A fixed combination of 3 drugs in one pill.
Sold as Capacet, Esgic, Fioricet, Repan, Vanatol and 2 more.
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 (44/100)
Safety ×35%
F
Evidence ×25%
F
Regulatory ×15%
C
Money & lawsuits ×15%
D
Options ×10%
F
Safety: 48
Graded by its riskiest ingredient, butalbital (48)
Carries an FDA boxed warning, the strongest warning the FDA issues (-30)
Federally controlled substance: dependence and misuse risk (-10)
Death appears in 2.7x the share of reports seen across all of FAERS (-12)
Evidence: 16
Graded by its riskiest ingredient, butalbital (16)
3 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed
No Cochrane review found (-5)
Regulatory history: 70
Graded by its riskiest ingredient, acetaminophen (70)
Recalls since 2016: 3 Class I, 25 Class II, 0 Class III across 12 generic makers (-30)
Money & lawsuits: 60
Graded by its riskiest ingredient, acetaminophen (60)
Pharma paid doctors $0 tied to this drug last year: negligible
Named in 1 active federal multidistrict litigation(s) (-40)
Options: 40
Graded by its riskiest ingredient, butalbital (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 acetaminophen and butalbital and caffeine. Why both together, instead of only the one I need?
In 2013 the FDA issued a safety communication about this drug (FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen). Does that risk apply to me?
The most-reported problems in FDA's adverse event data are fatigue, nausea. 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 phenacetin? What would make you pick one of those instead?
This drug is in active federal litigation. What is the claim, and does it affect my risk?
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.)
This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?
This is a controlled substance. What is the plan for how long I take it and how I stop?
The most-reported problems in FDA's adverse event data are toxicity to various agents, headache, completed suicide, fatigue. 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?
The most-reported problems in FDA's adverse event data are fatigue, pain, alopecia. How would we recognize and handle those?
Why this one over propentofylline? What would make you pick one of those instead?