Pulmicort Flexhaler: adverse event reports filed with FDA

4,350

reports as suspect product

0% of all reports · about 229 a year

1

reports, 12 months to June 2026

6 in the 12 months before

15.1%

marked serious by the reporter

77.7% across the class

1.4%

record death among outcomes, as reported

62 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 Pulmicort Flexhaler reports recording the termmedian drug in corticosteroid

1. Dyspnoeashortness of breath22.5%980
2. Off label useused for a purpose or in a way not on the label18.1%787
3. Asthmaasthma14.8%643
4. Intentional product misusedeliberate use not as intended14%608
5. Coughcough13.9%604
6. Drug ineffectivethe medicine did not work as expected13%564
7. Drug dose omissiona dose was missed11.8%513
8. Device malfunctionthe device did not work properly11.4%498
9. Malaisegeneral feeling of being unwell7.7%333
10. Circumstance or information capable of leading to medication errora situation that could lead to a medication error7.4%324
11. Product use issuea problem in how the product was used7.1%308
12. Device issuea problem with the device6.4%277
13. Wheezingwheezing6%259
14. Intentional device misuse5.9%258
15. Product quality issuea problem with the product itself5.7%247
16. Device use issue4.7%204
17. Wrong technique in device usage process4.6%201
18. Chest discomfortchest discomfort4.3%187
19. Device failurethe device failed4.2%184
20. Dysphoniaa hoarse voice3.6%157
21. Feeling abnormalfeeling odd or not right3.6%157
22. Product use in unapproved indicationused for a purpose not on the label3.5%152
23. Product dose omission issuea dose was missed3%131
24. Fatiguetiredness2.9%125
25. Product dose omissiona dose was missed2.8%123
26. Device delivery system issuea problem with the delivery system2.6%111
27. Incorrect dose administeredthe wrong dose was given2.5%109
28. Nasopharyngitisa cold2.4%106
29. Drug dose omission by device2.4%105
30. Bronchitischest infection2.3%101

Top 30 of 475 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. 99.8% 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 4,350 reports.

Drugs most often listed in the same reports

Other products listed in reports where Pulmicort Flexhaler 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 Pulmicort Flexhaler as a suspect or interacting product; reports listing it only as a concomitant medication (560) 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.