Fluticasone Furoate / Vilanterol Trifenatate

Common brands: Breo Ellipta, Ventolin Hfa, Albuterol, Prednisone, Prednisone Delayed Release

Top reporter: Glaxosmithkline Llc

Corticosteroid [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Provitamin D2 Compound [EPC]Loop Diuretic [EPC]Proton Pump Inhibitor [EPC]
35,202
Total Reports
12,465
Serious Reports
1,426
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (4.05%)

Patient Demographics

Male
10,726
Female
21,146

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Fluticasone Furoate / Vilanterol Trifenatate.

# Reaction Reports % of Total
1 DYSPNOEA 6,080
11.6%
2 DRUG INEFFECTIVE 3,967
7.6%
3 ASTHMA 3,927
7.5%
4 COUGH 3,368
6.4%
5 WHEEZING 2,630
5.0%
6 WRONG TECHNIQUE IN DEVICE USAGE PROCESS 2,269
4.3%
7 PNEUMONIA 2,117
4.0%
8 PRODUCT COMPLAINT 1,810
3.5%
9 PRODUCT DOSE OMISSION ISSUE 1,734
3.3%
10 FATIGUE 1,703
3.2%
11 THERAPEUTIC PRODUCT EFFECT INCOMPLETE 1,529
2.9%
12 OFF LABEL USE 1,509
2.9%
13 MALAISE 1,440
2.7%
14 LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES 1,371
2.6%
15 HEADACHE 1,299
2.5%
16 NAUSEA 1,254
2.4%
17 DYSPHONIA 1,228
2.3%
18 DIZZINESS 1,203
2.3%
19 CHEST DISCOMFORT 1,174
2.2%
20 PRODUCTIVE COUGH 1,140
2.2%
21 CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1,084
2.1%
22 CONDITION AGGRAVATED 1,064
2.0%
23 OBSTRUCTIVE AIRWAYS DISORDER 1,048
2.0%
24 PRODUCT USE IN UNAPPROVED INDICATION 1,022
1.9%
25 SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION 1,004
1.9%
26 DIARRHOEA 974
1.9%
27 PAIN 948
1.8%
28 DRUG DOSE OMISSION 871
1.7%
29 DEATH 864
1.6%
30 BRONCHITIS 825
1.6%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.