Ipratropium bromide: adverse event reports filed with FDA

8,310

reports as suspect product

0% of all reports · about 369 a year

400

reports, 12 months to June 2026

354 in the 12 months before

80.2%

marked serious by the reporter

39.6% across the class

13.4%

record death among outcomes, as reported

1,114 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 Ipratropium bromide reports recording the termmedian drug in anticholinergic

1. Asthmaasthma31.2%2,594
2. Dyspnoeashortness of breath30.5%2,535
3. Wheezingwheezing23.1%1,921
4. Coughcough15.4%1,282
5. Therapeutic product effect incomplete14.9%1,241
6. Obstructive airways disorder13.7%1,142
7. Drug ineffectivethe medicine did not work as expected13.7%1,139
8. Pneumonialung infection11.1%925
9. Loss of personal independence in daily activities9.8%813
10. Sleep disorder due to a general medical condition9.2%764
11. Chest discomfortchest discomfort9%744
12. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease8.9%741
13. Condition aggravatedthe condition being treated got worse8.1%670
14. Off label useused for a purpose or in a way not on the label8%661
15. Productive cougha cough with phlegm7.2%597
16. Vomitingbeing sick7.1%589
17. Blood count abnormal6.5%536
18. Oedema peripheralswelling of the legs, ankles or hands6.3%526
19. Nauseafeeling sick5.9%494
20. Malaisegeneral feeling of being unwell5.8%486
21. Gastrooesophageal reflux diseaseacid reflux5.8%485
22. Lower respiratory tract infectiona chest infection5.7%475
23. Dyspnoea exertional5.6%469
24. Pyrexiafever5.5%459
25. Full blood count abnormal5.5%454
26. Bronchiectasis4.9%410
27. Constipationconstipation4.9%407
28. Stressstress4.8%399
29. General physical health deteriorationgeneral decline in health4.6%382
30. Product dose omission issuea dose was missed4.5%377

Top 30 of 1,222 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. 27.1% 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 8,310 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ipratropium 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 Ipratropium bromide as a suspect or interacting product; reports listing it only as a concomitant medication (25,017) 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.