Sufentanil citrate adverse event reports that FDA received

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

Name type: Generic name
Class: Opioid agonist
Also reported as: Sufentanil Citrate Injection

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.

Reports on file

From April 2004 to June 2026, FDA received 787 adverse event reports that name Sufentanil citrate. In these reports the drug is a suspect or interacting product.

In the same period, 459 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 92 reports in the 12 months to June 2026 and 100 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 citrate 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 15 reports that name Sufentanil citrate.
In January to March 2026, FDA received 27.
In April to June 2025, FDA received 22.

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 68 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 750 of the 787 reports (95.3%).

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 68 terms.

Reaction terms in the reports that name Sufentanil citrate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 787 reports
Anaphylactic shocka severe allergic reaction with collapse	187	23.8%
Hypotensionlow blood pressure	93	11.8%
Anaphylactic reactiona severe, sudden allergic reaction	66	8.4%
Tachycardiafast heart rate	48	6.1%
Bronchospasmtightening of the airways	46	5.8%
Toxic epidermal necrolysisa severe skin reaction with peeling	38	4.8%
Urticariahives	32	4.1%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	31	3.9%
Cardiac arrestthe heart stopped	30	3.8%
Drug ineffectivethe medicine did not work as expected	30	3.8%
Circulatory collapsecollapse of the circulation	27	3.4%
Erythemaskin redness	26	3.3%
Bradycardiaslow heart rate	25	3.2%
Shockshock, a collapse of the circulation	23	2.9%
Haemodynamic instability	22	2.8%
Haemothorax	22	2.8%
Shock haemorrhagic	22	2.8%
Acute generalised exanthematous pustulosis	20	2.5%
Face oedemaswelling of the face	19	2.4%
Hypersensitivityan allergic-type reaction	18	2.3%
Back pain	17	2.2%
Adverse reaction	16	2%
Angiopathy	16	2%
Blood pressure increaseda raised blood pressure reading	16	2%
Emphysema	16	2%
Epistaxisnosebleed	16	2%
Flatulencewind	16	2%
Haemorrhagebleeding	16	2%
Hypovolaemia	16	2%
Inspiratory capacity decreased	16	2%
Mechanical ventilation complication	16	2%
Pleural effusionfluid around the lung	16	2%
Pneumothoraxa collapsed lung	16	2%
Rashskin rash	16	2%
Dermatitis allergic	13	1.7%
Angioedemadeep swelling of skin or mucous membranes	12	1.5%
Sedationdrowsiness	12	1.5%
Painpain, site not specified	11	1.4%
Renal failure acute	9	1.1%
Respiratory depressionslow or shallow breathing	9	1.1%
Cytolytic hepatitis	8	1%
Deliriumsudden confusion	8	1%
Toxic skin eruption	8	1%
Anaesthetic complication	7	0.9%
Clostridium difficile colitisa bowel infection with C. difficile	7	0.9%
Drug exposure during pregnancythe medicine was taken during pregnancy	7	0.9%
Hypertensionhigh blood pressure	7	0.9%
Klebsiella infection	7	0.9%
Off label useused for a purpose or in a way not on the label	7	0.9%
Oxygen saturation decreased	7	0.9%

Download all 68 terms of Sufentanil citrate (CSV)

The counts add to more than 787 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	Generic name	3,698
Sufentanil citrate (this page)	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 citrate, 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	12	11	0	6	2	0	0	4	1
2005	12	11	1	3	7	0	0	2	1
2006	20	17	3	2	4	0	1	8	3
2007	20	20	3	6	10	1	0	5	0
2008	34	34	1	15	13	0	0	10	0
2009	17	17	1	10	7	0	0	2	0
2010	24	24	3	4	15	2	0	4	0
2011	47	47	7	20	16	1	1	14	0
2012	54	54	8	31	19	0	0	16	0
2013	5	5	1	1	1	0	0	2	0
2014	4	3	0	3	1	0	0	0	1
2015	5	5	0	2	3	0	0	1	0
2016	10	6	1	1	2	0	0	4	4
2017	8	5	0	4	2	0	0	2	3
2018	16	15	0	9	2	0	0	10	1
2019	50	49	3	21	20	0	0	16	1
2020	49	48	3	10	23	0	0	25	1
2021	46	46	5	15	29	0	0	33	0
2022	53	53	7	14	23	1	0	31	0
2023	59	59	17	39	28	1	0	37	0
2024	78	78	4	33	23	1	0	47	0
2025	114	114	3	58	30	0	1	67	0
2026	50	50	10	20	19	0	0	25	0

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 citrate, 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 citrate, by the year in which FDA received them
Year	Reports
2004	8
2005	11
2006	21
2007	23
2008	34
2009	14
2010	27
2011	50
2012	55
2013	4
2014	4
2015	5
2016	10
2017	10
2018	18
2019	55
2020	71
2021	37
2022	50
2023	54
2024	83
2025	101
2026	42

Reports that name Sufentanil citrate, 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 citrate
Age	Reports	Share
Under 2	15	1.9%
2 to 11	16	2%
12 to 17	39	5%
18 to 44	182	23.1%
45 to 64	235	29.9%
65 to 74	125	15.9%
75 and over	88	11.2%
Age not given	87	11.1%

Sex of the patient in the reports that name Sufentanil citrate
Sex	Reports	Share
Female	388	49.3%
Male	356	45.2%
Unknown or not given	43	5.5%

Type of reporter in the reports that name Sufentanil citrate
Reporter	Reports	Share
Physician	339	43.1%
Pharmacist	50	6.4%
Other health professional	313	39.8%
Lawyer	0	0%
Consumer or non-health professional	50	6.4%
Not given	35	4.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 5.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Sufentanil citrate record
Indication as recorded (MedDRA)	Reports	Share
Anaesthesia	130	16.5%
General anaesthesia	109	13.9%
Induction of anaesthesia	93	11.8%
Sedation	31	3.9%
Analgesic therapy	20	2.5%
Gait disturbance	19	2.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 787 reports.

Pages near this one

Sufentanil same ingredient
Roxicodone same class
Tapentadol same class
Remifentanil hydrochloride same class
Tapentadol hydrochloride same class
Promethazine hydrochloride and codeine phosphate same class
Tramadol hcl same class
Sugammadex next in the A to Z list
Sufenta next in the A to Z list
Sugammadex sodium next in the A to Z list
Sudafed 24 Hour next in the A to Z list
Sulfa 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 Sufentanil citrateThe 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 citrate: adverse event reports that FDA received. https://reportedreactions.com/drug/sufentanil-citrate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Sufentanil citrate as a suspect or interacting product. The 459 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 citrate 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 citrate?

No. It is a count of what people reported to FDA: 787 reports from April 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 (43.1%), other health professional (39.8%) and pharmacist (6.4%). 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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