Advair Hfa: adverse event reports filed with FDA

19,622

reports as suspect product

0.1% of all reports · about 889 a year

589

reports, 12 months to June 2026

748 in the 12 months before

54.9%

marked serious by the reporter

77.7% across the class

4.8%

record death among outcomes, as reported

946 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 Advair Hfa reports recording the termmedian drug in corticosteroid

1. Asthmaasthma25.8%5,067
2. Dyspnoeashortness of breath25.3%4,971
3. Wheezingwheezing14.4%2,828
4. Drug ineffectivethe medicine did not work as expected14.3%2,803
5. Coughcough10.8%2,123
6. Pneumonialung infection9.5%1,868
7. Therapeutic product effect incomplete9.3%1,819
8. Malaisegeneral feeling of being unwell7.3%1,435
9. Drug hypersensitivityan allergic-type reaction to a medicine6.8%1,326
10. Loss of personal independence in daily activities6.8%1,325
11. Painpain, site not specified6.3%1,245
12. Sleep disorder due to a general medical condition6.2%1,210
13. Headachehead pain5.6%1,099
14. Productive cougha cough with phlegm5.1%1,004
15. Product quality issuea problem with the product itself4.7%926
16. Off label useused for a purpose or in a way not on the label4.7%923
17. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease4.7%922
18. Obstructive airways disorder4.7%922
19. Hypersensitivityan allergic-type reaction4.4%862
20. Dysphoniaa hoarse voice4.2%833
21. Chest discomfortchest discomfort4.2%827
22. Condition aggravatedthe condition being treated got worse4.2%819
23. Fatiguetiredness4.1%807
24. Vomitingbeing sick4%779
25. Chest painchest pain3.9%772
26. Hypertensionhigh blood pressure3.8%738
27. Upper respiratory tract infectiona cold or similar infection3.5%677
28. Overdosea dose above the recommended amount3.2%632
29. Hyperhidrosisexcessive sweating3.2%622
30. Pyrexiafever3.2%622

Top 30 of 1,601 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. 68.8% 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 19,622 reports.

Drugs most often listed in the same reports

Other products listed in reports where Advair Hfa 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 Advair Hfa as a suspect or interacting product; reports listing it only as a concomitant medication (39,801) 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.