Combivent Respimat: adverse event reports filed with FDA

574

reports as suspect product

0% of all reports · about 43 a year

83

reports, 12 months to June 2026

83 in the 12 months before

35.2%

marked serious by the reporter

39.6% across the class

2.6%

record death among outcomes, as reported

15 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 Combivent Respimat reports recording the termmedian drug in anticholinergic

1. Dyspnoeashortness of breath25.4%146
2. Off label useused for a purpose or in a way not on the label21.6%124
3. Intentional product use issuedeliberate use not as intended11.3%65
4. Product delivery mechanism issue9.2%53
5. Drug ineffectivethe medicine did not work as expected6.8%39
6. Asthmaasthma6.3%36
7. Product quality issuea problem with the product itself5.1%29
8. Coughcough4.2%24
9. Covid-19COVID-19 infection4.2%24
10. Pneumonialung infection4.2%24
11. Wheezingwheezing3.8%22
12. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease3.1%18
13. Device issuea problem with the device2.8%16
14. Product prescribing error2.8%16
15. Dizzinesslight-headedness or unsteadiness2.6%15
16. Device malfunctionthe device did not work properly2.4%14
17. Falla fall2.3%13
18. Device delivery system issuea problem with the delivery system1.7%10
19. Therapeutic product effect incomplete1.6%9
20. Fatiguetiredness1.4%8
21. Product use issuea problem in how the product was used1.4%8
22. Bronchitischest infection1.2%7
23. Chokingchoking1.2%7
24. Extra dose administered1.2%7
25. Headachehead pain1.2%7
26. Intentional product misusedeliberate use not as intended1.2%7
27. Malaisegeneral feeling of being unwell1.2%7
28. Prescribed overdose1.2%7
29. Astheniaweakness or lack of energy1%6
30. Cerebrovascular accidentstroke1%6

Top 30 of 161 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. 94.1% 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 574 reports.

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 Combivent Respimat as a suspect or interacting product; reports listing it only as a concomitant medication (2,122) 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.