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 (70/100)
Safety ×35%
B
Evidence ×25%
F
Regulatory ×15%
B
Money & lawsuits ×15%
A
Options ×10%
C
Safety: 80
Graded by its riskiest ingredient, chlorhexidine (80)
FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2017 (-8)
2,397 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site
Death appears in 3.0x the share of reports seen across all of FAERS (-12)
Evidence: 27
Graded by its riskiest ingredient, sodium nitrite (27)
25 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed
On the WHO Model List of Essential Medicines (shown for context; no score effect)
No Cochrane review found (-5)
24% of registered trials were terminated, withdrawn, or suspended (-8)
Regulatory history: 87
Graded by its riskiest ingredient, chlorhexidine (87)
Recalls since 2016: 0 Class I, 3 Class II, 1 Class III across 16 generic makers (-5)
7 label changes approved since 2021: the safety story is still moving (-8)
Money & lawsuits: 100
Graded by its riskiest ingredient, chlorhexidine (100)
Pharma paid doctors $1,742 tied to this drug last year: negligible
Not named in any pending federal MDL
Options: 70
Graded by its riskiest ingredient, sodium nitrite (70)
No generic version approved: brand-only pricing (-30)
26 same-class alternatives exist
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 chlorhexidine and sodium nitrite. Why both together, instead of only the one I need?
In 2017 the FDA issued a safety communication about this drug (FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate). Does that risk apply to me?
The most-reported problems in FDA's adverse event data are rash, fatigue, joint swelling, pain. How would we recognize and handle those?
Why this one over acetic acid, acriflavine hydrochloride, aluminum acetotartrate? 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 completed suicide, methaemoglobinaemia, toxicity to various agents, overdose. How would we recognize and handle those?
Why this one over 4-dimethylaminophenol, acetylcysteine, amyl nitrite? What would make you pick one of those instead?
There is no generic. Is there an older generic in the same class that works as well for my situation?