Drug · FAERS side-effect profile with label screen
Sevoflurane side effects: what 8,262 FDA adverse event reports show
Who reports
8,262 reports · 95% serious · 557 with death outcome · 49% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available.
FDA label, Indications and Usage
What it is
DESCRIPTION Sevoflurane, USP, volatile liquid for inhalation, a nonflammable and nonexplosive liquid administered by vaporization, is a halogenated general inhalation anesthetic drug. Sevoflur.
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 2Labeled (related wording) 6Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 27
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. 959 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 |
|---|---|---|---|---|---|---|
| Anaesthetic complication neurological | 519 | 3,410.0 2,992.9–3,885.1ROR 3,638.4 · χ² 747,350 / p <1e-300 | 1,370.4 EB05 1,274.3 · IC025 +9.1 3/3 methods agree | Not in label — unassessed | serious n=517 · 100% clinician | no trial data cached |
| End-tidal co2 increased | 18 | 1,802.3 983.7–3,302.2ROR 1,806.3 · χ² 17,808 / p <1e-300 | 494.5 EB05 331.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Negative pressure pulmonary oedema | 38 | 1,761.6 1,163.9–2,666.2ROR 1,769.7 · χ² 38,219 / p <1e-300 | 678.5 EB05 516.0 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 23% (drug 49%) · 95% clinician | no trial data cached |
| Epilepsy with myoclonic-atonic seizures | 11 | 1,619.8 758.9–3,457.0ROR 1,621.9 · χ² 9,843 / p <1e-300 | 362.5 EB05 216.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Acute postoperative sialadenitis | 11 | 1,529.8 722.8–3,237.9ROR 1,531.8 · χ² 9,503 / p <1e-300 | 357.8 EB05 213.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Unwanted awareness during anaesthesia | 90 | 962.8 755.7–1,226.6ROR 973.4 · χ² 61,760 / p <1e-300 | 605.5 EB05 507.6 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=86 · ♀ 71% (drug 49%) · 95% clinician | no trial data cached |
| Myoglobin urine present | 66 | 912.8 689.2–1,209.0ROR 920.1 · χ² 43,384 / p <1e-300 | 559.9 EB05 455.4 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=65 · ♀ 97% (drug 49%) · 95% clinician | no trial data cached |
| Tracheal deviation | 23 | 885.8 550.8–1,424.4ROR 888.2 · χ² 14,367 / p <1e-300 | 423.2 EB05 297.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 49%) · 100% clinician | no trial data cached |
| Recurrence of neuromuscular blockade | 41 | 789.5 556.1–1,120.8ROR 793.4 · χ² 23,950 / p <1e-300 | 468.5 EB05 360.1 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=40 | no trial data cached |
| Mitochondrial enzyme deficiency | 11 | 744.2 379.8–1,458.4ROR 745.2 · χ² 5,733 / p <1e-300 | 287.4 EB05 171.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Delayed recovery from anaesthesia | 192 | 646.0 552.0–756.0ROR 661.3 · χ² 97,777 / p <1e-300 | 488.6 EB05 433.3 · IC025 +7.5 3/3 methods agree | Labeled (related wording) related wording | serious n=184 · 98% clinician | no trial data cached |
| Hyperthermia malignant | 287 | 613.5 540.2–696.8ROR 635.6 · χ² 140,478 / p <1e-300 | 477.2 EB05 432.6 · IC025 +7.9 3/3 methods agree | Labeled (related wording) related wording | serious n=283 · ♀ 25% (drug 49%) · 98% clinician | no trial data cached |
| Airway peak pressure increased | 26 | 524.9 344.1–800.6ROR 526.5 · χ² 10,809 / p <1e-300 | 328.9 EB05 235.9 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=26 | no trial data cached |
| Neuromuscular block prolonged | 62 | 508.9 387.6–668.1ROR 512.7 · χ² 25,696 / p <1e-300 | 374.1 EB05 302.3 · IC025 +6.2 3/3 methods agree | Labeled (related wording) related wording | serious n=59 · 93% clinician | no trial data cached |
| Basal ganglion degeneration | 15 | 469.4 270.5–814.4ROR 470.2 · χ² 5,516 / p <1e-300 | 263.0 EB05 169.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Anaesthetic complication pulmonary | 11 | 357.6 190.2–672.4ROR 358.1 · χ² 3,118 / p <1e-300 | 203.2 EB05 121.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Postoperative delirium | 22 | 335.8 215.3–523.8ROR 336.7 · χ² 6,183 / p <1e-300 | 235.7 EB05 164.1 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · 100% clinician | no trial data cached |
| Phrenic nerve paralysis | 25 | 331.1 218.3–502.2ROR 332.1 · χ² 6,978 / p <1e-300 | 239.2 EB05 170.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 49%) · 100% clinician | no trial data cached |
| Neuromuscular blockade | 25 | 312.9 206.6–474.0ROR 313.9 · χ² 6,635 / p <1e-300 | 229.6 EB05 163.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | no trial data cached |
| Procedural hypertension | 17 | 250.3 152.1–411.9ROR 250.8 · χ² 3,614 / p <1e-300 | 181.6 EB05 120.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Carcinoid crisis | 16 | 191.6 115.3–318.5ROR 192.0 · χ² 2,644 / p <1e-300 | 147.2 EB05 96.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Airway complication of anaesthesia | 18 | 189.3 117.3–305.5ROR 189.7 · χ² 2,962 / p <1e-300 | 148.6 EB05 99.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Myotonia | 15 | 182.3 108.0–307.7ROR 182.6 · χ² 2,354 / p <1e-300 | 140.1 EB05 90.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Anaesthetic complication | 148 | 148.8 126.2–175.4ROR 151.5 · χ² 20,370 / p <1e-300 | 138.0 EB05 120.3 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious n=95 · 96% clinician | no trial data cached |
| Glossoptosis | 12 | 147.3 82.3–263.5ROR 147.5 · χ² 1,511 / p <1e-300 | 114.3 EB05 69.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Nephrogenic diabetes insipidus | 46 | 105.6 78.7–141.8ROR 106.2 · χ² 4,475 / p <1e-300 | 97.4 EB05 76.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 12% (drug 49%) · 98% clinician | no trial data cached |
| Spinal cord infarction | 17 | 102.3 63.0–166.1ROR 102.5 · χ² 1,542 / p <1e-300 | 88.8 EB05 58.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Operative haemorrhage | 17 | 99.2 61.1–161.0ROR 99.4 · χ² 1,496 / p <1e-300 | 86.5 EB05 57.2 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | no trial data cached |
| Diabetes insipidus | 88 | 95.7 77.4–118.3ROR 96.7 · χ² 7,852 / p <1e-300 | 90.4 EB05 75.7 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=88 · 99% clinician | no trial data cached |
| Pco2 increased | 26 | 95.4 64.5–141.1ROR 95.7 · χ² 2,250 / p <1e-300 | 86.3 EB05 61.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | no trial data cached |
| Neonatal respiratory depression | 12 | 93.9 52.8–167.0ROR 94.0 · χ² 975 / p 2e-214 | 79.5 EB05 48.4 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Procedural hypotension | 30 | 92.0 64.0–132.4ROR 92.4 · χ² 2,518 / p <1e-300 | 84.2 EB05 61.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | no trial data cached |
| Status asthmaticus | 14 | 76.5 45.0–130.2ROR 76.6 · χ² 941 / p 8e-207 | 67.7 EB05 42.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Endotracheal intubation complication | 17 | 75.9 46.8–122.8ROR 76.0 · χ² 1,147 / p 9e-252 | 68.3 EB05 45.1 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=16 | no trial data cached |
| Basal ganglia infarction | 10 | 75.2 40.1–141.0ROR 75.3 · χ² 640 / p 1e-141 | 64.5 EB05 37.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Blood pressure measurement | 18 | 73.4 45.9–117.2ROR 73.5 · χ² 1,179 / p 1e-258 | 66.5 EB05 44.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Laryngospasm | 68 | 65.7 51.7–83.5ROR 66.2 · χ² 4,159 / p <1e-300 | 63.0 EB05 51.4 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=66 · 97% clinician | no trial data cached |
| Hypercapnia | 71 | 61.7 48.8–78.0ROR 62.2 · χ² 4,079 / p <1e-300 | 59.3 EB05 48.6 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=71 · 98% clinician | no trial data cached |
| Maternal exposure during delivery | 23 | 61.5 40.7–93.0ROR 61.7 · χ² 1,278 / p 4e-280 | 57.4 EB05 40.3 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=18 · ♀ 100% (drug 49%) · 100% clinician | no trial data cached |
| Vasoplegia syndrome | 36 | 57.8 41.6–80.4ROR 58.1 · χ² 1,910 / p <1e-300 | 55.0 EB05 41.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=36 · 100% 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 |
|---|---|---|---|---|---|---|
| Hypotension (low blood pressure) | 600 | 7.6 7.1–8.2ROR 8.1 · χ² 3,468 / p <1e-300 | 7.6 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · 96% clinician | no trial data cached |
| Anaesthetic complication neurological | 519 | 3,410.0 2,992.9–3,885.1ROR 3,638.4 · χ² 747,350 / p <1e-300 | 1,370.4 EB05 1,274.3 · IC025 +9.1 3/3 methods agree | Not in label — unassessed | serious n=517 · 100% clinician | no trial data cached |
| Drug interaction | 494 | 7.9 7.3–8.6ROR 8.4 · χ² 2,994 / p <1e-300 | 7.9 EB05 7.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 97% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 420 | 12.9 11.8–14.2ROR 13.6 · χ² 4,603 / p <1e-300 | 12.8 EB05 11.8 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 · 97% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 377 | 18.1 16.4–20.0ROR 18.9 · χ² 6,056 / p <1e-300 | 18.0 EB05 16.5 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.9 · 94% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 295 | 0.6 0.5–0.6ROR 0.6 · χ² 103 / p 2e-24 | 0.6 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 · 97% clinician | no trial data cached |
| Hyperthermia malignant | 287 | 613.5 540.2–696.8ROR 635.6 · χ² 140,478 / p <1e-300 | 477.2 EB05 432.6 · IC025 +7.9 3/3 methods agree | Labeled (related wording) related wording | serious n=283 · ♀ 25% (drug 49%) · 98% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 275 | 7.9 7.0–8.8ROR 8.1 · χ² 1,646 / p <1e-300 | 7.8 EB05 7.0 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · 93% clinician | no trial data cached |
| Anaphylactic shock | 252 | 25.2 22.3–28.5ROR 26.0 · χ² 5,780 / p <1e-300 | 24.9 EB05 22.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 · 92% clinician | no trial data cached |
| Serotonin syndrome | 252 | 33.9 30.0–38.3ROR 34.9 · χ² 7,906 / p <1e-300 | 33.4 EB05 30.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 20.4 · 96% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 235 | 10.9 9.6–12.4ROR 11.2 · χ² 2,099 / p <1e-300 | 10.8 EB05 9.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 95% clinician | no trial data cached |
| Oxygen saturation decreased | 224 | 10.2 9.0–11.6ROR 10.5 · χ² 1,852 / p <1e-300 | 10.1 EB05 9.0 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 6.6 · 95% clinician | no trial data cached |
| Off label use (used outside approved label) | 220 | 0.6 0.6–0.7ROR 0.6 · χ² 45 / p 1e-11 | 0.6 EB05 0.6 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.7 · 93% clinician | no trial data cached |
| Foetal exposure during pregnancy | 220 | 6.9 6.0–7.8ROR 7.0 · χ² 1,103 / p 4e-242 | 6.8 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · 98% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 215 | 3.6 3.1–4.1ROR 3.7 · χ² 401 / p 2e-89 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.2 · 98% 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.
- Anaesthetic complication neurological — n=519, PRR 3,410.0
- Negative pressure pulmonary oedema — n=38, PRR 1,761.6
- Unwanted awareness during anaesthesia — n=90, PRR 962.8
- Tracheal deviation — n=23, PRR 885.8
- Recurrence of neuromuscular blockade — n=41, PRR 789.5
- Phrenic nerve paralysis — n=25, PRR 331.1
- Neuromuscular blockade — n=25, PRR 312.9
- Nephrogenic diabetes insipidus — n=46, PRR 105.6
- Diabetes insipidus — n=88, PRR 95.7
- Pco2 increased — n=26, PRR 95.4
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 Sevoflurane?
In FDA FAERS, the most frequently co-reported reaction terms for Sevoflurane are hypotension, anaesthetic complication neurological, cardiac arrest, bradycardia, hyperthermia malignant, 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 Sevoflurane have an FDA boxed warning?
No. The FDA label retrieved for Sevoflurane has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sevoflurane 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 22700993-851a-48aa-941e-1d2b6b04081f, effective 20250430; matched on
openfda.generic_name.exact:"SEVOFLURANE") - 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, 999 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.