Fluticasone propionate and salmeterol: adverse event reports filed with FDA

5,387

reports as suspect product

0% of all reports · about 244 a year

1,005

reports, 12 months to June 2026

652 in the 12 months before

55.8%

marked serious by the reporter

77.7% across the class

8.8%

record death among outcomes, as reported

472 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 Fluticasone propionate and salmeterol reports recording the termmedian drug in corticosteroid

1. Product dose omission issuea dose was missed28.8%1,552
2. Dyspnoeashortness of breath12.7%685
3. Drug ineffectivethe medicine did not work as expected8.9%479
4. Asthmaasthma7.4%399
5. Pneumonialung infection6.2%335
6. Off label useused for a purpose or in a way not on the label5.6%301
7. Coughcough5.3%283
8. Product quality issuea problem with the product itself5.2%279
9. Product use issuea problem in how the product was used4.7%254
10. Deaththe patient died; cause not stated by this term4.3%232
11. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease3.9%210
12. Malaisegeneral feeling of being unwell3.1%167
13. Dysphoniaa hoarse voice3%159
14. Hospitalisationadmission to hospital2.4%130
15. Drug administration errora mistake in giving the medicine2.3%125
16. Wheezingwheezing2.1%111
17. Investigation2%106
18. Bronchitischest infection1.8%97
19. Accidental underdose1.6%85
20. Fatiguetiredness1.6%84
21. Headachehead pain1.6%84
22. Chest discomfortchest discomfort1.5%83
23. Wrong technique in product usage processthe product was used in the wrong way1.5%81
24. Dizzinesslight-headedness or unsteadiness1.5%80
25. Falla fall1.5%80
26. Lung disordera lung problem, type not specified1.4%74
27. Nasopharyngitisa cold1.4%73
28. Chest painchest pain1.3%71
29. Myocardial infarctionheart attack1.3%71
30. Condition aggravatedthe condition being treated got worse1.3%68

Top 30 of 797 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. 86.8% 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 5,387 reports.

Drugs most often listed in the same reports

Other products listed in reports where Fluticasone propionate and salmeterol 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 Fluticasone propionate and salmeterol as a suspect or interacting product; reports listing it only as a concomitant medication (7,184) 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.