Prescription medicine
Amlodipine and hydrochlorothiazide and olmesartan Brand names: Tribenzor
Amlodipine and hydrochlorothiazide and olmesartan (Tribenzor) is a prescription medicine with an FDA approval on record since 2010. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $0.776 per unit (Olmsrtn-amldpn-hydrochlorothiazide 20-5-12.5) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the amlodipine and hydrochlorothiazide and olmesartan FDA label on DailyMed (effective July 12, 2023, Cosette Pharmaceuticals, Inc.); the NDA 200175 record on Drugs@FDA; every amlodipine and hydrochlorothiazide and olmesartan label on DailyMed.
Highlights of the record
FDA label of July 12, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue Tribenzor as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Tribenzor as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ).
Used for
From the label: indications and usageTribenzor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure.
Forms and strengths
- 20 mg / 5 mg / 12.5 mg
- 40 mg / 5 mg / 25 mg
- 40 mg / 10 mg / 12.5 mg
- 40 mg / 5 mg / 12.5 mg
- 40 mg / 10 mg / 25 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 23, 2010 Tribenzor, Cosette; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first October 26, 2016; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 8 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.776 per unit Olmsrtn-amldpn-hydrochlorothiazide 20-5-12.5
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,260 through July 30, 2026
What is amlodipine and hydrochlorothiazide and olmesartan used for?
From the label: indications and usageTribenzor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Tribenzor. […]
Conditions named in the indications of amlodipine and hydrochlorothiazide and olmesartan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin 2 Receptor Blocker, Calcium Channel Blocker, Dihydropyridine Calcium Channel Blocker and Thiazide Diuretic.
Source: FDA drug label (Tribenzor), Cosette Pharmaceuticals, Inc., effective July 12, 2023 (SPL set 2f56d0bc-236b-41a0-9fc0-21cdfea8d890), via openFDA; the full label on DailyMed
Is there a generic for amlodipine and hydrochlorothiazide and olmesartan (Tribenzor)?
The FDA approved the first generic amlodipine and hydrochlorothiazide and olmesartan on October 26, 2016. 7 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists amlodipine and hydrochlorothiazide and olmesartan from 8 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2010 earliest approval on file
- 2016 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amlodipine and hydrochlorothiazide and olmesartan (Tribenzor)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.776 per unit (Olmsrtn-amldpn-hydrochlorothiazide 20-5-12.5), down 14% from $0.899 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Olmsrtn-amldpn-hydrochlorothiazide 20-5-12.5 (generic)
- Tribenzor 40-10-25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Olmsrtn-amldpn-hydrochlorothiazide 20-5-12.5 | Generic | $0.776 per unit | n/a | -14% |
| Olmsrtn-amldpn-hydrochlorothiazide 40-10-12.5 | Generic | $1.15 per unit | n/a | -27% |
| Olmsrtn-amldpn-hydrochlorothiazide 40-10-25 mg | Generic | $0.989 per unit | n/a | -25% |
| Olmsrtn-amldpn-hydrochlorothiazide 40-5-12.5 | Generic | $1.02 per unit | n/a | -25% |
| Olmsrtn-amldpn-hydrochlorothiazide 40-5-25 mg | Generic | $0.995 per unit | n/a | -19% |
| Tribenzor 40-10-25 mg tablet | Brand | $19.41 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $582.42 | +9% |
| Tribenzor 40-5-12.5 mg tablet | Brand | $19.54 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $586.16 | +20% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the amlodipine and hydrochlorothiazide and olmesartan label say about other medicines?
The amlodipine and hydrochlorothiazide and olmesartan label names 8 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aliskiren | contraindications | Do not co-administer aliskiren with Tribenzor in patients with diabetes [ See Drug Interactions ( 7.2 )]. |
| Cholestyramine | drug interactions | Cholestyramine and colestipol: Reduced absorption of thiazides. Can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics. |
| Colesevelam | drug interactions | Use with Colesevelam Hydrochloride: Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. |
| Colestipol | drug interactions | Cholestyramine and colestipol: Reduced absorption of thiazides. Can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics. |
| Cyclosporine | drug interactions | Immunosuppressants: Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. |
| Lithium | drug interactions | Increases in serum lithium concentrations and lithium toxicity. |
| Simvastatin | drug interactions | Amlodipine ( 7.2 ): Limit simvastatin to 20 mg daily when coadministered. Increased exposure to cyclosporin and tacrolimus. |
| Tacrolimus | drug interactions | Amlodipine ( 7.2 ): Limit simvastatin to 20 mg daily when coadministered. Increased exposure to cyclosporin and tacrolimus. |
Check amlodipine and hydrochlorothiazide and olmesartan against other medicines
Source: FDA drug label (Tribenzor), Cosette Pharmaceuticals, Inc., effective July 12, 2023 (SPL set 2f56d0bc-236b-41a0-9fc0-21cdfea8d890), via openFDA; the full label on DailyMed
What do FAERS reports show for amlodipine and hydrochlorothiazide and olmesartan?
The FDA Adverse Event Reporting System holds 1,260 reports that list amlodipine and hydrochlorothiazide and olmesartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 36 are coded as a death and 460 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as amlodipine and hydrochlorothiazide and olmesartan?
49 other medicines are given the same way (oral) and in the same FDA class as amlodipine and hydrochlorothiazide and olmesartan or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Diltiazem | High blood pressure | 42 labelers | $0.144 per capsule 24h ER(cd) 120 mg capsule | A presentation being discontinued |
| Losartan | High blood pressure | 44 labelers | $0.0327 per tablet 50 mg tablet | No current entry |
| Valsartan | High blood pressure | 34 labelers | $0.0963 per tablet 40 mg tablet | A presentation being discontinued |
| Nifedipine | High blood pressure | 32 labelers | $0.130 per tablet 30 mg tablet | No current entry |
| Verapamil | High blood pressure | 24 labelers | $0.191 per tablet 180 mg tablet | A presentation being discontinued |
| Irbesartan | High blood pressure | 23 labelers | $0.107 per tablet 150 mg tablet | No current entry |
| Telmisartan | High blood pressure | 28 labelers | $0.106 per tablet 20 mg tablet | No current entry |
| Felodipine | High blood pressure | 14 labelers | $0.123 per tablet 5 mg tablet | No current entry |
Every medicine labeled for the same conditions as amlodipine and hydrochlorothiazide and olmesartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does amlodipine and hydrochlorothiazide and olmesartan compare with medicines for the same use?
1 side-by-side page set amlodipine and hydrochlorothiazide and olmesartan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to amlodipine and hydrochlorothiazide and olmesartan
- 49 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Amlodipine and hydrochlorothiazide and olmesartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other