Fluticasone Furoate, Umeclidinium Bromide / Vilanterol Trifenatate

Common brands: Trelegy Ellipta, Albuterol, Ventolin Hfa, Proair Digihaler, Proair Respiclick

Top reporter: Glaxosmithkline Llc

Corticosteroid [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Interleukin-4 Receptor alpha Antagonist [EPC]Loop Diuretic [EPC]Proton Pump Inhibitor [EPC]
39,140
Total Reports
28,747
Serious Reports
3,184
Death Reports
30
Reported Reactions
Death Report Ratio: High (8.13%)

Patient Demographics

Male
12,800
Female
19,346

Reported Adverse Reactions (30)

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

# Reaction Reports % of Total
1 DYSPNOEA 5,453
11.7%
2 DRUG INEFFECTIVE 3,315
7.1%
3 PRODUCT DOSE OMISSION ISSUE 3,095
6.6%
4 WRONG TECHNIQUE IN DEVICE USAGE PROCESS 3,071
6.6%
5 PRODUCT COMPLAINT 2,739
5.9%
6 COUGH 2,654
5.7%
7 DEATH 2,294
4.9%
8 PNEUMONIA 1,949
4.2%
9 ASTHMA 1,661
3.6%
10 CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1,505
3.2%
11 FATIGUE 1,278
2.7%
12 PRODUCT USE IN UNAPPROVED INDICATION 1,234
2.6%
13 OFF LABEL USE 1,221
2.6%
14 HEADACHE 1,200
2.6%
15 DYSPHONIA 1,123
2.4%
16 CONDITION AGGRAVATED 1,048
2.3%
17 HOSPITALISATION 974
2.1%
18 NAUSEA 974
2.1%
19 WHEEZING 911
2.0%
20 DIZZINESS 888
1.9%
21 INCORRECT DOSE ADMINISTERED 876
1.9%
22 DIARRHOEA 861
1.8%
23 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 855
1.8%
24 PRODUCTIVE COUGH 852
1.8%
25 MALAISE 814
1.7%
26 COVID-19 774
1.7%
27 FALL 765
1.6%
28 ARTHRALGIA 747
1.6%
29 PAIN 722
1.6%
30 PRODUCT DISPENSING ERROR 717
1.5%

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.