Drug · FAERS side-effect profile with label screen
Rocuronium side effects: what 6,197 FDA adverse event reports show
Drug class
Nondepolarizing neuromuscular blocking agent
FDA label, Indications wording
Who reports
6,197 reports · 95% serious · 519 with death outcome · 50% 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 7Labeled (related wording) 1Lab value / disease marker 4Not in label — unassessed 28
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.
- 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. 167 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 |
|---|---|---|---|---|---|---|
| Anaphylactic shock | 352 | 47.1 42.5–52.2ROR 49.9 · χ² 15,641 / p <1e-300 | 46.4 EB05 42.4 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.0 · 97% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 703 | 43.9 40.9–47.0ROR 49.3 · χ² 29,096 / p <1e-300 | 43.3 EB05 40.6 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.6 · 94% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 172 | 41.1 35.5–47.7ROR 42.3 · χ² 6,619 / p <1e-300 | 40.5 EB05 35.7 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.1 · 92% clinician | no trial data cached |
| Serotonin syndrome | 152 | 27.1 23.1–31.7ROR 27.8 · χ² 3,767 / p <1e-300 | 26.8 EB05 23.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 · 96% clinician | no trial data cached |
| Circulatory collapse | 111 | 22.1 18.4–26.6ROR 22.5 · χ² 2,202 / p <1e-300 | 21.9 EB05 18.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · 96% clinician | no trial data cached |
| Respiratory depression | 60 | 16.6 12.9–21.4ROR 16.8 · χ² 862 / p 8e-190 | 16.4 EB05 13.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · 97% clinician | no trial data cached |
| Ventricular fibrillation | 53 | 16.2 12.4–21.2ROR 16.3 · χ² 736 / p 2e-162 | 16.0 EB05 12.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · 96% clinician | no trial data cached |
| Hypoxia (low oxygen) | 154 | 14.9 12.8–17.4ROR 15.3 · χ² 1,981 / p <1e-300 | 14.8 EB05 12.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · 98% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 317 | 13.0 11.7–14.5ROR 13.6 · χ² 3,497 / p <1e-300 | 12.9 EB05 11.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 97% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 202 | 12.9 11.3–14.8ROR 13.3 · χ² 2,205 / p <1e-300 | 12.8 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 96% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 60 | 12.8 9.9–16.4ROR 12.9 · χ² 638 / p 6e-141 | 12.5 EB05 10.0 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 8.2 · ♀ 98% (drug 50%) · 93% clinician | no trial data cached |
| Blood potassium increased | 59 | 12.3 9.6–15.9ROR 12.5 · χ² 602 / p 3e-133 | 12.1 EB05 9.6 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 9.7 · ♀ 94% (drug 50%) · 92% clinician | no trial data cached |
| Covid-19 pneumonia | 41 | 11.7 8.6–15.9ROR 11.8 · χ² 390 / p 5e-87 | 11.3 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · ♀ 17% (drug 50%) | no trial data cached |
| Ventricular tachycardia | 57 | 11.7 9.0–15.1ROR 11.8 · χ² 544 / p 1e-120 | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 95% clinician | no trial data cached |
| Atelectasis | 32 | 11.2 7.9–15.8ROR 11.3 · χ² 286 / p 2e-64 | 10.6 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Premature delivery | 52 | 11.0 8.4–14.5ROR 11.1 · χ² 463 / p 5e-103 | 10.7 EB05 8.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 100% (drug 50%) · 98% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 89 | 10.8 8.8–13.3ROR 11.0 · χ² 782 / p 2e-172 | 10.6 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · ♀ 22% (drug 50%) | no trial data cached |
| Premature baby | 95 | 10.7 8.7–13.0ROR 10.8 · χ² 822 / p 4e-181 | 10.5 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 97% clinician | no trial data cached |
| Hypotension (low blood pressure) | 622 | 10.5 9.8–11.4ROR 11.6 · χ² 5,395 / p <1e-300 | 10.5 EB05 9.8 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 · 95% clinician | no trial data cached |
| Pneumothorax | 49 | 10.5 7.9–13.9ROR 10.6 · χ² 410 / p 2e-91 | 10.1 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · ♀ 18% (drug 50%) | no trial data cached |
| Generalised tonic-clonic seizure | 49 | 10.2 7.7–13.4ROR 10.2 · χ² 395 / p 4e-88 | 9.7 EB05 7.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Posterior reversible encephalopathy syndrome | 28 | 10.0 6.9–14.4ROR 10.0 · χ² 217 / p 2e-49 | 9.2 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 71% (drug 50%) · 92% clinician | no trial data cached |
| Muscle rigidity | 33 | 9.4 6.7–13.2ROR 9.4 · χ² 238 / p 6e-54 | 8.7 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 97% clinician | no trial data cached |
| Hypothermia | 28 | 9.4 6.5–13.6ROR 9.4 · χ² 200 / p 8e-46 | 8.6 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 93% clinician | no trial data cached |
| Status epilepticus | 31 | 9.3 6.5–13.2ROR 9.3 · χ² 221 / p 3e-50 | 8.6 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 94% clinician | no trial data cached |
| Cardiogenic shock | 39 | 9.3 6.8–12.7ROR 9.3 · χ² 279 / p 6e-63 | 8.7 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Tachypnoea | 37 | 9.3 6.7–12.8ROR 9.3 · χ² 264 / p 1e-59 | 8.7 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 17% (drug 50%) · 92% clinician | no trial data cached |
| Dystonia | 53 | 9.2 7.1–12.1ROR 9.3 · χ² 380 / p 5e-85 | 8.8 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 100% clinician | no trial data cached |
| Emphysema | 27 | 9.0 6.2–13.2ROR 9.1 · χ² 185 / p 2e-42 | 8.2 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 12% (drug 50%) · 100% clinician | no trial data cached |
| Shock | 60 | 8.9 6.9–11.5ROR 9.0 · χ² 413 / p 4e-92 | 8.5 EB05 6.8 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 · ♀ 30% (drug 50%) · 97% clinician | no trial data cached |
| Neuroleptic malignant syndrome | 30 | 8.6 6.0–12.2ROR 8.6 · χ² 192 / p 5e-44 | 7.8 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 27% (drug 50%) · 97% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 86 | 8.4 6.8–10.3ROR 8.5 · χ² 549 / p 1e-121 | 8.1 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 7% (drug 50%) · 93% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 216 | 8.2 7.2–9.4ROR 8.5 · χ² 1,370 / p 3e-300 | 8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 92% clinician | no trial data cached |
| Paralysis | 33 | 7.8 5.5–10.9ROR 7.8 · χ² 188 / p 4e-43 | 7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 94% clinician | no trial data cached |
| Sinus bradycardia | 22 | 7.7 5.1–11.7ROR 7.7 · χ² 121 / p 2e-28 | 6.8 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 100% clinician | no trial data cached |
| Oxygen saturation decreased | 126 | 7.7 6.4–9.1ROR 7.8 · χ² 723 / p 2e-159 | 7.5 EB05 6.4 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 5.0 · 95% clinician | no trial data cached |
| Blood creatine phosphokinase increased | 66 | 7.6 6.0–9.7ROR 7.7 · χ² 375 / p 1e-83 | 7.3 EB05 5.9 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 · ♀ 85% (drug 50%) · 94% clinician | no trial data cached |
| Acute respiratory failure | 42 | 7.4 5.5–10.1ROR 7.5 · χ² 227 / p 1e-51 | 7.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Respiratory arrest | 59 | 7.2 5.6–9.3ROR 7.3 · χ² 308 / p 3e-69 | 6.9 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Face oedema | 35 | 7.0 5.0–9.7ROR 7.0 · χ² 174 / p 5e-40 | 6.5 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 19% (drug 50%) · 97% clinician | 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) | 703 | 43.9 40.9–47.0ROR 49.3 · χ² 29,096 / p <1e-300 | 43.3 EB05 40.6 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.6 · 94% clinician | no trial data cached |
| Hypotension (low blood pressure) | 622 | 10.5 9.8–11.4ROR 11.6 · χ² 5,395 / p <1e-300 | 10.5 EB05 9.8 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 · 95% clinician | no trial data cached |
| Anaphylactic shock | 352 | 47.1 42.5–52.2ROR 49.9 · χ² 15,641 / p <1e-300 | 46.4 EB05 42.4 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.0 · 97% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 317 | 13.0 11.7–14.5ROR 13.6 · χ² 3,497 / p <1e-300 | 12.9 EB05 11.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 97% clinician | no trial data cached |
| Drug interaction | 304 | 6.5 5.8–7.2ROR 6.8 · χ² 1,415 / p <1e-300 | 6.4 EB05 5.8 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 98% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 216 | 8.2 7.2–9.4ROR 8.5 · χ² 1,370 / p 3e-300 | 8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 92% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 202 | 12.9 11.3–14.8ROR 13.3 · χ² 2,205 / p <1e-300 | 12.8 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 96% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 172 | 41.1 35.5–47.7ROR 42.3 · χ² 6,619 / p <1e-300 | 40.5 EB05 35.7 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.1 · 92% clinician | no trial data cached |
| Hypoxia (low oxygen) | 154 | 14.9 12.8–17.4ROR 15.3 · χ² 1,981 / p <1e-300 | 14.8 EB05 12.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · 98% clinician | no trial data cached |
| Serotonin syndrome | 152 | 27.1 23.1–31.7ROR 27.8 · χ² 3,767 / p <1e-300 | 26.8 EB05 23.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 · 96% clinician | no trial data cached |
| Respiratory failure | 142 | 6.6 5.6–7.8ROR 6.7 · χ² 669 / p 7e-148 | 6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 92% clinician | no trial data cached |
| Urticaria (hives) | 140 | 2.8 2.4–3.4ROR 2.9 · χ² 167 / p 1e-38 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 95% clinician | no trial data cached |
| Foetal exposure during pregnancy | 128 | 5.3 4.5–6.3ROR 5.4 · χ² 448 / p 1e-99 | 5.2 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 · 97% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 127 | 2.8 2.4–3.4ROR 2.9 · χ² 149 / p 2e-34 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 1.7 · ♀ 29% (drug 50%) · 93% clinician | no trial data cached |
| Oxygen saturation decreased | 126 | 7.7 6.4–9.1ROR 7.8 · χ² 723 / p 2e-159 | 7.5 EB05 6.4 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 5.0 · 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.
- Serotonin syndrome — n=152, PRR 27.1
- Circulatory collapse — n=111, PRR 22.1
- Respiratory depression — n=60, PRR 16.6
- Ventricular fibrillation — n=53, PRR 16.2
- Hypoxia — n=154, PRR 14.9
- Cardiac arrest — n=317, PRR 13.0
- Bradycardia — n=202, PRR 12.9
- Covid-19 pneumonia — n=41, PRR 11.7
- Ventricular tachycardia — n=57, PRR 11.7
- Atelectasis — n=32, PRR 11.2
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, 207 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.