Serevent Diskus (salmeterol xinafoate) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Salmeterol xinafoate

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 September 2004 to June 2026, FDA received 989 adverse event reports that name Serevent Diskus. In these reports the drug is a suspect or interacting product.

In the same period, 1,387 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 25 reports in the 12 months to June 2026 and 41 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, 25 (under 0.1%) name Serevent Diskus. Reports from consumers or other non-health professionals were 80.4% of the reports that name Serevent Diskus 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 Serevent Diskus 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 5 reports that name Serevent Diskus.
In January to March 2026, FDA received 6.
In April to June 2025, FDA received 8.

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 132 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 980 of the 989 reports (99.1%).

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 132 terms.

Reaction terms in the reports that name Serevent Diskus, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 989 reports
Drug ineffectivethe medicine did not work as expected	170	17.2%
Dyspnoeashortness of breath	131	13.2%
Cough	76	7.7%
Asthma	71	7.2%
Dysphoniaa hoarse voice	62	6.3%
Wrong technique in device usage process	62	6.3%
Off label useused for a purpose or in a way not on the label	61	6.2%
Chest discomfort	58	5.9%
Device use errora mistake in using the device	58	5.9%
Drug dose omissiona dose was missed	58	5.9%
Nauseafeeling sick	54	5.5%
Product complaint	50	5.1%
Product quality issuea problem with the product itself	45	4.6%
Product use issuea problem in how the product was used	44	4.4%
Cerebrovascular accidentstroke	43	4.3%
Respiratory failurethe lungs could not supply enough oxygen	42	4.2%
Areflexia	40	4%
Brain scan abnormal	40	4%
Ischaemic stroke	40	4%
Respiratory distressdifficulty breathing	40	4%
Cerebral artery thrombosis	39	3.9%
Deaththe patient died; cause not stated by this term	39	3.9%
Disease recurrencethe disease came back	39	3.9%
Hemiplegia	39	3.9%
Facial paralysis	38	3.8%
Anxiety	37	3.7%
Product dose omission issuea dose was missed	36	3.6%
Headachehead pain	34	3.4%
Malaisegeneral feeling of being unwell	33	3.3%
Underdoseless than the intended dose	32	3.2%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	28	2.8%
Wheezing	27	2.7%
Pneumonialung infection	25	2.5%
Dizzinesslight-headedness or unsteadiness	24	2.4%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	22	2.2%
Oropharyngeal discomfort	22	2.2%
Product dose omissiona dose was missed	22	2.2%
Product use in unapproved indicationused for a purpose not on the label	22	2.2%
Wrong technique in product usage processthe product was used in the wrong way	21	2.1%
Intentional product misusedeliberate use not as intended	20	2%
Overdosea dose above the recommended amount	20	2%
Abdominal pain upperupper stomach pain	19	1.9%
Chest pain	19	1.9%
Fatiguetiredness	19	1.9%
Hypoaesthesia eye	19	1.9%
Throat tightnessa tight throat	19	1.9%
Diarrhoealoose or frequent stools	18	1.8%
Painpain, site not specified	18	1.8%
Productive cougha cough with phlegm	18	1.8%
Tremorshaking	18	1.8%

Download all 132 terms of Serevent Diskus (CSV)

The counts add to more than 989 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 Salmeterol xinafoate with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Salmeterol xinafoate	Generic name	2,557
Serevent Diskus (this page)	Brand name	989

Sum of the separately reported names: 3,546. 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 Serevent Diskus, 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	0	0	0	0	0	0	0	0	0
2006	0	0	0	0	0	0	0	0	0
2012	12	11	1	0	5	0	0	7	1
2013	15	14	1	0	6	0	0	8	1
2014	9	2	0	0	1	0	0	2	7
2015	124	43	6	0	17	2	0	39	81
2016	151	51	3	2	23	0	0	44	100
2017	118	23	1	0	9	0	0	23	95
2018	97	51	4	4	22	0	0	43	46
2019	98	31	3	0	14	1	0	23	67
2020	72	29	13	1	17	1	0	21	43
2021	41	20	10	0	5	0	0	16	21
2022	79	51	19	0	13	2	1	38	28
2023	40	22	9	0	1	1	0	17	18
2024	64	44	18	1	17	1	0	34	20
2025	42	31	14	1	23	7	0	26	11
2026	27	21	17	9	12	7	5	19	6

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 Serevent Diskus, 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 Serevent Diskus, by the year in which FDA received them
Year	Reports
2004	1
2005	1
2006	1
2011	2
2012	14
2013	17
2014	24
2015	127
2016	145
2017	108
2018	99
2019	101
2020	91
2021	70
2022	52
2023	36
2024	65
2025	24
2026	11

Reports that name Serevent Diskus, 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 Serevent Diskus
Age	Reports	Share
Under 2	0	0%
2 to 11	14	1.4%
12 to 17	2	0.2%
18 to 44	31	3.1%
45 to 64	95	9.6%
65 to 74	132	13.3%
75 and over	143	14.5%
Age not given	572	57.8%

Sex of the patient in the reports that name Serevent Diskus
Sex	Reports	Share
Female	603	61%
Male	300	30.3%
Unknown or not given	86	8.7%

Type of reporter in the reports that name Serevent Diskus
Reporter	Reports	Share
Physician	56	5.7%
Pharmacist	16	1.6%
Other health professional	115	11.6%
Lawyer	0	0%
Consumer or non-health professional	795	80.4%
Not given	7	0.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 74.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Serevent Diskus record
Indication as recorded (MedDRA)	Reports	Share
Asthma	174	17.6%
Chronic obstructive pulmonary disease	151	15.3%
Dyspnoea	17	1.7%
Emphysema	7	0.7%
Bronchiectasis	2	0.2%
Bronchitis	2	0.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 989 reports.

Pages near this one

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for Serevent DiskusThe 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. Serevent Diskus: adverse event reports that FDA received. https://reportedreactions.com/drug/serevent-diskus/ 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 Serevent Diskus as a suspect or interacting product. The 1,387 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 Serevent Diskus 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 Serevent Diskus?

No. It is a count of what people reported to FDA: 989 reports from September 2004 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 (80.4%), other health professional (11.6%) and physician (5.7%). 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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