A fixed combination of 2 drugs in one pill.
Sold as Imodium Advanced, Imodium Multi-Symptom Relief.
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.
Ingredients with a page of their own link to it: the FDA label, side-effect reports, recalls, evidence, and payments behind this grade are there.
Score breakdown (58/100)
Safety ×35%
F
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
A
Options ×10%
C
Safety: 34
Graded by its riskiest ingredient, loperamide (34)
Carries an FDA boxed warning, the strongest warning the FDA issues (-30)
FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2018 (-16)
17,671 FDA reports naming it as the suspect drug per million Medicare fills, 6.4x the median drug on this site (-15)
Death share in reports is near or below the FAERS average (1.2x)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
Evidence: 39
Graded by its riskiest ingredient, simethicone (39)
77 randomized trials and 10 systematic reviews/meta-analyses indexed in PubMed
No Cochrane review found (-5)
Only 24% of completed registered trials posted results (-15)
Regulatory history: 98
Graded by its riskiest ingredient, loperamide (98)
Recalls since 2016: 0 Class I, 1 Class II, 1 Class III across 30 generic makers (-2)
Money & lawsuits: 100
Graded by its riskiest ingredient, loperamide (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, simethicone (70)
Sold over the counter under an FDA monograph: no application to approve, many makers
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 loperamide and simethicone. Why both together, instead of only the one I need?
In 2018 the FDA issued a safety communication about this drug (FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use). Does that risk apply to me?
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 diarrhoea, nausea, fatigue. 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 difenoxin, diphenoxylate, eluxadoline? 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?