72/100 · Elevated
Manufactured by GlaxoSmithKline LLC
Moderate Safety Concerns with Fluticasone Propionate and Salmeterol Xinafoate
162,228 FDA adverse event reports analyzed
Last updated: 2026-05-12
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by GlaxoSmithKline LLC. Based on analysis of 162,228 FDA adverse event reports, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE 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 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE include DYSPNOEA, ASTHMA, DRUG INEFFECTIVE, COUGH, PNEUMONIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE.
Fluticasone Propionate And Salmeterol Xinafoate 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 162,228 adverse event reports for this medication, which is primarily manufactured by Glaxosmithkline Llc.
The most commonly reported adverse events include Dyspnoea, Asthma, Drug Ineffective. Of classified reports, 57.8% 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, warranting caution. Drug ineffectiveness and product quality issues are frequent, suggesting variability in efficacy and product integrity.
Patients taking Fluticasone Propionate And Salmeterol Xinafoate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other medications, such as beta-blockers, can exacerbate respiratory symptoms. Warnings are issued for patients with severe asthma or chronic obstructive pulmonary disease (COPD). This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Fluticasone Propionate And Salmeterol Xinafoate received a safety concern score of 72/100 (elevated concern). This is based on a 57.8% serious event ratio across 58,442 classified reports. The score accounts for 162,228 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: 36,759, Male: 17,529, Unknown: 35. The most frequently reported age groups are age 65 (1,387 reports), age 58 (1,007 reports), age 64 (955 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 58,442 classified reports for FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE:
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 medications, such as beta-blockers, can exacerbate respiratory symptoms. Warnings are issued for patients with severe asthma or chronic obstructive pulmonary disease (COPD).
If you are taking Fluticasone Propionate And Salmeterol Xinafoate, here are important things to know. The most commonly reported side effects include dyspnoea, asthma, drug ineffective, cough, pneumonia. 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 and seek medical attention if they worsen. Follow prescribed dosing instructions and report any side effects 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.
The FDA continues to monitor the safety of this combination therapy, and updates will be provided based on ongoing reviews.
The FDA has received approximately 162,228 adverse event reports associated with Fluticasone Propionate And Salmeterol Xinafoate. 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 Fluticasone Propionate And Salmeterol Xinafoate include Dyspnoea, Asthma, Drug Ineffective, Cough, Pneumonia. By volume, the top reported reactions are: Dyspnoea (9,751 reports), Asthma (7,923 reports), Drug Ineffective (5,357 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Fluticasone Propionate And Salmeterol Xinafoate.
Out of 58,442 classified reports, 33,795 (57.8%) were classified as serious and 24,647 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 Fluticasone Propionate And Salmeterol Xinafoate break down by patient sex as follows: Female: 36,759, Male: 17,529, Unknown: 35. 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 Fluticasone Propionate And Salmeterol Xinafoate adverse events are: age 65: 1,387 reports, age 58: 1,007 reports, age 64: 955 reports, age 61: 930 reports, age 72: 927 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 Fluticasone Propionate And Salmeterol Xinafoate adverse event reports is Glaxosmithkline 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 Fluticasone Propionate And Salmeterol Xinafoate include: Wheezing, Fatigue, Malaise, Headache, Pain. 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 Fluticasone Propionate And Salmeterol Xinafoate 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.
Fluticasone Propionate And Salmeterol Xinafoate 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 Fluticasone Propionate And Salmeterol Xinafoate's adverse event data include: Pneumonia and other respiratory infections are reported, indicating potential risks.. Death and serious adverse events are noted, highlighting severe safety concerns.. Drug ineffectiveness and product quality issues are common, suggesting variability in treatment outcomes.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other medications, such as beta-blockers, can exacerbate respiratory symptoms. Warnings are issued for patients with severe asthma or chronic obstructive pulmonary disease (COPD). Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Fluticasone Propionate And Salmeterol Xinafoate.
Monitor for respiratory symptoms and seek medical attention if they worsen. Follow prescribed dosing instructions and report any side effects to your healthcare provider.
Fluticasone Propionate And Salmeterol Xinafoate has 162,228 adverse event reports on file with the FDA. Serious adverse events such as pneumonia and death are reported, warranting caution. The volume of reports for Fluticasone Propionate And Salmeterol Xinafoate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of this combination therapy, and updates will be provided based on ongoing reviews. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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