Brand name · Umeclidinium bromide and vilanterol trifenatate
Anoro Ellipta: adverse event reports filed with FDA
12,554 reports list it as a suspect or interacting product, 2013–2026. Class: Anticholinergic.
- 12,554
- reports as suspect product
- 0.1% of all reports · about 942 a year
- 346
- reports, 12 months to June 2026
- 528 in the 12 months before
- 26.3%
- marked serious by the reporter
- 39.6% across the class
- 3.5%
- record death among outcomes, as reported
- 438 reports · not verified by FDA
12,554 adverse event reports received by FDA list the brand name Anoro Ellipta (umeclidinium bromide and vilanterol trifenatate) as a suspect or interacting product, from March 2013 to June 2026. A further 4,022 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 346 reports listed it, down 34% from 528 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 942 reports a year and 0.1% of the 20,646,523 reports in the database, and 7.9% of the reports for the anticholinergic class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are dyspnoea (14.9%), wrong technique in device usage process (12.9%) and drug ineffective (11.4%). A report can list several reactions, so shares add to more than 100%; 867 different terms appear across these reports. Dyspnoea is recorded in 14.9% of these reports, about the same share as in the median anticholinergic drug (14.8%).
26.3% of the reports are marked serious by the reporter (39.6% across the class); 3.5% record death among the outcomes and 12.5% record hospitalisation, as reported. 92.3% of the reports came from consumers, and the largest patient age group is 75 and over (14.4%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Anoro Ellipta reports recording the termmedian drug in anticholinergic
- Dyspnoeashortness of breath14.9%1,873
- Wrong technique in device usage process12.9%1,615
- Drug ineffectivethe medicine did not work as expected11.4%1,437
- Product complaint9.4%1,183
- Coughcough7%878
- Product dose omission issuea dose was missed6.1%765
- Drug dispensing errora dispensing mistake4%496
- Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease3.6%450
- Drug dose omissiona dose was missed3.6%449
- Device use errora mistake in using the device3.4%429
- Condition aggravatedthe condition being treated got worse3.2%405
- Pneumonialung infection3.2%399
- Product dose omissiona dose was missed3%374
- Product use in unapproved indicationused for a purpose not on the label3%373
- Product quality issuea problem with the product itself2.8%357
- Wheezingwheezing2.3%292
- Off label useused for a purpose or in a way not on the label2.2%280
- Malaisegeneral feeling of being unwell2.2%278
- Productive cougha cough with phlegm2.1%266
- Dysphoniaa hoarse voice2.1%258
- Dizzinesslight-headedness or unsteadiness2%251
- Overdosea dose above the recommended amount1.9%241
- Oropharyngeal painsore throat1.8%223
- Deaththe patient died; cause not stated by this term1.7%218
- Underdoseless than the intended dose1.7%217
- Product packaging confusion1.7%213
- Pain in extremitypain in an arm or leg1.7%212
- Headachehead pain1.7%208
- Product label confusion1.6%205
- Circumstance or information capable of leading to medication errora situation that could lead to a medication error1.6%197
Top 30 of 867 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 24 drugs in the anticholinergic class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 159,807 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 92.9% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Chronic obstructive pulmonary disease | 3,975 | 31.7% |
| Asthma | 318 | 2.5% |
| Dyspnoea | 308 | 2.5% |
| Emphysema | 290 | 2.3% |
| Bronchitis | 49 | 0.4% |
| Lung disorder | 30 | 0.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 12,554 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Anoro Ellipta reports |
|---|---|---|
| Breo Ellipta | 535 | 4.3% |
| Trelegy Ellipta | 515 | 4.1% |
| Albuterol sulfate | 410 | 3.3% |
| Albuterol | 361 | 2.9% |
| Ventolin Hfa | 347 | 2.8% |
| Tiotropium bromide | 327 | 2.6% |
| Prednisone | 289 | 2.3% |
| Aspirin | 276 | 2.2% |
| Advair Diskus | 259 | 2.1% |
| Advair Hfa | 198 | 1.6% |
Other products listed in reports where Anoro Ellipta is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Anoro Ellipta | Anticholinergic | All reports |
|---|---|---|---|
| Reports as suspect product | 12,554 | 159,807 | 20,646,523 |
| Share of that pool | — | 7.9% | 0.1% |
| Reports, latest 12 months | 346 | — | 1,332,454 |
| Marked serious | 26.3% | 39.6% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 35 | 63 | 91 |
| Hospitalisation recorded, per 1,000 reports | 125 | 202 | 213 |
| Consumer-filed share | 92.3% | 70.6% | 45.8% |
| Top term, share of reports | Dyspnoea 14.9% | median 14.8% | 2.7% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the anticholinergic class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Tiotropium bromide | generic | 76,917 | 616 | 32.3% |
| Trelegy Ellipta | brand | 26,795 | 2,472 | 35.1% |
| Ipratropium bromide | generic | 8,310 | 400 | 80.2% |
| Spiriva Respimat | brand | 5,581 | 246 | 49.3% |
| Incruse Ellipta | brand | 4,575 | 129 | 36.1% |
| Tudorza Pressair | brand | 3,858 | 8 | 32.1% |
| Stiolto Respimat | brand | 2,899 | 172 | 25.2% |
| Atropine | generic | 2,386 | 160 | 95.7% |
| Glycopyrrolate | generic | 2,225 | 258 | 92.3% |
| Transderm Scop | brand | 1,498 | 15 | 43% |
| Benztropine | generic | 1,492 | 167 | 94.2% |
| Bevespi Aerosphere | brand | 1,467 | 62 | 35.6% |
| Scopolamine | generic | 1,260 | 125 | 68.6% |
| Atropine sulfate | generic | 1,168 | 47 | 84.7% |
| Aclidinium bromide | generic | 1,013 | 63 | 98.6% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Anoro Ellipta reports
How many adverse event reports has FDA received for Anoro Ellipta?
12,554 reports list Anoro Ellipta as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 346 of them arrived in the latest 12 months. Another 4,022 list it only as a concomitant medication.
What reactions are recorded in Anoro Ellipta reports?
dyspnoea (14.9%), wrong technique in device usage process (12.9%), drug ineffective (11.4%), product complaint (9.4%) and cough (7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Anoro Ellipta was responsible.
How serious are the reports?
26.3% are marked serious by the reporter. Among the outcomes recorded, 3.5% of reports include death and 12.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (92.3%), physician (3%) and other health professional (2.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Anoro Ellipta rising?
346 reports in the 12 months to June 2026, down 34% from 528 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Anoro Ellipta was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Anoro Ellipta?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Anoro Ellipta as a suspect or interacting product; reports listing it only as a concomitant medication (4,022) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.