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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.

BREO ELLIPTA: 218 Adverse Event Reports & Safety Profile

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218
Total FAERS Reports
1 (0.5%)
Deaths Reported
20
Hospitalizations
218
As Primary/Secondary Suspect
4
Life-Threatening
5
Disabilities

First Report: 200805 · Latest Report: 20140531

What Are the Most Common BREO ELLIPTA Side Effects?

#1 Most Reported
Dyspnoea
36 reports (16.5%)
#2 Most Reported
Drug ineffective
22 reports (10.1%)
#3 Most Reported
Cough
18 reports (8.3%)

All BREO ELLIPTA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 36 16.5% 0 9
Drug ineffective 22 10.1% 0 3
Cough 18 8.3% 0 1
Dysphonia 14 6.4% 0 0
Pneumonia 13 6.0% 0 7
Anxiety 12 5.5% 0 4
Oropharyngeal pain 9 4.1% 0 1
Nausea 8 3.7% 0 1
Dyspnoea exertional 7 3.2% 0 3
Headache 7 3.2% 0 1
Ill-defined disorder 7 3.2% 0 1
Off label use 7 3.2% 0 1
Chest pain 6 2.8% 0 0
Feeling abnormal 6 2.8% 0 0
Oral candidiasis 6 2.8% 0 0
Vision blurred 6 2.8% 0 0
Chest discomfort 5 2.3% 0 2
Dry mouth 5 2.3% 0 1
Dry throat 5 2.3% 0 0
Fatigue 5 2.3% 0 2

Who Reports BREO ELLIPTA Side Effects? Age & Gender Data

Average age: 70.0 years. Most reports from: US. View detailed demographics →

Is BREO ELLIPTA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 2 0 2
2011 1 0 1
2012 2 0 2
2013 28 0 4
2014 88 0 5

View full timeline →

What Is BREO ELLIPTA Used For?

IndicationReports
Chronic obstructive pulmonary disease 129
Product used for unknown indication 45
Asthma 8
Emphysema 7

BREO ELLIPTA vs Alternatives: Which Is Safer?

BREO ELLIPTA vs BREXANOLONE BREO ELLIPTA vs BREXPIPRAZOLE BREO ELLIPTA vs BREXUCABTAGENE AUTOLEUCEL BREO ELLIPTA vs BRIGATINIB BREO ELLIPTA vs BRILINTA BREO ELLIPTA vs BRILIQUE BREO ELLIPTA vs BRIMONIDINE BREO ELLIPTA vs BRIMONIDINE\BRINZOLAMIDE BREO ELLIPTA vs BRIMONIDINE\TIMOLOL BREO ELLIPTA vs BRINTELLIX

Official FDA Label for BREO ELLIPTA

Official prescribing information from the FDA-approved drug label.