Drug · FAERS side-effect profile with label screen

Atracurium side effects: what 703 FDA adverse event reports show

Atracurium Besylate · 29 reaction terms · 486 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Atracurium Besylate (Atracurium Besylate)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

703 reports · 96% serious · 94 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Atracurium besylate 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 Atracurium besylate is an intermediate-duration, nondepolarizing, skeletal muscle relaxant for intravenous administration. Atracurium besylate is designated as 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester.

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 16 strongest signals

Labeled adverse reaction 4Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 10

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.
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. 13 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
Anaphylactic shock	66	77.0 61.2–96.9ROR 84.9 · χ² 4,869 / p <1e-300	75.2 EB05 61.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 46.3 · 97% clinician	no trial data cached
Bronchospasm (airway tightening)	35	73.1 52.9–101.0ROR 76.9 · χ² 2,413 / p <1e-300	70.2 EB05 52.8 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 44.2	no trial data cached
Hepatic cytolysis	20	48.9 31.7–75.3ROR 50.3 · χ² 890 / p 7e-196	46.8 EB05 32.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 29.3 · 100% clinician	no trial data cached
Ventricular fibrillation	16	42.9 26.4–69.7ROR 43.9 · χ² 613 / p 1e-135	40.9 EB05 26.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 25.7	no trial data cached
Anaphylactic reaction (severe allergic reaction)	66	35.9 28.5–45.2ROR 39.5 · χ² 2,206 / p <1e-300	35.5 EB05 28.9 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.9 · 95% clinician	no trial data cached
Leukocytosis	21	34.7 22.8–52.9ROR 35.7 · χ² 653 / p 2e-144	33.7 EB05 23.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 21.3 · 100% clinician	no trial data cached
Eosinophilia	19	32.5 20.8–50.6ROR 33.3 · χ² 548 / p 1e-121	31.5 EB05 21.3 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 20.4	no trial data cached
Circulatory collapse	18	31.4 19.9–49.6ROR 32.2 · χ² 500 / p 5e-111	30.5 EB05 20.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.9	no trial data cached
Cyanosis (blue skin from low oxygen)	15	28.4 17.2–46.9ROR 29.0 · χ² 370 / p 1e-82	27.5 EB05 17.6 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.0	no trial data cached
Rash maculo-papular	21	28.3 18.6–43.1ROR 29.1 · χ² 526 / p 1e-116	27.6 EB05 19.1 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 18.8 · 100% clinician	no trial data cached
Serotonin syndrome	15	23.4 14.2–38.6ROR 23.9 · χ² 300 / p 2e-67	22.7 EB05 14.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.1	no trial data cached
Bradycardia (slow heart rate)	40	22.5 16.6–30.4ROR 23.8 · χ² 801 / p 2e-176	22.2 EB05 17.0 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.2 · 96% clinician	no trial data cached
Dystonia	13	19.9 11.6–34.2ROR 20.3 · χ² 215 / p 5e-49	19.1 EB05 11.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 13.2	no trial data cached
Post procedural complication	11	17.1 9.5–30.7ROR 17.3 · χ² 151 / p 6e-35	15.8 EB05 8.4 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 11.1	no trial data cached
Blood creatine phosphokinase increased	16	16.3 10.1–26.5ROR 16.7 · χ² 215 / p 5e-49	15.6 EB05 9.7 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 10.9	no trial data cached
Respiratory arrest	13	13.9 8.1–23.9ROR 14.2 · χ² 144 / p 2e-33	12.7 EB05 7.1 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.4	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
Anaphylactic reaction (severe allergic reaction)	66	35.9 28.5–45.2ROR 39.5 · χ² 2,206 / p <1e-300	35.5 EB05 28.9 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.9 · 95% clinician	no trial data cached
Anaphylactic shock	66	77.0 61.2–96.9ROR 84.9 · χ² 4,869 / p <1e-300	75.2 EB05 61.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 46.3 · 97% clinician	no trial data cached
Bradycardia (slow heart rate)	40	22.5 16.6–30.4ROR 23.8 · χ² 801 / p 2e-176	22.2 EB05 17.0 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.2 · 96% clinician	no trial data cached
Bronchospasm (airway tightening)	35	73.1 52.9–101.0ROR 76.9 · χ² 2,413 / p <1e-300	70.2 EB05 52.8 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 44.2	no trial data cached
Rash maculo-papular	21	28.3 18.6–43.1ROR 29.1 · χ² 526 / p 1e-116	27.6 EB05 19.1 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 18.8 · 100% clinician	no trial data cached
Leukocytosis	21	34.7 22.8–52.9ROR 35.7 · χ² 653 / p 2e-144	33.7 EB05 23.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 21.3 · 100% clinician	no trial data cached
Hepatic cytolysis	20	48.9 31.7–75.3ROR 50.3 · χ² 890 / p 7e-196	46.8 EB05 32.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 29.3 · 100% clinician	no trial data cached
Eosinophilia	19	32.5 20.8–50.6ROR 33.3 · χ² 548 / p 1e-121	31.5 EB05 21.3 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 20.4	no trial data cached
Circulatory collapse	18	31.4 19.9–49.6ROR 32.2 · χ² 500 / p 5e-111	30.5 EB05 20.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.9	no trial data cached
Blood creatine phosphokinase increased	16	16.3 10.1–26.5ROR 16.7 · χ² 215 / p 5e-49	15.6 EB05 9.7 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 10.9	no trial data cached
Ventricular fibrillation	16	42.9 26.4–69.7ROR 43.9 · χ² 613 / p 1e-135	40.9 EB05 26.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 25.7	no trial data cached
Serotonin syndrome	15	23.4 14.2–38.6ROR 23.9 · χ² 300 / p 2e-67	22.7 EB05 14.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.1	no trial data cached
Cyanosis (blue skin from low oxygen)	15	28.4 17.2–46.9ROR 29.0 · χ² 370 / p 1e-82	27.5 EB05 17.6 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.0	no trial data cached
Respiratory arrest	13	13.9 8.1–23.9ROR 14.2 · χ² 144 / p 2e-33	12.7 EB05 7.1 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.4	no trial data cached
Dystonia	13	19.9 11.6–34.2ROR 20.3 · χ² 215 / p 5e-49	19.1 EB05 11.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 13.2	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.

Anaphylactic shock — n=66, PRR 77.0
Hepatic cytolysis — n=20, PRR 48.9
Leukocytosis — n=21, PRR 34.7
Rash maculo-papular — n=21, PRR 28.3

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 Atracurium?

In FDA FAERS, the most frequently co-reported reaction terms for Atracurium are anaphylactic reaction, anaphylactic shock, bradycardia, bronchospasm, rash maculo-papular, leukocytosis. 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 Atracurium have an FDA boxed warning?

No. The FDA label retrieved for Atracurium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Atracurium 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 efe90ee2-fe9e-421f-9e54-2961085d3b12, effective 20241204; matched on openfda.generic_name.exact:"ATRACURIUM BESYLATE")
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, 29 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.