Drug · FAERS side-effect profile with label screen
Cisatracurium side effects: what 2,195 FDA adverse event reports show
Drug class
Nondepolarizing neuromuscular blocker
FDA label, Indications wording of the closest related product
Label matched
Cisatracurium Besylate (Cisatracurium 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
2,195 reports · 97% serious · 369 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Cisatracurium besylate injection, USP is indicated: as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age to provide skeletal muscle relaxation in adults during surgical pro.
FDA label, Indications and Usage
What it is
Cisatracurium besylate injection, USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action.
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 4Labeled (related wording) 3Reporting / coding artifact 1Not in label — unassessed 32
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.
- 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.
- 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. 56 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 | 126 | 47.2 39.8–55.9ROR 50.0 · χ² 5,630 / p <1e-300 | 46.7 EB05 40.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 28.1 · 98% clinician | no trial data cached |
| Myoclonus | 36 | 28.9 20.9–40.0ROR 29.4 · χ² 941 / p 8e-207 | 28.5 EB05 21.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.1 · ♀ 94% (drug 45%) · 97% clinician | no trial data cached |
| Serotonin syndrome | 55 | 27.5 21.2–35.8ROR 28.2 · χ² 1,378 / p <1e-300 | 27.2 EB05 21.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 · 94% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 72 | 27.0 21.5–33.9ROR 27.9 · χ² 1,773 / p <1e-300 | 26.8 EB05 22.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 · ♀ 2% (drug 45%) · 100% clinician | no trial data cached |
| Ventricular fibrillation | 27 | 23.2 15.9–33.8ROR 23.5 · χ² 551 / p 4e-122 | 22.8 EB05 16.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 · 100% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 32 | 21.4 15.2–30.2ROR 21.7 · χ² 601 / p 5e-133 | 21.1 EB05 15.6 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.6 · 90% clinician | no trial data cached |
| Acute respiratory distress syndrome | 38 | 20.6 15.0–28.2ROR 20.9 · χ² 687 / p 1e-151 | 20.3 EB05 15.4 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.2 · ♀ 19% (drug 45%) · 95% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 117 | 20.4 17.1–24.3ROR 21.5 · χ² 2,139 / p <1e-300 | 20.3 EB05 17.4 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 · 97% clinician | no trial data cached |
| Respiratory depression | 26 | 20.3 13.8–29.8ROR 20.5 · χ² 457 / p 1e-101 | 20.0 EB05 14.2 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.9 · 96% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 84 | 19.3 15.7–23.8ROR 20.0 · χ² 1,441 / p <1e-300 | 19.2 EB05 16.0 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.5 · ♀ 19% (drug 45%) · 96% clinician | no trial data cached |
| Hypoxia (low oxygen) | 70 | 19.1 15.2–24.1ROR 19.7 · χ² 1,182 / p 2e-259 | 19.0 EB05 15.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · 94% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 54 | 18.5 14.2–24.1ROR 19.0 · χ² 877 / p 5e-193 | 18.4 EB05 14.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · 94% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 29 | 18.4 12.8–26.4ROR 18.6 · χ² 459 / p 3e-102 | 18.1 EB05 13.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · 93% clinician | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 30 | 18.2 12.8–26.0ROR 18.5 · χ² 470 / p 1e-104 | 17.9 EB05 13.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 · 100% clinician | no trial data cached |
| Cardiogenic shock | 26 | 17.4 11.9–25.6ROR 17.6 · χ² 386 / p 3e-86 | 17.1 EB05 12.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · ♀ 67% (drug 45%) · 100% clinician | no trial data cached |
| Metabolic acidosis | 57 | 17.2 13.3–22.3ROR 17.7 · χ² 855 / p 3e-188 | 17.1 EB05 13.6 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · 91% clinician | no trial data cached |
| Circulatory collapse | 29 | 16.2 11.3–23.3ROR 16.4 · χ² 399 / p 5e-89 | 15.9 EB05 11.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · ♀ 67% (drug 45%) · 100% clinician | no trial data cached |
| Neuroleptic malignant syndrome | 20 | 16.1 10.4–24.9ROR 16.2 · χ² 268 / p 2e-60 | 15.6 EB05 10.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · 95% clinician | no trial data cached |
| Covid-19 pneumonia | 18 | 14.5 9.1–23.0ROR 14.6 · χ² 212 / p 2e-48 | 13.8 EB05 8.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Toxic skin eruption | 15 | 14.2 8.6–23.5ROR 14.3 · χ² 171 / p 2e-39 | 13.2 EB05 7.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Sinus tachycardia | 21 | 14.2 9.3–21.7ROR 14.3 · χ² 244 / p 3e-55 | 13.6 EB05 8.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 90% (drug 45%) | no trial data cached |
| Shock | 33 | 13.8 9.9–19.4ROR 14.0 · χ² 380 / p 6e-85 | 13.5 EB05 9.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · 97% clinician | no trial data cached |
| Muscle rigidity | 17 | 13.6 8.5–21.9ROR 13.7 · χ² 186 / p 1e-42 | 12.7 EB05 7.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Hyperbilirubinaemia | 14 | 13.0 7.7–21.9ROR 13.1 · χ² 143 / p 3e-33 | 11.7 EB05 6.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Brain oedema | 17 | 12.9 8.0–20.7ROR 13.0 · χ² 174 / p 4e-40 | 11.9 EB05 7.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Hepatocellular injury | 19 | 12.8 8.2–20.0ROR 12.9 · χ² 195 / p 2e-44 | 11.9 EB05 7.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Bradycardia (slow heart rate) | 67 | 12.1 9.5–15.3ROR 12.4 · χ² 669 / p 7e-148 | 11.9 EB05 9.6 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 · 97% clinician | no trial data cached |
| Mydriasis | 15 | 11.2 6.8–18.5ROR 11.3 · χ² 129 / p 3e-30 | 9.8 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Hepatic cytolysis | 14 | 11.0 6.5–18.5ROR 11.0 · χ² 117 / p 2e-27 | 9.5 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Sinus bradycardia | 11 | 10.9 6.0–19.6ROR 10.9 · χ² 89 / p 2e-21 | 8.9 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Septic shock | 47 | 10.4 7.8–13.8ROR 10.6 · χ² 390 / p 4e-87 | 10.0 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 20% (drug 45%) · 98% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 83 | 9.6 7.8–11.8ROR 9.9 · χ² 631 / p 2e-139 | 9.3 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 97% clinician | no trial data cached |
| Hypertensive crisis | 11 | 9.4 5.2–17.0ROR 9.5 · χ² 75 / p 3e-18 | 7.6 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Post procedural complication | 18 | 8.9 5.6–14.2ROR 9.0 · χ² 119 / p 5e-28 | 7.8 EB05 5.0 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | no trial data cached |
| Eosinophilia | 16 | 8.8 5.4–14.3ROR 8.8 · χ² 102 / p 2e-24 | 7.5 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Acute respiratory failure | 17 | 8.5 5.3–13.6ROR 8.5 · χ² 105 / p 6e-25 | 7.3 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Encephalopathy | 21 | 8.2 5.4–12.5ROR 8.3 · χ² 126 / p 2e-29 | 7.2 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 100% clinician | no trial data cached |
| Ventricular tachycardia | 14 | 8.1 4.8–13.6ROR 8.1 · χ² 80 / p 2e-19 | 6.7 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Delirium | 29 | 8.0 5.6–11.5ROR 8.1 · χ² 171 / p 2e-39 | 7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 76% (drug 45%) · 97% clinician | no trial data cached |
| Respiratory failure | 61 | 8.0 6.2–10.2ROR 8.2 · χ² 367 / p 4e-82 | 7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | 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 |
|---|---|---|---|---|---|---|
| Hypotension (low blood pressure) | 150 | 7.2 6.1–8.4ROR 7.6 · χ² 796 / p 2e-175 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 97% clinician | no trial data cached |
| Anaphylactic shock | 126 | 47.2 39.8–55.9ROR 50.0 · χ² 5,630 / p <1e-300 | 46.7 EB05 40.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 28.1 · 98% clinician | no trial data cached |
| Drug interaction | 117 | 7.0 5.9–8.4ROR 7.4 · χ² 605 / p 6e-134 | 6.9 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 97% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 117 | 20.4 17.1–24.3ROR 21.5 · χ² 2,139 / p <1e-300 | 20.3 EB05 17.4 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 · 97% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 84 | 19.3 15.7–23.8ROR 20.0 · χ² 1,441 / p <1e-300 | 19.2 EB05 16.0 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.5 · ♀ 19% (drug 45%) · 96% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 83 | 9.6 7.8–11.8ROR 9.9 · χ² 631 / p 2e-139 | 9.3 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 97% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 72 | 27.0 21.5–33.9ROR 27.9 · χ² 1,773 / p <1e-300 | 26.8 EB05 22.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 · ♀ 2% (drug 45%) · 100% clinician | no trial data cached |
| Hypoxia (low oxygen) | 70 | 19.1 15.2–24.1ROR 19.7 · χ² 1,182 / p 2e-259 | 19.0 EB05 15.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · 94% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 68 | 7.3 5.8–9.2ROR 7.5 · χ² 366 / p 8e-82 | 7.0 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 100% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 67 | 12.1 9.5–15.3ROR 12.4 · χ² 669 / p 7e-148 | 11.9 EB05 9.6 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 · 97% clinician | no trial data cached |
| Respiratory failure | 61 | 8.0 6.2–10.2ROR 8.2 · χ² 367 / p 4e-82 | 7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Metabolic acidosis | 57 | 17.2 13.3–22.3ROR 17.7 · χ² 855 / p 3e-188 | 17.1 EB05 13.6 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · 91% clinician | no trial data cached |
| Serotonin syndrome | 55 | 27.5 21.2–35.8ROR 28.2 · χ² 1,378 / p <1e-300 | 27.2 EB05 21.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 · 94% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 54 | 18.5 14.2–24.1ROR 19.0 · χ² 877 / p 5e-193 | 18.4 EB05 14.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · 94% clinician | no trial data cached |
| Septic shock | 47 | 10.4 7.8–13.8ROR 10.6 · χ² 390 / p 4e-87 | 10.0 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 20% (drug 45%) · 98% 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.
- Anaphylactic shock — n=126, PRR 47.2
- Myoclonus — n=36, PRR 28.9
- Serotonin syndrome — n=55, PRR 27.5
- Drug reaction with eosinophilia and systemic symptoms — n=72, PRR 27.0
- Ventricular fibrillation — n=27, PRR 23.2
- Hypoxia — n=70, PRR 19.1
- Multiple organ dysfunction syndrome — n=54, PRR 18.5
- Toxic epidermal necrolysis — n=29, PRR 18.4
- Cyanosis — n=30, PRR 18.2
- Cardiogenic shock — n=26, PRR 17.4
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 Cisatracurium?
In FDA FAERS, the most frequently co-reported reaction terms for Cisatracurium are hypotension, anaphylactic shock, anaphylactic reaction, rhabdomyolysis, cardiac arrest, drug reaction with eosinophilia and systemic symptoms. 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 Cisatracurium have an FDA boxed warning?
No. The FDA label retrieved for Cisatracurium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cisatracurium 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 23daa1f8-2a07-449d-97a6-11efdb0b9836, effective 20260429; matched on
openfda.generic_name.exact:"CISATRACURIUM 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, fieldpatient.drug.openfda.generic_name.exact, 96 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.