Budesonide and formoterol fumarate: adverse event reports filed with FDA

611

reports as suspect product

0% of all reports · about 29 a year

0

reports, 12 months to June 2026

0 in the 12 months before

96.9%

marked serious by the reporter

77.7% across the class

1.3%

record death among outcomes, as reported

8 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

Reactions recorded in the reports

share of Budesonide and formoterol fumarate reports recording the termmedian drug in corticosteroid

1. Asthmaasthma77.3%472
2. Dyspnoeashortness of breath47.6%291
3. Wheezingwheezing44.7%273
4. Therapeutic product effect incomplete43.4%265
5. Blood count abnormal31.4%192
6. Loss of personal independence in daily activities30.4%186
7. Sleep disorder due to a general medical condition25.2%154
8. Coughcough21.6%132
9. Obstructive airways disorder21.3%130
10. Pneumonialung infection11.9%73
11. Chest discomfortchest discomfort11.6%71
12. Productive cougha cough with phlegm11.1%68
13. Eosinophil count increased9.5%58
14. Drug ineffectivethe medicine did not work as expected9.2%56
15. Gastrooesophageal reflux diseaseacid reflux7.5%46
16. Bronchiectasis6.2%38
17. Sputum discoloured6.2%38
18. Hospitalisationadmission to hospital6.1%37
19. Hypertensionhigh blood pressure5.7%35
20. Blood test abnormal5.4%33
21. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease4.9%30
22. Nasal congestiona blocked nose4.9%30
23. Eosinophilia4.7%29
24. Diabetes mellitusdiabetes4.6%28
25. Drug hypersensitivityan allergic-type reaction to a medicine4.4%27
26. Fatiguetiredness4.4%27
27. Hypothyroidismunderactive thyroid4.4%27
28. Pulmonary function test decreased4.4%27
29. Condition aggravatedthe condition being treated got worse4.3%26
30. Dyspnoea exertional4.1%25

Top 30 of 349 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 74 drugs in the corticosteroid 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 808,789 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. 5.2% 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 611 reports.

Drugs most often listed in the same reports

Other products listed in reports where Budesonide and formoterol fumarate 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 corticosteroid 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 Budesonide and formoterol fumarate as a suspect or interacting product; reports listing it only as a concomitant medication (448) 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.