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What the label lists and what reports show

Sevoflurane side effects

Sevoflurane's FDA label lists its adverse reactions in its own words. FAERS holds 8,262 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hypotension (600 reports).

  • Generic listed

Check it at the source: the sevoflurane FDA label on DailyMed (effective February 12, 2025, AbbVie Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Clinical Trials Experience Adverse events are derived from controlled clinical studies conducted in the United States, Canada, and Europe. The reference drugs were isoflurane, enflurane, and propofol in adults and halothane in pediatric patients. The studies were conducted using a variety of premedications, other anesthetics, and surgical procedures of varying length. Most adverse events reported were mild and transient, and may reflect the surgical procedures, patient characteristics (including disease) and/or medications administered. Of the 5182 patients enrolled in the clinical studies, 2906 were exposed to sevoflurane, including 118 adults and 507 pediatric patients who underwent mask induction. Each patient was counted once for each type of adverse event. …

Source: FDA drug label, AbbVie Inc., effective February 12, 2025 (SPL set c9aa6489-5a36-44ed-9512-b996833d82f7), via openFDA; the full label on DailyMed

What do FAERS reports show?

8,262 reports list sevoflurane among the medicines taken, each a report of something that happened, not proof the medicine caused it; 557 are coded as a death and 2,863 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Hypotension (named in the label)600
  • Anaesthetic Complication Neurological519
  • Drug Interaction (a use or a product term, not a reaction)494
  • Cardiac Arrest (named in the label)420
  • Bradycardia (named in the label)377
  • Drug Ineffective (a use or a product term, not a reaction)295
  • Hyperthermia Malignant287
  • Tachycardia (named in the label)274
  • Anaphylactic Shock252
  • Serotonin Syndrome252
  • Anaphylactic Reaction (named in the label)235
  • Oxygen Saturation Decreased224
  • Foetal Exposure During Pregnancy (a use or a product term, not a reaction)220
  • Off Label Use (a use or a product term, not a reaction)220
  • Acute Kidney Injury215
  • Blood Pressure Decreased195
  • Delayed Recovery From Anaesthesia192
  • Rhabdomyolysis187
  • Bronchospasm (named in the label)181
  • Hypoxia (named in the label)166
  • Dyspnoea (named in the label)154
  • Ventricular Fibrillation (named in the label)150
  • Anaesthetic Complication148
  • Nausea (named in the label)148
  • Hypertension (named in the label)147

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Sevoflurane: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions