A fixed combination of 2 drugs in one pill.
Sold as Lomotil.
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 (64/100)
Safety ×35%
C
Evidence ×25%
F
Regulatory ×15%
C
Money & lawsuits ×15%
A
Options ×10%
C
Safety: 71
Graded by its riskiest ingredient, atropine (71)
7,592 FDA reports naming it as the suspect drug per million Medicare fills, 2.7x the median drug on this site (-9)
Death appears in 1.9x the share of reports seen across all of FAERS (-5)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
1 Class I recall(s): reasonable probability of serious harm (-10)
Evidence: 26
Graded by its riskiest ingredient, diphenoxylate (26)
14 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed
No Cochrane review found (-5)
Regulatory history: 68
Graded by its riskiest ingredient, atropine (68)
Recalls since 2016: 1 Class I, 3 Class II, 0 Class III across 19 generic makers (-24)
6 label changes approved since 2021: the safety story is still moving (-8)
Money & lawsuits: 100
Graded by its riskiest ingredient, atropine (100)
Pharma paid doctors $0 tied to this drug last year: negligible
Not named in any pending federal MDL
Options: 70
Graded by its riskiest ingredient, diphenoxylate (70)
No generic version approved: brand-only pricing (-30)
4 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
311,469Medicare Part D patients (2024)
741,981prescriptions filled
$21average cost per fill
$15Mtotal Medicare spend
Product
Fills
$/fill
Diphenoxylate-Atropine
741,208
$20
Lomotil
773
$319
Questions to ask your prescriber
This is a fixed combination of atropine and diphenoxylate. Why both together, instead of only the one I need?
The most-reported problems in FDA's adverse event data are diarrhoea, 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 cyclopentolate, homatropine, hyoscyamine? 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.)
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 diarrhoea, nausea, fatigue. How would we recognize and handle those?
Why this one over difenoxin, eluxadoline, loperamide? 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?