.6 · χ² 1,499 / p <1e-300 | 13.2 EB05 11.4 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 · 93% consumer | no trial data cached |
| Therapy non-responder | 135 | 13.1 11.1–15.5ROR 13.5 · χ² 1,501 / p <1e-300 | 13.0 EB05 11.3 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 · 83% consumer | no trial data cached |
| Pain in jaw | 85 | 13.0 10.5–16.1ROR 13.2 · χ² 929 / p 3e-204 | 12.9 EB05 10.7 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 · ♀ 87% (drug 60%) · 93% consumer | no trial data cached |
| Pulmonary arterial hypertension | 41 | 12.2 9.0–16.6ROR 12.3 · χ² 410 / p 2e-91 | 11.8 EB05 8.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Therapy partial responder | 42 | 12.1 8.9–16.4ROR 12.2 · χ² 416 / p 1e-92 | 11.7 EB05 8.9 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 86% consumer | no trial data cached |
| Respiratory depression | 32 | 11.3 8.0–16.0ROR 11.4 · χ² 290 / p 2e-65 | 10.8 EB05 7.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 · 90% clinician | no trial data cached |
| Cystitis | 83 | 11.3 9.1–13.9ROR 11.4 · χ² 765 / p 9e-169 | 11.1 EB05 9.1 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 · ♀ 38% (drug 60%) · 94% clinician | no trial data cached |
| Device use error | 85 | 10.8 8.8–13.4ROR 11.0 · χ² 747 / p 9e-165 | 10.6 EB05 8.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=33 · 94% consumer | no trial data cached |
| Shock | 54 | 10.3 7.9–13.4ROR 10.4 · χ² 442 / p 2e-98 | 9.9 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · ♀ 82% (drug 60%) | no trial data cached |
| Bronchospasm (airway tightening) | 33 | 10.0 7.1–14.1ROR 10.1 · χ² 258 / p 3e-58 | 9.4 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 97% clinician | no trial data cached |
| Pulmonary hypertension | 46 | 9.5 7.2–12.7ROR 9.6 · χ² 343 / p 8e-77 | 9.1 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 75% consumer | no trial data cached |
| Dizziness postural | 21 | 9.5 6.2–14.5ROR 9.5 · χ² 151 / p 6e-35 | 8.5 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=11 · 86% consumer | no trial data cached |
| Seasonal allergy | 30 | 9.2 6.4–13.2ROR 9.3 · χ² 211 / p 4e-48 | 8.5 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 · ♀ 100% (drug 60%) · 90% consumer | no trial data cached |
| Hepatotoxicity (liver damage) | 46 | 9.0 6.7–12.0ROR 9.1 · χ² 319 / p 1e-71 | 8.5 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.5 · ♀ 98% (drug 60%) | no trial data cached |
| Device leakage | 83 | 8.5 6.9–10.5ROR 8.6 · χ² 542 / p 4e-120 | 8.2 EB05 6.8 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious n=34 · ♀ 86% (drug 60%) · 94% consumer | no trial data cached |
| Micturition urgency | 22 | 8.4 5.5–12.8ROR 8.4 · χ² 136 / p 9e-32 | 7.5 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Abortion induced | 17 | 7.8 4.9–12.6ROR 7.8 · χ² 94 / p 1e-22 | 6.7 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Brain injury | 18 | 7.8 4.9–12.3ROR 7.8 · χ² 99 / p 1e-23 | 6.7 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.4 | no trial data cached |
| Hypoxia (low oxygen) | 61 | 7.5 5.9–9.7ROR 7.6 · χ² 339 / p 4e-76 | 7.2 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Device adhesion issue | 26 | 7.4 5.0–10.9ROR 7.4 · χ² 138 / p 4e-32 | 6.7 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=10 · 92% consumer | no trial data cached |
| Metabolic acidosis | 54 | 7.4 5.7–9.6ROR 7.5 · χ² 292 / p 9e-66 | 7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Oxygen saturation decreased | 95 | 7.4 6.0–9.0ROR 7.5 · χ² 518 / p 6e-115 | 7.2 EB05 6.0 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 5.8 | no trial data cached |
| Hyperhidrosis (excessive sweating) | 216 | 7.3 6.4–8.3ROR 7.6 · χ² 1,165 / p 1e-255 | 7.2 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 11% (drug 60%) | no trial data cached |
| Drug ineffective for unapproved indication | 93 | 7.2 5.9–8.8ROR 7.4 · χ² 494 / p 1e-109 | 7.0 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 12.4 · 90% clinician | no trial data cached |
| Liver function test abnormal | 48 | 7.1 5.4–9.4ROR 7.2 · χ² 246 / p 1e-55 | 6.7 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · 94% clinician | no trial data cached |
| Dyspnoea exertional | 60 | 6.9 5.4–8.9ROR 7.0 · χ² 298 / p 4e-67 | 6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 88% consumer | no trial data cached |
| Emphysema | 16 | 6.8 4.2–11.2ROR 6.9 · χ² 74 / p 4e-18 | 5.8 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Pneumothorax | 25 | 6.8 4.6–10.1ROR 6.9 · χ² 119 / p 6e-28 | 6.2 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 25% (drug 60%) | 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 |
|---|---|---|---|---|---|---|
| Infusion site pain | 733 | 263.7 246.1–282.5ROR 310.5 · χ² 180,520 / p <1e-300 | 246.8 EB05 232.2 · IC025 +7.6 3/3 methods agree | Labeled (related wording) related wording | serious n=190 · 95% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 526 | 1.7 1.6–1.9ROR 1.8 · χ² 172 / p 2e-39 | 1.7 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 3.5 · ♀ 34% (drug 60%) | no trial data cached |
| Off label use (used outside approved label) | 509 | 2.5 2.3–2.8ROR 2.7 · χ² 494 / p 1e-109 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Nausea | 503 | 2.8 2.5–3.0ROR 3.0 · χ² 585 / p 2e-129 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Headache | 319 | 2.2 2.0–2.5ROR 2.3 · χ² 215 / p 5e-49 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.5 · 87% consumer | no trial data cached |
| Drug abuse | 300 | 15.6 14.0–17.4ROR 16.5 · χ² 4,078 / p <1e-300 | 15.5 EB05 14.1 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 12.8 · ♀ 38% (drug 60%) · 98% clinician | no trial data cached |
| Dyspnoea (shortness of breath) | 292 | 2.2 2.0–2.5ROR 2.3 · χ² 203 / p 2e-46 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 · 78% consumer | no trial data cached |
| Hyperhidrosis (excessive sweating) | 216 | 7.3 6.4–8.3ROR 7.6 · χ² 1,165 / p 1e-255 | 7.2 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 11% (drug 60%) | no trial data cached |
| Sedation | 210 | 35.1 30.8–40.1ROR 36.7 · χ² 6,883 / p <1e-300 | 34.8 EB05 31.0 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 38.7 · ♀ 8% (drug 60%) | no trial data cached |
| Hypotension (low blood pressure) | 201 | 4.3 3.8–5.0ROR 4.5 · χ² 519 / p 3e-115 | 4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Nightmare | 195 | 24.4 21.3–28.0ROR 25.4 · χ² 4,337 / p <1e-300 | 24.2 EB05 21.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 33.2 · ♀ 3% (drug 60%) | no trial data cached |
| Product use in unapproved indication | 187 | 3.3 2.9–3.8ROR 3.4 · χ² 303 / p 3e-68 | 3.3 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 · ♀ 21% (drug 60%) | no trial data cached |
| Nephrolithiasis (kidney stones) | 174 | 16.5 14.3–19.1ROR 17.1 · χ² 2,518 / p <1e-300 | 16.4 EB05 14.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 · ♀ 3% (drug 60%) | no trial data cached |
| Therapy non-responder | 135 | 13.1 11.1–15.5ROR 13.5 · χ² 1,501 / p <1e-300 | 13.0 EB05 11.3 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 · 83% consumer | no trial data cached |
| Device dislocation | 133 | 13.3 11.2–15.7ROR 13.6 · χ² 1,499 / p <1e-300 | 13.2 EB05 11.4 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 · 93% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Dermatitis contact — n=96, PRR 36.9
- Nightmare — n=195, PRR 24.4
- Anaphylactic shock — n=99, PRR 16.8
- Nephrolithiasis — n=174, PRR 16.5
- Status epilepticus — n=41, PRR 15.7
- Unintentional medical device removal — n=38, PRR 14.1
- Pulmonary arterial hypertension — n=41, PRR 12.2
- Shock — n=54, PRR 10.3
- Bronchospasm — n=33, PRR 10.0
- Pulmonary hypertension — n=46, PRR 9.5
✓ A hand-written Bradford Hill causality assessment exists for this drug: Ketamine ↔ Cystitis.
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 Ketamine?
In FDA FAERS, the most frequently co-reported reaction terms for Ketamine are infusion site pain, nausea, headache, dyspnoea, hyperhidrosis, sedation. 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 Ketamine have an FDA boxed warning?
No. The FDA label retrieved for Ketamine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ketamine 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
- FDA label via openFDA (set ID 14e8f864-8b8a-4e7e-8439-e510d3107063, effective 20260327; matched on
openfda.generic_name.exact:"KETAMINE HYDROCHLORIDE") - 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, fieldpatient.drug.openfda.generic_name.exact, 222 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.