Drug · FAERS side-effect profile with label screen
Etomidate Injection side effects: what 2,114 FDA adverse event reports show
Who reports
2,114 reports · 92% serious · 444 with death outcome · 43% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Etomidate injection is indicated by intravenous injection for the induction of general anesthesia. When considering use of etomidate injection, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ) .
FDA label, Indications and Usage
What it is
DESCRIPTION Etomidate Injection, USP is a sterile, nonpyrogenic solution. Each milliliter contains etomidate, 2 mg, propylene glycol 35% v/v. The pH is 6.0 (4.0 to 7.0). It is intended for the induction of general anesthesia by intravenous injection.
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 2Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 33
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 67 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 |
|---|---|---|---|---|---|---|
| Multi-organ failure | 97 | 55.1 45.4–67.0ROR 57.7 · χ² 5,078 / p <1e-300 | 54.3 EB05 45.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 34.4 | no trial data cached |
| Fear | 136 | 50.0 42.5–58.9ROR 53.4 · χ² 6,460 / p <1e-300 | 49.4 EB05 42.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 42.3 | no trial data cached |
| Renal injury | 119 | 39.5 33.1–47.0ROR 41.8 · χ² 4,412 / p <1e-300 | 39.1 EB05 33.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 24.7 | no trial data cached |
| Anhedonia | 100 | 37.6 31.0–45.5ROR 39.4 · χ² 3,516 / p <1e-300 | 37.2 EB05 31.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 25.9 | no trial data cached |
| Ventricular fibrillation | 37 | 33.1 24.0–45.5ROR 33.6 · χ² 1,115 / p 8e-245 | 32.5 EB05 24.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 20.7 · ♀ 73% (drug 43%) · 97% clinician | no trial data cached |
| Anaphylactic shock | 78 | 30.3 24.3–37.7ROR 31.4 · χ² 2,175 / p <1e-300 | 30.0 EB05 24.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.7 · 95% clinician | no trial data cached |
| Serotonin syndrome | 49 | 25.5 19.3–33.6ROR 26.1 · χ² 1,126 / p 4e-247 | 25.2 EB05 19.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 · 98% clinician | no trial data cached |
| Injury | 167 | 23.5 20.3–27.2ROR 25.4 · χ² 3,578 / p <1e-300 | 23.4 EB05 20.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 18.2 | no trial data cached |
| Myoclonus | 28 | 23.3 16.2–33.7ROR 23.6 · χ² 576 / p 2e-127 | 23.0 EB05 16.7 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 · 96% clinician | no trial data cached |
| Muscle rigidity | 24 | 20.0 13.4–29.7ROR 20.2 · χ² 413 / p 5e-92 | 19.6 EB05 13.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 · 100% clinician | no trial data cached |
| Unevaluable event | 150 | 19.7 16.9–23.0ROR 21.1 · χ² 2,648 / p <1e-300 | 19.6 EB05 17.1 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 21.8 | no trial data cached |
| Respiratory depression | 23 | 18.6 12.4–28.0ROR 18.8 · χ² 366 / p 7e-82 | 18.3 EB05 12.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.0 · 100% clinician | no trial data cached |
| Shock | 42 | 18.3 13.6–24.7ROR 18.6 · χ² 669 / p 1e-147 | 18.1 EB05 13.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 · 100% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 143 | 17.1 14.6–20.1ROR 18.3 · χ² 2,163 / p <1e-300 | 17.1 EB05 14.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · 96% clinician | no trial data cached |
| Ventricular tachycardia | 28 | 16.8 11.6–24.3ROR 17.0 · χ² 400 / p 3e-89 | 16.5 EB05 11.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · ♀ 71% (drug 43%) · 100% clinician | no trial data cached |
| Adrenal insufficiency | 20 | 16.6 10.7–25.7ROR 16.7 · χ² 277 / p 1e-62 | 16.1 EB05 10.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · 100% clinician | no trial data cached |
| Renal failure (kidney failure) | 215 | 16.0 14.1–18.1ROR 17.7 · χ² 3,016 / p <1e-300 | 15.9 EB05 14.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Generalised tonic-clonic seizure | 25 | 15.2 10.3–22.4ROR 15.3 · χ² 317 / p 4e-71 | 14.8 EB05 10.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · ♀ 70% (drug 43%) · 100% clinician | no trial data cached |
| Poisoning deliberate | 14 | 14.9 8.9–25.2ROR 15.0 · χ² 168 / p 9e-39 | 13.9 EB05 8.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Bradycardia (slow heart rate) | 79 | 14.8 11.9–18.3ROR 15.3 · χ² 1,001 / p 5e-220 | 14.7 EB05 12.1 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 · ♀ 74% (drug 43%) · 96% clinician | no trial data cached |
| Cardiogenic shock | 21 | 14.6 9.5–22.4ROR 14.8 · χ² 253 / p 3e-57 | 14.0 EB05 9.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 61 | 14.6 11.4–18.6ROR 15.0 · χ² 757 / p 6e-167 | 14.4 EB05 11.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · ♀ 11% (drug 43%) · 93% clinician | no trial data cached |
| Stress | 103 | 14.2 11.8–17.2ROR 14.9 · χ² 1,256 / p 3e-275 | 14.1 EB05 12.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 | no trial data cached |
| Renal impairment | 115 | 13.6 11.4–16.3ROR 14.4 · χ² 1,339 / p 2e-293 | 13.6 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Renal failure acute | 59 | 13.6 10.6–17.5ROR 14.0 · χ² 677 / p 1e-149 | 13.4 EB05 10.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Bronchospasm (airway tightening) | 19 | 13.2 8.4–20.6ROR 13.3 · χ² 202 / p 4e-46 | 12.4 EB05 7.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Status epilepticus | 15 | 13.2 7.9–21.8ROR 13.3 · χ² 157 / p 3e-36 | 12.0 EB05 7.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Post procedural complication | 25 | 12.9 8.7–19.1ROR 13.0 · χ² 263 / p 2e-59 | 12.3 EB05 8.4 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Acute respiratory failure | 23 | 11.9 7.9–17.9ROR 12.0 · χ² 219 / p 6e-50 | 11.2 EB05 7.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 90% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 33 | 11.7 8.4–16.5ROR 11.9 · χ² 314 / p 2e-70 | 11.2 EB05 8.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 100% clinician | no trial data cached |
| Metabolic acidosis | 37 | 11.6 8.4–16.0ROR 11.8 · χ² 348 / p 5e-78 | 11.2 EB05 8.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 94% clinician | no trial data cached |
| Ejection fraction decreased | 18 | 11.5 7.2–18.2ROR 11.6 · χ² 162 / p 2e-37 | 10.4 EB05 6.5 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.5 | no trial data cached |
| Neuroleptic malignant syndrome | 13 | 10.9 6.3–18.7ROR 10.9 · χ² 107 / p 3e-25 | 9.3 EB05 5.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Emotional distress | 127 | 10.4 8.8–12.3ROR 11.0 · χ² 1,072 / p 2e-235 | 10.2 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Coma | 49 | 10.2 7.7–13.5ROR 10.4 · χ² 398 / p 7e-89 | 9.8 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 96% clinician | no trial data cached |
| Bacteraemia | 12 | 10.1 5.8–17.8ROR 10.2 · χ² 90 / p 1e-21 | 8.4 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Renal tubular necrosis | 10 | 10.1 5.4–18.7ROR 10.1 · χ² 73 / p 6e-18 | 8.0 EB05 4.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Disseminated intravascular coagulation | 14 | 9.8 5.8–16.6ROR 9.9 · χ² 103 / p 2e-24 | 8.3 EB05 5.0 · IC025 +2.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.2 | no trial data cached |
| Tachypnoea | 13 | 9.5 5.5–16.4ROR 9.6 · χ² 91 / p 8e-22 | 7.9 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Brain oedema | 12 | 9.4 5.4–16.6ROR 9.5 · χ² 82 / p 6e-20 | 7.7 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | 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 |
|---|---|---|---|---|---|---|
| Renal failure (kidney failure) | 215 | 16.0 14.1–18.1ROR 17.7 · χ² 3,016 / p <1e-300 | 15.9 EB05 14.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Injury | 167 | 23.5 20.3–27.2ROR 25.4 · χ² 3,578 / p <1e-300 | 23.4 EB05 20.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 18.2 | no trial data cached |
| Anxiety | 160 | 5.6 4.8–6.5ROR 5.9 · χ² 603 / p 2e-133 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Hypotension (low blood pressure) | 151 | 7.5 6.4–8.7ROR 8.0 · χ² 849 / p 6e-187 | 7.3 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · 96% clinician | no trial data cached |
| Unevaluable event | 150 | 19.7 16.9–23.0ROR 21.1 · χ² 2,648 / p <1e-300 | 19.6 EB05 17.1 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 21.8 | no trial data cached |
| Cardiac arrest (heart stopping) | 143 | 17.1 14.6–20.1ROR 18.3 · χ² 2,163 / p <1e-300 | 17.1 EB05 14.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · 96% clinician | no trial data cached |
| Fear | 136 | 50.0 42.5–58.9ROR 53.4 · χ² 6,460 / p <1e-300 | 49.4 EB05 42.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 42.3 | no trial data cached |
| Emotional distress | 127 | 10.4 8.8–12.3ROR 11.0 · χ² 1,072 / p 2e-235 | 10.2 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Renal injury | 119 | 39.5 33.1–47.0ROR 41.8 · χ² 4,412 / p <1e-300 | 39.1 EB05 33.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 24.7 | no trial data cached |
| Renal impairment | 115 | 13.6 11.4–16.3ROR 14.4 · χ² 1,339 / p 2e-293 | 13.6 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Stress | 103 | 14.2 11.8–17.2ROR 14.9 · χ² 1,256 / p 3e-275 | 14.1 EB05 12.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 | no trial data cached |
| Anhedonia | 100 | 37.6 31.0–45.5ROR 39.4 · χ² 3,516 / p <1e-300 | 37.2 EB05 31.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 25.9 | no trial data cached |
| Multi-organ failure | 97 | 55.1 45.4–67.0ROR 57.7 · χ² 5,078 / p <1e-300 | 54.3 EB05 45.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 34.4 | no trial data cached |
| Drug interaction | 89 | 5.6 4.5–6.8ROR 5.8 · χ² 331 / p 3e-74 | 5.4 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 · 97% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 79 | 14.8 11.9–18.3ROR 15.3 · χ² 1,001 / p 5e-220 | 14.7 EB05 12.1 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 · ♀ 74% (drug 43%) · 96% clinician | 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.
- Multi-organ failure — n=97, PRR 55.1
- Fear — n=136, PRR 50.0
- Renal injury — n=119, PRR 39.5
- Anhedonia — n=100, PRR 37.6
- Ventricular fibrillation — n=37, PRR 33.1
- Anaphylactic shock — n=78, PRR 30.3
- Serotonin syndrome — n=49, PRR 25.5
- Injury — n=167, PRR 23.5
- Muscle rigidity — n=24, PRR 20.0
- Shock — n=42, PRR 18.3
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 Etomidate?
In FDA FAERS, the most frequently co-reported reaction terms for Etomidate are renal failure, injury, anxiety, hypotension, cardiac arrest, fear. 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 Etomidate have an FDA boxed warning?
No. The FDA label retrieved for Etomidate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Etomidate 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 461e34d1-b862-4a02-9727-548c907aac48, effective 20230515; matched on
openfda.generic_name.exact:"ETOMIDATE") - 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, 107 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.