A fixed combination of 2 drugs in one pill.
Sold as Breyna, Symbicort.
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 (81/100)
Safety ×35%
B
Evidence ×25%
B
Regulatory ×15%
A
Money & lawsuits ×15%
C
Options ×10%
A
Safety: 80
Graded by its riskiest ingredient, budesonide (80)
27,136 FDA reports naming it as the suspect drug per million Medicare fills, 9.8x the median drug on this site (-15)
Death share in reports is near or below the FAERS average (0.6x)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
Evidence: 77
Graded by its riskiest ingredient, formoterol (77)
621 randomized trials and 62 systematic reviews/meta-analyses indexed in PubMed
On the WHO Model List of Essential Medicines (shown for context; no score effect)
12 independent Cochrane review(s) exist
Only 40% of completed registered trials posted results (-8)
Regulatory history: 88
Graded by its riskiest ingredient, budesonide (88)
Recalls since 2016: 0 Class I, 3 Class II, 0 Class III across 21 generic makers (-4)
8 label changes approved since 2021: the safety story is still moving (-8)
Money & lawsuits: 70
Graded by its riskiest ingredient, budesonide (70)
Pharma paid doctors $3,797,090 tied to this drug last year (-30)
Not named in any pending federal MDL
Options: 100
Graded by its riskiest ingredient, budesonide (100)
Generic versions approved (21 applications)
28 same-class alternatives exist
Money and lawsuits
In 2024, drug companies reported $5,643 in payments to US physicians and hospitals tied to this combination's brands across 185 transactions (Symbicort $5,643).
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
1,199,019Medicare Part D patients (2024)
3,615,874prescriptions filled
$266average cost per fill
$962Mtotal Medicare spend
Product
Fills
$/fill
Symbicort
1,913,647
$312
Budesonide-Formoterol Fumarate
1,147,488
$216
Breyna
554,739
$209
Questions to ask your prescriber
This is a fixed combination of budesonide and formoterol. Why both together, instead of only the one I need?
The most-reported problems in FDA's adverse event data are dyspnoea, asthma. 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 dyspnoea, asthma, cough, wheezing. How would we recognize and handle those?
Why this one over albuterol, bambuterol, bitolterol? What would make you pick one of those instead?