65/100 · Elevated
Manufactured by GlaxoSmithKline LLC
Moderate Safety Concerns for Fluticasone Furoate and Vilanterol Trifenate
88,399 FDA adverse event reports analyzed
Last updated: 2026-05-12
FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by GlaxoSmithKline LLC. Based on analysis of 88,399 FDA adverse event reports, FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE 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 FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE include DYSPNOEA, DRUG INEFFECTIVE, ASTHMA, COUGH, WHEEZING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE.
Fluticasone Furoate And Vilanterol Trifenatate 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 88,399 adverse event reports for this medication, which is primarily manufactured by Glaxosmithkline Llc.
The most commonly reported adverse events include Dyspnoea, Drug Ineffective, Asthma. Of classified reports, 41.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common adverse reactions include dyspnea, asthma, and cough, indicating potential respiratory issues.
Serious adverse events, such as pneumonia and death, are reported but at a lower frequency. Drug ineffectiveness and product complaints suggest issues with efficacy and usability. A wide range of reactions, including cardiovascular and gastrointestinal symptoms, indicate a diverse safety profile.
Patients taking Fluticasone Furoate And Vilanterol Trifenatate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other medications, particularly those affecting the respiratory system, should be monitored. Warnings are present for improper device usage and potential misuse. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Fluticasone Furoate And Vilanterol Trifenatate received a safety concern score of 65/100 (elevated concern). This is based on a 41.2% serious event ratio across 34,641 classified reports. The score accounts for 88,399 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: 20,803, Male: 10,595, Unknown: 61. The most frequently reported age groups are age 74 (484 reports), age 76 (470 reports), age 60 (457 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 34,641 classified reports for FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE:
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, particularly those affecting the respiratory system, should be monitored. Warnings are present for improper device usage and potential misuse.
If you are taking Fluticasone Furoate And Vilanterol Trifenatate, here are important things to know. The most commonly reported side effects include dyspnoea, drug ineffective, asthma, cough, wheezing. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the prescribed dosage and usage instructions carefully to avoid adverse reactions. Report any serious or persistent side effects 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 the safety of this drug, and updates will be provided as necessary. Patients should report any adverse reactions to the FDA's MedWatch program.
The FDA has received approximately 88,399 adverse event reports associated with Fluticasone Furoate And Vilanterol Trifenatate. 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 Furoate And Vilanterol Trifenatate include Dyspnoea, Drug Ineffective, Asthma, Cough, Wheezing. By volume, the top reported reactions are: Dyspnoea (6,003 reports), Drug Ineffective (3,905 reports), Asthma (3,867 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 Furoate And Vilanterol Trifenatate.
Out of 34,641 classified reports, 14,282 (41.2%) were classified as serious and 20,359 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 Furoate And Vilanterol Trifenatate break down by patient sex as follows: Female: 20,803, Male: 10,595, Unknown: 61. 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 Furoate And Vilanterol Trifenatate adverse events are: age 74: 484 reports, age 76: 470 reports, age 60: 457 reports, age 65: 452 reports, age 70: 451 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 Furoate And Vilanterol Trifenatate 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 Furoate And Vilanterol Trifenatate include: Wrong Technique In Device Usage Process, Pneumonia, Product Complaint, Product Dose Omission Issue, Fatigue. 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 Furoate And Vilanterol Trifenatate 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 Furoate And Vilanterol Trifenatate 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. The most common adverse reactions include dyspnea, asthma, and cough, indicating potential respiratory issues.
Key safety signals identified in Fluticasone Furoate And Vilanterol Trifenatate's adverse event data include: Pneumonia and death are reported as serious adverse events.. Drug ineffectiveness and product complaints are frequent.. A diverse range of reactions, including cardiovascular and gastrointestinal symptoms, are 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, particularly those affecting the respiratory system, should be monitored. Warnings are present for improper device usage and potential misuse. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Fluticasone Furoate And Vilanterol Trifenatate.
Follow the prescribed dosage and usage instructions carefully to avoid adverse reactions. Report any serious or persistent side effects to your healthcare provider immediately.
Fluticasone Furoate And Vilanterol Trifenatate has 88,399 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and death, are reported but at a lower frequency. The volume of reports for Fluticasone Furoate And Vilanterol Trifenatate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of this drug, and updates will be provided as necessary. Patients should report any adverse reactions to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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