Generic name
Fluticasone propionate: adverse event reports filed with FDA
7,225 reports list it as a suspect or interacting product, 2004–2026. Class: Corticosteroid. Also reported as Fluticasone Propionate Nasal Spray, Fluticasone Propionate Nasal Spray Usp, Fluticasone Propionate Nasal 50 Mcg.
- 7,225
- reports as suspect product
- 0% of all reports · about 321 a year
- 596
- reports, 12 months to June 2026
- 755 in the 12 months before
- 53.1%
- marked serious by the reporter
- 77.7% across the class
- 5.7%
- record death among outcomes, as reported
- 411 reports · not verified by FDA
7,225 adverse event reports received by FDA list fluticasone propionate, a generic name as a suspect or interacting product, from January 2004 to June 2026. A further 23,939 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 596 reports listed it, down 21% from 755 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 321 reports a year and 0% of the 20,646,523 reports in the database, and 0.9% of the reports for the corticosteroid class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are drug ineffective (18.4%), asthma (12.5%) and off label use (12.1%). A report can list several reactions, so shares add to more than 100%; 1,156 different terms appear across these reports. Drug ineffective is recorded in 18.4% of these reports, a larger share than in the median corticosteroid drug (13.4%).
53.1% of the reports are marked serious by the reporter (77.7% across the class); 5.7% record death among the outcomes and 17.6% record hospitalisation, as reported. 59.3% of the reports came from consumers, and the largest patient age group is 45 to 64 (14.4%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 reports recording the termmedian drug in corticosteroid
- Drug ineffectivethe medicine did not work as expected18.4%1,331
- Asthmaasthma12.5%904
- Off label useused for a purpose or in a way not on the label12.1%872
- Dyspnoeashortness of breath10.6%766
- Headachehead pain9.8%709
- Painpain, site not specified8.2%590
- Coughcough7.3%527
- Product dose omission issuea dose was missed7%507
- Product use issuea problem in how the product was used6.7%484
- Wheezingwheezing6.5%473
- Pyrexiafever6.2%451
- Malaisegeneral feeling of being unwell5.7%414
- Infusion related reactiona reaction during or soon after an infusion5.7%409
- Drug hypersensitivityan allergic-type reaction to a medicine5.6%408
- Hypertensionhigh blood pressure5.5%399
- Epistaxisnosebleed5.5%397
- Vomitingbeing sick5.4%390
- Nauseafeeling sick5.2%373
- Hypersensitivityan allergic-type reaction5.1%371
- Rashskin rash4.9%354
- Pneumonialung infection4.8%346
- Exposure during pregnancythe medicine was taken during pregnancy4.6%335
- Joint swellinga swollen joint4.3%309
- Hepatic enzyme increasedraised liver enzymes4.2%306
- Condition aggravatedthe condition being treated got worse4.2%304
- Drug intolerancethe medicine was not tolerated4.1%297
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease4.1%297
- Product use in unapproved indicationused for a purpose not on the label4%287
- Fatiguetiredness3.9%281
Top 30 of 1,156 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 61.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Asthma | 811 | 11.2% |
| Hypersensitivity | 468 | 6.5% |
| Nasal congestion | 184 | 2.5% |
| Seasonal allergy | 142 | 2% |
| Multiple allergies | 130 | 1.8% |
| Rhinitis allergic | 103 | 1.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 7,225 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Fluticasone propionate reports |
|---|---|---|
| Acetaminophen | 814 | 11.3% |
| Albuterol sulfate | 774 | 10.7% |
| Albuterol | 712 | 9.9% |
| Prednisone | 646 | 8.9% |
| Hydromorphone hydrochloride | 644 | 8.9% |
| Cetirizine hydrochloride | 564 | 7.8% |
| Rituximab | 552 | 7.6% |
| Singulair | 519 | 7.2% |
| Advair Hfa | 512 | 7.1% |
| Ergocalciferol | 499 | 6.9% |
Other products listed in reports where Fluticasone propionate 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
| Measure | Fluticasone propionate | Corticosteroid | All reports |
|---|---|---|---|
| Reports as suspect product | 7,225 | 808,789 | 20,646,523 |
| Share of that pool | — | 0.9% | 0% |
| Reports, latest 12 months | 596 | — | 1,332,454 |
| Marked serious | 53.1% | 77.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 57 | 146 | 91 |
| Hospitalisation recorded, per 1,000 reports | 176 | 336 | 213 |
| Consumer-filed share | 59.3% | 29.1% | 45.8% |
| Top term, share of reports | Drug ineffective 18.4% | median 13.4% | 6.3% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Prednisone | generic | 183,867 | 15,614 | 91.4% |
| Dexamethasone | generic | 129,677 | 9,216 | 95.1% |
| Prednisolone | generic | 87,806 | 6,624 | 97.6% |
| Methylprednisolone | generic | 49,537 | 4,430 | 95.2% |
| Symbicort | brand | 39,119 | 1,177 | 50.6% |
| Breo Ellipta | brand | 22,220 | 628 | 31.7% |
| Hydrocortisone | generic | 21,263 | 2,386 | 89.5% |
| Advair Diskus | brand | 20,518 | 120 | 29% |
| Advair Hfa | brand | 19,622 | 589 | 54.9% |
| Budesonide | generic | 14,714 | 1,083 | 82.2% |
| Desoximetasone | generic | 12,209 | 1,525 | 99.2% |
| Flovent | brand | 10,772 | 171 | 42.1% |
| Methylprednisolone sodium succinate | generic | 10,772 | 1,630 | 97.8% |
| Solu-medrol | generic | 10,288 | 432 | 88.8% |
| Cipro | brand | 9,791 | 108 | 57.3% |
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.
Questions about Fluticasone propionate reports
How many adverse event reports has FDA received for Fluticasone propionate?
7,225 reports list Fluticasone propionate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 596 of them arrived in the latest 12 months. Another 23,939 list it only as a concomitant medication.
What reactions are recorded in Fluticasone propionate reports?
drug ineffective (18.4%), asthma (12.5%), off label use (12.1%), dyspnoea (10.6%) and headache (9.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Fluticasone propionate was responsible.
How serious are the reports?
53.1% are marked serious by the reporter. Among the outcomes recorded, 5.7% of reports include death and 17.6% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (59.3%), other health professional (21.5%) and physician (11.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Fluticasone propionate rising?
596 reports in the 12 months to June 2026, down 21% from 755 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Fluticasone propionate was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Fluticasone propionate?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 as a suspect or interacting product; reports listing it only as a concomitant medication (23,939) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.