Breztri: adverse event reports filed with FDA

7,186

reports as suspect product

0% of all reports · about 1,065 a year

1,957

reports, 12 months to June 2026

2,364 in the 12 months before

40%

marked serious by the reporter

77.7% across the class

15.6%

record death among outcomes, as reported

1,118 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 Breztri reports recording the termmedian drug in corticosteroid

1. Device delivery system issuea problem with the delivery system21.3%1,533
2. Dyspnoeashortness of breath19.6%1,411
3. Product dose omission issuea dose was missed17.8%1,279
4. Wrong technique in device usage process15.9%1,140
5. Device use issue15.1%1,084
6. Deaththe patient died; cause not stated by this term14.2%1,018
7. Device malfunctionthe device did not work properly11.1%800
8. Incorrect dose administered by devicethe device gave the wrong dose11.1%797
9. Wrong technique in product usage processthe product was used in the wrong way8.4%606
10. Product use issuea problem in how the product was used6.9%499
11. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease6.6%476
12. Drug dose omission by device6.4%458
13. Coughcough6.2%449
14. Drug ineffectivethe medicine did not work as expected6.2%447
15. Incorrect dose administeredthe wrong dose was given5.6%403
16. Visual impairmentreduced vision4.6%328
17. Asthmaasthma4.5%324
18. Dysphoniaa hoarse voice3.9%281
19. Device defective3.6%262
20. Device issuea problem with the device3.4%243
21. Pneumonialung infection3%218
22. Off label useused for a purpose or in a way not on the label2.7%191
23. Illness2.3%167
24. Feeling abnormalfeeling odd or not right2.2%158
25. Overdosea dose above the recommended amount2.1%150
26. Memory impairmentmemory problems2.1%149
27. Condition aggravatedthe condition being treated got worse2%144
28. Malaisegeneral feeling of being unwell1.8%132
29. Wheezingwheezing1.8%132
30. Drug delivery system issue1.8%129

Top 30 of 688 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. 92.2% 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 7,186 reports.

Drugs most often listed in the same reports

Other products listed in reports where Breztri 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 Breztri as a suspect or interacting product; reports listing it only as a concomitant medication (3,205) 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.