Sufentanil adverse event reports that FDA received

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

Name type: Generic name
Also reported as: Sufentanil /00723502/

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 3,698 adverse event reports that name Sufentanil. In these reports the drug is a suspect or interacting product.

In the same period, 1,701 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 319 reports in the 12 months to June 2026 and 324 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, 319 (under 0.1%) name Sufentanil. Reports from consumers or other non-health professionals were 5% of the reports that name Sufentanil 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 Sufentanil 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 73 reports that name Sufentanil.
In January to March 2026, FDA received 84.
In April to June 2025, FDA received 85.

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 352 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 3,672 of the 3,698 reports (99.3%).

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 352 terms.

Reaction terms in the reports that name Sufentanil, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,698 reports
Anaphylactic shocka severe allergic reaction with collapse	666	18%
Hypotensionlow blood pressure	319	8.6%
Anaphylactic reactiona severe, sudden allergic reaction	183	4.9%
Drug ineffectivethe medicine did not work as expected	167	4.5%
Tachycardiafast heart rate	149	4%
Exposure during pregnancythe medicine was taken during pregnancy	120	3.2%
Cardiac arrestthe heart stopped	108	2.9%
Cardio-respiratory arrestthe heart and breathing stopped	106	2.9%
Bronchospasmtightening of the airways	105	2.8%
Drug interactionan interaction between medicines	104	2.8%
Off label useused for a purpose or in a way not on the label	104	2.8%
Rashskin rash	103	2.8%
Rash maculo-papulara rash of flat and raised spots	101	2.7%
Anaesthetic complication neurological	95	2.6%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	92	2.5%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	84	2.3%
Urticariahives	84	2.3%
Eosinophilia	79	2.1%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	79	2.1%
Condition aggravatedthe condition being treated got worse	75	2%
Bradycardiaslow heart rate	70	1.9%
Hypertensionhigh blood pressure	70	1.9%
Toxicity to various agentspoisoning or toxic effect of one or more substances	70	1.9%
Erythemaskin redness	63	1.7%
Maternal exposure during delivery	61	1.6%
Acute generalised exanthematous pustulosis	59	1.6%
Pyrexiafever	59	1.6%
Multiple organ dysfunction syndromeseveral organs failing	58	1.6%
Rhabdomyolysismuscle breakdown	58	1.6%
Hepatic cytolysis	55	1.5%
Dyspnoeashortness of breath	54	1.5%
Oxygen saturation decreased	54	1.5%
Thrombocytopenialow platelets	54	1.5%
Hypersensitivityan allergic-type reaction	51	1.4%
Myoclonus	51	1.4%
Circulatory collapsecollapse of the circulation	50	1.4%
Toxic epidermal necrolysisa severe skin reaction with peeling	49	1.3%
Painpain, site not specified	48	1.3%
Premature babya baby born early	48	1.3%
Agitationrestlessness	47	1.3%
Hepatocellular injury	47	1.3%
Respiratory depressionslow or shallow breathing	47	1.3%
Cholestasis	46	1.2%
Hyperthermia malignant	45	1.2%
Leukocytosis	44	1.2%
Acute respiratory distress syndrome	43	1.2%
Constipation	43	1.2%
Metabolic acidosistoo much acid in the body fluids	42	1.1%
Nauseafeeling sick	42	1.1%
Somnolencedrowsiness	42	1.1%

Download all 352 terms of Sufentanil (CSV)

The counts add to more than 3,698 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 Sufentanil with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Sufentanil (this page)	Generic name	3,698
Sufentanil citrate	Generic name	787

Sum of the separately reported names: 4,485. 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 Sufentanil, 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	18	13	1	7	1	1	0	5	5
2005	4	4	1	3	1	0	0	0	0
2007	3	3	1	0	1	0	0	2	0
2008	3	3	0	3	1	0	0	1	0
2009	37	37	2	14	24	2	0	14	0
2010	23	23	3	8	6	1	0	7	0
2011	10	10	3	4	2	0	0	3	0
2012	20	20	0	8	8	0	0	7	0
2013	146	145	7	27	65	0	0	82	1
2014	116	115	12	18	41	0	0	68	1
2015	85	85	4	27	35	0	0	48	0
2016	130	127	8	28	36	1	1	95	3
2017	75	71	5	12	26	0	0	44	4
2018	254	250	12	81	114	3	0	140	4
2019	314	313	14	80	125	1	9	162	1
2020	320	319	27	77	138	12	14	161	1
2021	337	332	81	113	121	2	1	222	5
2022	312	308	35	77	128	3	5	211	4
2023	498	495	41	203	162	1	1	302	3
2024	421	420	38	119	146	6	7	252	1
2025	379	377	21	171	146	1	0	223	2
2026	193	192	25	70	87	2	0	94	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 Sufentanil, 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 Sufentanil, by the year in which FDA received them
Year	Reports
2004	18
2005	4
2007	3
2008	3
2009	38
2010	23
2011	13
2012	41
2013	133
2014	121
2015	83
2016	133
2017	84
2018	293
2019	323
2020	330
2021	366
2022	312
2023	497
2024	404
2025	319
2026	157

Reports that name Sufentanil, 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 Sufentanil
Age	Reports	Share
Under 2	49	1.3%
2 to 11	67	1.8%
12 to 17	135	3.7%
18 to 44	941	25.4%
45 to 64	1,038	28.1%
65 to 74	482	13%
75 and over	333	9%
Age not given	653	17.7%

Sex of the patient in the reports that name Sufentanil
Sex	Reports	Share
Female	1,933	52.3%
Male	1,456	39.4%
Unknown or not given	309	8.4%

Type of reporter in the reports that name Sufentanil
Reporter	Reports	Share
Physician	1,774	48%
Pharmacist	368	10%
Other health professional	1,316	35.6%
Lawyer	11	0.3%
Consumer or non-health professional	184	5%
Not given	45	1.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 4.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Sufentanil record
Indication as recorded (MedDRA)	Reports	Share
Anaesthesia	700	18.9%
General anaesthesia	660	17.8%
Induction of anaesthesia	458	12.4%
Sedation	363	9.8%
Analgesic therapy	158	4.3%
Spinal anaesthesia	92	2.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,698 reports.

Drugs in the same reports

Other drugs that the reports of Sufentanil name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	387
Dexamethasone	786
Ketamine	939
Lidocaine	407
Midazolam	865
Morphine	361
Norepinephrine	290
Propofol	2,216
Rocuronium bromide	318
Sevoflurane	420

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

Sufentanil citrate same ingredient
Sufenta next in the A to Z list
Sudafed 24 Hour next in the A to Z list
Sugammadex next in the A to Z list
Sudafed 12 Hour next in the A to Z list
Sugammadex sodium next in the A to Z list
Sudafed next in the A to Z list
Sulfa next in the A to Z list
Sucralfate next in the A to Z list
Sulfadiazine next in the A to Z list
Succinylcholine chloride next in the A to Z list
Sulfamethoxazole next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for SufentanilThe 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. Sufentanil: adverse event reports that FDA received. https://reportedreactions.com/drug/sufentanil/ 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 Sufentanil as a suspect or interacting product. The 1,701 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 Sufentanil 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 Sufentanil?

No. It is a count of what people reported to FDA: 3,698 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?

Physician (48%), other health professional (35.6%) and pharmacist (10%). 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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