Aclidinium bromide: adverse event reports filed with FDA

1,013

reports as suspect product

0% of all reports · about 74 a year

63

reports, 12 months to June 2026

65 in the 12 months before

98.6%

marked serious by the reporter

39.6% across the class

1.2%

record death among outcomes, as reported

12 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 Aclidinium bromide reports recording the termmedian drug in anticholinergic

1. Asthmaasthma52%527
2. Wheezingwheezing50.2%509
3. Dyspnoeashortness of breath49.2%498
4. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease32.3%327
5. Therapeutic product effect incomplete30.6%310
6. Obstructive airways disorder29.3%297
7. Gastrooesophageal reflux diseaseacid reflux29%294
8. Loss of personal independence in daily activities25.5%258
9. Pneumonialung infection24.1%244
10. Bronchiectasis22.6%229
11. Productive cougha cough with phlegm22.1%224
12. Condition aggravatedthe condition being treated got worse21.4%217
13. Full blood count abnormal19.5%198
14. Coughcough18.8%190
15. Hypertensionhigh blood pressure18%182
16. Oedema peripheralswelling of the legs, ankles or hands15.4%156
17. Sleep disorder due to a general medical condition15.3%155
18. Coronary artery disease14.4%146
19. Dyspnoea exertional14.2%144
20. Asthma-chronic obstructive pulmonary disease overlap syndrome13.9%141
21. Nasal polyps13.8%140
22. Cardiac murmur13.4%136
23. Drug ineffectivethe medicine did not work as expected13.4%136
24. Rhinitis allergic13.4%136
25. Sarcoidosis13.4%136
26. Total lung capacity increased13.4%136
27. Lung neoplasm malignantlung cancer12.8%130
28. Breath sounds abnormal12.3%125
29. Vomitingbeing sick12%122
30. Off label useused for a purpose or in a way not on the label11.8%120

Top 30 of 442 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. 4.9% 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 1,013 reports.

Drugs most often listed in the same reports

Other products listed in reports where Aclidinium bromide 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 Aclidinium bromide as a suspect or interacting product; reports listing it only as a concomitant medication (852) 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.