Pulmicort Flexhaler (budesonide) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Budesonide
Class: Corticosteroid

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 July 2007 to October 2025, FDA received 4,350 adverse event reports that name Pulmicort Flexhaler. In these reports the drug is a suspect or interacting product.

In the same period, 560 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 1 report in the 12 months to June 2026 and 6 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, 1 (under 0.1%) name Pulmicort Flexhaler. Reports from consumers or other non-health professionals were 68.4% of the reports that name Pulmicort Flexhaler and 45.8% 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 Pulmicort Flexhaler 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 0 reports that name Pulmicort Flexhaler.
In January to March 2026, FDA received 0.
In April to June 2025, FDA received 1.

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 256 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 4,348 of the 4,350 reports (99.9%).

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 256 terms.

Reaction terms in the reports that name Pulmicort Flexhaler, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,350 reports
Dyspnoeashortness of breath	980	22.5%
Off label useused for a purpose or in a way not on the label	787	18.1%
Asthma	643	14.8%
Intentional product misusedeliberate use not as intended	608	14%
Cough	604	13.9%
Drug ineffectivethe medicine did not work as expected	564	13%
Drug dose omissiona dose was missed	513	11.8%
Device malfunctionthe device did not work properly	498	11.4%
Malaisegeneral feeling of being unwell	333	7.7%
Circumstance or information capable of leading to medication errora situation that could lead to a medication error	324	7.4%
Product use issuea problem in how the product was used	308	7.1%
Device issuea problem with the device	277	6.4%
Wheezing	259	6%
Intentional device misuse	258	5.9%
Product quality issuea problem with the product itself	247	5.7%
Device use issue	204	4.7%
Wrong technique in device usage process	201	4.6%
Chest discomfort	187	4.3%
Device failurethe device failed	184	4.2%
Dysphoniaa hoarse voice	157	3.6%
Feeling abnormalfeeling odd or not right	157	3.6%
Product use in unapproved indicationused for a purpose not on the label	152	3.5%
Product dose omission issuea dose was missed	131	3%
Fatiguetiredness	125	2.9%
Product dose omissiona dose was missed	123	2.8%
Device delivery system issuea problem with the delivery system	111	2.6%
Incorrect dose administeredthe wrong dose was given	109	2.5%
Nasopharyngitisa cold	106	2.4%
Drug dose omission by device	105	2.4%
Bronchitischest infection	101	2.3%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	100	2.3%
Dizzinesslight-headedness or unsteadiness	99	2.3%
Pneumonialung infection	95	2.2%
Condition aggravatedthe condition being treated got worse	91	2.1%
Incorrect dose administered by devicethe device gave the wrong dose	91	2.1%
Hypersensitivityan allergic-type reaction	90	2.1%
Headachehead pain	89	2%
Insomniadifficulty sleeping	87	2%
Throat irritationan irritated throat	87	2%
Visual impairmentreduced vision	81	1.9%
Chest pain	80	1.8%
Dysgeusiaaltered taste	75	1.7%
Device defective	74	1.7%
Product taste abnormalthe product tasted odd	74	1.7%
Anxiety	72	1.7%
Intentional drug misuse	69	1.6%
Memory impairmentmemory problems	67	1.5%
Oropharyngeal painsore throat	66	1.5%
Lung disordera lung problem, type not specified	64	1.5%
Weight decreasedweight loss	61	1.4%

Download all 256 terms of Pulmicort Flexhaler (CSV)

The counts add to more than 4,350 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 Budesonide with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Budesonide	Generic name	14,714
Pulmicort Flexhaler (this page)	Brand name	4,350
Pulmicort Respules	Brand name	1,710
Tarpeyo	Brand name	5,365
Uceris	Brand name	769

Sum of the separately reported names: 26,908. 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 Pulmicort Flexhaler, 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
2007	169	15	0	3	1	1	0	12	154
2008	274	19	0	1	8	0	0	10	255
2009	220	21	1	0	11	1	0	8	199
2010	255	16	1	1	12	0	0	4	239
2011	285	54	5	5	23	1	0	31	231
2012	335	75	4	1	27	3	0	52	260
2013	169	36	3	0	13	1	0	25	133
2014	365	51	5	3	19	1	0	30	314
2015	283	50	1	0	16	2	0	38	233
2016	245	37	0	1	20	0	0	23	208
2017	321	54	1	3	29	5	0	28	267
2018	257	43	2	1	24	3	0	28	214
2019	255	22	4	0	12	1	0	10	233
2020	199	40	4	1	11	0	0	29	159
2021	240	38	10	0	15	0	0	19	202
2022	236	43	9	2	14	3	0	24	193
2023	224	36	10	0	12	1	1	18	188
2024	16	6	2	0	2	0	0	3	10
2025	2	0	0	0	0	0	0	0	2
2026	0	0	0	0	0	0	0	0	0

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 Pulmicort Flexhaler, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Pulmicort Flexhaler, by the year in which FDA received them
Year	Reports
2007	16
2008	292
2009	228
2010	213
2011	323
2012	552
2013	143
2014	362
2015	295
2016	250
2017	284
2018	250
2019	239
2020	210
2021	221
2022	242
2023	212
2024	16
2025	2

Reports that name Pulmicort Flexhaler, 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 Pulmicort Flexhaler
Age	Reports	Share
Under 2	4	0.1%
2 to 11	167	3.8%
12 to 17	62	1.4%
18 to 44	237	5.4%
45 to 64	830	19.1%
65 to 74	667	15.3%
75 and over	592	13.6%
Age not given	1,791	41.2%

Sex of the patient in the reports that name Pulmicort Flexhaler
Sex	Reports	Share
Female	2,969	68.3%
Male	1,184	27.2%
Unknown or not given	197	4.5%

Type of reporter in the reports that name Pulmicort Flexhaler
Reporter	Reports	Share
Physician	153	3.5%
Pharmacist	279	6.4%
Other health professional	116	2.7%
Lawyer	1	under 0.1%
Consumer or non-health professional	2,976	68.4%
Not given	825	19%

Age and sex are as the report gives them. The reporter is the primary source in the report. 99.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Pulmicort Flexhaler record
Indication as recorded (MedDRA)	Reports	Share
Asthma	1,803	41.4%
Chronic obstructive pulmonary disease	293	6.7%
Dyspnoea	107	2.5%
Cough	106	2.4%
Bronchitis	76	1.7%
Emphysema	55	1.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,350 reports.

Drugs in the same reports

Other drugs that the reports of Pulmicort Flexhaler name, in any role, in order of name
Drug	Reports that name the two
Albuterol	349
Albuterol sulfate	111
Aspirin	137
Lisinopril	119
Nexium	155
Prednisone	130
Proair Hfa	123
Singulair	203
Symbicort	302
Tiotropium bromide	114

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

Budesonide same ingredient
Pulmicort Respules same ingredient
Tarpeyo same ingredient
Uceris same ingredient
Prednisone same class
Prednisolone sodium phosphate same class
Qnasl same class
Prednisolone acetate same class
Qvar Redihaler same class
Psyllium husk next in the A to Z list
Pseudoephedrine hydrochloride next in the A to Z list
Pulmicort Turbuhaler 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 Pulmicort FlexhalerThe 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. Pulmicort Flexhaler: adverse event reports that FDA received. https://reportedreactions.com/drug/pulmicort-flexhaler/ 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 Pulmicort Flexhaler as a suspect or interacting product. The 560 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 Pulmicort Flexhaler 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 Pulmicort Flexhaler?

No. It is a count of what people reported to FDA: 4,350 reports from July 2007 to October 2025. 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 (68.4%), pharmacist (6.4%) and physician (3.5%). 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.

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