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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.

AZELASTINE\FLUTICASONE: 1,266 Adverse Event Reports & Safety Profile

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1,266
Total FAERS Reports
6 (0.5%)
Deaths Reported
140
Hospitalizations
1,266
As Primary/Secondary Suspect
20
Life-Threatening
29
Disabilities

Active Ingredient: AZELASTINE HYDROCHLORIDE\FLUTICASONE PROPIONATE ·

First Report: 19820101 · Latest Report: 20250924

What Are the Most Common AZELASTINE\FLUTICASONE Side Effects?

#1 Most Reported
Drug ineffective
148 reports (11.7%)
#2 Most Reported
Dyspnoea
101 reports (8.0%)
#3 Most Reported
Asthma
101 reports (8.0%)

All AZELASTINE\FLUTICASONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 148 11.7% 0 45
Asthma 101 8.0% 0 39
Dyspnoea 101 8.0% 0 26
Headache 92 7.3% 0 2
Dysgeusia 91 7.2% 0 2
Epistaxis 82 6.5% 0 3
Off label use 80 6.3% 0 2
Pneumonia 77 6.1% 0 65
Product dose omission issue 70 5.5% 0 0
Product delivery mechanism issue 68 5.4% 0 0
Cough 65 5.1% 0 9
Condition aggravated 62 4.9% 0 14
Therapeutic product effect incomplete 58 4.6% 0 9
Fatigue 57 4.5% 0 12
Nasal congestion 53 4.2% 0 2
Wheezing 52 4.1% 0 17
Dizziness 49 3.9% 0 2
Somnolence 49 3.9% 0 1
Loss of personal independence in daily activities 45 3.6% 0 17
Product quality issue 44 3.5% 0 0

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

Gender: 65.0% female, 35.0% male. Average age: 55.1 years. Most reports from: US. View detailed demographics →

Is AZELASTINE\FLUTICASONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 1 0 1
2012 30 0 0
2013 131 0 5
2014 80 0 2
2015 92 0 5
2016 116 0 4
2017 62 0 3
2018 56 0 5
2019 44 0 5
2020 25 5 0
2021 38 0 16
2022 21 0 0
2023 45 0 8
2024 45 0 3
2025 24 0 0

View full timeline →

What Is AZELASTINE\FLUTICASONE Used For?

IndicationReports
Product used for unknown indication 304
Rhinitis allergic 213
Hypersensitivity 100
Seasonal allergy 85
Nasal congestion 77
Sinusitis 44
Upper-airway cough syndrome 40
Multiple allergies 30
Rhinitis 28
Rhinorrhoea 28

AZELASTINE\FLUTICASONE vs Alternatives: Which Is Safer?

AZELASTINE\FLUTICASONE vs AZELNIDIPINE AZELASTINE\FLUTICASONE vs AZILECT AZELASTINE\FLUTICASONE vs AZILSARTAN KAMEDOXOMIL AZELASTINE\FLUTICASONE vs AZILSARTAN KAMEDOXOMIL\CHLORTHALIDONE AZELASTINE\FLUTICASONE vs AZITHROMYCIN AZELASTINE\FLUTICASONE vs AZITHROMYCIN ANHYDROUS AZELASTINE\FLUTICASONE vs AZITHROMYCIN OR METHOTREXATE AZELASTINE\FLUTICASONE vs AZOSEMIDE AZELASTINE\FLUTICASONE vs AZTREONAM AZELASTINE\FLUTICASONE vs AZTREONAM LYSINE

Official FDA Label for AZELASTINE\FLUTICASONE

Official prescribing information from the FDA-approved drug label.