Prescription medicine
Hydrochlorothiazide and olmesartan Brand names: Benicar; first approved as Benicar Hct
Hydrochlorothiazide and olmesartan (Benicar) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 17 generic labelers, and pharmacies paid $0.165 per olmesartan-hydrochlorothiazide 20-12.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the hydrochlorothiazide and olmesartan FDA label on DailyMed (effective March 10, 2026, Cosette Pharmaceuticals, Inc.); the NDA 21532 record on Drugs@FDA; every hydrochlorothiazide and olmesartan label on DailyMed.
Highlights of the record
FDA label of March 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue BENICAR HCT as soon as possible [see Warnings and Precautions (5.1) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue BENICAR HCT as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 ).
Used for
From the label: indications and usageBENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure.
Forms and strengths
- 20 mg / 12.5 mg
- 40 mg / 12.5 mg
- 40 mg / 25 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- June 5, 2003 Benicar Hct, Cosette; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first October 26, 2016; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 19 of which 17 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.165 per tablet Olmesartan-hydrochlorothiazide 20-12.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2018 0 Class I among all firms' recalls; latest December 19, 2018
- FAERS reports
- 7,574 through July 30, 2026
What is hydrochlorothiazide and olmesartan used for?
From the label: indications and usageBENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. BENICAR HCT is not indicated for the initial therapy of hypertension [see Dosage and Administration (2) ]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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 BENICAR HCT. […]
Conditions named in the indications of hydrochlorothiazide and olmesartan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin 2 Receptor Blocker and Thiazide Diuretic.
Source: FDA drug label (Benicar HCT), Cosette Pharmaceuticals, Inc., effective March 10, 2026 (SPL set a90915ca-f9d3-4fff-8370-d5dc4cdfc521), via openFDA; the full label on DailyMed
Is there a generic for hydrochlorothiazide and olmesartan (Benicar)?
The FDA approved the first generic hydrochlorothiazide and olmesartan on October 26, 2016. 16 generic applications are approved; 12 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 hydrochlorothiazide and olmesartan from 17 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2003 earliest approval on file
- 2016 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for hydrochlorothiazide and olmesartan (Benicar)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.165 per Olmesartan-hydrochlorothiazide 20-12.5 mg tablet, down 5% from $0.174 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.
- Olmesartan-hydrochlorothiazide 20-12.5 mg tablet (generic)
- Benicar hct 40-12.5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Olmesartan-hydrochlorothiazide 20-12.5 mg tablet | Generic | $0.165 per tablet | $4.95 | -5% |
| Olmesartan-hydrochlorothiazide 40-12.5 mg tablet | Generic | $0.220 per tablet | $6.59 | -4% |
| Olmesartan-hydrochlorothiazide 40-25 mg tablet | Generic | $0.209 per tablet | $6.27 | -4% |
| Benicar hct 40-12.5 mg tablet | Brand | $17.20 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $516.04 | +10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has hydrochlorothiazide and olmesartan been recalled?
The FDA's Enforcement Report lists 1 recall naming hydrochlorothiazide and olmesartan since 2018: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 19, 2018 | Class II | Teva Pharmaceuticals USA | Failed dissolution specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the hydrochlorothiazide and olmesartan label say about other medicines?
The hydrochlorothiazide and olmesartan label names 5 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 | CONTRAINDICATIONS BENICAR HCT is contraindicated: In patients with hypersensitivity to any component of BENICAR HCT [see Adverse Reactions ( 6.1 , 6.2 )] In patients with anuria [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] For coadministration with aliskiren in patients with diabetes [ s ee Drug … |
| Cholestyramine | drug interactions | Dosage adjustment may be required ( 7.6 ) Cholestyramine and colestipol: Reduced absorption of thiazides |
| Colesevelam | drug interactions | Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.4 ) Colesevelam hydrochloride: |
| Colestipol | drug interactions | Dosage adjustment may be required ( 7.6 ) Cholestyramine and colestipol: Reduced absorption of thiazides |
| Lithium | drug interactions | DRUG INTERACTIONS Lithium: Risk of lithium toxicity ( 7.2 ) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): |
Check hydrochlorothiazide and olmesartan against other medicines
Source: FDA drug label (Benicar HCT), Cosette Pharmaceuticals, Inc., effective March 10, 2026 (SPL set a90915ca-f9d3-4fff-8370-d5dc4cdfc521), via openFDA; the full label on DailyMed
What do FAERS reports show for hydrochlorothiazide and olmesartan?
The FDA Adverse Event Reporting System holds 7,574 reports that list hydrochlorothiazide and olmesartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 190 are coded as a death and 3,501 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 rose sharply in 2018 (1,476, against a median of 86 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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 hydrochlorothiazide and olmesartan?
55 other medicines are given the same way (oral) and in the same FDA class as 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 |
|---|---|---|---|---|
| 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 |
| 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 |
| Amlodipine and valsartan | High blood pressure | 9 labelers | $0.330 per unit 10-160 mg | No current entry |
| Candesartan | High blood pressure | 8 labelers | $0.478 per tablet 16 mg tablet | No current entry |
| Amlodipine and telmisartan | High blood pressure | 3 labelers | $2.88 per unit 40-10 | No current entry |
| Azilsartan | High blood pressure | 1 labeler | $5.47 per tablet 40 mg tablet | No current entry |
Every medicine labeled for the same conditions as hydrochlorothiazide and olmesartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to hydrochlorothiazide and olmesartan
- 55 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Hydrochlorothiazide and olmesartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other