A fixed combination of 3 drugs in one pill.
Sold as Tribenzor.
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 (58/100)
Safety ×35%
F
Evidence ×25%
F
Regulatory ×15%
B
Money & lawsuits ×15%
A
Options ×10%
C
Safety: 40
Graded by its riskiest ingredient, olmesartan (40)
Carries an FDA boxed warning, the strongest warning the FDA issues (-30)
FDA issued 3 Drug Safety Communication(s) naming this drug since 2010, most recently 2014 (-20)
Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)
1,684 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site
Death share in reports is near or below the FAERS average (0.6x)
Evidence: 38
Graded by its riskiest ingredient, olmesartan (38)
203 randomized trials and 15 systematic reviews/meta-analyses indexed in PubMed
Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)
No Cochrane review found (-5)
Only 32% of completed registered trials posted results (-15)
Regulatory history: 85
Graded by its riskiest ingredient, hydrochlorothiazide (85)
Recalls since 2016: 1 Class I, 0 Class II, 0 Class III across 32 generic makers (-15)
Money & lawsuits: 100
Graded by its riskiest ingredient, amlodipine (100)
Pharma paid doctors $10,750 tied to this drug last year: negligible
Not named in any pending federal MDL
Options: 70
Graded by its riskiest ingredient, olmesartan (70)
Generic versions approved (25 applications)
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 amlodipine and hydrochlorothiazide and olmesartan. Why both together, instead of only the one I need?
The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, nausea, dyspnoea. 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 clevidipine, felodipine, isradipine? 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 fatigue, nausea, diarrhoea. How would we recognize and handle those?
Why this one over bendroflumethiazide, chlorothiazide, cyclopenthiazide? What would make you pick one of those instead?
In 2014 the FDA issued a safety communication about this drug (FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label upd). Does that risk apply to me?
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 sprue-like enteropathy, diarrhoea, acute kidney injury, weight decreased. How would we recognize and handle those?