78/100 · Elevated
Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.
IPratropium Bromide Adverse Events: High Serious Reaction Rate
98,863 FDA adverse event reports analyzed
Last updated: 2026-05-12
IPRATROPIUM BROMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.. Based on analysis of 98,863 FDA adverse event reports, IPRATROPIUM BROMIDE has a safety score of 78 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 IPRATROPIUM BROMIDE include DYSPNOEA, ASTHMA, PNEUMONIA, COUGH, WHEEZING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IPRATROPIUM BROMIDE.
Ipratropium Bromide has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 98,863 adverse event reports for this medication, which is primarily manufactured by Boehringer Ingelheim Pharmaceuticals, Inc..
The most commonly reported adverse events include Dyspnoea, Asthma, Pneumonia. Of classified reports, 76.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High incidence of serious respiratory issues like pneumonia and asthma.
Significant number of reports of cardiovascular events, including myocardial infarction and atrial fibrillation. Multiple gastrointestinal issues, including diarrhea and nausea, are commonly reported. A notable number of cases involving falls and respiratory failure highlight potential safety concerns. Drug ineffectiveness and off-label use are frequent, indicating potential misuse or inefficacy.
Patients taking Ipratropium Bromide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. IPratropium Bromide may interact with other medications, leading to adverse effects. Warnings include potential cardiovascular and respiratory risks. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ipratropium Bromide received a safety concern score of 78/100 (high concern). This is based on a 76.9% serious event ratio across 34,217 classified reports. The score accounts for 98,863 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 18,293, Male: 13,553, Unknown: 111. The most frequently reported age groups are age 80 (726 reports), age 75 (689 reports), age 74 (629 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 34,217 classified reports for IPRATROPIUM 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.
IPratropium Bromide may interact with other medications, leading to adverse effects. Warnings include potential cardiovascular and respiratory risks.
If you are taking Ipratropium Bromide, here are important things to know. The most commonly reported side effects include dyspnoea, asthma, pneumonia, cough, wheezing. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for respiratory symptoms such as asthma and pneumonia, especially in elderly patients. Be cautious of cardiovascular symptoms like chest pain and arrhythmias, and report any issues to healthcare providers. 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.
The FDA continues to monitor Ipratropium Bromide for safety. Healthcare providers should be vigilant about potential serious adverse events and ensure proper use.
The FDA has received approximately 98,863 adverse event reports associated with Ipratropium 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 Ipratropium Bromide include Dyspnoea, Asthma, Pneumonia, Cough, Wheezing. By volume, the top reported reactions are: Dyspnoea (5,830 reports), Asthma (3,908 reports), Pneumonia (3,023 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ipratropium Bromide.
Out of 34,217 classified reports, 26,311 (76.9%) were classified as serious and 7,906 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 Ipratropium Bromide break down by patient sex as follows: Female: 18,293, Male: 13,553, Unknown: 111. 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 Ipratropium Bromide adverse events are: age 80: 726 reports, age 75: 689 reports, age 74: 629 reports, age 70: 610 reports, age 65: 609 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 Ipratropium 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 Ipratropium Bromide include: Drug Ineffective, Fatigue, Nausea, Chronic Obstructive Pulmonary Disease, Off Label Use. 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 Ipratropium 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.
Ipratropium Bromide has a safety concern score of 78 out of 100 (high 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. High incidence of serious respiratory issues like pneumonia and asthma.
Key safety signals identified in Ipratropium Bromide's adverse event data include: High rate of serious respiratory reactions (pneumonia, asthma, respiratory failure).. Cardiovascular events (myocardial infarction, atrial fibrillation) are frequently reported.. Gastrointestinal issues (diarrhea, nausea) are common, suggesting potential side effects.. Falls and respiratory failure are significant safety signals, indicating potential risks.. Off-label use and drug ineffectiveness are prevalent, suggesting misuse or inefficacy.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
IPratropium Bromide may interact with other medications, leading to adverse effects. Warnings include potential cardiovascular and respiratory risks. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ipratropium Bromide.
Monitor for respiratory symptoms such as asthma and pneumonia, especially in elderly patients. Be cautious of cardiovascular symptoms like chest pain and arrhythmias, and report any issues to healthcare providers.
Ipratropium Bromide has 98,863 adverse event reports on file with the FDA. Significant number of reports of cardiovascular events, including myocardial infarction and atrial fibrillation. The volume of reports for Ipratropium Bromide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Ipratropium Bromide for safety. Healthcare providers should be vigilant about potential serious adverse events and ensure proper use. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Boehringer Ingelheim Pharmaceuticals, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with IPRATROPIUM BROMIDE:
Drugs related to IPRATROPIUM BROMIDE based on therapeutic use, drug class, or shared indications: