Prescription medicine
Amlodipine and olmesartan Brand names: Azor
Amlodipine and olmesartan (Azor) is a prescription medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $0.248 per unit (Amlodipine-olmesartan 10-20 mg) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the amlodipine and olmesartan FDA label on DailyMed (effective July 12, 2023, Cosette Pharmaceuticals, Inc.); the NDA 22100 record on Drugs@FDA; every amlodipine 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 Azor 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 Azor 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 usageAzor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure.
Forms and strengths
- 5 mg / 20 mg
- 5 mg / 40 mg
- 10 mg / 20 mg
- 10 mg / 40 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- September 26, 2007 Azor, Cosette; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first October 26, 2016; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 16 of which 14 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.248 per unit Amlodipine-olmesartan 10-20 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2018 0 Class I among all firms' recalls; latest July 8, 2026
- FAERS reports
- 2,672 through July 30, 2026
What is amlodipine and olmesartan used for?
From the label: indications and usageAzor 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 Azor. […]
Conditions named in the indications of amlodipine and olmesartan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin 2 Receptor Blocker, Calcium Channel Blocker and Dihydropyridine Calcium Channel Blocker.
Source: FDA drug label (Azor), Cosette Pharmaceuticals, Inc., effective July 12, 2023 (SPL set c5535406-b63b-49aa-88b9-169aaf0ed08e), via openFDA; the full label on DailyMed
Is there a generic for amlodipine and olmesartan (Azor)?
The FDA approved the first generic amlodipine and olmesartan on October 26, 2016. 14 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists amlodipine and olmesartan from 14 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.
- 2007 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 amlodipine and olmesartan (Azor)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.248 per unit (Amlodipine-olmesartan 10-20 mg), down 28% from $0.346 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.
- Amlodipine-olmesartan 5-20 mg (generic)
- Azor 5-20 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amlodipine-olmesartan 10-20 mg | Generic | $0.248 per unit | n/a | -28% |
| Amlodipine-olmesartan 10-40 mg | Generic | $0.299 per unit | n/a | -8% |
| Amlodipine-olmesartan 5-20 mg | Generic | $0.219 per unit | n/a | -18% |
| Amlodipine-olmesartan 5-40 mg | Generic | $0.319 per unit | n/a | -14% |
| Azor 10-40 mg tablet | Brand | $19.54 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $586.15 | +10% |
| Azor 5-20 mg tablet | Brand | $15.32 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $459.73 | +9% |
| Azor 5-40 mg tablet | Brand | $19.63 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $589.04 | +10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has amlodipine and olmesartan been recalled?
The FDA's Enforcement Report lists 6 recalls naming amlodipine and olmesartan since 2018: 0 Class I (the most serious), 5 Class II, 1 Class III; 3 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 8, 2026 | Class II | Ascend Laboratories, LLC | Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications |
| May 5, 2026 | Class II | Ascend Laboratories, LLC | Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications |
| July 21, 2025 | Class II | Ascend Laboratories, LLC | Failed Dissolution Specifications: low dissolution results |
| February 15, 2022 | Class II | Macleods Pharma Usa Inc | cGMP deviations |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| November 30, 2018 | Class III | Aurobindo Pharma USA Inc. | Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach). |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the amlodipine and olmesartan label say about other medicines?
The amlodipine and olmesartan label names 6 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 Do not co-administer aliskiren with Azor in patients with diabetes [ see Drug Interactions ( 7.2 )]. |
| 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. |
| Cyclosporine | drug interactions | DRUG INTERACTIONS Amlodipine ( 7.1 ): If simvastatin is co-administered with amlodipine, do not exceed 20 mg daily of simvastatin. Increased exposure of cyclosporine and tacrolimus. |
| Lithium | drug interactions | Increases in serum lithium concentrations and lithium toxicity. |
| Simvastatin | drug interactions | DRUG INTERACTIONS Amlodipine ( 7.1 ): If simvastatin is co-administered with amlodipine, do not exceed 20 mg daily of simvastatin. Increased exposure of cyclosporine and tacrolimus. |
| Tacrolimus | drug interactions | DRUG INTERACTIONS Amlodipine ( 7.1 ): If simvastatin is co-administered with amlodipine, do not exceed 20 mg daily of simvastatin. Increased exposure of cyclosporine and tacrolimus. |
Source: FDA drug label (Azor), Cosette Pharmaceuticals, Inc., effective July 12, 2023 (SPL set c5535406-b63b-49aa-88b9-169aaf0ed08e), via openFDA; the full label on DailyMed
What do FAERS reports show for amlodipine and olmesartan?
The FDA Adverse Event Reporting System holds 2,672 reports that list amlodipine and olmesartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 101 are coded as a death and 956 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 olmesartan?
62 other medicines are given the same way (oral) and in the same FDA class as amlodipine 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 |
| 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 |
| 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 |
Every medicine labeled for the same conditions as amlodipine and olmesartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to amlodipine and olmesartan
- 62 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Amlodipine and olmesartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other