72/100 · Elevated
Manufactured by AstraZeneca Pharmaceuticals LP
Moderate Safety Concerns with Budecort Respules
236,943 FDA adverse event reports analyzed
Last updated: 2026-05-12
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. Based on analysis of 236,943 FDA adverse event reports, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE 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 BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE include DYSPNOEA, ASTHMA, COUGH, DRUG INEFFECTIVE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE.
Budesonide And Formoterol Fumarate Dihydrate 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 236,943 adverse event reports for this medication, which is primarily manufactured by Astrazeneca Pharmaceuticals Lp.
The most commonly reported adverse events include Dyspnoea, Asthma, Cough. Of classified reports, 60.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Dyspnea and asthma are the most common reactions, indicating potential respiratory issues.
Serious adverse events, such as pneumonia and death, are reported but less frequent. Drug ineffectiveness and intentional misuse are significant concerns, suggesting misuse or product issues. Pain and chest discomfort are frequently reported, indicating possible side effects.
Patients taking Budesonide And Formoterol Fumarate Dihydrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other bronchodilators and corticosteroids are possible, and patients should be warned against intentional misuse. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Budesonide And Formoterol Fumarate Dihydrate received a safety concern score of 72/100 (elevated concern). This is based on a 60.7% serious event ratio across 93,787 classified reports. The score accounts for 236,943 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: 55,261, Male: 31,163, Unknown: 108. The most frequently reported age groups are age 65 (1,483 reports), age 67 (1,447 reports), age 62 (1,423 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 93,787 classified reports for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE:
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.
Interactions with other bronchodilators and corticosteroids are possible, and patients should be warned against intentional misuse.
If you are taking Budesonide And Formoterol Fumarate Dihydrate, here are important things to know. The most commonly reported side effects include dyspnoea, asthma, cough, drug ineffective, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosing instructions carefully to avoid drug ineffectiveness and misuse. Report any serious adverse events to your healthcare provider immediately. 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 these reports and may require additional safety measures or labeling changes.
The FDA has received approximately 236,943 adverse event reports associated with Budesonide And Formoterol Fumarate Dihydrate. 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 Budesonide And Formoterol Fumarate Dihydrate include Dyspnoea, Asthma, Cough, Drug Ineffective, Off Label Use. By volume, the top reported reactions are: Dyspnoea (17,377 reports), Asthma (11,764 reports), Cough (7,696 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Budesonide And Formoterol Fumarate Dihydrate.
Out of 93,787 classified reports, 56,896 (60.7%) were classified as serious and 36,891 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 Budesonide And Formoterol Fumarate Dihydrate break down by patient sex as follows: Female: 55,261, Male: 31,163, Unknown: 108. 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 Budesonide And Formoterol Fumarate Dihydrate adverse events are: age 65: 1,483 reports, age 67: 1,447 reports, age 62: 1,423 reports, age 61: 1,420 reports, age 68: 1,406 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 Budesonide And Formoterol Fumarate Dihydrate adverse event reports is Astrazeneca Pharmaceuticals Lp. 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 Budesonide And Formoterol Fumarate Dihydrate include: Pneumonia, Wheezing, Fatigue, Malaise, Headache. 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 Budesonide And Formoterol Fumarate Dihydrate 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.
Budesonide And Formoterol Fumarate Dihydrate 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. Dyspnea and asthma are the most common reactions, indicating potential respiratory issues.
Key safety signals identified in Budesonide And Formoterol Fumarate Dihydrate's adverse event data include: Pneumonia and death are serious adverse events, though less common.. Drug ineffectiveness and intentional misuse are key signals of potential misuse or product issues.. Pain and chest discomfort are frequently reported, indicating possible side effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other bronchodilators and corticosteroids are possible, and patients should be warned against intentional misuse. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Budesonide And Formoterol Fumarate Dihydrate.
Follow prescribed dosing instructions carefully to avoid drug ineffectiveness and misuse. Report any serious adverse events to your healthcare provider immediately.
Budesonide And Formoterol Fumarate Dihydrate has 236,943 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and death, are reported but less frequent. The volume of reports for Budesonide And Formoterol Fumarate Dihydrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor these reports and may require additional safety measures or labeling changes. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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