A fixed combination of 2 drugs in one pill.
Sold as Azstarys.
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 (53/100)
Safety ×35%
D
Evidence ×25%
F
Regulatory ×15%
B
Money & lawsuits ×15%
C
Options ×10%
F
Safety: 60
Graded by its riskiest ingredient, dexmethylphenidate (60)
Carries an FDA boxed warning, the strongest warning the FDA issues (-30)
Federally controlled substance: dependence and misuse risk (-10)
Death share in reports is near or below the FAERS average (0.1x)
Evidence: 16
Graded by its riskiest ingredient, serdexmethylphenidate (16)
3 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed
No Cochrane review found (-5)
Regulatory history: 87
Graded by its riskiest ingredient, dexmethylphenidate (87)
Recalls since 2016: 0 Class I, 0 Class II, 1 Class III across 21 generic makers (-0)
7 label changes approved since 2021: the safety story is still moving (-8)
Label lists recent major changes to warnings or indications (-5)
Money & lawsuits: 70
Graded by its riskiest ingredient, dexmethylphenidate (100)
Pharma paid doctors $0 tied to this drug last year: negligible
Not named in any pending federal MDL
For the combination product itself:
Pharma paid doctors $1,667,199 tied to this drug last year (-30)
Not named in any pending federal MDL
Options: 40
Graded by its riskiest ingredient, serdexmethylphenidate (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 $1,667,199 in payments to US physicians and hospitals tied to this combination's brands across 76,309 transactions (Azstarys $1,667,199).
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 dexmethylphenidate and serdexmethylphenidate. Why both together, instead of only the one I need?
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 anxiety, nausea, headache. How would we recognize and handle those?
Why this one over amphetamine, armodafinil, atomoxetine? 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.)
There is no generic. Is there an older generic in the same class that works as well for my situation?