A fixed combination of 2 drugs in one pill.
Sold as Breo.
A combination is graded by its riskiest ingredient: each part of the score is the lowest of the ingredients' scores. This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Each ingredient has its own full page with the FDA label, side-effect reports, recalls, evidence, and payments. Open them for the detail behind this grade.
Score breakdown (67/100)
Safety ×35%
B
Evidence ×25%
C
Regulatory ×15%
B
Money & lawsuits ×15%
F
Options ×10%
F
Safety: 83
Graded by its riskiest ingredient, vilanterol (83)
Death appears in 3.7x the share of reports seen across all of FAERS (-12)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
Evidence: 63
Graded by its riskiest ingredient, vilanterol (63)
106 randomized trials and 15 systematic reviews/meta-analyses indexed in PubMed
On the WHO Model List of Essential Medicines (shown for context; no score effect)
1 independent Cochrane review(s) exist
Regulatory history: 86
Graded by its riskiest ingredient, fluticasone (86)
Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 25 generic makers (-1)
17 label changes approved since 2021: the safety story is still moving (-8)
Label lists recent major changes to warnings or indications (-5)
Money & lawsuits: 35
Graded by its riskiest ingredient, fluticasone (35)
Maker paid $3 billion ($1B criminal, $2B civil) in 2012 to settle federal allegations naming this drug (Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to) (-35)
Pharma paid doctors $1,294,173 tied to this drug last year (-30)
Not named in any pending federal MDL
Options: 40
Graded by its riskiest ingredient, vilanterol (40)
No generic version approved: brand-only pricing (-30)
No same-class alternatives found: little leverage to switch (-30)
Money and lawsuits
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this combination's brands across 0 transactions.
No pending federal MDL names this combination or its brands.
The ingredients' own payments and lawsuits are on their pages and already count toward this grade.
Who takes it and what it costs
704,534Medicare Part D patients (2024)
2,789,395prescriptions filled
$512average cost per fill
$1,428Mtotal Medicare spend
Product
Fills
$/fill
Breo Ellipta
2,617,269
$520
Fluticasone-Vilanterol
172,126
$390
Questions to ask your prescriber
This is a fixed combination of fluticasone and vilanterol. Why both together, instead of only the one I need?
The maker paid $3 billion in 2012 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?
The most-reported problems in FDA's adverse event data are dyspnoea, fatigue, headache. How would we recognize and handle those?
Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
Why this one over amcinonide, beclomethasone, betamethasone? What would make you pick one of those instead?
The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?
What result are we expecting, by when, and what is the plan if it does not happen?
If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)
The most-reported problems in FDA's adverse event data are abdominal pain, dyspnoea, constipation. How would we recognize and handle those?
There is no generic. Is there an older generic in the same class that works as well for my situation?