ProAir Digihaleralbuterol
According to the FDA label: Albuterol tablets, USP are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
83,025 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with ProAir Digihaler 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 12,437 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Wrong Technique in Product Usage Process 10,573 reports
A report that the medication was used or administered with the wrong technique, such as an incorrect injection or inhaler method. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →No Adverse Event 8,271 reports
A report that was filed but did not actually describe any adverse event. This is a record-keeping category.
Full definition in the glossary →- Device Delivery System Issue 7,770 reports
Drug Dose Omission by Device 7,507 reports
A report that a dose was missed because a device, such as a pump or injector, did not deliver it. This is a usage and device category.
Full definition in the glossary →Asthma 6,648 reports
A condition where the airways narrow and swell, causing wheezing and difficulty breathing.
Full definition in the glossary →Cough 5,924 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 5,043 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 →Fatigue 4,790 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Product Dose Omission Issue 4,720 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Headache 4,426 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 4,327 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 →Wheezing 4,218 reports
A whistling sound when breathing, usually a sign the airways are narrowed.
Full definition in the glossary →Nausea 3,760 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 3,737 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
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 | 43,069 |
| Male | 22,693 |
| Unknown | 50 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 2,924 |
| 18-34 | 3,517 |
| 35-49 | 5,424 |
| 50-64 | 11,500 |
| 65-74 | 8,819 |
| 75+ | 6,938 |
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 ProAir Digihaler. 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 | 48,869 |
| Other Serious | 23,825 |
| Hospitalization | 17,222 |
| Death | 3,754 |
| Life-Threatening | 1,445 |
| Disability | 1,193 |
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 ProAir Digihaler. 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 |
|---|---|
| 2004 | 280 |
| 2005 | 91 |
| 2006 | 73 |
| 2007 | 100 |
| 2008 | 346 |
| 2009 | 162 |
| 2010 | 191 |
| 2011 | 354 |
| 2012 | 496 |
| 2013 | 539 |
| 2014 | 665 |
| 2015 | 1,214 |
| 2016 | 2,107 |
| 2017 | 1,648 |
| 2018 | 1,882 |
| 2019 | 2,801 |
| 2020 | 6,180 |
| 2021 | 8,174 |
| 2022 | 9,809 |
| 2023 | 12,837 |
| 2024 | 15,051 |
| 2025 | 14,896 |
| 2026 (partial) | 3,129 |
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 ProAir Digihaler
In FDA adverse event reports that mention ProAir Digihaler, these medications appeared most often in the same report.
- Ergocalciferol (13,097 reports)
- Montelukast (11,716 reports)
- Acetaminophen (11,429 reports)
- Prednisone (11,084 reports)
- Dupilumab (10,920 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