Spirivatiotropium
According to the FDA label: Tiotropium bromide inhalation powder is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Tiotropium bromide inhalation powder is indicated to reduce exacerbations in COPD patients.
135,604 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Spiriva 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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- Incorrect Route Of Drug Administration 23,320 reports
Dyspnoea 22,483 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Asthma 10,939 reports
A condition where the airways narrow and swell, causing wheezing and difficulty breathing.
Full definition in the glossary →Drug Ineffective 9,427 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 →Cough 8,694 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 8,442 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Wheezing 6,849 reports
A whistling sound when breathing, usually a sign the airways are narrowed.
Full definition in the glossary →Chronic Obstructive Pulmonary Disease 6,268 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 →Product Quality Issue 5,973 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 →Fatigue 5,398 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 4,722 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 →Malaise 4,564 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Nausea 4,054 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fall 3,943 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Headache 3,890 reports
Pain in the head or upper neck.
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 | 76,585 |
| Male | 49,917 |
| Unknown | 445 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 455 |
| 18-34 | 1,210 |
| 35-49 | 4,720 |
| 50-64 | 22,083 |
| 65-74 | 25,028 |
| 75+ | 23,970 |
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 Spiriva. 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 | 67,830 |
| Hospitalization | 39,118 |
| Other Serious | 38,243 |
| Death | 9,763 |
| Life-Threatening | 3,678 |
| Disability | 2,159 |
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 Spiriva. 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 | 1,292 |
| 2005 | 2,060 |
| 2006 | 1,845 |
| 2007 | 2,924 |
| 2008 | 5,101 |
| 2009 | 5,565 |
| 2010 | 6,478 |
| 2011 | 6,243 |
| 2012 | 7,664 |
| 2013 | 9,766 |
| 2014 | 10,466 |
| 2015 | 12,811 |
| 2016 | 12,446 |
| 2017 | 8,460 |
| 2018 | 7,429 |
| 2019 | 7,135 |
| 2020 | 6,729 |
| 2021 | 6,632 |
| 2022 | 4,487 |
| 2023 | 3,545 |
| 2024 | 3,255 |
| 2025 | 2,685 |
| 2026 (partial) | 586 |
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 Spiriva
In FDA adverse event reports that mention Spiriva, these medications appeared most often in the same report.
- Albuterol (28,908 reports)
- Budesonide And Formoterol (16,791 reports)
- Prednisone (14,320 reports)
- Furosemide (14,204 reports)
- Aspirin (12,235 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