Drug Safety Information for BREO ELLIPTA (Fluticasone furoate; vilanterol trifenatate)
FDA Safety-related Labeling Changes for BREO ELLIPTA (FLUTICASONE FUROATE; VILANTEROL TRIFENATATE) Rx Drug: Safety Information Link
Required post-approval safety study:
Conduct a randomized, double-blind, parallel-group study to evaluate the efficacy and long-term safety of fluticasone furoate/vilanterol (FF/VI) and fluticasone furoate (FF) in children 5 to less than 18 years of age. Due Date: 2021-07-31
Original FDA Drug Approval Date for BREO ELLIPTA: 2013-05-10
Adverse Drug Reactions for BREO ELLIPTA* (Fluticasone furoate; vilanterol trifenatate)
These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).
Top 20 Adverse Effects Associated with BREO ELLIPTA
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Dyspnoea | 225 |
2 | Drug ineffective | 220 |
3 | Cough | 113 |
4 | Dysphonia | 75 |
5 | Overdose | 74 |
6 | Product quality issue | 56 |
7 | Off label use | 53 |
8 | Malaise | 52 |
9 | Headache | 52 |
10 | Pneumonia | 49 |
11 | Chronic obstructive pulmonary disease | 47 |
12 | Oropharyngeal pain | 44 |
13 | Nausea | 44 |
14 | Dizziness | 43 |
15 | Fatigue | 41 |
16 | Drug administration error | 40 |
17 | Feeling abnormal | 39 |
18 | Productive cough | 36 |
19 | Rash | 34 |
20 | Chest discomfort | 33 |
* This side effect also appears in "Top 10 Side Effects of BREO ELLIPTA " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking BREO ELLIPTA
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Chronic obstructive pulmonary disease | 1841 |
2 | Product used for unknown indication | 603 |
3 | Asthma | 275 |
4 | Emphysema | 184 |
5 | Dyspnoea | 171 |
6 | Bronchitis | 123 |
7 | Cough | 35 |
8 | Lung disorder | 34 |
9 | Respiratory disorder | 27 |
10 | Bronchitis chronic | 26 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for BREO ELLIPTA
Total Reports Filed with FDA: 3722
Number of FDA Adverse Event Reports by Patient Age for BREO ELLIPTA
Total Reports Filed with FDA: 3722*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fluticasone furoate; vilanterol trifenatate (Breo ellipta)
Charts are based on 3722 reports filed with the FDA between 2004 and June 2015.
Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.
Click to go back to search results and BREO ELLIPTA Reviews and Review Summary .
Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.