Umeclidinium bromide adverse event reports that FDA received

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

Name type: Generic name

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 July 2014 to June 2026, FDA received 1,855 adverse event reports that name Umeclidinium bromide. In these reports the drug is a suspect or interacting product.

In the same period, 522 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 136 reports in the 12 months to June 2026 and 154 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, 136 (under 0.1%) name Umeclidinium bromide. Reports from other health professionals were 40.3% of the reports that name Umeclidinium bromide and 19.7% 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 Umeclidinium bromide 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 20 reports that name Umeclidinium bromide.
In January to March 2026, FDA received 29.
In April to June 2025, FDA received 10.

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 378 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 1,850 of the 1,855 reports (99.7%).

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 378 terms.

Reaction terms in the reports that name Umeclidinium bromide, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,855 reports
Asthma	1,216	65.6%
Dyspnoeashortness of breath	1,080	58.2%
Wheezing	972	52.4%
Therapeutic product effect incomplete	900	48.5%
Obstructive airways disorder	634	34.2%
Loss of personal independence in daily activities	621	33.5%
Cough	500	27%
Condition aggravatedthe condition being treated got worse	482	26%
Full blood count abnormal	437	23.6%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	427	23%
Sleep disorder due to a general medical condition	405	21.8%
Productive cougha cough with phlegm	357	19.2%
Oedema peripheralswelling of the legs, ankles or hands	303	16.3%
Gastrooesophageal reflux diseaseacid reflux	292	15.7%
Vomitingbeing sick	281	15.1%
Pain in extremitypain in an arm or leg	278	15%
Nauseafeeling sick	276	14.9%
Anxiety	272	14.7%
Pneumonialung infection	267	14.4%
Drug ineffectivethe medicine did not work as expected	263	14.2%
Abdominal painstomach or belly pain	261	14.1%
Bronchiectasis	255	13.7%
Off label useused for a purpose or in a way not on the label	253	13.6%
Pulmonary embolisma blood clot in the lung	245	13.2%
Abdominal distensiona bloated abdomen	236	12.7%
Chest discomfort	232	12.5%
Constipation	231	12.5%
Dyspnoea exertional	229	12.3%
Nasal polyps	220	11.9%
Respiratory symptom	220	11.9%
Blood count abnormal	219	11.8%
General physical health deteriorationgeneral decline in health	214	11.5%
Lung disordera lung problem, type not specified	214	11.5%
Stress	212	11.4%
Thrombosis	212	11.4%
Sepsisa severe body-wide response to infection	210	11.3%
Appendicitis	209	11.3%
Ascitesfluid in the abdomen	209	11.3%
Appendicolith	208	11.2%
Cardiogenic shockshock from the heart failing to pump	206	11.1%
Hyponatraemialow blood sodium	202	10.9%
Multiple organ dysfunction syndromeseveral organs failing	202	10.9%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	201	10.8%
Osteoporosisthinning of the bones	189	10.2%
Drug intolerancethe medicine was not tolerated	184	9.9%
Hypertensionhigh blood pressure	180	9.7%
Vasculitisinflammation of blood vessels	177	9.5%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	175	9.4%
Haemoptysiscoughing up blood	172	9.3%
Sleep disordera sleep problem	167	9%

Download all 378 terms of Umeclidinium bromide (CSV)

The counts add to more than 1,855 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 Umeclidinium bromide with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Umeclidinium bromide (this page)	Generic name	1,855
Incruse Ellipta	Brand name	4,575

Sum of the separately reported names: 6,430. 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 Umeclidinium bromide, 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
2015	3	3	0	0	2	0	0	1	0
2016	2	2	0	1	2	0	0	2	0
2017	15	15	1	1	11	0	0	9	0
2018	43	42	0	0	25	2	1	23	1
2019	100	99	5	2	52	2	0	66	1
2020	159	159	4	3	94	0	2	113	0
2021	444	441	31	12	223	1	2	360	3
2022	332	328	62	38	146	19	8	275	4
2023	217	217	52	76	128	51	17	192	0
2024	199	197	47	90	108	33	13	184	2
2025	217	217	70	92	160	35	30	206	0
2026	124	123	55	56	98	32	23	119	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 Umeclidinium bromide, 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 Umeclidinium bromide, by the year in which FDA received them
Year	Reports
2014	1
2015	3
2016	3
2017	26
2018	62
2019	151
2020	253
2021	558
2022	249
2023	181
2024	183
2025	136
2026	49

Reports that name Umeclidinium bromide, 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 Umeclidinium bromide
Age	Reports	Share
Under 2	0	0%
2 to 11	0	0%
12 to 17	0	0%
18 to 44	116	6.3%
45 to 64	504	27.2%
65 to 74	342	18.4%
75 and over	546	29.4%
Age not given	347	18.7%

Sex of the patient in the reports that name Umeclidinium bromide
Sex	Reports	Share
Female	718	38.7%
Male	944	50.9%
Unknown or not given	193	10.4%

Type of reporter in the reports that name Umeclidinium bromide
Reporter	Reports	Share
Physician	357	19.2%
Pharmacist	18	1%
Other health professional	747	40.3%
Lawyer	0	0%
Consumer or non-health professional	729	39.3%
Not given	4	0.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 2.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Umeclidinium bromide record
Indication as recorded (MedDRA)	Reports	Share
Asthma	280	15.1%
Dyspnoea	195	10.5%
Chronic obstructive pulmonary disease	125	6.7%
Bronchial obstruction	19	1%
Productive cough	12	0.6%
Emphysema	2	0.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,855 reports.

Drugs in the same reports

Other drugs that the reports of Umeclidinium bromide name, in any role, in order of name
Drug	Reports that name the two
Albuterol	809
Albuterol sulfate	605
Betamethasone	329
Breo Ellipta	771
Budesonide	360
Ipratropium bromide	611
Nucala	518
Prednisone	984
Singulair	477
Tiotropium bromide	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

Incruse Ellipta same ingredient
Umeclidinium Br+vilanterol Trifenatate next in the A to Z list
Umeclidinium Bromide Vilanterol Trifenatate next in the A to Z list
Umbralisib next in the A to Z list
Unasyn next in the A to Z list
Ultravist next in the A to Z list
Uniphyl next in the A to Z list
Ultram Er next in the A to Z list
Unisom next in the A to Z list
Ultram next in the A to Z list
Unisom SleepTabs next in the A to Z list
Ultracet next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for Umeclidinium bromideThe 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. Umeclidinium bromide: adverse event reports that FDA received. https://reportedreactions.com/drug/umeclidinium-bromide/ 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 Umeclidinium bromide as a suspect or interacting product. The 522 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 Umeclidinium bromide 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 Umeclidinium bromide?

No. It is a count of what people reported to FDA: 1,855 reports from July 2014 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 (40.3%), consumer or non-health professional (39.3%) and physician (19.2%). 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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