Drug · FAERS side-effect profile with label screen
Vecuronium side effects: what 1,526 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Vecuronium Bromide (Vecuronium Bromide)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
1,526 reports · 90% serious · 230 with death outcome · 50% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Vecuronium bromide for injection is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
FDA label, Indications and Usage
What it is
DESCRIPTION Vecuronium bromide for injection is a nondepolarizing neuromuscular blocking agent of intermediate duration, chemically designated as piperidinium, 1-[(2β, 3α, 5α, 16β, 17β)-3, 17-bis(acetyloxy)-2-(1-piperidinyl) androstan-16-yl]-1-methyl-, bromide.
FDA label, Description section
Boxed warning
THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.
FDA 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 — boxed warning 3Labeled adverse reaction 2Labeled (related wording) 1Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 30
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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. 34 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 | 76 | 59.8 48.0–74.5ROR 62.9 · χ² 4,318 / p <1e-300 | 58.7 EB05 48.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 37.9 | no trial data cached |
| Ventricular fibrillation | 42 | 52.0 38.6–70.1ROR 53.5 · χ² 2,044 / p <1e-300 | 50.7 EB05 39.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 32.3 · ♀ 29% (drug 50%) · 97% clinician | no trial data cached |
| Fear | 94 | 47.8 39.3–58.2ROR 50.9 · χ² 4,253 / p <1e-300 | 47.2 EB05 39.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 40.8 | no trial data cached |
| Renal injury | 84 | 38.6 31.3–47.5ROR 40.7 · χ² 3,031 / p <1e-300 | 38.1 EB05 31.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 | no trial data cached |
| Ventricular extrasystoles | 27 | 35.8 24.6–52.0ROR 36.4 · χ² 876 / p 8e-193 | 34.9 EB05 25.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 23.4 | no trial data cached |
| Ventricular tachycardia | 42 | 34.9 25.9–47.1ROR 35.9 · χ² 1,347 / p 3e-295 | 34.3 EB05 26.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 21.8 · ♀ 27% (drug 50%) | no trial data cached |
| Bronchospasm (airway tightening) | 34 | 32.7 23.5–45.6ROR 33.4 · χ² 1,012 / p 2e-222 | 32.1 EB05 24.0 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.3 · 90% clinician | no trial data cached |
| Anhedonia | 62 | 32.2 25.3–41.1ROR 33.6 · χ² 1,843 / p <1e-300 | 31.9 EB05 25.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 | no trial data cached |
| Post procedural complication | 42 | 30.1 22.3–40.5ROR 30.9 · χ² 1,149 / p 3e-252 | 29.6 EB05 22.8 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 17.8 | no trial data cached |
| Anaphylactic shock | 49 | 26.3 20.0–34.7ROR 27.2 · χ² 1,168 / p 3e-256 | 26.0 EB05 20.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · 90% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 93 | 24.1 19.8–29.3ROR 25.6 · χ² 2,037 / p <1e-300 | 23.9 EB05 20.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · 94% clinician | no trial data cached |
| Injury | 105 | 20.4 17.0–24.6ROR 21.9 · χ² 1,926 / p <1e-300 | 20.4 EB05 17.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.1 | no trial data cached |
| Blood creatine phosphokinase increased | 43 | 20.2 15.1–27.2ROR 20.8 · χ² 767 / p 5e-169 | 20.0 EB05 15.5 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 14.3 · ♀ 23% (drug 50%) · 91% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 79 | 19.8 16.0–24.5ROR 20.8 · χ² 1,392 / p <1e-300 | 19.7 EB05 16.3 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 12.0 | no trial data cached |
| Paralysis | 20 | 19.1 12.4–29.6ROR 19.4 · χ² 326 / p 4e-73 | 18.7 EB05 12.6 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.4 | no trial data cached |
| Unevaluable event | 102 | 18.5 15.4–22.4ROR 19.8 · χ² 1,680 / p <1e-300 | 18.5 EB05 15.6 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 20.8 | no trial data cached |
| Cardiac arrest (heart stopping) | 109 | 18.1 15.1–21.7ROR 19.4 · χ² 1,748 / p <1e-300 | 18.0 EB05 15.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 54 | 17.8 13.7–23.2ROR 18.5 · χ² 843 / p 1e-185 | 17.7 EB05 14.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · ♀ 30% (drug 50%) | no trial data cached |
| Sinus bradycardia | 11 | 15.6 8.7–28.2ROR 15.7 · χ² 136 / p 9e-32 | 14.2 EB05 7.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Renal impairment | 95 | 15.6 12.9–19.0ROR 16.6 · χ² 1,289 / p 1e-282 | 15.5 EB05 13.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Serotonin syndrome | 20 | 14.4 9.3–22.2ROR 14.6 · χ² 236 / p 2e-53 | 13.8 EB05 8.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 95% clinician | no trial data cached |
| Tachypnoea | 14 | 14.2 8.4–23.9ROR 14.3 · χ² 159 / p 1e-36 | 13.1 EB05 7.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Atelectasis | 10 | 14.2 7.6–26.3ROR 14.3 · χ² 110 / p 6e-26 | 12.4 EB05 6.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Stress | 73 | 14.0 11.2–17.5ROR 14.6 · χ² 867 / p 6e-191 | 13.8 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 | no trial data cached |
| Renal failure (kidney failure) | 134 | 13.8 11.7–16.2ROR 15.0 · χ² 1,584 / p <1e-300 | 13.7 EB05 11.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Hypotonia | 10 | 13.7 7.4–25.4ROR 13.8 · χ² 105 / p 5e-25 | 11.8 EB05 5.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Respiratory depression | 12 | 13.5 7.7–23.7ROR 13.6 · χ² 126 / p 1e-29 | 12.0 EB05 6.5 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 | no trial data cached |
| Respiratory arrest | 27 | 13.4 9.2–19.4ROR 13.6 · χ² 296 / p 1e-66 | 12.9 EB05 9.0 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.5 | no trial data cached |
| No therapeutic response | 12 | 13.3 7.6–23.4ROR 13.4 · χ² 125 / p 3e-29 | 11.8 EB05 6.4 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 10.8 | no trial data cached |
| Renal failure acute | 41 | 13.1 9.7–17.7ROR 13.4 · χ² 447 / p 2e-99 | 12.8 EB05 9.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Metabolic acidosis | 29 | 12.6 8.8–18.1ROR 12.8 · χ² 298 / p 4e-67 | 12.1 EB05 8.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 21% (drug 50%) | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 14 | 12.2 7.2–20.6ROR 12.3 · χ² 133 / p 4e-31 | 10.9 EB05 6.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Acute hepatic failure | 12 | 12.1 6.9–21.3ROR 12.2 · χ² 112 / p 2e-26 | 10.5 EB05 5.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Disseminated intravascular coagulation | 12 | 11.7 6.6–20.5ROR 11.8 · χ² 107 / p 2e-25 | 10.0 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Blood pressure decreased | 56 | 11.6 9.0–15.0ROR 12.0 · χ² 534 / p 2e-118 | 11.3 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.7 · 95% clinician | no trial data cached |
| Coagulopathy | 14 | 11.6 6.9–19.5ROR 11.7 · χ² 125 / p 3e-29 | 10.2 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Cardiogenic shock | 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 |
| Shock | 19 | 11.4 7.3–17.9ROR 11.6 · χ² 171 / p 2e-39 | 10.5 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Hypoxia (low oxygen) | 29 | 11.4 7.9–16.3ROR 11.6 · χ² 264 / p 1e-59 | 10.8 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Brain oedema | 10 | 10.9 5.9–20.2ROR 11.0 · χ² 80 / p 2e-19 | 8.8 EB05 4.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | 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) | 134 | 13.8 11.7–16.2ROR 15.0 · χ² 1,584 / p <1e-300 | 13.7 EB05 11.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Hypotension (low blood pressure) | 124 | 8.5 7.2–10.1ROR 9.2 · χ² 822 / p 5e-181 | 8.3 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · 91% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 109 | 18.1 15.1–21.7ROR 19.4 · χ² 1,748 / p <1e-300 | 18.0 EB05 15.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Injury | 105 | 20.4 17.0–24.6ROR 21.9 · χ² 1,926 / p <1e-300 | 20.4 EB05 17.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.1 | no trial data cached |
| Unevaluable event | 102 | 18.5 15.4–22.4ROR 19.8 · χ² 1,680 / p <1e-300 | 18.5 EB05 15.6 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 20.8 | no trial data cached |
| Renal impairment | 95 | 15.6 12.9–19.0ROR 16.6 · χ² 1,289 / p 1e-282 | 15.5 EB05 13.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Fear | 94 | 47.8 39.3–58.2ROR 50.9 · χ² 4,253 / p <1e-300 | 47.2 EB05 39.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 40.8 | no trial data cached |
| Bradycardia (slow heart rate) | 93 | 24.1 19.8–29.3ROR 25.6 · χ² 2,037 / p <1e-300 | 23.9 EB05 20.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · 94% clinician | no trial data cached |
| Renal injury | 84 | 38.6 31.3–47.5ROR 40.7 · χ² 3,031 / p <1e-300 | 38.1 EB05 31.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 79 | 19.8 16.0–24.5ROR 20.8 · χ² 1,392 / p <1e-300 | 19.7 EB05 16.3 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 12.0 | no trial data cached |
| Emotional distress | 78 | 8.8 7.1–11.0ROR 9.2 · χ² 536 / p 6e-119 | 8.6 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Multi-organ failure | 76 | 59.8 48.0–74.5ROR 62.9 · χ² 4,318 / p <1e-300 | 58.7 EB05 48.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 37.9 | no trial data cached |
| Stress | 73 | 14.0 11.2–17.5ROR 14.6 · χ² 867 / p 6e-191 | 13.8 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 | no trial data cached |
| Tachycardia (fast heart rate) | 68 | 10.5 8.3–13.3ROR 11.0 · χ² 579 / p 4e-128 | 10.3 EB05 8.3 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Anhedonia | 62 | 32.2 25.3–41.1ROR 33.6 · χ² 1,843 / p <1e-300 | 31.9 EB05 25.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 | 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=76, PRR 59.8
- Ventricular fibrillation — n=42, PRR 52.0
- Fear — n=94, PRR 47.8
- Renal injury — n=84, PRR 38.6
- Ventricular extrasystoles — n=27, PRR 35.8
- Ventricular tachycardia — n=42, PRR 34.9
- Anhedonia — n=62, PRR 32.2
- Anaphylactic shock — n=49, PRR 26.3
- Bradycardia — n=93, PRR 24.1
- Injury — n=105, PRR 20.4
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 Vecuronium?
In FDA FAERS, the most frequently co-reported reaction terms for Vecuronium are renal failure, hypotension, cardiac arrest, injury, renal impairment, 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 Vecuronium have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.
Do FAERS signals prove that Vecuronium 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 53653418-0464-4cd2-a987-3d31be36098f, effective 20250618; matched on
openfda.generic_name.exact:"VECURONIUM BROMIDE") - 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, 74 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.