Prescription medicine
Olmesartan Brand names: Benicar
Olmesartan (Benicar) is a prescription medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 30 generic labelers, and pharmacies paid $0.0805 per olmesartan medoxomil 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the olmesartan FDA label on DailyMed (effective September 23, 2025, Cosette Pharmaceuticals, Inc.); the NDA 21286 record on Drugs@FDA; every olmesartan label on DailyMed.
Highlights of the record
FDA label of September 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue Benicar 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 ). WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Benicar 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 usageBenicar is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure.
Forms and strengths
- 5 mg
- 20 mg
- 40 mg
Film-coated tablet; coated tablet; tablet.
On the market
- Earliest approval on file
- April 25, 2002 Benicar, Cosette; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 25 first October 26, 2016; 18 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 31 of which 30 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0805 per tablet Olmesartan medoxomil 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2020 0 Class I among all firms' recalls; latest April 29, 2021
- FAERS reports
- 35,743 through July 30, 2026
What is olmesartan used for?
From the label: indications and usageBenicar is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. 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. […]
Conditions named in the indications of olmesartan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin 2 Receptor Blocker.
Source: FDA drug label (Benicar), Cosette Pharmaceuticals, Inc., effective September 23, 2025 (SPL set dc3f1fd4-5578-4c5d-be7b-12e3f8f3e7df), via openFDA; the full label on DailyMed
Is there a generic for olmesartan (Benicar)?
The FDA approved the first generic olmesartan on October 26, 2016. 25 generic applications are approved; 18 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 olmesartan from 30 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.
- 2002 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 olmesartan (Benicar)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0805 per Olmesartan medoxomil 20 mg tablet, up 1% from $0.0793 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 medoxomil 20 mg tablet (generic)
- Benicar 5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Olmesartan medoxomil 20 mg tablet | Generic | $0.0805 per tablet | $2.41 | +1% |
| Olmesartan medoxomil 40 mg tablet | Generic | $0.111 per tablet | $3.33 | -6% |
| Olmesartan medoxomil 5 mg tablet | Generic | $0.0575 per tablet | $1.72 | -2% |
| Benicar 20 mg tablet | Brand | $12.32 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $369.49 | +9% |
| Benicar 40 mg tablet | Brand | $17.24 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $517.25 | +10% |
| Benicar 5 mg tablet | Brand | $10.13 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $303.81 | +10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has olmesartan been recalled?
The FDA's Enforcement Report lists 2 recalls naming olmesartan since 2020: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 29, 2021 | Class III | Ascend Laboratories LLC | Presence of Foreign Tablet/Capsule |
| January 24, 2020 | Class II | Ascend Laboratories LLC | cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the olmesartan label say about other medicines?
The olmesartan label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name olmesartan. 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 Do not co-administer aliskiren with Benicar in patients with diabetes [see Drug Interactions (7.3) ]. |
| Amiloride | drug interactions | Concomitant use of olmesartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in … |
| Colesevelam | drug interactions | Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. |
| Heparin | drug interactions | … supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium. |
| Lithium | drug interactions | Increases in serum lithium concentrations and lithium toxicity ( 7.4 ). |
| Spironolactone | drug interactions | Concomitant use of olmesartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in … |
| Triamterene | drug interactions | Concomitant use of olmesartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in … |
Other labels that name olmesartan
Source: FDA drug label (Benicar), Cosette Pharmaceuticals, Inc., effective September 23, 2025 (SPL set dc3f1fd4-5578-4c5d-be7b-12e3f8f3e7df), via openFDA; the full label on DailyMed
What do FAERS reports show for olmesartan?
The FDA Adverse Event Reporting System holds 35,743 reports that list olmesartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,618 are coded as a death and 13,467 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 olmesartan?
69 other medicines are given the same way (oral) and in the same FDA class as 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 |
| Hydrochlorothiazide and losartan | High blood pressure | 29 labelers | $0.0762 per tablet 100-12.5 mg tablet | No current entry |
| Hydrochlorothiazide and valsartan | High blood pressure | 18 labelers | $0.101 per tablet 160-12.5 mg tablet | No current entry |
| 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 |
Every medicine labeled for the same conditions as olmesartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does olmesartan compare with medicines for the same use?
16 side-by-side pages set olmesartan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to olmesartan
- 69 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Olmesartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other