65/100 · Elevated
Manufactured by GlaxoSmithKline LLC
Safety Profile of Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenate: Common Issues and Serious Adverse Events
70,190 FDA adverse event reports analyzed
Last updated: 2026-05-12
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by GlaxoSmithKline LLC. Based on analysis of 70,190 FDA adverse event reports, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE 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, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE include DYSPNOEA, DRUG INEFFECTIVE, PRODUCT DOSE OMISSION ISSUE, WRONG TECHNIQUE IN DEVICE USAGE PROCESS, PRODUCT COMPLAINT. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE.
Fluticasone Furoate, Umeclidinium Bromide 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 70,190 adverse event reports for this medication, which is primarily manufactured by Glaxosmithkline Llc.
The most commonly reported adverse events include Dyspnoea, Drug Ineffective, Product Dose Omission Issue. Of classified reports, 41.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. - Common issues include device usage errors, dose omissions, and product complaints.
- Serious adverse events such as death, pneumonia, and hospitalization are reported. - The majority of reactions are non-serious, but the diversity of reactions is notable.
Patients taking Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Warnings include device usage errors and dose omissions, which can lead to ineffective treatment or serious adverse events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate received a safety concern score of 65/100 (elevated concern). This is based on a 41.1% serious event ratio across 37,340 classified reports. The score accounts for 70,190 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: 18,441, Male: 12,249. The most frequently reported age groups are age 65 (527 reports), age 72 (499 reports), age 70 (487 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 37,340 classified reports for FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE 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.
Warnings include device usage errors and dose omissions, which can lead to ineffective treatment or serious adverse events.
If you are taking Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate, here are important things to know. The most commonly reported side effects include dyspnoea, drug ineffective, product dose omission issue, wrong technique in device usage process, product complaint. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Ensure proper device usage and follow the prescribed dosing schedule. Report any issues with the product to the manufacturer or 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 is ongoing, with a focus on ensuring proper device usage and accurate dosing.
The FDA has received approximately 70,190 adverse event reports associated with Fluticasone Furoate, Umeclidinium Bromide 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, Umeclidinium Bromide And Vilanterol Trifenatate include Dyspnoea, Drug Ineffective, Product Dose Omission Issue, Wrong Technique In Device Usage Process, Product Complaint. By volume, the top reported reactions are: Dyspnoea (5,246 reports), Drug Ineffective (3,162 reports), Product Dose Omission Issue (2,933 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, Umeclidinium Bromide And Vilanterol Trifenatate.
Out of 37,340 classified reports, 15,339 (41.1%) were classified as serious and 22,001 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, Umeclidinium Bromide And Vilanterol Trifenatate break down by patient sex as follows: Female: 18,441, Male: 12,249. 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, Umeclidinium Bromide And Vilanterol Trifenatate adverse events are: age 65: 527 reports, age 72: 499 reports, age 70: 487 reports, age 68: 478 reports, age 74: 476 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, Umeclidinium Bromide 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, Umeclidinium Bromide And Vilanterol Trifenatate include: Cough, Death, Pneumonia, Asthma, Chronic Obstructive Pulmonary Disease. 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, Umeclidinium Bromide 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, Umeclidinium Bromide 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. - Common issues include device usage errors, dose omissions, and product complaints.
Key safety signals identified in Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate's adverse event data include: Death and pneumonia are among the most serious adverse events.. Device usage errors and dose omissions are frequent issues.. A wide range of reactions, including respiratory and cardiovascular issues, are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Warnings include device usage errors and dose omissions, which can lead to ineffective treatment or serious adverse events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate.
Ensure proper device usage and follow the prescribed dosing schedule. Report any issues with the product to the manufacturer or healthcare provider.
Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate has 70,190 adverse event reports on file with the FDA. - Serious adverse events such as death, pneumonia, and hospitalization are reported. The volume of reports for Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on ensuring proper device usage and accurate dosing. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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