A fixed combination of 2 drugs in one pill.
Sold as Arthrotec.
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 (76/100)
Safety ×35%
C
Evidence ×25%
C
Regulatory ×15%
B
Money & lawsuits ×15%
A
Options ×10%
A
Safety: 63
Graded by its riskiest ingredient, diclofenac (63)
Carries an FDA boxed warning, the strongest warning the FDA issues (-30)
Prescrire lists one form only (oral diclofenac) as a drug to avoid; shown for context, no score effect
3,543 FDA reports naming it as the suspect drug per million Medicare fills, 1.3x the median drug on this site (-2)
Death share in reports is near or below the FAERS average (0.9x)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
Evidence: 67
Graded by its riskiest ingredient, diclofenac (67)
1070 randomized trials and 43 systematic reviews/meta-analyses indexed in PubMed
10 independent Cochrane review(s) exist
Only 24% of completed registered trials posted results (-15)
'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)
Regulatory history: 81
Graded by its riskiest ingredient, diclofenac (81)
Recalls since 2016: 0 Class I, 4 Class II, 1 Class III across 76 generic makers (-6)
27 label changes approved since 2021: the safety story is still moving (-8)
Label lists recent major changes to warnings or indications (-5)
Money & lawsuits: 100
Graded by its riskiest ingredient, diclofenac (100)
Pharma paid doctors $35,100 tied to this drug last year: negligible
Not named in any pending federal MDL
Options: 100
Graded by its riskiest ingredient, diclofenac (100)
Generic versions approved (76 applications)
34 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
11,536Medicare Part D patients (2024)
37,476prescriptions filled
$176average cost per fill
$7Mtotal Medicare spend
Product
Fills
$/fill
Diclofenac Sodium-Misoprostol
36,705
$162
Arthrotec 75
578
$851
Arthrotec 50
193
$760
Questions to ask your prescriber
This is a fixed combination of diclofenac and misoprostol. Why both together, instead of only the one I need?
An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?
This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?
The most-reported problems in FDA's adverse event data are pain, product use in unapproved indication. 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 aceclofenac, acemetacin, benzydamine? 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 foetal exposure during pregnancy, haemorrhage, abortion incomplete. How would we recognize and handle those?
Why this one over carboprost, dinoprost, dinoprostone? What would make you pick one of those instead?