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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE: 25,904 Adverse Event Reports & Safety Profile

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25,904
Total FAERS Reports
2,293 (8.9%)
Deaths Reported
5,045
Hospitalizations
25,904
As Primary/Secondary Suspect
317
Life-Threatening
177
Disabilities

Active Ingredient: FLUTICASONE FUROATE\UMECLIDINIUM BROMIDE\VILANTEROL TRIFENATATE ·

First Report: 1998 · Latest Report: 20250923

What Are the Most Common FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE Side Effects?

#1 Most Reported
Dyspnoea
3,539 reports (13.7%)
#2 Most Reported
Wrong technique in device usage process
2,673 reports (10.3%)
#3 Most Reported
Drug ineffective
2,522 reports (9.7%)

All FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 3,539 13.7% 151 928
Wrong technique in device usage process 2,673 10.3% 1 75
Drug ineffective 2,522 9.7% 53 404
Product complaint 2,417 9.3% 3 75
Product dose omission issue 2,235 8.6% 18 209
Death 1,660 6.4% 1,634 147
Cough 1,520 5.9% 16 192
Asthma 1,275 4.9% 77 971
Hospitalisation 1,259 4.9% 40 1,257
Chronic obstructive pulmonary disease 1,145 4.4% 180 797
Pneumonia 1,064 4.1% 117 707
Dysphonia 943 3.6% 0 46
Product use in unapproved indication 735 2.8% 83 168
Condition aggravated 718 2.8% 160 262
Product dispensing error 692 2.7% 2 10
Incorrect dose administered 640 2.5% 27 104
Off label use 583 2.3% 98 97
Wheezing 574 2.2% 61 213
Productive cough 512 2.0% 57 168
Extra dose administered 482 1.9% 3 18

Who Reports FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE Side Effects? Age & Gender Data

Gender: 57.8% female, 42.2% male. Average age: 69.1 years. Most reports from: US. View detailed demographics →

Is FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 0 0
2003 2 0 0
2004 1 0 0
2005 1 0 0
2006 1 0 1
2009 1 0 1
2010 2 0 2
2011 3 0 1
2012 3 0 1
2013 5 1 1
2014 10 0 4
2015 18 5 12
2016 12 0 10
2017 43 2 15
2018 478 37 79
2019 1,079 174 201
2020 828 115 176
2021 1,224 82 232
2022 1,218 75 290
2023 1,210 52 266
2024 1,064 77 267
2025 752 43 130

View full timeline →

What Is FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE Used For?

IndicationReports
Product used for unknown indication 13,652
Chronic obstructive pulmonary disease 8,730
Asthma 2,468
Emphysema 377
Dyspnoea 290
Cough 96
Lung disorder 85
Bronchitis 81
Asthma-chronic obstructive pulmonary disease overlap syndrome 68
Pulmonary fibrosis 40

FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE vs Alternatives: Which Is Safer?

FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE vs FLUTICASONE FUROATE\VILANTEROL TRIFENATATE FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE vs FLUTICASONE\FLUTICASONE FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE vs FLUTICASONE\FORMOTEROL FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE vs FLUTICASONE\SALMETEROL FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE vs FLUVASTATIN FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE vs FLUVOXAMINE FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE vs FOLATE FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE vs FOLIC ACID FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE vs FOLINIC ACID FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE vs FOLLICLE STIMULATING HORMONE BETA POLYPEPTIDE\LUTROPIN ALFA

Official FDA Label for FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE

Official prescribing information from the FDA-approved drug label.