Etomidate side effects: what 2,215 FDA adverse event reports show

Etomidate · 117 reaction terms · 4,127 drug–reaction co-reports · data 2026-09-14

Drug class

General Anesthetic

FDA label (Established Pharmacologic Class) · compare the class

Who reports

2,215 reports · 92% serious · 477 with death outcome · 44% 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. 77 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
Multi-organ failure	108	58.6 48.7–70.5ROR 61.6 · χ² 6,028 / p <1e-300	57.7 EB05 49.1 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 36.5	no trial data cached
Fear	155	54.4 46.8–63.4ROR 58.5 · χ² 8,042 / p <1e-300	53.8 EB05 47.1 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 46.0	no trial data cached
Renal injury	135	42.8 36.3–50.4ROR 45.5 · χ² 5,447 / p <1e-300	42.3 EB05 36.7 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 26.7	no trial data cached
Anhedonia	113	40.6 33.9–48.6ROR 42.7 · χ² 4,307 / p <1e-300	40.1 EB05 34.3 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 28.0	no trial data cached
Ventricular fibrillation	38	32.4 23.6–44.4ROR 33.0 · χ² 1,122 / p 3e-246	31.8 EB05 24.2 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 20.3 · ♀ 74% (drug 44%) · 97% clinician	no trial data cached
Anaphylactic shock	78	28.9 23.2–35.9ROR 29.9 · χ² 2,069 / p <1e-300	28.6 EB05 23.7 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 17.9 · 95% clinician	no trial data cached
Injury	187	25.1 21.9–28.8ROR 27.3 · χ² 4,309 / p <1e-300	25.0 EB05 22.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 19.5	no trial data cached
Serotonin syndrome	49	24.3 18.4–32.1ROR 24.8 · χ² 1,070 / p 5e-235	24.1 EB05 18.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.0 · 98% clinician	no trial data cached
Myoclonus	28	22.3 15.4–32.2ROR 22.6 · χ² 547 / p 3e-121	21.9 EB05 15.9 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.4 · 96% clinician	no trial data cached
Unevaluable event	169	21.2 18.3–24.5ROR 22.9 · χ² 3,235 / p <1e-300	21.1 EB05 18.6 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 23.4	no trial data cached
Muscle rigidity	24	19.0 12.8–28.4ROR 19.2 · χ² 392 / p 2e-87	18.7 EB05 13.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 13.4 · 100% clinician	no trial data cached
Shock	43	17.9 13.3–24.0ROR 18.2 · χ² 668 / p 2e-147	17.7 EB05 13.6 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.2 · 100% clinician	no trial data cached
Respiratory depression	23	17.8 11.8–26.7ROR 18.0 · χ² 347 / p 8e-78	17.4 EB05 12.0 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.4 · 100% clinician	no trial data cached
Renal failure (kidney failure)	240	17.0 15.1–19.2ROR 19.0 · χ² 3,618 / p <1e-300	17.0 EB05 15.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Cardiac arrest (heart stopping)	147	16.8 14.4–19.7ROR 17.9 · χ² 2,177 / p <1e-300	16.8 EB05 14.6 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.5 · 96% clinician	no trial data cached
Ventricular tachycardia	29	16.6 11.6–23.8ROR 16.8 · χ² 409 / p 3e-91	16.3 EB05 11.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.1 · ♀ 72% (drug 44%) · 100% clinician	no trial data cached
Adrenal insufficiency	20	15.8 10.2–24.5ROR 16.0 · χ² 263 / p 2e-59	15.3 EB05 10.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.5 · 100% clinician	no trial data cached
Stress	117	15.4 12.9–18.4ROR 16.2 · χ² 1,566 / p <1e-300	15.3 EB05 13.1 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 16.0	no trial data cached
Cardiogenic shock	23	15.3 10.2–23.0ROR 15.4 · χ² 293 / p 7e-66	14.8 EB05 10.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Renal impairment	128	14.5 12.3–17.2ROR 15.3 · χ² 1,600 / p <1e-300	14.4 EB05 12.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.4	no trial data cached
Generalised tonic-clonic seizure	25	14.5 9.8–21.4ROR 14.6 · χ² 300 / p 1e-67	14.0 EB05 9.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.2 · ♀ 70% (drug 44%) · 100% clinician	no trial data cached
Bradycardia (slow heart rate)	81	14.5 11.7–17.9ROR 15.0 · χ² 1,002 / p 4e-220	14.3 EB05 11.9 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.3 · ♀ 73% (drug 44%) · 96% clinician	no trial data cached
Poisoning deliberate	14	14.3 8.5–24.1ROR 14.3 · χ² 159 / p 7e-37	13.2 EB05 7.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.9	no trial data cached
Rhabdomyolysis (muscle breakdown)	61	13.9 10.8–17.8ROR 14.3 · χ² 717 / p 3e-158	13.7 EB05 11.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.7 · ♀ 11% (drug 44%) · 93% clinician	no trial data cached
Renal failure acute	63	13.9 10.9–17.7ROR 14.3 · χ² 740 / p 3e-163	13.7 EB05 11.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.8	no trial data cached
Bronchospasm (airway tightening)	19	12.6 8.0–19.7ROR 12.7 · χ² 191 / p 1e-43	11.7 EB05 7.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Status epilepticus	15	12.6 7.6–20.8ROR 12.6 · χ² 148 / p 2e-34	11.4 EB05 6.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Acute respiratory failure	25	12.4 8.4–18.3ROR 12.5 · χ² 250 / p 1e-56	11.7 EB05 8.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.8 · ♀ 22% (drug 44%) · 91% clinician	no trial data cached
Post procedural complication	25	12.3 8.3–18.2ROR 12.4 · χ² 249 / p 3e-56	11.7 EB05 8.0 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 6.4	no trial data cached
Multiple organ dysfunction syndrome	36	12.2 8.8–16.9ROR 12.4 · χ² 360 / p 1e-80	11.8 EB05 8.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.6 · ♀ 23% (drug 44%) · 100% clinician	no trial data cached
Metabolic acidosis	40	12.0 8.8–16.3ROR 12.2 · χ² 392 / p 2e-87	11.6 EB05 8.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.5 · 95% clinician	no trial data cached
Renal tubular necrosis	12	11.6 6.6–20.3ROR 11.6 · χ² 105 / p 5e-25	9.9 EB05 5.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.3	no trial data cached
Emotional distress	145	11.3 9.7–13.2ROR 12.0 · χ² 1,359 / p 1e-297	11.2 EB05 9.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.0	no trial data cached
Ejection fraction decreased	18	11.0 6.9–17.4ROR 11.0 · χ² 153 / p 2e-35	9.8 EB05 6.2 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 7.1	no trial data cached
Neuroleptic malignant syndrome	13	10.4 6.0–17.8ROR 10.4 · χ² 101 / p 5e-24	8.7 EB05 5.0 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 6.5	no trial data cached
Hypoxia (low oxygen)	37	10.0 7.3–13.8ROR 10.1 · χ² 291 / p 2e-65	9.4 EB05 7.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Coma	50	9.9 7.6–13.1ROR 10.1 · χ² 394 / p 7e-88	9.5 EB05 7.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.1 · 94% clinician	no trial data cached
Bacteraemia	12	9.7 5.5–17.0ROR 9.7 · χ² 85 / p 2e-20	7.9 EB05 4.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.1	no trial data cached
Disseminated intravascular coagulation	14	9.4 5.6–15.8ROR 9.4 · χ² 97 / p 4e-23	7.9 EB05 4.7 · IC025 +2.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 5.9	no trial data cached
Tachypnoea	13	9.1 5.3–15.6ROR 9.1 · χ² 86 / p 1e-20	7.5 EB05 4.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.9	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)	240	17.0 15.1–19.2ROR 19.0 · χ² 3,618 / p <1e-300	17.0 EB05 15.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Injury	187	25.1 21.9–28.8ROR 27.3 · χ² 4,309 / p <1e-300	25.0 EB05 22.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 19.5	no trial data cached
Anxiety	181	6.0 5.2–6.9ROR 6.5 · χ² 761 / p 9e-168	5.9 EB05 5.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Unevaluable event	169	21.2 18.3–24.5ROR 22.9 · χ² 3,235 / p <1e-300	21.1 EB05 18.6 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 23.4	no trial data cached
Fear	155	54.4 46.8–63.4ROR 58.5 · χ² 8,042 / p <1e-300	53.8 EB05 47.1 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 46.0	no trial data cached
Hypotension (low blood pressure)	153	7.2 6.2–8.4ROR 7.7 · χ² 823 / p 2e-181	7.1 EB05 6.2 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.1 · 96% clinician	no trial data cached
Cardiac arrest (heart stopping)	147	16.8 14.4–19.7ROR 17.9 · χ² 2,177 / p <1e-300	16.8 EB05 14.6 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.5 · 96% clinician	no trial data cached
Emotional distress	145	11.3 9.7–13.2ROR 12.0 · χ² 1,359 / p 1e-297	11.2 EB05 9.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.0	no trial data cached
Renal injury	135	42.8 36.3–50.4ROR 45.5 · χ² 5,447 / p <1e-300	42.3 EB05 36.7 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 26.7	no trial data cached
Renal impairment	128	14.5 12.3–17.2ROR 15.3 · χ² 1,600 / p <1e-300	14.4 EB05 12.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.4	no trial data cached
Stress	117	15.4 12.9–18.4ROR 16.2 · χ² 1,566 / p <1e-300	15.3 EB05 13.1 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 16.0	no trial data cached
Anhedonia	113	40.6 33.9–48.6ROR 42.7 · χ² 4,307 / p <1e-300	40.1 EB05 34.3 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 28.0	no trial data cached
Multi-organ failure	108	58.6 48.7–70.5ROR 61.6 · χ² 6,028 / p <1e-300	57.7 EB05 49.1 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 36.5	no trial data cached
Drug interaction	90	5.4 4.4–6.6ROR 5.6 · χ² 318 / p 2e-71	5.2 EB05 4.4 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.4 · 97% clinician	no trial data cached
Bradycardia (slow heart rate)	81	14.5 11.7–17.9ROR 15.0 · χ² 1,002 / p 4e-220	14.3 EB05 11.9 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.3 · ♀ 73% (drug 44%) · 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=108, PRR 58.6
Fear — n=155, PRR 54.4
Renal injury — n=135, PRR 42.8
Anhedonia — n=113, PRR 40.6
Ventricular fibrillation — n=38, PRR 32.4
Anaphylactic shock — n=78, PRR 28.9
Injury — n=187, PRR 25.1
Serotonin syndrome — n=49, PRR 24.3
Muscle rigidity — n=24, PRR 19.0
Shock — n=43, PRR 17.9

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, fear, hypotension, cardiac arrest. 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, field patient.drug.openfda.generic_name.exact, 117 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.