Drug · FAERS side-effect profile with label screen
Remifentanil side effects: what 2,362 FDA adverse event reports show
Drug class
Opioid agonist
FDA label, Indications wording of the closest related product
Label matched
Remifentanil Hydrochloride (Remifentanil Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,362 reports · 96% serious · 244 with death outcome · 49% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Remifentanil Hydrochloride for injection is indicated for intravenous (IV) administration: As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. For continuation as an analgesi.
FDA label, Indications and Usage
What it is
Remifentanil Hydrochloride for injection is an opioid agonist.
FDA label, Description section
Boxed warning
ADDICTION, ABUSE, AND MISUSE WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF REMIFENTANIL HYDROCHLORIDE FOR INJECTION Addiction, Abuse, and Misuse Because the use of Remifentanil Hydrochloride for injection e.
FDA 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 — boxed warning 3Labeled adverse reaction 10Labeled (related wording) 4Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 18
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. 43 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 | 357 | 125.4 113.9–138.1ROR 147.6 · χ² 43,372 / p <1e-300 | 122.9 EB05 112.5 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 74.4 | no trial data cached |
| Bronchospasm (airway tightening) | 78 | 48.6 39.1–60.5ROR 50.3 · χ² 3,574 / p <1e-300 | 47.8 EB05 39.6 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.0 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 60 | 35.5 27.6–45.5ROR 36.4 · χ² 1,968 / p <1e-300 | 35.0 EB05 28.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.2 · 93% clinician | no trial data cached |
| Ventricular fibrillation | 39 | 31.2 22.8–42.6ROR 31.7 · χ² 1,106 / p 7e-243 | 30.7 EB05 23.4 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.2 · ♀ 26% (drug 49%) · 92% clinician | no trial data cached |
| Circulatory collapse | 52 | 27.1 20.7–35.4ROR 27.7 · χ² 1,277 / p 7e-280 | 26.8 EB05 21.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 150 | 24.3 20.8–28.4ROR 25.9 · χ² 3,328 / p <1e-300 | 24.2 EB05 21.1 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.8 | no trial data cached |
| Post procedural complication | 40 | 18.5 13.6–25.1ROR 18.8 · χ² 644 / p 3e-142 | 18.3 EB05 14.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 7.8 · 100% clinician | no trial data cached |
| Respiratory depression | 25 | 18.1 12.3–26.8ROR 18.3 · χ² 387 / p 2e-86 | 17.8 EB05 12.5 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.2 | no trial data cached |
| Bradycardia (slow heart rate) | 88 | 14.7 12.0–18.1ROR 15.3 · χ² 1,113 / p 2e-244 | 14.6 EB05 12.2 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 | no trial data cached |
| Ventricular tachycardia | 26 | 13.9 9.5–20.4ROR 14.1 · χ² 299 / p 2e-67 | 13.5 EB05 9.4 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.4 · 96% clinician | no trial data cached |
| Blood pressure decreased | 103 | 13.8 11.4–16.7ROR 14.4 · χ² 1,213 / p 5e-266 | 13.7 EB05 11.6 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.2 | no trial data cached |
| Cardiac arrest (heart stopping) | 121 | 13.0 10.9–15.4ROR 13.6 · χ² 1,329 / p 2e-291 | 12.9 EB05 11.0 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 | no trial data cached |
| Post procedural haemorrhage | 15 | 11.4 6.9–18.9ROR 11.5 · χ² 132 / p 7e-31 | 10.1 EB05 6.0 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 7.6 | no trial data cached |
| Hypoxia (low oxygen) | 45 | 11.4 8.5–15.2ROR 11.6 · χ² 417 / p 6e-93 | 11.0 EB05 8.4 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 51 | 10.9 8.3–14.3ROR 11.1 · χ² 449 / p 8e-100 | 10.5 EB05 8.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 29% (drug 49%) · 98% clinician | no trial data cached |
| Respiratory arrest | 34 | 10.9 7.8–15.2ROR 11.0 · χ² 295 / p 2e-66 | 10.3 EB05 7.5 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · 91% clinician | no trial data cached |
| Lymphopenia | 17 | 10.7 6.7–17.2ROR 10.8 · χ² 140 / p 1e-32 | 9.5 EB05 5.9 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Serotonin syndrome | 23 | 10.7 7.1–16.1ROR 10.8 · χ² 192 / p 5e-44 | 9.8 EB05 6.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · ♀ 78% (drug 49%) · 96% clinician | no trial data cached |
| Sinus tachycardia | 17 | 10.7 6.6–17.1ROR 10.7 · χ² 139 / p 2e-32 | 9.5 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 30 | 10.4 7.3–14.9ROR 10.6 · χ² 247 / p 7e-56 | 9.8 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 12% (drug 49%) · 100% clinician | no trial data cached |
| Ventricular extrasystoles | 12 | 10.3 5.8–18.0ROR 10.3 · χ² 91 / p 7e-22 | 8.5 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Status epilepticus | 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 6.1 | no trial data cached |
| Shock | 25 | 9.7 6.6–14.4ROR 9.8 · χ² 187 / p 6e-43 | 8.9 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 95% clinician | no trial data cached |
| Toxic skin eruption | 11 | 9.7 5.4–17.4ROR 9.7 · χ² 77 / p 8e-19 | 7.8 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Oxygen saturation decreased | 58 | 9.2 7.2–11.9ROR 9.4 · χ² 418 / p 3e-93 | 8.9 EB05 7.0 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.9 | no trial data cached |
| Tachycardia (fast heart rate) | 87 | 8.7 7.1–10.7ROR 9.0 · χ² 587 / p 5e-130 | 8.5 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Rash maculo-papular | 21 | 8.4 5.5–12.9ROR 8.5 · χ² 130 / p 2e-30 | 7.4 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 100% clinician | no trial data cached |
| Cardio-respiratory arrest | 39 | 8.2 6.0–11.2ROR 8.4 · χ² 241 / p 1e-54 | 7.7 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 95% clinician | no trial data cached |
| Multi-organ failure | 16 | 8.1 5.0–13.2ROR 8.2 · χ² 93 / p 3e-22 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Altered state of consciousness | 19 | 7.8 5.0–12.3ROR 7.9 · χ² 107 / p 3e-25 | 6.8 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Hepatocellular injury | 12 | 7.5 4.3–13.2ROR 7.5 · χ² 61 / p 3e-15 | 6.1 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Muscle rigidity | 10 | 7.4 4.0–13.8ROR 7.5 · χ² 49 / p 1e-12 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Body temperature increased | 17 | 7.4 4.6–11.8ROR 7.4 · χ² 87 / p 4e-21 | 6.3 EB05 4.1 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 | no trial data cached |
| Hepatic cytolysis | 10 | 7.3 3.9–13.5ROR 7.3 · χ² 48 / p 2e-12 | 5.7 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Hypotension (low blood pressure) | 159 | 7.1 6.1–8.2ROR 7.5 · χ² 827 / p 3e-182 | 6.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.8 | no trial data cached |
| Blood creatine phosphokinase increased | 23 | 7.0 4.7–10.5ROR 7.0 · χ² 112 / p 2e-26 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 4.7 · 100% clinician | no trial data cached |
| Mydriasis | 10 | 6.9 3.7–12.9ROR 7.0 · χ² 45 / p 1e-11 | 5.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Renal failure acute | 33 | 6.8 4.9–9.6ROR 6.9 · χ² 158 / p 2e-36 | 6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 · ♀ 76% (drug 49%) | no trial data cached |
| Drug eruption | 13 | 6.6 3.8–11.3ROR 6.6 · χ² 56 / p 4e-14 | 5.4 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Premature baby | 22 | 6.5 4.3–9.8ROR 6.5 · χ² 96 / p 5e-23 | 5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 95% clinician | 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 shock | 357 | 125.4 113.9–138.1ROR 147.6 · χ² 43,372 / p <1e-300 | 122.9 EB05 112.5 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 74.4 | no trial data cached |
| Hypotension (low blood pressure) | 159 | 7.1 6.1–8.2ROR 7.5 · χ² 827 / p 3e-182 | 6.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.8 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 150 | 24.3 20.8–28.4ROR 25.9 · χ² 3,328 / p <1e-300 | 24.2 EB05 21.1 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.8 | no trial data cached |
| Cardiac arrest (heart stopping) | 121 | 13.0 10.9–15.4ROR 13.6 · χ² 1,329 / p 2e-291 | 12.9 EB05 11.0 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 | no trial data cached |
| Blood pressure decreased | 103 | 13.8 11.4–16.7ROR 14.4 · χ² 1,213 / p 5e-266 | 13.7 EB05 11.6 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.2 | no trial data cached |
| Bradycardia (slow heart rate) | 88 | 14.7 12.0–18.1ROR 15.3 · χ² 1,113 / p 2e-244 | 14.6 EB05 12.2 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 | no trial data cached |
| Tachycardia (fast heart rate) | 87 | 8.7 7.1–10.7ROR 9.0 · χ² 587 / p 5e-130 | 8.5 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Bronchospasm (airway tightening) | 78 | 48.6 39.1–60.5ROR 50.3 · χ² 3,574 / p <1e-300 | 47.8 EB05 39.6 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.0 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 60 | 35.5 27.6–45.5ROR 36.4 · χ² 1,968 / p <1e-300 | 35.0 EB05 28.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.2 · 93% clinician | no trial data cached |
| Oxygen saturation decreased | 58 | 9.2 7.2–11.9ROR 9.4 · χ² 418 / p 3e-93 | 8.9 EB05 7.0 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.9 | no trial data cached |
| Circulatory collapse | 52 | 27.1 20.7–35.4ROR 27.7 · χ² 1,277 / p 7e-280 | 26.8 EB05 21.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 51 | 10.9 8.3–14.3ROR 11.1 · χ² 449 / p 8e-100 | 10.5 EB05 8.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 29% (drug 49%) · 98% clinician | no trial data cached |
| Hypoxia (low oxygen) | 45 | 11.4 8.5–15.2ROR 11.6 · χ² 417 / p 6e-93 | 11.0 EB05 8.4 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Post procedural complication | 40 | 18.5 13.6–25.1ROR 18.8 · χ² 644 / p 3e-142 | 18.3 EB05 14.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 7.8 · 100% clinician | no trial data cached |
| Cardio-respiratory arrest | 39 | 8.2 6.0–11.2ROR 8.4 · χ² 241 / p 1e-54 | 7.7 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 95% 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=357, PRR 125.4
- Toxic epidermal necrolysis — n=60, PRR 35.5
- Circulatory collapse — n=52, PRR 27.1
- Rhabdomyolysis — n=51, PRR 10.9
- Drug reaction with eosinophilia and systemic symptoms — n=30, PRR 10.4
- Shock — n=25, PRR 9.7
- Rash maculo-papular — n=21, PRR 8.4
- Cardio-respiratory arrest — n=39, PRR 8.2
- Premature baby — n=22, PRR 6.5
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 Remifentanil?
In FDA FAERS, the most frequently co-reported reaction terms for Remifentanil are anaphylactic shock, hypotension, anaphylactic reaction, cardiac arrest, blood pressure decreased, bradycardia. 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 Remifentanil have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: ADDICTION, ABUSE, AND MISUSE WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF REMIFENTANIL HYDROCHLORIDE FOR INJECTION Addiction, Abuse, and Misuse Because the use of Remifentanil Hydrochloride for injection e.
Do FAERS signals prove that Remifentanil 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 9d289052-1eb6-4ba2-a3ca-d2e542a052ae, effective 20240101; matched on
openfda.generic_name.exact:"REMIFENTANIL HYDROCHLORIDE") - 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, 83 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.