Fluticasone (fluticasone propionate) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Fluticasone
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Fluticasone propionate
Class: Corticosteroid
Also reported as: Fluticasone Nasal Spray, Fluticasone /00972202/, Fluticasone Spray

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2005 to June 2026, FDA received 4,279 adverse event reports that name Fluticasone. In these reports the drug is a suspect or interacting product.

In the same period, 32,733 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 403 reports in the 12 months to June 2026 and 471 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 403 (under 0.1%) name Fluticasone. Reports from other health professionals were 38% of the reports that name Fluticasone and 19.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Fluticasone is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 77 reports that name Fluticasone.
In January to March 2026, FDA received 105.
In April to June 2025, FDA received 111.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 676 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 4,223 of the 4,279 reports (98.7%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 676 terms.

Reaction terms in the reports that name Fluticasone, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,279 reports
Drug ineffectivethe medicine did not work as expected	870	20.3%
Asthma	786	18.4%
Dyspnoeashortness of breath	714	16.7%
Off label useused for a purpose or in a way not on the label	582	13.6%
Wheezing	529	12.4%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	502	11.7%
Pneumonialung infection	453	10.6%
Condition aggravatedthe condition being treated got worse	438	10.2%
Vomitingbeing sick	424	9.9%
Cough	378	8.8%
Therapeutic product effect incomplete	365	8.5%
Painpain, site not specified	330	7.7%
Product use in unapproved indicationused for a purpose not on the label	324	7.6%
Nauseafeeling sick	303	7.1%
Hypertensionhigh blood pressure	302	7.1%
Headachehead pain	285	6.7%
Oedemaswelling from fluid	258	6%
Malaisegeneral feeling of being unwell	255	6%
Drug interactionan interaction between medicines	249	5.8%
Pyrexiafever	234	5.5%
Constipation	216	5%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	215	5%
Lung disordera lung problem, type not specified	211	4.9%
General physical health deteriorationgeneral decline in health	207	4.8%
Obstructive airways disorder	205	4.8%
Abdominal painstomach or belly pain	204	4.8%
Drug intolerancethe medicine was not tolerated	200	4.7%
Infusion related reactiona reaction during or soon after an infusion	200	4.7%
Full blood count abnormal	197	4.6%
Gastrooesophageal reflux diseaseacid reflux	197	4.6%
Fatiguetiredness	194	4.5%
Product use issuea problem in how the product was used	189	4.4%
Astheniaweakness or lack of energy	183	4.3%
Sleep disordera sleep problem	178	4.2%
Dizzinesslight-headedness or unsteadiness	173	4%
Chronic sinusitis	170	4%
Dry mouth	169	3.9%
Chest pain	168	3.9%
Obesity	166	3.9%
Productive cougha cough with phlegm	159	3.7%
Product dose omission issuea dose was missed	158	3.7%
Weight decreasedweight loss	155	3.6%
Anaemialow red blood cells	153	3.6%
Arthralgiajoint pain	153	3.6%
Depressionlow mood	153	3.6%
Hepatic enzyme increasedraised liver enzymes	148	3.5%
Anxiety	145	3.4%
Intentional product misusedeliberate use not as intended	144	3.4%
Rashskin rash	138	3.2%
Treatment failurethe treatment did not work	137	3.2%

Download all 676 terms of Fluticasone (CSV)

The counts add to more than 4,279 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Fluticasone propionate with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Fluticasone propionate	Generic name	7,225
Flonase	Brand name	9,393
Flonase Allergy Relief	Brand name	3,415
Flovent	Brand name	10,772
Fluticasone (this page)	Brand name	4,279
Xhance	Brand name	1,593

Sum of the separately reported names: 36,677. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Fluticasone, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	0	0	0	0	0	0	0	0	0
2005	4	4	0	0	2	1	0	1	0
2006	2	2	0	0	0	0	0	2	0
2007	0	0	0	0	0	0	0	0	0
2008	12	8	2	0	2	0	0	6	4
2009	41	28	2	0	13	1	0	14	13
2010	23	10	1	3	5	0	0	6	13
2011	8	8	1	0	0	1	0	7	0
2012	39	24	2	2	10	1	0	17	15
2013	103	55	5	4	18	8	0	42	48
2014	118	68	1	1	30	6	1	42	50
2015	125	76	2	1	27	7	1	54	49
2016	107	55	5	0	24	1	0	44	52
2017	114	82	8	9	25	4	2	69	32
2018	208	151	10	9	63	8	3	108	57
2019	361	210	34	6	82	7	3	163	151
2020	366	204	18	6	80	5	2	163	162
2021	463	229	5	4	101	2	1	170	234
2022	305	216	29	2	79	9	2	170	89
2023	509	262	51	31	119	42	2	237	247
2024	476	431	79	57	190	46	12	391	45
2025	530	478	174	117	225	86	46	411	52
2026	365	314	120	109	149	86	69	285	51

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Fluticasone, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Fluticasone, by the year in which FDA received them
Year	Reports
2005	3
2006	3
2008	8
2009	46
2010	26
2011	13
2012	47
2013	96
2014	125
2015	125
2016	107
2017	127
2018	245
2019	407
2020	415
2021	530
2022	306
2023	531
2024	500
2025	437
2026	182

Reports that name Fluticasone, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Fluticasone
Age	Reports	Share
Under 2	33	0.8%
2 to 11	236	5.5%
12 to 17	68	1.6%
18 to 44	571	13.3%
45 to 64	600	14%
65 to 74	783	18.3%
75 and over	473	11.1%
Age not given	1,515	35.4%

Sex of the patient in the reports that name Fluticasone
Sex	Reports	Share
Female	2,217	51.8%
Male	1,465	34.2%
Unknown or not given	597	14%

Type of reporter in the reports that name Fluticasone
Reporter	Reports	Share
Physician	721	16.8%
Pharmacist	129	3%
Other health professional	1,624	38%
Lawyer	7	0.2%
Consumer or non-health professional	1,726	40.3%
Not given	72	1.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 45.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Fluticasone record
Indication as recorded (MedDRA)	Reports	Share
Asthma	334	7.8%
Hypersensitivity	142	3.3%
Nasal congestion	90	2.1%
Chronic obstructive pulmonary disease	80	1.9%
Seasonal allergy	45	1.1%
Nutritional supplementation	41	1%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,279 reports.

Drugs in the same reports

Other drugs that the reports of Fluticasone name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	513
Albuterol	620
Albuterol sulfate	445
Cholecalciferol	393
Ergocalciferol	674
Hydromorphone hydrochloride	513
Montelukast	518
Pantoprazole	482
Prednisone	887
Rituximab	418

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Fluticasone propionate same ingredient
Flonase same ingredient
Flonase Allergy Relief same ingredient
Flovent same ingredient
Xhance same ingredient
Fluorometholone same class
Fluticasone furoate same class
Fluocinonide same class
Fluocinolone acetonide same class
Fluticasone propionate and salmeterol same class
Flutamide next in the A to Z list
Fluticasone Fur+umeclidinium+vilanterol next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for FluticasoneThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Fluticasone: adverse event reports that FDA received. https://reportedreactions.com/drug/fluticasone/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Fluticasone as a suspect or interacting product. The 32,733 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Fluticasone was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Fluticasone?

No. It is a count of what people reported to FDA: 4,279 reports from February 2005 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (40.3%), other health professional (38%) and physician (16.8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

To the top of the page