Sevoflurane: adverse event reports filed with FDA

5,472

reports as suspect product

0% of all reports · about 243 a year

818

reports, 12 months to June 2026

360 in the 12 months before

96.8%

marked serious by the reporter

94.2% across the class

6.9%

record death among outcomes, as reported

380 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Sevoflurane reports recording the termmedian drug in general anesthetic

1. Anaesthetic complication neurological9.3%509
2. Hypotensionlow blood pressure7.4%405
3. Hyperthermia malignant6.1%333
4. Cardiac arrestthe heart stopped4.9%266
5. Drug interactionan interaction between medicines4.6%251
6. Bradycardiaslow heart rate4.4%241
7. Foetal exposure during pregnancythe unborn baby was exposed to the medicine3.7%205
8. Acute kidney injurysudden loss of kidney function3.4%186
9. Tachycardiafast heart rate3.4%186
10. Oxygen saturation decreased2.6%141
11. Delayed recovery from anaesthesia2.5%139
12. Rhabdomyolysismuscle breakdown2.5%137
13. Anaphylactic shocka severe allergic reaction with collapse2.4%130
14. Drug ineffectivethe medicine did not work as expected2.4%130
15. Off label useused for a purpose or in a way not on the label2.2%121
16. Hypoxialow oxygen2%108
17. Ventricular fibrillationa chaotic rhythm from the lower heart chambers2%108
18. Dyspnoeashortness of breath1.9%105
19. Alanine aminotransferase increasedraised liver enzyme (ALT)1.8%101
20. Ventricular tachycardiaa fast rhythm from the lower heart chambers1.8%98
21. Bronchospasmtightening of the airways1.7%94
22. Nauseafeeling sick1.7%94
23. Blood creatine phosphokinase increased1.6%90
24. Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor1.6%87
25. Pulmonary alveolar haemorrhage1.5%84
26. Heart rate increaseda fast heart rate reading1.5%82
27. Low birth weight baby1.5%82
28. Pulmonary oedemafluid in the lungs1.5%82
29. Blood pressure decreaseda low blood pressure reading1.5%81
30. Apnoeapauses in breathing1.5%80

Top 30 of 746 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 8 drugs in the general anesthetic class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 31,985 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 19.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 5,472 reports.

Drugs most often listed in the same reports

Other products listed in reports where Sevoflurane is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the general anesthetic class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Sevoflurane as a suspect or interacting product; reports listing it only as a concomitant medication (2,729) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.