Sugammadex Sodium side effects: what 1,234 FDA adverse event reports show

Sugammadex Sodium · Bridion · 32 reaction terms · 779 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Bridion

openFDA label

Who reports

1,234 reports · 95% serious · 43 with death outcome · 53% 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 21 strongest signals

Labeled adverse reaction 6Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 11

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. 11 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
Bronchospasm (airway tightening)	53	63.1 48.5–82.2ROR 65.9 · χ² 3,170 / p <1e-300	61.6 EB05 48.9 · IC025 +4.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 41.2 · 94% clinician	no trial data cached
Anaphylactic reaction (severe allergic reaction)	156	48.4 41.8–56.1ROR 55.3 · χ² 7,192 / p <1e-300	48.0 EB05 42.0 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 28.8 · 95% clinician	no trial data cached
Anaphylactic shock	68	45.2 35.9–57.0ROR 47.8 · χ² 2,891 / p <1e-300	44.6 EB05 36.4 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 27.4 · 97% clinician	no trial data cached
Tachypnoea	23	28.9 19.3–43.3ROR 29.4 · χ² 591 / p 7e-131	28.2 EB05 19.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 17.9 · ♀ 19% (drug 53%) · 96% clinician	no trial data cached
Bradycardia (slow heart rate)	80	25.6 20.7–31.7ROR 27.3 · χ² 1,870 / p <1e-300	25.4 EB05 21.1 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.0 · 97% clinician	no trial data cached
Serotonin syndrome	19	16.9 10.8–26.4ROR 17.1 · χ² 268 / p 1e-60	16.4 EB05 10.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.3	no trial data cached
Post procedural haemorrhage	11	16.0 8.9–28.9ROR 16.2 · χ² 140 / p 1e-32	14.7 EB05 7.7 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 9.8	no trial data cached
Muscle rigidity	11	15.7 8.7–28.2ROR 15.8 · χ² 137 / p 8e-32	14.3 EB05 7.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Hypoxia (low oxygen)	32	15.5 11.0–21.8ROR 15.9 · χ² 421 / p 9e-94	15.2 EB05 11.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.5 · 97% clinician	no trial data cached
Muscle twitching	21	15.5 10.1–23.6ROR 15.7 · χ² 270 / p 7e-61	14.9 EB05 9.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.5 · ♀ 90% (drug 53%) · 90% clinician	no trial data cached
Body temperature increased	17	14.1 8.8–22.6ROR 14.3 · χ² 194 / p 2e-44	13.3 EB05 8.2 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 10.5	no trial data cached
Cardiomyopathy	12	13.8 7.9–24.2ROR 13.9 · χ² 130 / p 2e-30	12.4 EB05 6.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Paralysis	11	13.0 7.2–23.4ROR 13.1 · χ² 110 / p 4e-26	11.3 EB05 5.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached
Cardiac arrest (heart stopping)	62	12.7 10.0–16.2ROR 13.3 · χ² 660 / p 7e-146	12.5 EB05 10.0 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.7	no trial data cached
Pallor	19	11.8 7.6–18.5ROR 12.0 · χ² 178 / p 7e-41	10.9 EB05 6.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.3	no trial data cached
Oxygen saturation decreased	36	11.0 7.9–15.1ROR 11.3 · χ² 317 / p 3e-71	10.5 EB05 7.7 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious PRR 7.3	no trial data cached
Rash maculo-papular	12	9.2 5.2–16.2ROR 9.3 · χ² 80 / p 2e-19	7.5 EB05 4.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Angioedema (deep swelling of face/throat)	21	8.1 5.3–12.4ROR 8.2 · χ² 124 / p 5e-29	7.1 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.9 · ♀ 80% (drug 53%) · 100% clinician	no trial data cached
Dyskinesia (involuntary movements)	19	8.0 5.1–12.4ROR 8.1 · χ² 109 / p 8e-26	6.9 EB05 4.6 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 6.5	no trial data cached
Respiratory arrest	11	6.7 3.7–12.1ROR 6.8 · χ² 48 / p 2e-12	5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.1	no trial data cached
Foetal exposure during pregnancy	12	2.5 1.4–4.4ROR 2.5 · χ² 9 / p 0.001	2.4 EB05 1.5 · IC025 +0.3	Reporting / coding artifact	serious PRR 1.6	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)	156	48.4 41.8–56.1ROR 55.3 · χ² 7,192 / p <1e-300	48.0 EB05 42.0 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 28.8 · 95% clinician	no trial data cached
Bradycardia (slow heart rate)	80	25.6 20.7–31.7ROR 27.3 · χ² 1,870 / p <1e-300	25.4 EB05 21.1 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.0 · 97% clinician	no trial data cached
Anaphylactic shock	68	45.2 35.9–57.0ROR 47.8 · χ² 2,891 / p <1e-300	44.6 EB05 36.4 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 27.4 · 97% clinician	no trial data cached
Cardiac arrest (heart stopping)	62	12.7 10.0–16.2ROR 13.3 · χ² 660 / p 7e-146	12.5 EB05 10.0 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.7	no trial data cached
Bronchospasm (airway tightening)	53	63.1 48.5–82.2ROR 65.9 · χ² 3,170 / p <1e-300	61.6 EB05 48.9 · IC025 +4.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 41.2 · 94% clinician	no trial data cached
Oxygen saturation decreased	36	11.0 7.9–15.1ROR 11.3 · χ² 317 / p 3e-71	10.5 EB05 7.7 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious PRR 7.3	no trial data cached
Hypoxia (low oxygen)	32	15.5 11.0–21.8ROR 15.9 · χ² 421 / p 9e-94	15.2 EB05 11.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.5 · 97% clinician	no trial data cached
Tachypnoea	23	28.9 19.3–43.3ROR 29.4 · χ² 591 / p 7e-131	28.2 EB05 19.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 17.9 · ♀ 19% (drug 53%) · 96% clinician	no trial data cached
Angioedema (deep swelling of face/throat)	21	8.1 5.3–12.4ROR 8.2 · χ² 124 / p 5e-29	7.1 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.9 · ♀ 80% (drug 53%) · 100% clinician	no trial data cached
Muscle twitching	21	15.5 10.1–23.6ROR 15.7 · χ² 270 / p 7e-61	14.9 EB05 9.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.5 · ♀ 90% (drug 53%) · 90% clinician	no trial data cached
Dyskinesia (involuntary movements)	19	8.0 5.1–12.4ROR 8.1 · χ² 109 / p 8e-26	6.9 EB05 4.6 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 6.5	no trial data cached
Pallor	19	11.8 7.6–18.5ROR 12.0 · χ² 178 / p 7e-41	10.9 EB05 6.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.3	no trial data cached
Serotonin syndrome	19	16.9 10.8–26.4ROR 17.1 · χ² 268 / p 1e-60	16.4 EB05 10.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.3	no trial data cached
Body temperature increased	17	14.1 8.8–22.6ROR 14.3 · χ² 194 / p 2e-44	13.3 EB05 8.2 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 10.5	no trial data cached
Foetal exposure during pregnancy	12	2.5 1.4–4.4ROR 2.5 · χ² 9 / p 0.001	2.4 EB05 1.5 · IC025 +0.3	Reporting / coding artifact	serious PRR 1.6	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.

Tachypnoea — n=23, PRR 28.9
Hypoxia — n=32, PRR 15.5
Muscle twitching — n=21, PRR 15.5
Angioedema — n=21, PRR 8.1

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, anaphylactic shock, cardiac arrest, bronchospasm, oxygen saturation decreased. 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, field patient.drug.openfda.generic_name.exact, 32 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.