Prescription medicine
Losartan Brand names: Cozaar, Arbli
Losartan (Cozaar) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 43 generic labelers, and pharmacies paid $0.0327 per losartan potassium 50 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the losartan FDA label on DailyMed (effective January 20, 2026, Organon LLC); the NDA 20386 record on Drugs@FDA; every losartan label on DailyMed.
Highlights of the record
FDA label of January 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue COZAAR as soon as possible. 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 COZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Used for
From the label: indications and usageCOZAAR is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old.
Forms and strengths
- 25 mg
- 50 mg
- 100 mg
- 10 mg/ml
Film-coated tablet; tablet; suspension.
On the market
- Earliest approval on file
- April 14, 1995 Cozaar, Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 25 first April 6, 2010; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 45 of which 43 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 7, 2041 Arbli oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0327 per tablet Losartan potassium 50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 77 since 2013 0 Class I among all firms' recalls; latest June 26, 2023
- FAERS reports
- 200,566 through July 30, 2026
What is losartan used for?
From the label: indications and usageCOZAAR is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2 ) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. […]
Conditions named in the indications of losartan's FDA labels, with every medicine labeled for each:
From other losartan labelsStroke prevention: Patients with Left Ventricular Hypertrophy COZAAR is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use …
FDA pharmacologic class: Angiotensin 2 Receptor Blocker.
Source: FDA drug label (COZAAR), Organon LLC, effective January 20, 2026 (SPL set 9949448f-c3b9-44ee-94ed-c1aca8c90f39), via openFDA; the full label on DailyMed
What does the patient leaflet for losartan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about COZAAR?COZAAR can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking COZAAR, tell your doctor right away.
Source: FDA drug label (COZAAR), Organon LLC, effective January 20, 2026 (SPL set 9949448f-c3b9-44ee-94ed-c1aca8c90f39), via openFDA; the full label on DailyMed
Is there a generic for losartan (Cozaar)?
The FDA approved the first generic losartan on April 6, 2010. 25 generic applications are approved; 16 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 losartan from 43 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.
The Orange Book lists no patent for Cozaar tablets; a patent listed only for Arbli oral suspension runs to October 7, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1995 earliest approval on file
- 2010 first generic approved
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for losartan (Cozaar)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0327 per Losartan potassium 50 mg tablet, up 2% from $0.032 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.
- Losartan potassium 50 mg tablet (generic)
- Cozaar 50 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Losartan potassium 100 mg tablet | Generic | $0.0445 per tablet | $1.34 | +0.1% |
| Losartan potassium 25 mg tablet | Generic | $0.0218 per tablet | $0.655 | -14% |
| Losartan potassium 50 mg tablet | Generic | $0.0327 per tablet | $0.980 | +2% |
| Cozaar 100 mg tablet | Brand | $6.14 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $184.20 | +5% |
| Cozaar 25 mg tablet | Brand | $3.36 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $100.91 | +5% |
| Cozaar 50 mg tablet | Brand | $4.49 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $134.81 | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has losartan been recalled?
The FDA's Enforcement Report lists 77 recalls naming losartan since 2013: 0 Class I (the most serious), 77 Class II, 0 Class III; 25 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 26, 2023 | Class II | Strides Pharma Inc. | Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. |
| June 6, 2022 | Class II | PD-Rx Pharmaceuticals, Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| May 18, 2022 | Class II | Strides Pharma Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| April 15, 2022 | Class II | Macleods Pharma Usa Inc | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| April 6, 2022 | Class II | RemedyRepack Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. |
| March 31, 2022 | Class II | Lupin Pharmaceuticals Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| August 6, 2020 | Class II | Hetero Labs Limited (Unit V) | Failed Tablet/Capsule Specification; complaint of bulging tablet |
| April 3, 2020 | Class II | Golden State Medical Supply Inc. | CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the losartan label say about other medicines?
The losartan label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 10 other medicines name losartan. 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 | For coadministration with aliskiren in patients with diabetes. |
| Cimetidine | drug interactions | Drug Interactions No clinically significant drug interactions have been found in studies of losartan potassium with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital. |
| Digoxin | drug interactions | Drug Interactions No clinically significant drug interactions have been found in studies of losartan potassium with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital. |
| Erythromycin | drug interactions | The AUC of active metabolite following oral losartan was not affected by erythromycin, an inhibitor of P450 3A4, but the AUC of losartan was increased by 30%. |
| Fluconazole | drug interactions | Fluconazole, an inhibitor of cytochrome P450 2C9, decreased the AUC of the active metabolite by approximately 40%, but increased the AUC of losartan by approximately 70% following multiple doses. |
| Hydrochlorothiazide | drug interactions | Drug Interactions No clinically significant drug interactions have been found in studies of losartan potassium with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital. |
| Ketoconazole | drug interactions | Conversion of losartan to its active metabolite after intravenous administration is not affected by ketoconazole, an inhibitor of P450 3A4. |
| Lisinopril | drug interactions | The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 mL/min), randomized them to lisinopril or placebo on a background of losartan therapy and … |
| Lithium | drug interactions | Risk of lithium toxicity. ( 7.2 ) NSAIDs: Increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects. ( 7.3 ) Dual Inhibition of the Renin-Angiotensin System: |
| Phenobarbital | drug interactions | Drug Interactions No clinically significant drug interactions have been found in studies of losartan potassium with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital. |
| Rifampin | drug interactions | However, rifampin has been shown to decrease the AUC of losartan and its active metabolite by 30% and 40%, respectively. |
| Warfarin | drug interactions | Drug Interactions No clinically significant drug interactions have been found in studies of losartan potassium with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital. |
Other labels that name losartan
Source: FDA drug label (COZAAR), Organon LLC, effective January 20, 2026 (SPL set 9949448f-c3b9-44ee-94ed-c1aca8c90f39), via openFDA; the full label on DailyMed
What do FAERS reports show for losartan?
The FDA Adverse Event Reporting System holds 200,566 reports that list losartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14,810 are coded as a death and 60,827 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 losartan?
71 other medicines are given the same way (oral) and in the same FDA class as losartan 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 |
|---|---|---|---|---|
| Valsartan | High blood pressure | 34 labelers | $0.0963 per tablet 40 mg tablet | A presentation being discontinued |
| Olmesartan | High blood pressure | 31 labelers | $0.0805 per tablet 20 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, Chronic kidney disease | 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 |
| Hydrochlorothiazide and olmesartan | High blood pressure | 17 labelers | $0.165 per tablet 20-12.5 mg tablet | No current entry |
| Amlodipine and olmesartan | High blood pressure | 14 labelers | $0.248 per unit 10-20 mg | No current entry |
| Amlodipine and hydrochlorothiazide and olmesartan | High blood pressure | 8 labelers | $0.776 per unit 20-5-12.5 | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does losartan compare with medicines for the same use?
33 side-by-side pages set losartan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
- Amlodipine
- Atenolol
- Benazepril
- Bisoprolol
- Candesartan
- Captopril
- Carvedilol
- Chlorthalidone
- Clonidine
- Diltiazem
- Doxazosin
- Enalapril
- Felodipine
- Furosemide
- Guanfacine
- Hydrochlorothiazide
- Irbesartan
- Labetalol
- Lisinopril
- Metoprolol
- Minoxidil
- Nebivolol
- Nifedipine
- Olmesartan
- Prazosin
- Propranolol
- Quinapril
- Ramipril
- Rosuvastatin
- Spironolactone
- Telmisartan
- Valsartan
- Verapamil
What next?
- Alternatives to losartan
- 71 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Losartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other