Sevoflurane adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Sevoflurane
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: General anesthetic
Also reported as: Sevoflurane Usp

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 5,472 adverse event reports that name Sevoflurane. In these reports the drug is a suspect or interacting product.

In the same period, 2,729 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 818 reports in the 12 months to June 2026 and 360 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 818 (0.1%) name Sevoflurane. Reports from consumers or other non-health professionals were 3.3% of the reports that name Sevoflurane and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Sevoflurane is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 386 reports that name Sevoflurane.
In January to March 2026, FDA received 87.
In April to June 2025, FDA received 98.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 406 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 5,449 of the 5,472 reports (99.6%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 406 terms.

Reaction terms in the reports that name Sevoflurane, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 5,472 reports
Anaesthetic complication neurological	509	9.3%
Hypotensionlow blood pressure	405	7.4%
Hyperthermia malignant	333	6.1%
Cardiac arrestthe heart stopped	266	4.9%
Drug interactionan interaction between medicines	251	4.6%
Bradycardiaslow heart rate	241	4.4%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	205	3.7%
Acute kidney injurysudden loss of kidney function	186	3.4%
Tachycardiafast heart rate	186	3.4%
Oxygen saturation decreased	141	2.6%
Delayed recovery from anaesthesia	139	2.5%
Rhabdomyolysismuscle breakdown	137	2.5%
Anaphylactic shocka severe allergic reaction with collapse	130	2.4%
Drug ineffectivethe medicine did not work as expected	130	2.4%
Off label useused for a purpose or in a way not on the label	121	2.2%
Hypoxialow oxygen	108	2%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	108	2%
Dyspnoeashortness of breath	105	1.9%
Alanine aminotransferase increasedraised liver enzyme (ALT)	101	1.8%
Ventricular tachycardiaa fast rhythm from the lower heart chambers	98	1.8%
Bronchospasmtightening of the airways	94	1.7%
Nauseafeeling sick	94	1.7%
Blood creatine phosphokinase increased	90	1.6%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	87	1.6%
Pulmonary alveolar haemorrhage	84	1.5%
Heart rate increaseda fast heart rate reading	82	1.5%
Low birth weight baby	82	1.5%
Pulmonary oedemafluid in the lungs	82	1.5%
Blood pressure decreaseda low blood pressure reading	81	1.5%
Apnoeapauses in breathing	80	1.5%
Hypertensionhigh blood pressure	76	1.4%
Anaphylactic reactiona severe, sudden allergic reaction	75	1.4%
Post procedural complicationa complication after a procedure	74	1.4%
Premature babya baby born early	72	1.3%
Hyperthermia	71	1.3%
Torsade de pointesa serious irregular heart rhythm	71	1.3%
Blood potassium increased	69	1.3%
Respiratory failurethe lungs could not supply enough oxygen	69	1.3%
Vomitingbeing sick	69	1.3%
Electrocardiogram QT prolongeda QT prolongation on the ECG	65	1.2%
Blood lactate dehydrogenase increased	64	1.2%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	64	1.2%
Metabolic acidosistoo much acid in the body fluids	64	1.2%
Unwanted awareness during anaesthesia	63	1.2%
Cardio-respiratory arrestthe heart and breathing stopped	61	1.1%
Troponin increased	61	1.1%
Amylase increased	60	1.1%
Toxic encephalopathy	60	1.1%
Myoglobin urine present	59	1.1%
Diabetes insipidus	57	1%

Download all 406 terms of Sevoflurane (CSV)

The counts add to more than 5,472 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Sevoflurane with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Sevoflurane (this page)	Generic name	5,472
Ultane	Brand name	343

Sum of the separately reported names: 5,815. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Sevoflurane, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	82	60	8	21	21	3	0	20	22
2005	61	53	6	11	20	3	0	28	8
2006	59	54	6	13	18	1	0	32	5
2007	101	99	12	22	38	3	0	51	2
2008	109	103	21	22	37	5	0	59	6
2009	136	131	18	35	52	7	0	70	5
2010	148	146	19	30	47	5	0	83	2
2011	245	239	42	52	79	6	0	121	6
2012	295	294	23	33	42	4	0	243	1
2013	255	253	15	35	48	2	0	193	2
2014	290	288	19	22	33	2	0	235	2
2015	153	147	15	16	31	3	0	107	6
2016	202	195	15	19	46	1	1	152	7
2017	149	142	10	22	46	0	0	105	7
2018	231	226	11	44	84	9	0	171	5
2019	230	218	8	47	102	2	2	170	12
2020	273	268	17	52	140	11	4	185	5
2021	329	322	22	48	108	6	2	254	7
2022	318	309	16	57	127	0	2	249	9
2023	382	372	23	80	130	9	2	285	10
2024	350	332	14	89	154	13	7	236	18
2025	578	560	23	81	174	2	0	474	18
2026	496	487	17	60	120	13	0	401	9

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Sevoflurane, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Sevoflurane, by the year in which FDA received them
Year	Reports
2004	79
2005	55
2006	61
2007	102
2008	109
2009	137
2010	147
2011	255
2012	305
2013	263
2014	288
2015	205
2016	144
2017	151
2018	271
2019	236
2020	275
2021	344
2022	323
2023	379
2024	326
2025	544
2026	473

Reports that name Sevoflurane, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Sevoflurane
Age	Reports	Share
Under 2	221	4%
2 to 11	407	7.4%
12 to 17	276	5%
18 to 44	886	16.2%
45 to 64	809	14.8%
65 to 74	355	6.5%
75 and over	222	4.1%
Age not given	2,296	42%

Sex of the patient in the reports that name Sevoflurane
Sex	Reports	Share
Female	1,916	35%
Male	1,946	35.6%
Unknown or not given	1,610	29.4%

Type of reporter in the reports that name Sevoflurane
Reporter	Reports	Share
Physician	2,110	38.6%
Pharmacist	294	5.4%
Other health professional	2,570	47%
Lawyer	4	0.1%
Consumer or non-health professional	179	3.3%
Not given	315	5.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 19.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Sevoflurane record
Indication as recorded (MedDRA)	Reports	Share
Maintenance of anaesthesia	1,094	20%
Anaesthesia	1,065	19.5%
General anaesthesia	925	16.9%
Induction of anaesthesia	517	9.4%
Induction and maintenance of anaesthesia	364	6.7%
Anaesthesia procedure	104	1.9%

The reporter fills in the indication, and the field is often empty. Each share is of all 5,472 reports.

Drugs in the same reports

Other drugs that the reports of Sevoflurane name, in any role, in order of name
Drug	Reports that name the two
Dexamethasone	487
Fentanyl	1,830
Lidocaine	464
Midazolam	904
Nitrous oxide	412
Propofol	2,601
Remifentanil	922
Rocuronium	1,003
Rocuronium bromide	500
Sufentanil	470

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Ultane same ingredient
Propofol same class
Suprane same class
Ketamine hydrochloride same class
Ketalar same class
Sevelamer hydrochloride next in the A to Z list
Sevorane next in the A to Z list
Sevelamer carbonate next in the A to Z list
Shingrix next in the A to Z list
Sevelamer next in the A to Z list
Shower To Shower Talcum Product next in the A to Z list
Serzone next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for SevofluraneThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

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Reported Reactions. Sevoflurane: adverse event reports that FDA received. https://reportedreactions.com/drug/sevoflurane/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Sevoflurane as a suspect or interacting product. The 2,729 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Sevoflurane was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Sevoflurane?

No. It is a count of what people reported to FDA: 5,472 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (47%), physician (38.6%) and pharmacist (5.4%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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