Sufentanil side effects: what 1,247 FDA adverse event reports show
Drug class
Opioid agonist
Label matched
Sufentanil Citrate (Sufentanil Citrate)
Who reports
1,247 reports · 98% serious · 179 with death outcome · 51% female
Used for
Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients: • as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated. • as a primary anesthet.
What it is
Sufentanil Citrate Injection, USP is a sterile, nonpyrogenic solution of sufentanil citrate in water for injection. Sufentanil Citrate is a potent opioid analgesic which is administered either epidurally or by intravenous injection.
Boxed warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF SUFENTANIL CITRATE INJECTION Addiction, Abuse, and Misuse Because the use of Sufentanil Citrate Injection exposes patients and other users to the risks of opioid addict.
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.
- 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. 16 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 |
|---|---|---|---|---|---|---|
| Anaphylactic shock | 229 | 151.7 134.9–170.7ROR 185.7 · χ² 33,873 / p <1e-300 | 148.5 EB05 133.1 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 88.5 · 93% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 69 | 81.5 64.8–102.6ROR 86.2 · χ² 5,384 / p <1e-300 | 79.4 EB05 64.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 52.8 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 52 | 58.2 44.6–76.0ROR 60.7 · χ² 2,860 / p <1e-300 | 56.9 EB05 45.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 34.2 · 94% clinician | no trial data cached |
| Circulatory collapse | 38 | 37.5 27.4–51.3ROR 38.6 · χ² 1,311 / p 3e-287 | 36.8 EB05 28.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 22.1 · 97% clinician | no trial data cached |
| Multi-organ failure | 34 | 32.7 23.4–45.5ROR 33.6 · χ² 1,011 / p 3e-222 | 32.1 EB05 24.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 19.2 | no trial data cached |
| Fear | 50 | 31.1 23.7–40.8ROR 32.4 · χ² 1,426 / p <1e-300 | 30.7 EB05 24.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 24.8 | no trial data cached |
| Shock | 42 | 31.0 23.0–41.8ROR 32.1 · χ² 1,190 / p 5e-261 | 30.6 EB05 23.6 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.3 · 95% clinician | no trial data cached |
| Emphysema | 16 | 26.6 16.4–43.4ROR 27.0 · χ² 369 / p 1e-82 | 25.9 EB05 16.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.7 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 79 | 24.2 19.6–30.0ROR 25.8 · χ² 1,739 / p <1e-300 | 24.1 EB05 19.9 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.4 | no trial data cached |
| Face oedema | 24 | 23.9 16.1–35.5ROR 24.3 · χ² 503 / p 1e-111 | 23.4 EB05 16.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 · ♀ 26% (drug 51%) | no trial data cached |
| Renal injury | 42 | 23.6 17.5–31.7ROR 24.4 · χ² 886 / p 7e-195 | 23.3 EB05 18.0 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.9 | no trial data cached |
| Respiratory depression | 17 | 23.4 14.6–37.5ROR 23.7 · χ² 342 / p 1e-76 | 22.8 EB05 14.9 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 14.1 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 33 | 21.8 15.5–30.5ROR 22.3 · χ² 633 / p 6e-140 | 21.5 EB05 16.0 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.8 · ♀ 26% (drug 51%) · 100% clinician | no trial data cached |
| Pneumothorax | 20 | 21.3 13.8–32.8ROR 21.6 · χ² 366 / p 7e-82 | 20.8 EB05 14.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Ventricular fibrillation | 14 | 21.2 12.6–35.7ROR 21.4 · χ² 249 / p 2e-56 | 20.5 EB05 12.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Anhedonia | 32 | 20.4 14.5–28.7ROR 20.9 · χ² 570 / p 3e-126 | 20.1 EB05 14.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · ♀ 28% (drug 51%) | no trial data cached |
| Adverse reaction | 16 | 20.3 12.5–33.1ROR 20.6 · χ² 275 / p 5e-62 | 19.7 EB05 12.6 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=16 | no trial data cached |
| Dermatitis allergic | 13 | 17.6 10.2–30.2ROR 17.7 · χ² 187 / p 8e-43 | 16.7 EB05 9.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 | no trial data cached |
| Toxic skin eruption | 10 | 16.7 9.0–30.9ROR 16.8 · χ² 132 / p 8e-31 | 15.2 EB05 7.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Bradycardia (slow heart rate) | 42 | 13.3 9.9–17.9ROR 13.7 · χ² 467 / p 8e-104 | 13.0 EB05 9.9 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 | no trial data cached |
| Tachycardia (fast heart rate) | 70 | 13.3 10.6–16.7ROR 14.0 · χ² 785 / p 6e-173 | 13.1 EB05 10.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 · ♀ 26% (drug 51%) | no trial data cached |
| Injury | 54 | 12.9 9.9–16.7ROR 13.4 · χ² 581 / p 1e-128 | 12.6 EB05 9.9 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 12 | 12.8 7.3–22.5ROR 12.9 · χ² 119 / p 5e-28 | 11.3 EB05 6.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Cardiac arrest (heart stopping) | 61 | 12.4 9.7–15.8ROR 13.0 · χ² 630 / p 3e-139 | 12.2 EB05 9.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 · 98% clinician | no trial data cached |
| Unevaluable event | 53 | 11.8 9.1–15.4ROR 12.3 · χ² 514 / p 4e-114 | 11.5 EB05 9.0 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 12.3 | no trial data cached |
| Ventricular tachycardia | 11 | 11.2 6.2–20.1ROR 11.3 · χ² 92 / p 4e-22 | 9.3 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Hypotension (low blood pressure) | 132 | 11.1 9.4–13.0ROR 12.3 · χ² 1,214 / p 3e-266 | 11.0 EB05 9.5 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Sedation | 15 | 9.7 5.9–16.0ROR 9.8 · χ² 108 / p 1e-25 | 8.3 EB05 5.0 · IC025 +2.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.9 | no trial data cached |
| Eosinophilia | 10 | 9.6 5.2–17.9ROR 9.7 · χ² 69 / p 5e-17 | 7.6 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Stress | 41 | 9.6 7.1–13.0ROR 9.9 · χ² 308 / p 3e-69 | 9.1 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Renal failure (kidney failure) | 74 | 9.3 7.5–11.6ROR 9.8 · χ² 544 / p 1e-120 | 9.0 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Post procedural complication | 10 | 8.7 4.7–16.2ROR 8.8 · χ² 61 / p 3e-15 | 6.8 EB05 3.8 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Rash maculo-papular | 11 | 8.4 4.6–15.1ROR 8.4 · χ² 64 / p 6e-16 | 6.7 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 11 | 8.3 4.6–15.0ROR 8.4 · χ² 64 / p 7e-16 | 6.6 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Renal failure acute | 19 | 7.4 4.8–11.6ROR 7.5 · χ² 100 / p 9e-24 | 6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Drug exposure during pregnancy | 14 | 6.8 4.1–11.5ROR 6.9 · χ² 64 / p 6e-16 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 15 | 5.7 3.5–9.5ROR 5.8 · χ² 54 / p 1e-13 | 4.9 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Emotional distress | 40 | 5.5 4.1–7.5ROR 5.7 · χ² 145 / p 1e-33 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Lactic acidosis | 10 | 5.2 2.8–9.7ROR 5.3 · χ² 30 / p 2e-8 | 4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | 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 |
|---|---|---|---|---|---|---|
| Anaphylactic shock | 229 | 151.7 134.9–170.7ROR 185.7 · χ² 33,873 / p <1e-300 | 148.5 EB05 133.1 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 88.5 · 93% clinician | no trial data cached |
| Hypotension (low blood pressure) | 132 | 11.1 9.4–13.0ROR 12.3 · χ² 1,214 / p 3e-266 | 11.0 EB05 9.5 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 79 | 24.2 19.6–30.0ROR 25.8 · χ² 1,739 / p <1e-300 | 24.1 EB05 19.9 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.4 | no trial data cached |
| Renal failure (kidney failure) | 74 | 9.3 7.5–11.6ROR 9.8 · χ² 544 / p 1e-120 | 9.0 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Tachycardia (fast heart rate) | 70 | 13.3 10.6–16.7ROR 14.0 · χ² 785 / p 6e-173 | 13.1 EB05 10.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 · ♀ 26% (drug 51%) | no trial data cached |
| Bronchospasm (airway tightening) | 69 | 81.5 64.8–102.6ROR 86.2 · χ² 5,384 / p <1e-300 | 79.4 EB05 64.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 52.8 | no trial data cached |
| Cardiac arrest (heart stopping) | 61 | 12.4 9.7–15.8ROR 13.0 · χ² 630 / p 3e-139 | 12.2 EB05 9.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 · 98% clinician | no trial data cached |
| Injury | 54 | 12.9 9.9–16.7ROR 13.4 · χ² 581 / p 1e-128 | 12.6 EB05 9.9 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 | no trial data cached |
| Unevaluable event | 53 | 11.8 9.1–15.4ROR 12.3 · χ² 514 / p 4e-114 | 11.5 EB05 9.0 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 12.3 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 52 | 58.2 44.6–76.0ROR 60.7 · χ² 2,860 / p <1e-300 | 56.9 EB05 45.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 34.2 · 94% clinician | no trial data cached |
| Fear | 50 | 31.1 23.7–40.8ROR 32.4 · χ² 1,426 / p <1e-300 | 30.7 EB05 24.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 24.8 | no trial data cached |
| Bradycardia (slow heart rate) | 42 | 13.3 9.9–17.9ROR 13.7 · χ² 467 / p 8e-104 | 13.0 EB05 9.9 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 | no trial data cached |
| Renal injury | 42 | 23.6 17.5–31.7ROR 24.4 · χ² 886 / p 7e-195 | 23.3 EB05 18.0 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.9 | no trial data cached |
| Shock | 42 | 31.0 23.0–41.8ROR 32.1 · χ² 1,190 / p 5e-261 | 30.6 EB05 23.6 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.3 · 95% clinician | no trial data cached |
| Stress | 41 | 9.6 7.1–13.0ROR 9.9 · χ² 308 / p 3e-69 | 9.1 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | 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=229, PRR 151.7
- Bronchospasm — n=69, PRR 81.5
- Toxic epidermal necrolysis — n=52, PRR 58.2
- Circulatory collapse — n=38, PRR 37.5
- Multi-organ failure — n=34, PRR 32.7
- Fear — n=50, PRR 31.1
- Face oedema — n=24, PRR 23.9
- Pneumothorax — n=20, PRR 21.3
- Anhedonia — n=32, PRR 20.4
- Stress — n=41, PRR 9.6
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 Sufentanil?
In FDA FAERS, the most frequently co-reported reaction terms for Sufentanil are anaphylactic shock, hypotension, anaphylactic reaction, renal failure, tachycardia, bronchospasm. 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 Sufentanil have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF SUFENTANIL CITRATE INJECTION Addiction, Abuse, and Misuse Because the use of Sufentanil Citrate Injection exposes patients and other users to the risks of opioid addict.
Do FAERS signals prove that Sufentanil 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 20293943-46ff-4345-1aa4-929b4e017a25, effective 20260601; matched on
openfda.generic_name.exact:"SUFENTANIL CITRATE") - 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, 55 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.