Drug · FAERS side-effect profile with label screen
Rocuronium Bromide side effects: what 11,713 FDA adverse event reports show
Drug class
Nondepolarizing neuromuscular blocking agent
FDA label, Indications wording
Who reports
11,713 reports · 91% serious · 938 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
FDA label, Indications and Usage
What it is
Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1- [17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide.
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 1Labeled (related wording) 8Likely indication confounding 1Reporting / coding artifact 5Lab value / disease marker 4Not in label — unassessed 21
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. 963 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 |
|---|---|---|---|---|---|---|
| Recurrence of neuromuscular blockade | 103 | 2,674.2 1,969.8–3,630.5ROR 2,697.9 · χ² 108,391 / p <1e-300 | 887.2 EB05 752.5 · IC025 +7.1 3/3 methods agree | Labeled (related wording) related wording | serious n=100 · 95% clinician | no trial data cached |
| Negative pressure pulmonary oedema | 49 | 2,011.8 1,336.3–3,028.9ROR 2,020.3 · χ² 45,094 / p <1e-300 | 686.7 EB05 540.0 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=49 · ♀ 9% (drug 51%) · 100% clinician | no trial data cached |
| Trigemino-cardiac reflex | 33 | 1,213.8 779.5–1,890.0ROR 1,217.2 · χ² 22,983 / p <1e-300 | 507.0 EB05 377.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 26% (drug 51%) · 100% clinician | no trial data cached |
| Neuromuscular block prolonged | 149 | 1,206.7 980.5–1,485.0ROR 1,222.2 · χ² 105,910 / p <1e-300 | 656.3 EB05 572.5 · IC025 +7.5 3/3 methods agree | Labeled (related wording) related wording | serious n=139 · 97% clinician | no trial data cached |
| Airway peak pressure increased | 57 | 1,082.1 778.5–1,503.9ROR 1,087.4 · χ² 37,502 / p <1e-300 | 547.2 EB05 438.1 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=57 · 100% clinician | no trial data cached |
| Anaesthetic complication neurological | 270 | 756.6 656.9–871.6ROR 774.5 · χ² 142,105 / p <1e-300 | 510.7 EB05 461.6 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious n=269 · ♀ 27% (drug 51%) · 100% clinician | no trial data cached |
| Neuromuscular blockade | 61 | 656.7 489.7–880.6ROR 660.1 · χ² 28,633 / p <1e-300 | 416.2 EB05 335.7 · IC025 +6.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=59 · 98% clinician | no trial data cached |
| Mechanical ventilation complication | 38 | 609.9 422.0–881.5ROR 611.9 · χ² 16,719 / p <1e-300 | 369.1 EB05 280.7 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=38 · ♀ 19% (drug 51%) · 100% clinician | no trial data cached |
| Myoglobin urine present | 62 | 591.7 444.0–788.4ROR 594.8 · χ² 26,943 / p <1e-300 | 389.9 EB05 315.0 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=61 · ♀ 100% (drug 51%) · 95% clinician | no trial data cached |
| End-tidal co2 increased | 10 | 535.0 263.7–1,085.2ROR 535.5 · χ² 3,691 / p <1e-300 | 230.5 EB05 133.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Chest wall rigidity | 12 | 407.4 217.5–763.0ROR 407.8 · χ² 3,629 / p <1e-300 | 217.2 EB05 132.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Anaesthetic complication pulmonary | 14 | 334.0 188.7–591.2ROR 334.4 · χ² 3,634 / p <1e-300 | 203.4 EB05 128.8 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Pseudocholinesterase deficiency | 10 | 326.9 166.5–641.8ROR 327.2 · χ² 2,473 / p <1e-300 | 181.2 EB05 105.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Burkholderia test positive | 17 | 283.1 169.7–472.3ROR 283.6 · χ² 3,879 / p <1e-300 | 191.8 EB05 126.9 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Airway complication of anaesthesia | 35 | 279.6 195.8–399.2ROR 280.4 · χ² 8,149 / p <1e-300 | 213.5 EB05 160.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=32 · 91% clinician | no trial data cached |
| Hyperthermia malignant | 198 | 277.4 239.1–321.9ROR 282.2 · χ² 46,895 / p <1e-300 | 234.5 EB05 208.3 · IC025 +7.0 3/3 methods agree | Labeled (related wording) related wording | serious n=196 · ♀ 17% (drug 51%) · 99% clinician | no trial data cached |
| Delayed recovery from anaesthesia | 125 | 272.1 225.6–328.2ROR 275.0 · χ² 29,023 / p <1e-300 | 227.7 EB05 196.1 · IC025 +6.6 3/3 methods agree | Labeled (related wording) related wording | serious n=117 · 93% clinician | no trial data cached |
| Postoperative delirium | 22 | 236.8 151.8–369.4ROR 237.3 · χ² 4,350 / p <1e-300 | 177.1 EB05 123.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=22 · 95% clinician | no trial data cached |
| Unwanted awareness during anaesthesia | 31 | 186.8 129.1–270.4ROR 187.3 · χ² 5,014 / p <1e-300 | 153.2 EB05 113.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 74% (drug 51%) · 97% clinician | no trial data cached |
| Inspiratory capacity decreased | 26 | 186.6 124.6–279.4ROR 187.0 · χ² 4,175 / p <1e-300 | 150.4 EB05 107.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 51%) · 100% clinician | no trial data cached |
| Procedural hypotension | 76 | 174.3 137.8–220.4ROR 175.4 · χ² 11,759 / p <1e-300 | 152.7 EB05 126.0 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=75 · 97% clinician | no trial data cached |
| Carcinoid crisis | 16 | 135.2 81.3–224.6ROR 135.3 · χ² 1,856 / p <1e-300 | 109.5 EB05 71.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Ventricular asystole | 11 | 118.4 64.3–218.0ROR 118.5 · χ² 1,093 / p 7e-240 | 93.5 EB05 55.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Endotracheal intubation complication | 35 | 113.8 80.9–160.1ROR 114.1 · χ² 3,571 / p <1e-300 | 101.2 EB05 76.1 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=33 · 93% clinician | no trial data cached |
| Pulmonary hypertensive crisis | 15 | 106.8 63.4–179.8ROR 106.9 · χ² 1,384 / p <1e-300 | 89.6 EB05 57.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Atrioventricular dissociation | 12 | 105.9 59.2–189.6ROR 106.0 · χ² 1,080 / p 4e-237 | 86.6 EB05 52.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Drug effect prolonged | 31 | 105.0 73.2–150.9ROR 105.3 · χ² 2,918 / p <1e-300 | 93.6 EB05 69.1 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious n=26 · ♀ 85% (drug 51%) · 97% clinician | no trial data cached |
| Hyperdynamic left ventricle | 13 | 99.4 56.8–173.7ROR 99.5 · χ² 1,107 / p 5e-243 | 83.0 EB05 51.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Maternal exposure during delivery | 49 | 95.1 71.4–126.7ROR 95.5 · χ² 4,239 / p <1e-300 | 87.3 EB05 68.6 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=41 · ♀ 100% (drug 51%) · 91% clinician | no trial data cached |
| Skin test positive | 43 | 85.6 63.1–116.2ROR 85.9 · χ² 3,348 / p <1e-300 | 78.9 EB05 61.0 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=42 · ♀ 80% (drug 51%) · 100% clinician | no trial data cached |
| Brachial plexopathy | 10 | 84.5 44.8–159.3ROR 84.5 · χ² 710 / p 1e-156 | 70.3 EB05 40.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Feeding intolerance | 19 | 79.9 50.5–126.4ROR 80.0 · χ² 1,341 / p 6e-294 | 71.2 EB05 48.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Vocal cord dysfunction | 21 | 78.5 50.8–121.6ROR 78.7 · χ² 1,466 / p <1e-300 | 70.6 EB05 48.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | no trial data cached |
| Intensive care unit acquired weakness | 16 | 78.2 47.4–129.1ROR 78.4 · χ² 1,096 / p 2e-240 | 69.1 EB05 45.1 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Therapeutic product effect prolonged | 18 | 75.0 46.8–120.1ROR 75.1 · χ² 1,190 / p 5e-261 | 67.0 EB05 44.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=17 | no trial data cached |
| Wrist surgery | 37 | 74.7 53.8–103.8ROR 75.0 · χ² 2,512 / p <1e-300 | 69.3 EB05 52.5 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=37 · ♀ 100% (drug 51%) | no trial data cached |
| Kounis syndrome | 90 | 74.2 60.2–91.6ROR 74.8 · χ² 6,169 / p <1e-300 | 70.2 EB05 58.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=90 · 98% clinician | no trial data cached |
| Anaphylactic shock | 1,004 | 73.0 68.7–77.5ROR 79.7 · χ² 68,466 / p <1e-300 | 70.0 EB05 66.5 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 44.3 · 97% clinician | no trial data cached |
| Hypocapnia | 15 | 66.5 39.7–111.4ROR 66.6 · χ² 871 / p 1e-191 | 59.5 EB05 38.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Coronary artery embolism | 10 | 62.6 33.3–117.6ROR 62.7 · χ² 527 / p 5e-117 | 54.6 EB05 31.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | 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) | 1,279 | 42.7 40.5–45.0ROR 47.8 · χ² 50,903 / p <1e-300 | 41.7 EB05 39.8 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.5 · 93% clinician | no trial data cached |
| Hypotension (low blood pressure) | 1,124 | 10.1 9.6–10.7ROR 11.1 · χ² 9,240 / p <1e-300 | 10.0 EB05 9.5 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 · 95% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 1,112 | 1.5 1.4–1.6ROR 1.6 · χ² 205 / p 8e-47 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Anaphylactic shock | 1,004 | 73.0 68.7–77.5ROR 79.7 · χ² 68,466 / p <1e-300 | 70.0 EB05 66.5 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 44.3 · 97% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 662 | 14.4 13.4–15.5ROR 15.2 · χ² 8,214 / p <1e-300 | 14.3 EB05 13.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 94% clinician | no trial data cached |
| Drug interaction | 466 | 5.3 4.8–5.8ROR 5.4 · χ² 1,615 / p <1e-300 | 5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 97% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 428 | 8.7 7.9–9.5ROR 9.0 · χ² 2,891 / p <1e-300 | 8.6 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · 94% clinician | no trial data cached |
| Off label use (used outside approved label) | 413 | 0.9 0.8–0.9ROR 0.8 · χ² 11 / p 5e-4 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 · 93% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 397 | 13.5 12.2–14.8ROR 13.9 · χ² 4,547 / p <1e-300 | 13.4 EB05 12.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 93% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 377 | 48.4 43.8–53.5ROR 50.0 · χ² 17,000 / p <1e-300 | 47.0 EB05 43.2 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.3 · 91% clinician | no trial data cached |
| Rash | 292 | 1.2 1.1–1.4ROR 1.2 · χ² 10 / p 7e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.6 · 93% clinician | no trial data cached |
| Urticaria (hives) | 278 | 3.0 2.7–3.4ROR 3.0 · χ² 369 / p 1e-82 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 94% clinician | no trial data cached |
| Anaesthetic complication neurological | 270 | 756.6 656.9–871.6ROR 774.5 · χ² 142,105 / p <1e-300 | 510.7 EB05 461.6 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious n=269 · ♀ 27% (drug 51%) · 100% clinician | no trial data cached |
| Oxygen saturation decreased | 265 | 8.5 7.6–9.6ROR 8.7 · χ² 1,752 / p <1e-300 | 8.4 EB05 7.6 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 5.8 · 94% clinician | no trial data cached |
| Hypoxia (low oxygen) | 263 | 13.5 12.0–15.2ROR 13.8 · χ² 3,018 / p <1e-300 | 13.4 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · 95% 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.
- Trigemino-cardiac reflex — n=33, PRR 1,213.8
- Anaesthetic complication neurological — n=270, PRR 756.6
- Airway complication of anaesthesia — n=35, PRR 279.6
- Postoperative delirium — n=22, PRR 236.8
- Unwanted awareness during anaesthesia — n=31, PRR 186.8
- Inspiratory capacity decreased — n=26, PRR 186.6
- Procedural hypotension — n=76, PRR 174.3
- Vocal cord dysfunction — n=21, PRR 78.5
- Kounis syndrome — n=90, PRR 74.2
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 Rocuronium?
In FDA FAERS, the most frequently co-reported reaction terms for Rocuronium are anaphylactic reaction, hypotension, anaphylactic shock, cardiac arrest, tachycardia, bradycardia. 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 Rocuronium have an FDA boxed warning?
No. The FDA label retrieved for Rocuronium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Rocuronium 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 41efca22-7a40-91b1-e063-6294a90a8018, effective 20251024; matched on
openfda.generic_name.exact:"ROCURONIUM") - 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, 1,003 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.