Serevent Diskussalmeterol
According to the FDA label: SEREVENT DISKUS is a LABA indicated for: • Treatment of asthma in patients aged 4 years and older with an ICS. ( 1.1 ) • Prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older. ( 1.2 ) • Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). ( 1.3 ) Important limitation of use: Not indicated for relief of acute bronchospasm.
8,541 adverse event reports submitted to the FDA (1999–2026)
Top Reported Adverse Events
The most frequently reported events in association with Serevent Diskus in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Dyspnoea 1,252 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 1,223 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Asthma 904 reports
A condition where the airways narrow and swell, causing wheezing and difficulty breathing.
Full definition in the glossary →Cough 586 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Headache 457 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 404 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Nausea 395 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Wheezing 368 reports
A whistling sound when breathing, usually a sign the airways are narrowed.
Full definition in the glossary →Dizziness 366 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Chest Discomfort 355 reports
A feeling of unease, tightness, or mild pain in the chest. Related to chest pain, and like chest pain it is worth discussing with a doctor.
Full definition in the glossary →Fatigue 349 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Pharmaceutical Product Complaint 319 reports
A report of a possible problem with a medication's quality, packaging, or condition. This is a quality-tracking category.
Full definition in the glossary →Chest Pain 299 reports
Pain or discomfort in the chest. Chest pain has many causes, but it is always worth taking seriously and discussing with a doctor.
Full definition in the glossary → See all drugs reporting this event →Malaise 293 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Diarrhoea 276 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 5,192 |
| Male | 2,955 |
| Unknown | 11 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 199 |
| 18-34 | 226 |
| 35-49 | 725 |
| 50-64 | 1,532 |
| 65-74 | 1,446 |
| 75+ | 1,360 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Serevent Diskus. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 3,523 |
| Other Serious | 2,767 |
| Hospitalization | 2,472 |
| Death | 953 |
| Disability | 412 |
| Life-Threatening | 362 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Serevent Diskus. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1999 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1,506 |
| 2005 | 678 |
| 2006 | 563 |
| 2007 | 426 |
| 2008 | 446 |
| 2009 | 446 |
| 2010 | 434 |
| 2011 | 313 |
| 2012 | 283 |
| 2013 | 316 |
| 2014 | 328 |
| 2015 | 331 |
| 2016 | 370 |
| 2017 | 282 |
| 2018 | 292 |
| 2019 | 307 |
| 2020 | 252 |
| 2021 | 245 |
| 2022 | 180 |
| 2023 | 169 |
| 2024 | 230 |
| 2025 | 123 |
| 2026 (partial) | 18 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Serevent Diskus
In FDA adverse event reports that mention Serevent Diskus, these medications appeared most often in the same report.
- Albuterol (2,350 reports)
- Montelukast (1,149 reports)
- Tiotropium (1,075 reports)
- Furosemide (852 reports)
- Prednisone (774 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026