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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\FORMOTEROL: 229 Adverse Event Reports & Safety Profile

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229
Total FAERS Reports
6 (2.6%)
Deaths Reported
85
Hospitalizations
229
As Primary/Secondary Suspect
19
Life-Threatening
16
Disabilities

Active Ingredient: FLUTICASONE PROPIONATE\FORMOTEROL FUMARATE ·

First Report: 20000101 · Latest Report: 20240903

What Are the Most Common FLUTICASONE\FORMOTEROL Side Effects?

#1 Most Reported
Asthma
54 reports (23.6%)
#2 Most Reported
Dyspnoea
43 reports (18.8%)
#3 Most Reported
Drug ineffective
37 reports (16.2%)

All FLUTICASONE\FORMOTEROL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Asthma 54 23.6% 1 31
Dyspnoea 43 18.8% 3 32
Drug ineffective 37 16.2% 0 23
Thrombosis 30 13.1% 0 0
Drug intolerance 23 10.0% 0 16
Peripheral swelling 22 9.6% 0 0
Chronic obstructive pulmonary disease 20 8.7% 0 10
Off label use 20 8.7% 0 3
Eosinophilia 18 7.9% 0 18
Obstructive airways disorder 17 7.4% 0 15
Bronchitis 15 6.6% 0 15
Maternal exposure during pregnancy 15 6.6% 0 6
Pain 15 6.6% 0 0
Asthma-chronic obstructive pulmonary disease overlap syndrome 14 6.1% 0 14
Breath sounds abnormal 14 6.1% 0 14
Bronchial hyperreactivity 14 6.1% 0 14
Cardiac disorder 14 6.1% 0 14
Cardiomyopathy 14 6.1% 0 14
Ischaemic cardiomyopathy 14 6.1% 0 14
Pulmonary function test abnormal 14 6.1% 0 14

Who Reports FLUTICASONE\FORMOTEROL Side Effects? Age & Gender Data

Gender: 73.7% female, 26.3% male. Average age: 50.3 years. Most reports from: FR. View detailed demographics →

Is FLUTICASONE\FORMOTEROL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 1
2015 16 0 1
2016 18 0 5
2017 6 1 2
2018 7 0 3
2019 25 0 2
2020 18 0 0
2021 9 2 7
2022 7 0 0
2023 13 0 13
2024 1 0 0

View full timeline →

What Is FLUTICASONE\FORMOTEROL Used For?

IndicationReports
Asthma 107
Product used for unknown indication 80
Chronic obstructive pulmonary disease 14

FLUTICASONE\FORMOTEROL vs Alternatives: Which Is Safer?

FLUTICASONE\FORMOTEROL vs FLUTICASONE\SALMETEROL FLUTICASONE\FORMOTEROL vs FLUVASTATIN FLUTICASONE\FORMOTEROL vs FLUVOXAMINE FLUTICASONE\FORMOTEROL vs FOLATE FLUTICASONE\FORMOTEROL vs FOLIC ACID FLUTICASONE\FORMOTEROL vs FOLINIC ACID FLUTICASONE\FORMOTEROL vs FOLLICLE STIMULATING HORMONE BETA POLYPEPTIDE\LUTROPIN ALFA FLUTICASONE\FORMOTEROL vs FOLLITROPIN FLUTICASONE\FORMOTEROL vs FOLLITROPIN ALFA FLUTICASONE\FORMOTEROL vs FOLLITROPIN BETA

Official FDA Label for FLUTICASONE\FORMOTEROL

Official prescribing information from the FDA-approved drug label.