65/100 · Elevated
Manufactured by H2-Pharma LLC
Moderate Safety Concerns with Budesonide Use
134,730 FDA adverse event reports analyzed
Last updated: 2026-05-12
BUDESONIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by H2-Pharma LLC. Based on analysis of 134,730 FDA adverse event reports, BUDESONIDE has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for BUDESONIDE include DYSPNOEA, DRUG INEFFECTIVE, OFF LABEL USE, ASTHMA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUDESONIDE.
Budesonide has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 134,730 adverse event reports for this medication, which is primarily manufactured by H2-Pharma Llc.
The most commonly reported adverse events include Dyspnoea, Drug Ineffective, Off Label Use. Of classified reports, 65.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Dyspnea and pneumonia are among the most serious adverse reactions reported.
A significant number of reports involve drug ineffectiveness and off-label use. Weight changes and gastrointestinal issues are commonly reported.
Patients taking Budesonide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Budesonide may interact with other medications, and warnings include potential for drug hypersensitivity and increased blood pressure. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Budesonide received a safety concern score of 65/100 (elevated concern). This is based on a 65.4% serious event ratio across 55,358 classified reports. The score accounts for 134,730 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: 29,971, Male: 20,479, Unknown: 107. The most frequently reported age groups are age 65 (919 reports), age 60 (848 reports), age 72 (825 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 55,358 classified reports for BUDESONIDE:
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.
Budesonide may interact with other medications, and warnings include potential for drug hypersensitivity and increased blood pressure.
If you are taking Budesonide, here are important things to know. The most commonly reported side effects include dyspnoea, drug ineffective, off label use, asthma, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosages and use only as directed by a healthcare provider. Report any serious adverse reactions immediately to your healthcare provider. 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 includes monitoring for serious adverse events and ensuring proper use to avoid off-label applications.
The FDA has received approximately 134,730 adverse event reports associated with Budesonide. 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 include Dyspnoea, Drug Ineffective, Off Label Use, Asthma, Fatigue. By volume, the top reported reactions are: Dyspnoea (6,362 reports), Drug Ineffective (6,019 reports), Off Label Use (5,694 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.
Out of 55,358 classified reports, 36,185 (65.4%) were classified as serious and 19,173 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 break down by patient sex as follows: Female: 29,971, Male: 20,479, Unknown: 107. 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 adverse events are: age 65: 919 reports, age 60: 848 reports, age 72: 825 reports, age 62: 771 reports, age 71: 753 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 adverse event reports is H2-Pharma Llc. 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 include: Cough, Headache, Diarrhoea, Condition Aggravated, Nausea. 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 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 has a safety concern score of 65 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 pneumonia are among the most serious adverse reactions reported.
Key safety signals identified in Budesonide's adverse event data include: Serious adverse events such as pneumonia and death are reported.. Drug ineffectiveness and off-label use are frequent.. Gastrointestinal issues like diarrhea and nausea are common.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Budesonide may interact with other medications, and warnings include potential for drug hypersensitivity and increased blood pressure. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Budesonide.
Follow prescribed dosages and use only as directed by a healthcare provider. Report any serious adverse reactions immediately to your healthcare provider.
Budesonide has 134,730 adverse event reports on file with the FDA. A significant number of reports involve drug ineffectiveness and off-label use. The volume of reports for Budesonide reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight includes monitoring for serious adverse events and ensuring proper use to avoid off-label applications. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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