Remifentanil adverse event reports that FDA received

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

Name type: Product name as reported
Also reported as: Remifentanil /01229902/

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 February 2004 to June 2026, FDA received 2,548 adverse event reports that name Remifentanil. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 1,926 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 213 reports in the 12 months to June 2026 and 170 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, 213 (under 0.1%) name Remifentanil. Reports from consumers or other non-health professionals were 2.2% of the reports that name Remifentanil 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 Remifentanil 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 51 reports that name Remifentanil.
In January to March 2026, FDA received 22.
In April to June 2025, FDA received 54.

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 207 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 2,532 of the 2,548 reports (99.4%).

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 207 terms.

Reaction terms in the reports that name Remifentanil, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,548 reports
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	201	7.9%
Drug interactionan interaction between medicines	186	7.3%
Hypotensionlow blood pressure	182	7.1%
Anaphylactic shocka severe allergic reaction with collapse	178	7%
Cardiac arrestthe heart stopped	160	6.3%
Bradycardiaslow heart rate	138	5.4%
Anaphylactic reactiona severe, sudden allergic reaction	130	5.1%
Anaesthetic complication neurological	119	4.7%
Off label useused for a purpose or in a way not on the label	86	3.4%
Drug ineffectivethe medicine did not work as expected	81	3.2%
Premature babya baby born early	77	3%
Low birth weight baby	76	3%
Respiratory depressionslow or shallow breathing	64	2.5%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	56	2.2%
Hypoxialow oxygen	54	2.1%
Tachycardiafast heart rate	54	2.1%
Hyperthermia malignant	52	2%
Apnoeapauses in breathing	47	1.8%
Oxygen saturation decreased	47	1.8%
Cardio-respiratory arrestthe heart and breathing stopped	45	1.8%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	43	1.7%
Exposure during pregnancythe medicine was taken during pregnancy	42	1.6%
Delayed recovery from anaesthesia	41	1.6%
Pneumonialung infection	41	1.6%
Urticariahives	36	1.4%
Blood pressure decreaseda low blood pressure reading	34	1.3%
Premature delivery	33	1.3%
Bronchospasmtightening of the airways	31	1.2%
Rhabdomyolysismuscle breakdown	31	1.2%
Circulatory collapsecollapse of the circulation	30	1.2%
Unwanted awareness during anaesthesia	30	1.2%
Rashskin rash	28	1.1%
Toxic epidermal necrolysisa severe skin reaction with peeling	28	1.1%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	26	1%
Erythemaskin redness	26	1%
Neuromuscular block prolonged	26	1%
Toxicity to various agentspoisoning or toxic effect of one or more substances	26	1%
Hypertensionhigh blood pressure	25	1%
Loss of consciousnesspassing out	25	1%
Respiratory arrestbreathing stopped	25	1%
Dyspnoeashortness of breath	24	0.9%
Metabolic acidosistoo much acid in the body fluids	24	0.9%
Procedural hypotension	23	0.9%
Vomitingbeing sick	23	0.9%
Product use in unapproved indicationused for a purpose not on the label	22	0.9%
Diabetes insipidus	21	0.8%
Pruritusitching	21	0.8%
Hyperkalaemiahigh blood potassium	19	0.7%
Somnolencedrowsiness	19	0.7%
Condition aggravatedthe condition being treated got worse	18	0.7%

Download all 207 terms of Remifentanil (CSV)

The counts add to more than 2,548 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.

Outcomes by year

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

Outcomes in the reports that name Remifentanil, 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	4	4	0	4	0	0	0	0	0
2005	10	9	0	3	0	0	0	6	1
2006	21	21	2	1	8	0	0	15	0
2007	30	29	5	3	3	0	0	19	1
2008	23	23	1	2	6	0	0	16	0
2009	29	29	0	11	19	0	0	10	0
2010	26	26	1	7	9	1	0	19	0
2011	50	50	7	6	9	1	0	37	0
2012	112	112	0	3	9	0	0	105	0
2013	184	183	5	20	11	0	0	161	1
2014	86	86	6	13	13	2	0	65	0
2015	81	81	3	6	7	0	1	72	0
2016	100	99	3	12	18	1	0	77	1
2017	129	129	12	21	45	0	1	100	0
2018	175	171	12	48	56	4	0	112	4
2019	180	177	10	63	79	3	4	104	3
2020	213	210	10	62	75	10	13	128	3
2021	158	151	21	55	59	0	1	103	7
2022	204	203	10	60	101	1	0	152	1
2023	198	194	14	68	76	1	0	140	4
2024	204	203	17	55	77	1	4	149	1
2025	254	251	11	67	92	6	0	187	3
2026	77	76	11	39	36	9	0	43	1

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 Remifentanil, 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 Remifentanil, by the year in which FDA received them
Year	Reports
2004	4
2005	10
2006	21
2007	30
2008	23
2009	29
2010	25
2011	51
2012	112
2013	192
2014	82
2015	101
2016	89
2017	134
2018	193
2019	190
2020	212
2021	159
2022	192
2023	194
2024	192
2025	240
2026	73

Reports that name Remifentanil, 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 Remifentanil
Age	Reports	Share
Under 2	49	1.9%
2 to 11	58	2.3%
12 to 17	72	2.8%
18 to 44	587	23%
45 to 64	522	20.5%
65 to 74	287	11.3%
75 and over	179	7%
Age not given	794	31.2%

Sex of the patient in the reports that name Remifentanil
Sex	Reports	Share
Female	975	38.3%
Male	993	39%
Unknown or not given	580	22.8%

Type of reporter in the reports that name Remifentanil
Reporter	Reports	Share
Physician	916	35.9%
Pharmacist	129	5.1%
Other health professional	1,341	52.6%
Lawyer	1	under 0.1%
Consumer or non-health professional	57	2.2%
Not given	104	4.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 12.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Remifentanil record
Indication as recorded (MedDRA)	Reports	Share
Maintenance of anaesthesia	454	17.8%
Anaesthesia	412	16.2%
General anaesthesia	402	15.8%
Induction of anaesthesia	207	8.1%
Sedation	125	4.9%
Analgesic therapy	58	2.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,548 reports.

Drugs in the same reports

Other drugs that the reports of Remifentanil name, in any role, in order of name
Drug	Reports that name the two
Dexamethasone	295
Fentanyl	684
Ketamine	236
Lidocaine	325
Midazolam	456
Propofol	1,787
Rocuronium	607
Rocuronium bromide	271
Sevoflurane	699
Sufentanil	235

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

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Renagel next in the A to Z list
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Renflexis next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for RemifentanilThe 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.

Cite this page

Reported Reactions. Remifentanil: adverse event reports that FDA received. https://reportedreactions.com/drug/remifentanil/ 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 Remifentanil as a suspect or interacting product. The 1,926 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 Remifentanil 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 Remifentanil?

No. It is a count of what people reported to FDA: 2,548 reports from February 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 (52.6%), physician (35.9%) and pharmacist (5.1%). 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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