A fixed combination of 2 drugs in one pill.
Sold as Augmentin.
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 (78/100)
Safety ×35%
A
Evidence ×25%
D
Regulatory ×15%
B
Money & lawsuits ×15%
A
Options ×10%
F
Safety: 95
Graded by its riskiest ingredient, clavulanate (95)
Death share in reports is near or below the FAERS average (1.4x)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
Evidence: 51
Graded by its riskiest ingredient, clavulanate (51)
213 randomized trials and 9 systematic reviews/meta-analyses indexed in PubMed
2 independent Cochrane review(s) exist
Only 31% of completed registered trials posted results (-15)
Regulatory history: 86
Graded by its riskiest ingredient, amoxicillin (86)
Recalls since 2016: 0 Class I, 4 Class II, 1 Class III across 50 generic makers (-6)
10 label changes approved since 2021: the safety story is still moving (-8)
Money & lawsuits: 100
Graded by its riskiest ingredient, amoxicillin (100)
Pharma paid doctors $0 tied to this drug last year: negligible
Not named in any pending federal MDL
Options: 40
Graded by its riskiest ingredient, clavulanate (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
Not in the Medicare Part D spending file.
Questions to ask your prescriber
This is a fixed combination of amoxicillin and clavulanate. Why both together, instead of only the one I need?
The most-reported problems in FDA's adverse event data are chronic kidney disease, acute kidney injury, diarrhoea, drug hypersensitivity. How would we recognize and handle those?
Why this one over amdinocillin, amdinocillin pivoxil, ampicillin? What would make you pick one of those instead?
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 drug hypersensitivity, diarrhoea. 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?
There is no generic. Is there an older generic in the same class that works as well for my situation?