Advair Diskusfluticasone + salmeterol
According to the FDA label: ADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: • Twice-daily treatment of asthma in patients aged 4 years and older. ( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). ( 1.2 ) Important limitation of use: Not indicated for relief of acute bronchospasm.
37,008 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Advair 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.
Show these terms with plain-language definitions
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Dyspnoea 5,822 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 4,350 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 →Product Quality Issue 2,508 reports
A report of a possible problem with the medication's quality, such as appearance, packaging, or condition. This is a quality-tracking category.
Full definition in the glossary →Cough 2,222 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Product Dose Omission Issue 2,104 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Pneumonia 2,051 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Drug Dose Omission 1,996 reports
A report that a dose of medication was missed or skipped.
Full definition in the glossary →Asthma 1,902 reports
A condition where the airways narrow and swell, causing wheezing and difficulty breathing.
Full definition in the glossary →Malaise 1,508 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Wrong Technique in Device Usage Process 1,472 reports
A report that a device was used with the wrong technique. This is a usage category, the same idea as wrong technique in product usage process.
Full definition in the glossary →- Device Use Error 1,444 reports
Chronic Obstructive Pulmonary Disease 1,304 reports
A long-term lung condition, often called COPD, that makes breathing difficult. It often appears in reports as a condition being treated.
Full definition in the glossary →Underdose 1,241 reports
A report that less of a medication was taken than prescribed. This is a usage category.
Full definition in the glossary →Off Label Use 1,179 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Dysphonia 1,177 reports
Difficulty speaking, such as hoarseness or a change in the voice.
Full definition in the glossary →
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 | 23,688 |
| Male | 11,717 |
| Unknown | 96 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 275 |
| 18-34 | 737 |
| 35-49 | 1,822 |
| 50-64 | 5,506 |
| 65-74 | 4,623 |
| 75+ | 4,472 |
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 Advair 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 | 21,587 |
| Other Serious | 9,644 |
| Hospitalization | 8,585 |
| Death | 1,905 |
| Disability | 390 |
| Life-Threatening | 384 |
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 Advair 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 |
|---|---|
| 2003 | 3 |
| 2004 | 163 |
| 2005 | 80 |
| 2006 | 13 |
| 2007 | 15 |
| 2008 | 16 |
| 2009 | 34 |
| 2010 | 328 |
| 2011 | 622 |
| 2012 | 1,676 |
| 2013 | 4,671 |
| 2014 | 3,788 |
| 2015 | 5,405 |
| 2016 | 3,618 |
| 2017 | 3,249 |
| 2018 | 3,279 |
| 2019 | 2,602 |
| 2020 | 1,750 |
| 2021 | 1,200 |
| 2022 | 1,130 |
| 2023 | 935 |
| 2024 | 1,088 |
| 2025 | 583 |
| 2026 (partial) | 760 |
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 Advair Diskus
In FDA adverse event reports that mention Advair Diskus, these medications appeared most often in the same report.
- Albuterol (8,020 reports)
- Tiotropium (4,099 reports)
- Montelukast (2,740 reports)
- Aspirin (2,560 reports)
- Omeprazole (2,502 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