Drug · FAERS side-effect profile with label screen
Sugammadex side effects: what 2,665 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Bridion
openFDA label
Who reports
2,665 reports · 84% serious · 101 with death outcome · 52% female
openFDA FAERS counts, all years, deduplication not applied
Used for
BRIDION ® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery. BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery. ( 1 )
FDA label, Indications and Usage
What it is
BRIDION (sugammadex) injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6 A ,6 B ,6 C ,6 D ,6 E ,6 F ,6 G ,6 H -Octakis-S-(2-car.
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 14Labeled (related wording) 2Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 19
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.
- 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. 23 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 |
|---|---|---|---|---|---|---|
| Bronchospasm (airway tightening) | 174 | 96.8 83.8–111.9ROR 103.5 · χ² 16,212 / p <1e-300 | 94.7 EB05 83.4 · IC025 +6.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 58.1 | no trial data cached |
| Anaphylactic shock | 173 | 53.5 46.3–61.8ROR 57.1 · χ² 8,806 / p <1e-300 | 52.8 EB05 46.5 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 36.5 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 308 | 44.4 39.9–49.3ROR 50.0 · χ² 12,972 / p <1e-300 | 44.0 EB05 40.0 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 30.2 | no trial data cached |
| Bradycardia (slow heart rate) | 281 | 41.8 37.4–46.7ROR 46.6 · χ² 11,127 / p <1e-300 | 41.5 EB05 37.6 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 28.6 | no trial data cached |
| Cardiac arrest (heart stopping) | 188 | 17.9 15.6–20.5ROR 19.2 · χ² 2,986 / p <1e-300 | 17.8 EB05 15.8 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.2 | no trial data cached |
| Ventricular fibrillation | 25 | 17.7 12.0–26.2ROR 17.9 · χ² 377 / p 3e-84 | 17.4 EB05 12.2 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.1 · ♀ 26% (drug 52%) | no trial data cached |
| Hypoxia (low oxygen) | 60 | 13.5 10.5–17.3ROR 13.8 · χ² 681 / p 2e-150 | 13.3 EB05 10.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Respiratory arrest | 47 | 13.3 10.0–17.7ROR 13.5 · χ² 523 / p 5e-116 | 13.1 EB05 10.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Muscle twitching | 39 | 13.3 9.7–18.2ROR 13.5 · χ² 431 / p 5e-96 | 13.0 EB05 9.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · ♀ 74% (drug 52%) | no trial data cached |
| Oxygen saturation decreased | 93 | 13.1 10.8–16.0ROR 13.6 · χ² 1,031 / p 1e-226 | 13.0 EB05 10.9 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 9.5 | no trial data cached |
| Respiratory depression | 20 | 12.9 8.3–19.9ROR 12.9 · χ² 207 / p 4e-47 | 12.1 EB05 7.8 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 | no trial data cached |
| Paralysis | 23 | 12.6 8.4–19.0ROR 12.7 · χ² 234 / p 4e-53 | 11.9 EB05 8.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Tachypnoea | 21 | 12.2 8.0–18.7ROR 12.3 · χ² 205 / p 9e-47 | 11.4 EB05 7.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 100% clinician | no trial data cached |
| Hypotonia | 13 | 10.2 5.9–17.6ROR 10.3 · χ² 99 / p 1e-23 | 8.6 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Supraventricular tachycardia | 12 | 9.9 5.6–17.4ROR 9.9 · χ² 87 / p 5e-21 | 8.1 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 32 | 9.9 7.0–13.9ROR 10.0 · χ² 246 / p 9e-56 | 9.2 EB05 6.7 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Serotonin syndrome | 21 | 8.6 5.6–13.2ROR 8.7 · χ² 134 / p 2e-31 | 7.7 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 76% (drug 52%) · 95% clinician | no trial data cached |
| Angioedema (deep swelling of face/throat) | 47 | 8.4 6.3–11.1ROR 8.5 · χ² 299 / p 3e-67 | 7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Circulatory collapse | 18 | 8.3 5.2–13.1ROR 8.3 · χ² 108 / p 1e-25 | 7.2 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Ventricular tachycardia | 17 | 8.1 5.0–13.0ROR 8.1 · χ² 98 / p 2e-23 | 6.9 EB05 4.5 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Blood pressure decreased | 67 | 8.0 6.3–10.1ROR 8.1 · χ² 401 / p 1e-89 | 7.6 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Obstructive airways disorder | 11 | 7.8 4.3–14.0ROR 7.8 · χ² 58 / p 1e-14 | 6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Hypertensive crisis | 11 | 7.8 4.3–14.0ROR 7.8 · χ² 58 / p 1e-14 | 6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Cardiomyopathy | 13 | 6.9 4.0–11.9ROR 6.9 · χ² 60 / p 5e-15 | 5.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Post procedural haemorrhage | 10 | 6.7 3.6–12.5ROR 6.8 · χ² 43 / p 2e-11 | 5.3 EB05 3.1 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | no trial data cached |
| Eyelid oedema | 10 | 6.7 3.6–12.5ROR 6.7 · χ² 43 / p 2e-11 | 5.3 EB05 3.1 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Shock | 19 | 6.6 4.2–10.3ROR 6.6 · χ² 84 / p 2e-20 | 5.7 EB05 3.9 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 13 | 6.5 3.8–11.2ROR 6.5 · χ² 55 / p 6e-14 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Hypotension (low blood pressure) | 162 | 6.4 5.5–7.4ROR 6.7 · χ² 734 / p 5e-162 | 6.3 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Body temperature increased | 16 | 6.2 3.8–10.0ROR 6.2 · χ² 64 / p 6e-16 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 | no trial data cached |
| Respiratory distress | 19 | 5.4 3.5–8.5ROR 5.4 · χ² 64 / p 6e-16 | 4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Pulmonary oedema | 30 | 5.3 3.7–7.5ROR 5.3 · χ² 100 / p 9e-24 | 4.9 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Cardio-respiratory arrest | 28 | 5.2 3.6–7.6ROR 5.3 · χ² 92 / p 5e-22 | 4.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Pallor | 18 | 5.2 3.3–8.2ROR 5.2 · χ² 57 / p 2e-14 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Respiratory failure | 48 | 5.2 3.9–6.9ROR 5.3 · χ² 158 / p 1e-36 | 4.9 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · ♀ 23% (drug 52%) | no trial data cached |
| Tachycardia (fast heart rate) | 58 | 5.1 4.0–6.6ROR 5.2 · χ² 190 / p 2e-43 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Product prescribing issue | 13 | 5.0 2.9–8.7ROR 5.0 · χ² 38 / p 3e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Maternal exposure during pregnancy | 55 | 4.9 3.8–6.4ROR 5.0 · χ² 168 / p 1e-38 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.4 · ♀ 100% (drug 52%) · 94% clinician | no trial data cached |
| Unresponsive to stimuli | 16 | 4.9 3.0–8.0ROR 4.9 · χ² 46 / p 7e-12 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Altered state of consciousness | 13 | 4.7 2.8–8.2ROR 4.8 · χ² 35 / p 2e-9 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | 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) | 308 | 44.4 39.9–49.3ROR 50.0 · χ² 12,972 / p <1e-300 | 44.0 EB05 40.0 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 30.2 | no trial data cached |
| Bradycardia (slow heart rate) | 281 | 41.8 37.4–46.7ROR 46.6 · χ² 11,127 / p <1e-300 | 41.5 EB05 37.6 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 28.6 | no trial data cached |
| Cardiac arrest (heart stopping) | 188 | 17.9 15.6–20.5ROR 19.2 · χ² 2,986 / p <1e-300 | 17.8 EB05 15.8 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.2 | no trial data cached |
| Bronchospasm (airway tightening) | 174 | 96.8 83.8–111.9ROR 103.5 · χ² 16,212 / p <1e-300 | 94.7 EB05 83.4 · IC025 +6.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 58.1 | no trial data cached |
| Anaphylactic shock | 173 | 53.5 46.3–61.8ROR 57.1 · χ² 8,806 / p <1e-300 | 52.8 EB05 46.5 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 36.5 | no trial data cached |
| Hypotension (low blood pressure) | 162 | 6.4 5.5–7.4ROR 6.7 · χ² 734 / p 5e-162 | 6.3 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Oxygen saturation decreased | 93 | 13.1 10.8–16.0ROR 13.6 · χ² 1,031 / p 1e-226 | 13.0 EB05 10.9 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 9.5 | no trial data cached |
| Blood pressure decreased | 67 | 8.0 6.3–10.1ROR 8.1 · χ² 401 / p 1e-89 | 7.6 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Hypoxia (low oxygen) | 60 | 13.5 10.5–17.3ROR 13.8 · χ² 681 / p 2e-150 | 13.3 EB05 10.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Tachycardia (fast heart rate) | 58 | 5.1 4.0–6.6ROR 5.2 · χ² 190 / p 2e-43 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Maternal exposure during pregnancy | 55 | 4.9 3.8–6.4ROR 5.0 · χ² 168 / p 1e-38 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.4 · ♀ 100% (drug 52%) · 94% clinician | no trial data cached |
| Respiratory failure | 48 | 5.2 3.9–6.9ROR 5.3 · χ² 158 / p 1e-36 | 4.9 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · ♀ 23% (drug 52%) | no trial data cached |
| Angioedema (deep swelling of face/throat) | 47 | 8.4 6.3–11.1ROR 8.5 · χ² 299 / p 3e-67 | 7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Respiratory arrest | 47 | 13.3 10.0–17.7ROR 13.5 · χ² 523 / p 5e-116 | 13.1 EB05 10.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| No adverse event | 40 | 1.8 1.3–2.4ROR 1.8 · χ² 13 / p 2e-4 | 1.8 EB05 1.4 · IC025 +0.3 | Reporting / coding artifact | – | 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.
- Hypoxia — n=60, PRR 13.5
- Muscle twitching — n=39, PRR 13.3
- Paralysis — n=23, PRR 12.6
- Tachypnoea — n=21, PRR 12.2
- Serotonin syndrome — n=21, PRR 8.6
- Angioedema — n=47, PRR 8.4
- Cardio-respiratory arrest — n=28, PRR 5.2
- Respiratory failure — n=48, PRR 5.2
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 Sugammadex?
In FDA FAERS, the most frequently co-reported reaction terms for Sugammadex are anaphylactic reaction, bradycardia, cardiac arrest, bronchospasm, anaphylactic shock, hypotension. 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 Sugammadex have an FDA boxed warning?
No. The FDA label retrieved for Sugammadex has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sugammadex 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 37276948-ff0f-e0ab-e063-6394a90a0973, effective 20251218; matched on
openfda.generic_name.exact:"SUGAMMADEX") - 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, 63 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.