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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\SALMETEROL: 47,788 Adverse Event Reports & Safety Profile

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47,788
Total FAERS Reports
2,045 (4.3%)
Deaths Reported
11,693
Hospitalizations
47,788
As Primary/Secondary Suspect
634
Life-Threatening
539
Disabilities

Active Ingredient: FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE ·

First Report: 1120 · Latest Report: 20250925

What Are the Most Common FLUTICASONE\SALMETEROL Side Effects?

#1 Most Reported
Dyspnoea
9,783 reports (20.5%)
#2 Most Reported
Asthma
7,985 reports (16.7%)
#3 Most Reported
Drug ineffective
7,037 reports (14.7%)

All FLUTICASONE\SALMETEROL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 9,783 20.5% 198 3,315
Asthma 7,985 16.7% 271 3,855
Drug ineffective 7,037 14.7% 186 1,448
Cough 4,111 8.6% 30 1,024
Wheezing 3,948 8.3% 58 1,523
Pneumonia 3,217 6.7% 178 1,897
Product quality issue 2,986 6.3% 5 236
Malaise 2,588 5.4% 44 767
Therapeutic product effect incomplete 2,402 5.0% 54 1,319
Wrong technique in device usage process 2,259 4.7% 3 104
Drug dose omission 2,153 4.5% 7 372
Off label use 2,120 4.4% 206 425
Product dose omission issue 2,118 4.4% 32 147
Chronic obstructive pulmonary disease 1,904 4.0% 183 1,172
Device use error 1,749 3.7% 1 96
Dysphonia 1,729 3.6% 3 250
Hospitalisation 1,631 3.4% 33 1,606
Product complaint 1,601 3.4% 3 80
Underdose 1,600 3.4% 10 236
Loss of personal independence in daily activities 1,590 3.3% 48 890

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

Gender: 65.6% female, 34.4% male. Average age: 62.2 years. Most reports from: US. View detailed demographics →

Is FLUTICASONE\SALMETEROL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 40 1 19
2001 37 0 15
2002 34 0 12
2003 47 2 18
2004 69 5 24
2005 72 1 41
2006 69 2 26
2007 100 1 46
2008 122 1 46
2009 167 3 73
2010 165 3 84
2011 264 6 107
2012 420 7 183
2013 1,128 18 369
2014 2,626 111 817
2015 2,361 149 783
2016 1,908 141 642
2017 1,811 87 433
2018 1,660 66 496
2019 1,262 45 318
2020 951 62 259
2021 790 34 157
2022 569 19 109
2023 397 19 81
2024 333 20 54
2025 206 2 22

View full timeline →

What Is FLUTICASONE\SALMETEROL Used For?

IndicationReports
Product used for unknown indication 21,435
Asthma 13,295
Chronic obstructive pulmonary disease 8,896
Dyspnoea 1,359
Emphysema 1,018
Bronchitis 510
Cough 437
Lung disorder 228
Respiratory disorder 212
Bronchitis chronic 205

FLUTICASONE\SALMETEROL vs Alternatives: Which Is Safer?

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

Official FDA Label for FLUTICASONE\SALMETEROL

Official prescribing information from the FDA-approved drug label.