Tudorza Pressair: adverse event reports filed with FDA

3,858

reports as suspect product

0% of all reports · about 226 a year

8

reports, 12 months to June 2026

23 in the 12 months before

32.1%

marked serious by the reporter

39.6% across the class

2.5%

record death among outcomes, as reported

95 reports · not verified by FDA

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 Tudorza Pressair reports recording the termmedian drug in anticholinergic

1. Device malfunctionthe device did not work properly32.9%1,268
2. Dyspnoeashortness of breath26.4%1,017
3. Drug dose omissiona dose was missed25.5%982
4. Intentional product misusedeliberate use not as intended18.8%726
5. Product quality issuea problem with the product itself14%541
6. Off label useused for a purpose or in a way not on the label13.9%537
7. Device issuea problem with the device12.3%474
8. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease9%348
9. Intentional device misuse8.7%335
10. Device failurethe device failed7.6%292
11. Coughcough6.6%254
12. Product dose omission issuea dose was missed6.2%239
13. Malaisegeneral feeling of being unwell6%232
14. Product dose omissiona dose was missed5.3%206
15. Pneumonialung infection5.2%199
16. Memory impairmentmemory problems4.8%186
17. Product use in unapproved indicationused for a purpose not on the label4.8%185
18. Circumstance or information capable of leading to medication errora situation that could lead to a medication error4.7%183
19. Product use issuea problem in how the product was used4.5%175
20. Drug ineffectivethe medicine did not work as expected4.4%170
21. Visual impairmentreduced vision4.1%159
22. Fatiguetiredness3.9%152
23. Body height decreased3.8%146
24. Asthmaasthma3.3%129
25. Weight decreasedweight loss3.3%127
26. Dysphoniaa hoarse voice3.2%123
27. Feeling abnormalfeeling odd or not right3.1%119
28. Lung disordera lung problem, type not specified2.5%98
29. Wrong technique in device usage process2.5%97
30. Dizzinesslight-headedness or unsteadiness2.5%95

Top 30 of 582 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 98.4% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,858 reports.

Drugs most often listed in the same reports

Other products listed in reports where Tudorza Pressair 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

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

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.

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 Tudorza Pressair as a suspect or interacting product; reports listing it only as a concomitant medication (887) 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.