Ultiva (remifentanil hydrochloride) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Remifentanil hydrochloride
Class: Opioid agonist

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 April 2026, FDA received 613 adverse event reports that name Ultiva. In these reports the drug is a suspect or interacting product.

In the same period, 548 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 20 reports in the 12 months to June 2026 and 11 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, 20 (under 0.1%) name Ultiva. Reports from consumers or other non-health professionals were 11.6% of the reports that name Ultiva 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 Ultiva 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 3 reports that name Ultiva.
In January to March 2026, FDA received 7.
In April to June 2025, FDA received 4.

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 597 of the 613 reports (97.4%).

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 68 terms.

Reaction terms in the reports that name Ultiva, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 613 reports
Anaphylactic shocka severe allergic reaction with collapse	120	19.6%
Hypotensionlow blood pressure	45	7.3%
Bronchospasmtightening of the airways	34	5.5%
Tachycardiafast heart rate	32	5.2%
Anaphylactic reactiona severe, sudden allergic reaction	31	5.1%
Rashskin rash	31	5.1%
Blood pressure decreaseda low blood pressure reading	30	4.9%
Cardiac arrestthe heart stopped	29	4.7%
Renal failure acute	23	3.8%
Circulatory collapsecollapse of the circulation	21	3.4%
Erythemaskin redness	18	2.9%
Toxic epidermal necrolysisa severe skin reaction with peeling	18	2.9%
Drug interactionan interaction between medicines	17	2.8%
Haematuriablood in the urine	17	2.8%
Bradycardiaslow heart rate	16	2.6%
Coma	15	2.4%
Drug ineffectivethe medicine did not work as expected	15	2.4%
Cardio-respiratory arrestthe heart and breathing stopped	14	2.3%
Hypoxialow oxygen	14	2.3%
Lymphopenia	14	2.3%
Oliguria	14	2.3%
Generalised erythema	13	2.1%
Optic neuritis	11	1.8%
Painpain, site not specified	10	1.6%
Respiratory depressionslow or shallow breathing	10	1.6%
Cerebral haemorrhage	9	1.5%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	9	1.5%
Sinus tachycardia	9	1.5%
Tongue oedemaa swollen tongue	9	1.5%
Dyspnoeashortness of breath	8	1.3%
Oedemaswelling from fluid	8	1.3%
Urticariahives	8	1.3%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	8	1.3%
Acute kidney injurysudden loss of kidney function	7	1.1%
Blood pressure diastolic increased	7	1.1%
Blood pressure systolic increased	7	1.1%
Bradypnoea	7	1.1%
Circumoral oedema	7	1.1%
Delayed recovery from anaesthesia	7	1.1%
Feeling abnormalfeeling odd or not right	7	1.1%
Hallucinationseeing or hearing things that are not there	7	1.1%
Heart rate increaseda fast heart rate reading	7	1.1%
Hepatitis fulminant	7	1.1%
Hypertensionhigh blood pressure	7	1.1%
Inadequate analgesia	7	1.1%
Sedation complication	7	1.1%
Thrombocytopenialow platelets	7	1.1%
Transcription medication error	7	1.1%
Angioedemadeep swelling of skin or mucous membranes	6	1%
Blistera blister	6	1%

Download all 68 terms of Ultiva (CSV)

The counts add to more than 613 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 Remifentanil hydrochloride with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Remifentanil hydrochloride	Generic name	665
Ultiva (this page)	Brand name	613

Sum of the separately reported names: 1,278. 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 Ultiva, 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	Other Serious (Important Medical Events)	Not serious
2004	13	5	0	2	3	0	2	8
2005	17	13	0	6	5	0	4	4
2006	5	5	0	2	3	0	0	0
2007	18	18	10	5	8	1	0	0
2008	21	21	3	5	11	0	5	0
2009	34	33	2	14	8	1	11	1
2010	62	58	4	23	28	1	15	4
2011	43	43	9	22	9	0	14	0
2012	40	40	1	17	17	0	11	0
2013	48	44	12	16	24	0	22	4
2014	49	48	6	13	24	1	20	1
2015	28	27	3	14	4	3	14	1
2016	30	26	0	9	12	0	15	4
2017	16	14	1	5	6	0	8	2
2018	40	40	5	17	15	0	22	0
2019	16	16	0	9	5	1	9	0
2020	22	18	0	5	9	2	9	4
2021	14	14	3	5	3	3	7	0
2022	27	27	2	9	12	0	15	0
2023	16	16	1	6	6	0	10	0
2024	20	18	0	4	1	1	14	2
2025	23	23	0	9	9	2	20	0
2026	11	11	6	6	4	0	4	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 Ultiva, 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 Ultiva, by the year in which FDA received them
Year	Reports
2004	12
2005	17
2006	6
2007	18
2008	20
2009	34
2010	65
2011	49
2012	45
2013	46
2014	47
2015	27
2016	29
2017	18
2018	42
2019	12
2020	25
2021	11
2022	28
2023	16
2024	19
2025	17
2026	10

Reports that name Ultiva, 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 Ultiva
Age	Reports	Share
Under 2	15	2.4%
2 to 11	20	3.3%
12 to 17	19	3.1%
18 to 44	122	19.9%
45 to 64	193	31.5%
65 to 74	89	14.5%
75 and over	68	11.1%
Age not given	87	14.2%

Sex of the patient in the reports that name Ultiva
Sex	Reports	Share
Female	304	49.6%
Male	265	43.2%
Unknown or not given	44	7.2%

Type of reporter in the reports that name Ultiva
Reporter	Reports	Share
Physician	249	40.6%
Pharmacist	60	9.8%
Other health professional	204	33.3%
Lawyer	0	0%
Consumer or non-health professional	71	11.6%
Not given	29	4.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 7.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Ultiva record
Indication as recorded (MedDRA)	Reports	Share
General anaesthesia	106	17.3%
Anaesthesia	102	16.6%
Induction of anaesthesia	61	10%
Analgesic therapy	22	3.6%
Pain	13	2.1%
Maintenance of anaesthesia	7	1.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 613 reports.

Pages near this one

Remifentanil hydrochloride same ingredient
Tramadol hydrochloride and acetaminophen same class
Xtampza same class
Tramadol hydrochloride same class
Tramadol hcl same class
Ultibro Breezhaler next in the A to Z list
Ultomiris next in the A to Z list
Ultane next in the A to Z list
Ultracet next in the A to Z list
Uloric next in the A to Z list
Ultram next in the A to Z list
Uft 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 UltivaThe 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. Ultiva: adverse event reports that FDA received. https://reportedreactions.com/drug/ultiva/ 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 Ultiva as a suspect or interacting product. The 548 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 Ultiva 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 Ultiva?

No. It is a count of what people reported to FDA: 613 reports from January 2004 to April 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 (40.6%), other health professional (33.3%) and consumer or non-health professional (11.6%). 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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