73/100 · Elevated
Manufactured by GlaxoSmithKline LLC
Safety Concerns with Fluticasone Propionate and Salmeterol
78,422 FDA adverse event reports analyzed
Last updated: 2026-05-12
FLUTICASONE PROPIONATE AND SALMETEROL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by GlaxoSmithKline LLC. Based on analysis of 78,422 FDA adverse event reports, FLUTICASONE PROPIONATE AND SALMETEROL has a safety score of 73 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 include DYSPNOEA, DRUG INEFFECTIVE, PRODUCT QUALITY ISSUE, COUGH, ASTHMA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUTICASONE PROPIONATE AND SALMETEROL.
Fluticasone Propionate And Salmeterol has a safety concern score of 73 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 78,422 adverse event reports for this medication, which is primarily manufactured by Glaxosmithkline Llc.
The most commonly reported adverse events include Dyspnoea, Drug Ineffective, Product Quality Issue. Of classified reports, 41.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Dyspnea and respiratory issues are the most common adverse events, indicating potential risks to lung function.
Drug ineffectiveness and product quality issues suggest variability in treatment outcomes and product reliability. Serious adverse events, including pneumonia and death, highlight the need for careful monitoring.
Patients taking Fluticasone Propionate And Salmeterol 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 cardiovascular conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Fluticasone Propionate And Salmeterol received a safety concern score of 73/100 (elevated concern). This is based on a 41.2% serious event ratio across 40,230 classified reports. The score accounts for 78,422 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: 25,598, Male: 12,788, Unknown: 112. The most frequently reported age groups are age 64 (553 reports), age 66 (542 reports), age 71 (541 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 40,230 classified reports for FLUTICASONE PROPIONATE AND SALMETEROL:
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 cardiovascular conditions.
If you are taking Fluticasone Propionate And Salmeterol, here are important things to know. The most commonly reported side effects include dyspnoea, drug ineffective, product quality issue, cough, asthma. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor lung function regularly and report any changes to your healthcare provider. Follow the prescribed dosing schedule and do not alter the treatment without medical advice. 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 frequent updates to safety information and warnings for patients and healthcare providers.
The FDA has received approximately 78,422 adverse event reports associated with Fluticasone Propionate And Salmeterol. 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 include Dyspnoea, Drug Ineffective, Product Quality Issue, Cough, Asthma. By volume, the top reported reactions are: Dyspnoea (6,291 reports), Drug Ineffective (4,817 reports), Product Quality Issue (2,665 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.
Out of 40,230 classified reports, 16,570 (41.2%) were classified as serious and 23,660 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 break down by patient sex as follows: Female: 25,598, Male: 12,788, Unknown: 112. 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 adverse events are: age 64: 553 reports, age 66: 542 reports, age 71: 541 reports, age 73: 538 reports, age 70: 522 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 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 include: Pneumonia, Drug Dose Omission, Product Dose Omission Issue, Malaise, Wrong Technique In Device Usage Process. 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 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 has a safety concern score of 73 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 respiratory issues are the most common adverse events, indicating potential risks to lung function.
Key safety signals identified in Fluticasone Propionate And Salmeterol's adverse event data include: High frequency of dyspnea and respiratory issues. Significant number of serious adverse events (16,570 out of 40,230). Drug ineffectiveness and product quality issues reported. 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 cardiovascular conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Fluticasone Propionate And Salmeterol.
Monitor lung function regularly and report any changes to your healthcare provider. Follow the prescribed dosing schedule and do not alter the treatment without medical advice.
Fluticasone Propionate And Salmeterol has 78,422 adverse event reports on file with the FDA. Drug ineffectiveness and product quality issues suggest variability in treatment outcomes and product reliability. The volume of reports for Fluticasone Propionate And Salmeterol reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with frequent updates to safety information and warnings for patients and healthcare providers. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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