72/100 · Elevated
Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.
High Incidence of Respiratory Issues and Dyspnoea with Tiotropium Bromide
284,745 FDA adverse event reports analyzed
Last updated: 2026-05-12
TIOTROPIUM BROMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.. Based on analysis of 284,745 FDA adverse event reports, TIOTROPIUM BROMIDE has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for TIOTROPIUM BROMIDE include INCORRECT ROUTE OF DRUG ADMINISTRATION, DYSPNOEA, ASTHMA, DRUG INEFFECTIVE, COUGH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TIOTROPIUM BROMIDE.
Tiotropium Bromide has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 284,745 adverse event reports for this medication, which is primarily manufactured by Boehringer Ingelheim Pharmaceuticals, Inc..
The most commonly reported adverse events include Incorrect Route Of Drug Administration, Dyspnoea, Asthma. Of classified reports, 49.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are respiratory in nature, with dyspnoea being the most common reaction.
Serious adverse events, particularly pneumonia and respiratory failure, are notable. There is a significant number of reports related to incorrect drug administration and drug ineffectiveness.
Patients taking Tiotropium Bromide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Warnings include the risk of incorrect drug administration and drug ineffectiveness, which can lead to serious respiratory issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tiotropium Bromide received a safety concern score of 72/100 (elevated concern). This is based on a 49.9% serious event ratio across 134,922 classified reports. The score accounts for 284,745 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 76,221, Male: 49,686, Unknown: 445. The most frequently reported age groups are age 77 (2,720 reports), age 72 (2,671 reports), age 70 (2,627 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 134,922 classified reports for TIOTROPIUM BROMIDE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Warnings include the risk of incorrect drug administration and drug ineffectiveness, which can lead to serious respiratory issues.
If you are taking Tiotropium Bromide, here are important things to know. The most commonly reported side effects include incorrect route of drug administration, dyspnoea, asthma, drug ineffective, cough. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow prescribed dosing instructions and administration guidelines. Report any adverse events to your healthcare provider promptly. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with a focus on ensuring proper drug administration and monitoring for serious respiratory events.
The FDA has received approximately 284,745 adverse event reports associated with Tiotropium Bromide. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Tiotropium Bromide include Incorrect Route Of Drug Administration, Dyspnoea, Asthma, Drug Ineffective, Cough. By volume, the top reported reactions are: Incorrect Route Of Drug Administration (23,320 reports), Dyspnoea (22,314 reports), Asthma (10,819 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Tiotropium Bromide.
Out of 134,922 classified reports, 67,272 (49.9%) were classified as serious and 67,650 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Tiotropium Bromide break down by patient sex as follows: Female: 76,221, Male: 49,686, Unknown: 445. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Tiotropium Bromide adverse events are: age 77: 2,720 reports, age 72: 2,671 reports, age 70: 2,627 reports, age 71: 2,533 reports, age 73: 2,532 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Tiotropium Bromide adverse event reports is Boehringer Ingelheim Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Tiotropium Bromide include: Pneumonia, Wheezing, Chronic Obstructive Pulmonary Disease, Product Quality Issue, Fatigue. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Tiotropium Bromide to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Tiotropium Bromide has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The majority of adverse events are respiratory in nature, with dyspnoea being the most common reaction.
Key safety signals identified in Tiotropium Bromide's adverse event data include: High frequency of dyspnoea and pneumonia. Multiple reports of incorrect drug administration. Significant number of serious adverse events. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Warnings include the risk of incorrect drug administration and drug ineffectiveness, which can lead to serious respiratory issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tiotropium Bromide.
Always follow prescribed dosing instructions and administration guidelines. Report any adverse events to your healthcare provider promptly.
Tiotropium Bromide has 284,745 adverse event reports on file with the FDA. Serious adverse events, particularly pneumonia and respiratory failure, are notable. The volume of reports for Tiotropium Bromide reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on ensuring proper drug administration and monitoring for serious respiratory events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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