Succinylcholine side effects: what 1,647 FDA adverse event reports show
Drug class
Depolarizing neuromuscular blocker
Who reports
1,647 reports · 94% serious · 140 with death outcome · 52% female
Used for
Succinylcholine chloride injection is indicated in adults and pediatric patients: as an adjunct to general anesthesia to facilitate tracheal intubation to provide skeletal muscle relaxation during surgery or mechanical ventilation. Succinylcholine chlo.
What it is
Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride injection contains succinylcholine chloride as the active pharmaceutical ingredient.
Boxed warning
VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS Acute rhabdomyolysis with hyperkalemia followed by ventricular dysrhythmias, cardiac arrest, and death has oc.
Causality screen of the 39 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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. 18 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Serotonin syndrome | 68 | 45.4 36.0–57.3ROR 47.3 · χ² 2,902 / p <1e-300 | 44.7 EB05 36.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 28.1 · ♀ 26% (drug 52%) · 98% clinician | no trial data cached |
| Anaphylactic shock | 76 | 37.9 30.4–47.2ROR 39.6 · χ² 2,686 / p <1e-300 | 37.4 EB05 30.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · 100% clinician | no trial data cached |
| Status epilepticus | 30 | 33.8 23.7–48.3ROR 34.4 · χ² 921 / p 1e-202 | 33.1 EB05 24.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 · ♀ 90% (drug 52%) · 90% clinician | no trial data cached |
| Respiratory depression | 22 | 22.9 15.1–34.7ROR 23.2 · χ² 438 / p 1e-97 | 22.4 EB05 15.6 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.5 · 95% clinician | no trial data cached |
| Ventricular fibrillation | 18 | 20.6 13.0–32.6ROR 20.8 · χ² 316 / p 5e-71 | 20.1 EB05 13.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 | no trial data cached |
| Premature delivery | 25 | 19.9 13.5–29.4ROR 20.2 · χ² 430 / p 7e-96 | 19.6 EB05 13.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Paralysis | 22 | 19.5 12.9–29.6ROR 19.8 · χ² 368 / p 3e-82 | 19.1 EB05 13.2 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.8 | no trial data cached |
| Ventricular tachycardia | 24 | 18.5 12.4–27.5ROR 18.7 · χ² 379 / p 1e-84 | 18.1 EB05 12.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.5 · 91% clinician | no trial data cached |
| Muscle rigidity | 17 | 18.1 11.3–29.1ROR 18.3 · χ² 258 / p 2e-58 | 17.6 EB05 11.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.5 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 72 | 16.7 13.3–20.9ROR 17.4 · χ² 1,049 / p 2e-230 | 16.6 EB05 13.6 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.3 · 100% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 21 | 16.4 10.7–25.0ROR 16.6 · χ² 287 / p 9e-65 | 15.9 EB05 10.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · 95% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 49 | 15.0 11.4–19.8ROR 15.4 · χ² 627 / p 1e-138 | 14.8 EB05 11.6 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.1 · 94% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 94 | 14.5 11.9–17.6ROR 15.3 · χ² 1,167 / p 4e-256 | 14.4 EB05 12.1 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.9 · 100% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 16 | 14.2 8.7–23.2ROR 14.4 · χ² 184 / p 3e-42 | 13.3 EB05 8.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Premature baby | 33 | 13.9 9.9–19.5ROR 14.2 · χ² 383 / p 1e-85 | 13.6 EB05 9.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 100% clinician | no trial data cached |
| Blood calcium decreased | 12 | 13.6 7.7–23.8ROR 13.6 · χ² 127 / p 8e-30 | 12.1 EB05 6.5 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 10.4 | no trial data cached |
| Bradycardia (slow heart rate) | 54 | 13.0 10.0–16.8ROR 13.4 · χ² 585 / p 2e-129 | 12.7 EB05 10.0 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 · 98% clinician | no trial data cached |
| Sinus tachycardia | 14 | 12.6 7.5–21.2ROR 12.7 · χ² 138 / p 4e-32 | 11.3 EB05 6.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Hypoxia (low oxygen) | 34 | 12.4 8.9–17.2ROR 12.6 · χ² 344 / p 5e-77 | 11.9 EB05 8.7 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 · 94% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 33 | 12.0 8.6–16.9ROR 12.3 · χ² 324 / p 1e-72 | 11.6 EB05 8.4 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.6 · 100% clinician | no trial data cached |
| Neuroleptic malignant syndrome | 11 | 11.8 6.5–21.2ROR 11.9 · χ² 98 / p 2e-23 | 9.9 EB05 5.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Metabolic acidosis | 27 | 10.9 7.5–15.8ROR 11.0 · χ² 232 / p 9e-53 | 10.2 EB05 7.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 28% (drug 52%) · 96% clinician | no trial data cached |
| Foetal exposure during pregnancy | 69 | 10.8 8.6–13.6ROR 11.3 · χ² 607 / p 2e-134 | 10.6 EB05 8.6 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 · 94% clinician | no trial data cached |
| Exposure during pregnancy | 50 | 10.2 7.8–13.5ROR 10.5 · χ² 409 / p 3e-91 | 9.9 EB05 7.7 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Circulatory collapse | 13 | 9.7 5.6–16.6ROR 9.8 · χ² 93 / p 3e-22 | 8.1 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Pneumothorax | 12 | 9.6 5.5–17.0ROR 9.7 · χ² 85 / p 2e-20 | 7.9 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Encephalopathy | 18 | 9.4 5.9–14.8ROR 9.5 · χ² 126 / p 1e-29 | 8.2 EB05 5.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Hypotension (low blood pressure) | 138 | 8.8 7.5–10.3ROR 9.5 · χ² 952 / p 3e-209 | 8.6 EB05 7.5 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 · 96% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 59 | 8.5 6.6–10.9ROR 8.7 · χ² 382 / p 2e-85 | 8.1 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 · ♀ 24% (drug 52%) · 96% clinician | no trial data cached |
| Drug interaction | 102 | 8.2 6.8–9.9ROR 8.7 · χ² 641 / p 1e-141 | 8.0 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 · 99% clinician | no trial data cached |
| Post procedural complication | 11 | 7.3 4.0–13.1ROR 7.3 · χ² 54 / p 1e-13 | 5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Maternal exposure during pregnancy | 49 | 7.1 5.4–9.3ROR 7.3 · χ² 251 / p 1e-56 | 6.7 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · ♀ 100% (drug 52%) · 96% clinician | no trial data cached |
| Unresponsive to stimuli | 14 | 6.9 4.1–11.7ROR 7.0 · χ² 65 / p 3e-16 | 5.8 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Cardio-respiratory arrest | 21 | 6.4 4.2–9.7ROR 6.4 · χ² 90 / p 1e-21 | 5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Rash maculo-papular | 11 | 6.3 3.5–11.4ROR 6.4 · χ² 44 / p 2e-11 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Shock | 10 | 5.6 3.0–10.4ROR 5.6 · χ² 33 / p 4e-9 | 4.5 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Lactic acidosis | 13 | 5.2 3.0–8.9ROR 5.2 · χ² 40 / p 2e-10 | 4.4 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Sedation | 10 | 4.9 2.6–9.1ROR 4.9 · χ² 27 / p 9e-8 | 4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Aggression | 12 | 3.0 1.7–5.4ROR 3.1 · χ² 15 / p 7e-5 | 2.8 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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) | 138 | 8.8 7.5–10.3ROR 9.5 · χ² 952 / p 3e-209 | 8.6 EB05 7.5 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 · 96% clinician | no trial data cached |
| Drug interaction | 102 | 8.2 6.8–9.9ROR 8.7 · χ² 641 / p 1e-141 | 8.0 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 · 99% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 94 | 14.5 11.9–17.6ROR 15.3 · χ² 1,167 / p 4e-256 | 14.4 EB05 12.1 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.9 · 100% clinician | no trial data cached |
| Anaphylactic shock | 76 | 37.9 30.4–47.2ROR 39.6 · χ² 2,686 / p <1e-300 | 37.4 EB05 30.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · 100% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 72 | 16.7 13.3–20.9ROR 17.4 · χ² 1,049 / p 2e-230 | 16.6 EB05 13.6 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.3 · 100% clinician | no trial data cached |
| Foetal exposure during pregnancy | 69 | 10.8 8.6–13.6ROR 11.3 · χ² 607 / p 2e-134 | 10.6 EB05 8.6 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 · 94% clinician | no trial data cached |
| Serotonin syndrome | 68 | 45.4 36.0–57.3ROR 47.3 · χ² 2,902 / p <1e-300 | 44.7 EB05 36.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 28.1 · ♀ 26% (drug 52%) · 98% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 59 | 8.5 6.6–10.9ROR 8.7 · χ² 382 / p 2e-85 | 8.1 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 · ♀ 24% (drug 52%) · 96% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 54 | 13.0 10.0–16.8ROR 13.4 · χ² 585 / p 2e-129 | 12.7 EB05 10.0 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 · 98% clinician | no trial data cached |
| Exposure during pregnancy | 50 | 10.2 7.8–13.5ROR 10.5 · χ² 409 / p 3e-91 | 9.9 EB05 7.7 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Maternal exposure during pregnancy | 49 | 7.1 5.4–9.3ROR 7.3 · χ² 251 / p 1e-56 | 6.7 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · ♀ 100% (drug 52%) · 96% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 49 | 15.0 11.4–19.8ROR 15.4 · χ² 627 / p 1e-138 | 14.8 EB05 11.6 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.1 · 94% clinician | no trial data cached |
| Hypoxia (low oxygen) | 34 | 12.4 8.9–17.2ROR 12.6 · χ² 344 / p 5e-77 | 11.9 EB05 8.7 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 · 94% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 33 | 12.0 8.6–16.9ROR 12.3 · χ² 324 / p 1e-72 | 11.6 EB05 8.4 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.6 · 100% clinician | no trial data cached |
| Premature baby | 33 | 13.9 9.9–19.5ROR 14.2 · χ² 383 / p 1e-85 | 13.6 EB05 9.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 100% 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=68, PRR 45.4
- Anaphylactic shock — n=76, PRR 37.9
- Status epilepticus — n=30, PRR 33.8
- Premature delivery — n=25, PRR 19.9
- Generalised tonic-clonic seizure — n=21, PRR 16.4
- Premature baby — n=33, PRR 13.9
- Metabolic acidosis — n=27, PRR 10.9
- Cardio-respiratory arrest — n=21, PRR 6.4
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 Succinylcholine?
In FDA FAERS, the most frequently co-reported reaction terms for Succinylcholine are hypotension, cardiac arrest, anaphylactic shock, anaphylactic reaction, serotonin syndrome, tachycardia. 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 Succinylcholine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS Acute rhabdomyolysis with hyperkalemia followed by ventricular dysrhythmias, cardiac arrest, and death has oc.
Do FAERS signals prove that Succinylcholine 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 f55dd1c0-c259-219a-5bca-f139e9515d07, effective 20240225; matched on
openfda.generic_name.exact:"SUCCINYLCHOLINE") - 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, 57 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.