Skip to the answer

Losartan

Losartan is an angiotensin II receptor blocker (ARB) used to treat high blood pressure, reduce stroke risk in certain patients, and slow kidney disease progression in people with type 2 diabetes.

Brand names CozaarArbli
Drug class Angiotensin 2 Receptor Blocker
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 158 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Losartan at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Losartan is a widely used ARB (angiotensin II receptor blocker), around since about 1995 and available as a generic, that relaxes blood vessels by blocking a hormone that tightens them; it is a common first choice for high blood pressure and also lowers stroke risk with an enlarged heart muscle and protects the kidneys in type 2 diabetes. Most people tolerate it well, noticing only some early dizziness, and it is far less likely than lisinopril-type drugs to cause a dry cough. Its boxed warning is that it can seriously harm or kill an unborn baby, so stop it and call your prescriber as soon as you learn you are pregnant.

Clinical pearls

  • For aches, skip ibuprofen and naproxen when you can, since they weaken losartan and strain the kidneys; acetaminophen is usually safer.
  • Avoid potassium supplements unless approved, because losartan already raises potassium; expect blood tests for potassium and kidney function.
  • If you take lithium, losartan can push levels toward toxicity, so lithium blood levels need closer watching.
  • The full blood pressure drop builds over three to six weeks, so early home readings may look only modestly better.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Losartan can cause serious harm or death to an unborn baby. If you find out you are pregnant while taking losartan, stop taking it right away and contact your doctor immediately. Losartan affects the renin-angiotensin system — a pathway that is essential to normal fetal kidney development. Using it during the second or third trimester of pregnancy has been linked to reduced fetal kidney function, low amniotic fluid, lung problems, bone deformities, and fetal death. This risk applies to all forms and brands of losartan.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Oral suspension
Earliest FDA record1995
Companies listing it with the FDA41
FDA label last updatedJul 16, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Losartan, written from its FDA label.

What Losartan is used for

▾

Losartan is an ARB (angiotensin II receptor blocker) approved for several important cardiovascular and kidney-related conditions:

  • High blood pressure (hypertension): Treats high blood pressure in adults and in children 6 years and older, reducing the risk of stroke and heart attack.
  • Stroke risk reduction: Reduces the risk of stroke in patients who have both high blood pressure and left ventricular hypertrophy (enlarged heart muscle). Note: evidence suggests this benefit may not apply to Black patients.
  • Diabetic nephropathy (kidney disease from diabetes): Slows the progression of kidney disease in adults with type 2 diabetes who also have high blood pressure.

How Losartan works

▾

Losartan works by blocking angiotensin II — a powerful hormone that tightens blood vessels and raises blood pressure. It specifically targets the AT1 receptor, which is found in blood vessel walls and the adrenal glands. By blocking this receptor, losartan allows blood vessels to relax and reduces the release of aldosterone (a hormone that causes salt and water retention), bringing blood pressure down.

Unlike ACE inhibitors — another class of blood pressure drugs — losartan does not block the enzyme that breaks down bradykinin. This is why losartan is much less likely to cause the persistent dry cough that some people experience with ACE inhibitors.

Losartan dosage

▾

Losartan is taken by mouth, typically once daily, with or without food. Eating a meal may slightly slow absorption but does not meaningfully change how well the medicine works overall. Arbli oral suspension should be measured carefully with an oral dosing syringe or dosing cup.

  • The full blood-pressure-lowering effect may take up to 3 to 6 weeks to develop.
  • Children 6 years and older are dosed based on body weight, as directed by their prescriber.
  • People with liver problems or those who may be dehydrated typically start on a lower dose.

Always follow your prescriber's instructions and the directions on your label. Do not adjust your dose on your own.

Dosing details from the FDA-approved label

From the Losartan prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adult hypertensive patients
    • Usual starting dose is 50 mg once daily
    • Can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg
    • If the effect at trough with once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response
    • If blood pressure is not controlled by losartan alo
    • May be given with or without food and with other antihypertensive agents; dosing must be individualized
  • Adult hypertensive patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) or a history of hepatic impairment
    • 25 mg starting dose
    • Volume depletion or history of hepatic impairment
  • Elderly patients or patients with renal impairment, including patients on dialysis
    • No initial dosage adjustment is necessary
    • No initial adjustment for age or renal impairment
  • Pediatric hypertensive patients ≥ 6 years of age
    • Usual recommended starting dose is 0.7 mg/kg once daily (up to 50 mg total) administered as a tablet or a suspension
    • Dosage should be adjusted according to blood pressure response
    • Maximum: Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in pediatric patients
    • Weight-based dosing
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Hypertension Usual adult dose: 50 mg once daily. ( 2.1 ) Usual pediatric starting dose: 0.7 mg per kg once daily (up to 50 mg). ( 2.1 ) Hypertensive Patients with Left Ventricular Hypertrophy Usual starting dose: 50 mg once daily. ( 2.2 ) Add hydrochlorothiazide 12.5 mg and/or increase losartan potassium to 100 mg followed by an increase to hydrochlorothiazide 25 mg if further blood pressure response is needed. ( 2.2 , 14.2 ) Nephropathy in Type 2 Diabetic Patients Usual dose: 50 mg once daily. ( 2.3 ) Increase dose to 100 mg once daily if further blood pressure response is needed. ( 2.3 ) 2.1 Hypertension Adult Hypertension The usual starting dose of losartan potassium tablets is 50 mg once daily. The dosage can be increased to a maximum dose of 100 mg once daily as needed to control blood pressure [see Clinical Studies ( 14.1 )]. A starting dose of 25 mg is recommended for patients with possible intravascular depletion (e.g., on diuretic therapy). Pediatric Hypertension The usual recommended starting dose is 0.7 mg per kg once daily (up to 50 mg total) administered as a tablet or a suspension [see Dosage and Administration ( 2.5 )] . Dosage should be adjusted according to blood pressure response. Doses above 1.4 mg per kg (or in excess of 100 mg) daily have not been studied in pediatric patients [see Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.1 ), and Warnings and Precautions ( 5.2 )]. Losartan potassium tablets are not recommended in pediatric patients less than 6 years of age or in pediatric patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m 2 [see Use in Specific Populations ( 8.4 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14 )]. 2.2 Hypertensive Patients with Left Ventricular Hypertrophy The usual starting dose is 50 mg of losartan potassium once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of losartan potassium should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response [see Clinical Studies ( 14.2 )] . 2.3 Nephropathy in Type 2 Diabetic Patients The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response [see Clinical Studies ( 14.3 )] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Losartan side effects

▾

Most people tolerate losartan well — the rate of stopping due to side effects was actually lower than with placebo in clinical trials. The most common side effects include:

Common side effects

  • Dizziness
  • Upper respiratory infection (cold-like symptoms)
  • Nasal congestion (stuffy nose)
  • Back pain
  • Headache
  • Fatigue or weakness
  • Diarrhea
  • Cough

When to get medical help

  • Stop taking and seek emergency help if you develop swelling of the face, lips, tongue, throat, or experience difficulty breathing (signs of angioedema)
  • Call your doctor right away if you feel faint, lightheaded, or have a sudden drop in blood pressure — especially when starting the medication
  • Tell your doctor immediately if you notice a significant decrease in urination, which could signal a kidney problem
  • Seek care if you have muscle pain or weakness that could suggest rhabdomyolysis (serious muscle breakdown)
  • If you become pregnant, stop losartan and contact your doctor immediately — this drug can seriously harm or kill an unborn baby

Seek medical help right away if you notice swelling of the face, lips, tongue, or throat (angioedema), difficulty breathing, a severe drop in blood pressure, signs of kidney trouble (like very little urination), or unusual muscle pain — these are rare but serious reactions.

Losartan warnings and precautions

▾
  • Fetal toxicity (most critical): Losartan can cause serious injury or death to a developing baby. Stop immediately if you become pregnant and call your doctor.
  • Low blood pressure: People who are dehydrated or taking high-dose diuretics may develop symptomatic low blood pressure when starting losartan. Correct fluid/salt deficits before starting treatment.
  • Kidney function changes: Losartan can worsen kidney function, especially in people with kidney artery narrowing (renal artery stenosis), chronic kidney disease, severe heart failure, or significant dehydration. Kidney function should be monitored regularly in these patients.
  • High potassium (hyperkalemia): Losartan can raise potassium levels. This is monitored with periodic blood tests, and the dose may need to be reduced if potassium gets too high.
  • Angioedema (rare): Swelling of the throat or face has been reported rarely — get emergency help immediately if this occurs.

Losartan interactions

▾

Losartan can interact with several medications and substances. Let your doctor and pharmacist know about everything you take:

  • Potassium-raising agents (potassium supplements, potassium-sparing diuretics like spironolactone) — can raise potassium to dangerous levels when combined with losartan.
  • Lithium — losartan can increase lithium levels in the blood, raising the risk of lithium toxicity; levels should be monitored.
  • NSAIDs (ibuprofen, naproxen, aspirin at higher doses, COX-2 inhibitors) — can weaken losartan's blood-pressure-lowering effect and increase the risk of kidney problems, especially in older adults or people who are dehydrated.
  • Aliskiren — do not combine with losartan in patients with diabetes; avoid in those with kidney disease due to risk of low blood pressure, high potassium, and kidney failure.
  • ACE inhibitors (lisinopril, enalapril, etc.) — combining two drugs that block the renin-angiotensin system raises the risk of low blood pressure, high potassium, and acute kidney injury without added benefit for most patients.

Interactions listed in the FDA-approved label

From the Losartan prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Agents increasing serum potassium: Coadministration with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.
  • Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use.
  • NSAIDs, including selective COX-2 inhibitors: In elderly, volume-depleted (including those on diuretic therapy) or renally compromised patients, coadministration may result in deterioration of renal function, including possible acute renal failure (usually reversible), and the antihypertensive effect of losartan may be attenuated. Monitor renal function periodically in patients receiving losartan and NSAID therapy.
  • Dual blockade of the renin-angiotensin system (ARBs, ACE inhibitors, aliskiren): Associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function, and electrolytes. Do not coadminister aliskiren with losartan in patients with diabetes. Avoid use of aliskiren with losartan in patients with renal impairment.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Agents increasing Serum Potassium: Risk of hyperkalemia. ( 7.1 ) • Lithium: 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: Increased risk of renal impairment, hypotension, syncope, and hyperkalemia. ( 7.4 ) 7.1 Agents Increasing Serum Potassium Coadministration of losartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use. 7.3 Non-Steroidal Anti-inflammatory Drugs (NSAIDS) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including losartan) may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving losartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including losartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors. 7.4 Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿253 supplements and herbs with documented Losartan interactions, ranked by severity Check Losartan against a supplement or herb →

Before taking Losartan

▾
  • Pregnancy: Do not take losartan if you are pregnant or may become pregnant — it can cause serious fetal harm or death. Use effective contraception and tell your doctor right away if you become pregnant.
  • Breastfeeding: It is not known whether losartan passes into human breast milk. Discuss the risks and benefits with your doctor before breastfeeding while on this medication.
  • Children under 6: Losartan is not recommended for children younger than 6 years old.
  • Kidney disease: Use with caution in people with kidney problems; not recommended for children with a very low kidney filtration rate (GFR below 30 mL/min/1.73 m²).
  • Liver disease: A lower starting dose is recommended for people with a history of liver problems.
  • Diabetes + aliskiren: Do not take losartan together with aliskiren if you have diabetes — this combination is contraindicated.
  • Allergies: Do not take losartan if you are allergic to any ingredient in the product.
  • Dehydration or low-salt states: Tell your doctor if you are on a very low-sodium diet or losing fluids, as you may be at greater risk for low blood pressure when starting losartan.

Losartan overdose

▾

Taking too much losartan would most likely cause a significant drop in blood pressure (hypotension) and a rapid heart rate (tachycardia); a slowed heart rate (bradycardia) is also possible. If an overdose is suspected, seek emergency medical attention. Losartan cannot be removed from the body by hemodialysis (kidney dialysis machine).

What Losartan does in the body

▾

Losartan starts lowering blood pressure within about one week, though the maximum effect may take 3 to 6 weeks to appear. It does not cause a rebound rise in blood pressure if stopped suddenly, and it does not significantly change heart rate. Losartan also lowers levels of aldosterone (a hormone that raises blood pressure by causing the body to hold onto salt and water), although this effect has little impact on potassium levels in most people.

How your body processes Losartan

▾

After you take losartan by mouth, it is well absorbed and quickly converted — partly in the liver — into an active metabolite that does most of the blood-pressure-lowering work. Losartan itself peaks in the blood in about 1 hour; the active metabolite peaks in 3 to 4 hours and stays active for up to 24 hours, which is why once-daily dosing works. Losartan is cleared from the body mainly through the liver (bile) and kidneys, with a half-life of about 2 hours for the parent drug and 6 to 9 hours for the active metabolite. In people with kidney disease, blood levels of both forms can be meaningfully higher, so close monitoring is important.

How to store Losartan

▾

Store at 20°C to 25°C (68°F to 77°F) . Protect from light. Dispense in a tight, light-resistant container.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

253

Supplements & herbs that interact with Losartan

253 supplements and herbal products have documented interactions with Losartan in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 6
  • Moderate · 205
  • Minor · 42
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major AMERICAN MISTLETOE Major GRAPEFRUIT Major ST. JOHN'S WORT Major TYRAMINE Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate +245 more
Every supplement checked against Losartan — ranked by severity The full interaction hub: 6 major · 205 moderate · 42 minor · every one linked to its full report. Check Losartan against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Losartan has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

COENZYME Q10 Insufficient Evidence
See the full Losartan nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Losartan: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Losartan — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is losartan used for?

▾
Losartan is used mainly to treat high blood pressure in adults and children 6 and older. It's also used to lower the risk of stroke in people who have high blood pressure and an enlarged heart muscle, and to protect the kidneys in adults with type 2 diabetes and high blood pressure. Your doctor prescribed it for one or more of these reasons — if you're unsure which applies to you, it's a great question to ask them.

Does losartan cause a cough like some other blood pressure medicines?

▾
Cough is much less common with losartan than with ACE inhibitors (like lisinopril). In clinical trials, the rate of cough with losartan was similar to that seen with a placebo. So if you switched to losartan from an ACE inhibitor specifically because of cough, you're unlikely to have the same problem. That said, some people do report cough — if it bothers you, mention it to your doctor.

Can I take ibuprofen or other pain relievers while on losartan?

▾
It's best to check with your doctor or pharmacist first. NSAIDs like ibuprofen and naproxen can reduce how well losartan controls your blood pressure, and they can also put extra stress on your kidneys — especially if you're older, a bit dehydrated, or already have some kidney issues. For occasional pain, ask what the safest option is for you.

Is it safe to take losartan during pregnancy?

▾
No — losartan is not safe during pregnancy, and this is taken very seriously. It can cause serious kidney damage, low amniotic fluid, bone deformities, and even death in a developing baby, particularly in the second and third trimester. If you find out you're pregnant while taking it, stop immediately and call your doctor the same day. If you're of childbearing age, talk to your doctor about safe contraception while on this medication.

How long does it take for losartan to start working?

▾
You should see some blood pressure lowering within the first week of taking losartan. However, the full effect often takes 3 to 6 weeks to kick in, so don't be discouraged if your readings don't drop dramatically right away. Keep taking it as prescribed and check in with your doctor at your follow-up visit.

What symptoms should make me call my doctor right away?

▾
Call your doctor or get emergency help immediately if you have swelling of your face, lips, tongue, or throat — that's a rare but dangerous reaction called angioedema. Also call if you feel very dizzy or faint, notice you're urinating much less than usual, have unusual muscle pain or weakness, or if your potassium levels come back high on a blood test. These can be signs that losartan is affecting your kidneys or causing other serious problems that need prompt attention.

Is Losartan available over the counter?

▾
No. Losartan is a prescription medicine: every Losartan product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Losartan first available?

▾
The earliest FDA record we hold for Losartan is from 1995: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Losartan was first used.

Who makes Losartan?

▾
41 companies currently list Losartan products in the FDA's NDC Directory, including Bryant Ranch Prepack, NuCare Pharmaceuticals,Inc., A-S Medication Solutions. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Losartan on HelloPharmacist

📊Losartan supplement interactions253 checked — ranked by severity 🌿Drug & Supplement CheckerLosartan vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Losartan NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Losartan Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Losartan forms and strengths (how it comes)

Losartan is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Losartan inactive ingredients by manufacturer.

Tablet

By mouth
Brands Cozaar
How this form is used
What it may be used for
  • Treats high blood pressure in adults and children 6 years and older
  • Cozaar is used to reduce the risk of stroke in patients with high blood pressure and left ventricular hypertrophy (note: evidence suggests this benefit may not apply to Black patients)
  • Treats diabetic nephropathy in adults with type 2 diabetes and high blood pressure
Important instructions
  • Cozaar tablets are taken by mouth once daily, with or without food
  • Losartan Potassium tablets may be taken once or twice daily depending on your prescriber's instructions, with or without food
  • Losortan Potassium tablets are taken by mouth, with or without food, as directed by your prescriber
  • Children aged 6 and older may take the tablet form at a weight-based dose determined by their prescriber
Available strengths 3 strengths
25 mg 50 mg 100 mg
463 FDA-listed product records ⓘ

Oral suspension

By mouth
Brands Arbli
How this form is used
What it may be used for
  • Arbli is used to treat high blood pressure in adults and children 6 years and older
  • Arbli is used to reduce the risk of stroke in patients with high blood pressure and left ventricular hypertrophy (note: evidence suggests this benefit may not apply to Black patients)
  • Arbli is used to treat diabetic nephropathy in adults with type 2 diabetes and high blood pressure
Important instructions
  • Arbli oral suspension is taken by mouth once daily, as directed by your prescriber
  • Arbli should be measured using an oral dosing syringe or an oral dosing cup — ask your pharmacy for the appropriate measuring device
  • Arbli can be obtained from your pharmacy; use only the measuring device provided or recommended by your pharmacist
Available strengths 1 strength
10 mg/mL
1 FDA-listed product record ⓘ

Losartan on the U.S. market: products, makers and brands

How Losartan appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

41 companies list 206 Losartan product records with the FDA, mostly as tablet, oral suspension; the earliest marketing or approval year on record is 1995. Brand names on the directory include Cozaar, Arbli; the rest are generics.

2
Dose forms ⓘ
41
Labelers (makers, repackagers, distributors)
10
Brand names
206
FDA-listed product records ⓘ
1995
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (19) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack10%
NuCare Pharmaceuticals,Inc.8%
A-S Medication Solutions7%
Proficient Rx LP5%
PD-Rx Pharmaceuticals, Inc.5%
Lupin Pharmaceuticals, Inc.4%
Other makers61%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Losartan is used (Medicaid data)

A general measure of how commonly Losartan is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Losartan is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

5,992,816
Medicaid prescriptions filled (Q1–Q4 2025)
$60M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Losartan prescribed? Of the 1,601 medications we measure, Losartan ranks #28 by Medicaid prescriptions — more than 98% of them.

Where Losartan ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #28 of 1,601
#23 Famotidine 6,721,162 Rx #24 Bupropion 6,669,702 Rx #25 Fluoxetine 6,471,546 Rx #26 Escitalopram 6,377,287 Rx #27 Aspirin 6,339,210 Rx #28 Losartan 5,992,816 Rx #29 Metoprolol 5,974,670 Rx #30 Clonidine 5,852,758 Rx #31 Semaglutide 5,813,664 Rx #32 Pantoprazole 5,789,599 Rx #33 Quetiapine 5,743,048 Rx

Utilization by Losartan product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 50 mg oral tablet is the most-dispensed Losartan product — about 37% of these Medicaid prescriptions.

losartan potassium 50 MG Oral Tablet Most dispensed

2,206,750 Medicaid prescriptions (Q1–Q4 2025) 37% of Losartan prescriptions shown $21.9M gross reimbursement (before rebates) ≈ $9.94 per prescription (gross)

Summed across the 33 of 327 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 979492

losartan potassium 100 MG Oral Tablet

2,025,557 Medicaid prescriptions (Q1–Q4 2025) 34% of Losartan prescriptions shown $21.7M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 35 of 280 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 979480

losartan potassium 25 MG Oral Tablet

1,760,509 Medicaid prescriptions (Q1–Q4 2025) 29% of Losartan prescriptions shown $16.3M gross reimbursement (before rebates) ≈ $9.28 per prescription (gross)

Summed across the 31 of 276 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 979485

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Losartan, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 99 of 883 listed Losartan NDCs with Medicaid activity.

Compare Losartan products

A representative set of FDA-listed product records for Losartan — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 206 products — FDA National Drug Code Directory. See every product, package size and price: browse all 206 Losartan NDCs →

Losartan side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Losartan — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Losartan are fatigue, diarrhoea, nausea; about 64% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

211,341
Reports mentioning it
64%
Reported as serious
12
Distinct effects shown
Most reported effects
Fatigue
14,629
Diarrhoea
12,312
Nausea
12,021
Dyspnoea
10,814
Dizziness
10,340
Headache
9,993
Pain
9,233
Arthralgia
7,911
Asthenia
7,516
Malaise
7,191
Age groups
Elderly · 22,038Adult · 15,413Neonate · 57Adolescent · 46Child · 39Infant · 13

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Losartan in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Losartan FDA approval history

How Losartan went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Losartan was first approved by the FDA in 1995 (Brand: COZAAR · Organon); the first generic version was approved in 2010. It remains available in U.S. pharmacies today.

1995
Brand approved
Brand: COZAAR · Organon
2010
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Losartan recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 5 Losartan recalls since July 2021, covering 13 product listings. None of them is still listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class II Jun 26, 2023 · Terminated · Strides Pharma Inc.
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
  • Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Comple… Lots: Lot#: 7901903A, exp. date 04/2024 FDA record D-0895-2023 →
Class II Jun 6, 2022 · Terminated · PD-Rx Pharmaceuticals, Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
  • Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limit… Lots: Lots: G21C26 Exp. 07/31/22; H21B96 Exp. 07/31/22; I21B39 Exp. 07/31/22; I21C44 Exp. 07/31/22; D21F35 Exp. 10/31/22; E21A66 Exp. 10/31/22; E21C72 Exp. 10/31/22; E21F01 Exp. 10/31/22; F21C15 Exp. 10/31/22; F21E19 Exp. 10/31/22; G21B14 Exp. 1… FDA record D-1163-2022 →
  • Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited… Lots: Lots: D21D63 Exp. 11/30/22; E21A73 Exp. 11/30/22; E21D35 Exp. 11/30/22; F21A28 Exp. 11/30/22; F21D04 Exp. 09/30/22; G21B03 Exp. 11/30/22; G21E23 Exp. 11/30/22; H21B46 Exp. 11/30/22; H21D46 Exp. 08/31/23; H21D46 Exp. 08/31/23; I21B67 Exp. 0… FDA record D-1162-2022 →
  • Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited… Lots: Lots: D21C18 Exp. 09/30/22; E21A28 Exp. 09/30/22; E21C04 Exp. 09/30/22; E21D59 Exp. 09/30/22; G21B65 Exp. 09/30/22; H21A12 Exp. 09/30/22; H21D42 Exp. 09/30/22; K21D19 Exp. 10/31/22; A22A73 Exp. 10/31/22 FDA record D-1161-2022 →
Class II May 18, 2022 · Terminated · Strides Pharma Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
  • Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110,… Lots: 64380-935-05 Lots 7901047B, 7901048B, 7901049B & 7901050B, Exp Date Jul-22; Lots 7901185A, 7901186A, 7901187A & 7901188A, Exp Date Oct-22; Lots 7901250A, 7901251A & 7901252A, Exp Date Nov-22. 64380-935-08 Lots 7900813B, 7900814B, 7900908A,… FDA record D-0974-2022 →
  • Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, T… Lots: NDC 64380-934-05 Lot 7901146A, 7901147A, 7901148A & 7901149A, Exp Date Sep-22; Lot 7901279A, 7901280A, 7901281A, 7901282A, 7901283A & 7901284A, Exp Date Nov-22; Lot 7901359A, 7901360A & 7901361A, Exp Date Dec-22; Lot 7901362A, 7901406A, 79… FDA record D-0973-2022 →
  • Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Ta… Lots: NDC 64380-933-05 Lot 7901007A, Exp Date Jun-22; Lot 7901144A, 7901178A & 7901179A, Exp Date Sep-22; Lots 7901246A & 7901247A, Exp Date Oct-22; Lot 7901343A, Exp Date Dec-22. NDC 64380-933-08 Lot 7901006A, Exp Date Jun-22; Lot 7901145A & 79… FDA record D-0972-2022 →
Class II Apr 15, 2022 · Terminated · Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
  • Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma… Lots: Lot # BLI2107B, exp. date 06/2023 BLI2101A, exp. date 12/2022 BLI2103A, exp. date 12/2022 BLI2105A, exp. date 05/2023 FDA record D-0834-2022 →
  • Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma U… Lots: Lot # BLI2002A, exp. date 11/2022 BLI2004A, exp. date 11/2022 BLI2104B, exp. date 05/2023 FDA record D-0833-2022 →
  • Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Lots: Lot # BLH2002A, exp. date 11/2022 BLH2003B, exp. date 11/2022 BLH2004A, exp. date 11/2022 FDA record D-0832-2022 →
Class II Mar 31, 2022 · Terminated · Lupin Pharmaceuticals Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
  • Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin P… Lots: H903573, exp. date Oct-22 H002311, exp. date Dec-22 H100713, exp. date Mar-23 H001060, exp. date Nov-22 H002620, exp. date Jan-23 H100714, exp. date Mar-23 H001456, exp. date Nov-22 H002313, exp. date Jan-23 H100934, exp. date Mar-23 H0014… FDA record D-0840-2022 →
  • Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Ph… Lots: H903720, exp. date Oct-22 H001876, exp. date Dec-22 H003002, exp. date Jan-23 H903774, exp. date Oct-22 H001877, exp. date Dec-22 H003003, exp. date Feb-23 H000849, exp. date Nov-22 H002127, exp. date Dec-22 H003004, exp. date Feb-23 H0014… FDA record D-0839-2022 →
  • Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Ph… Lots: H001333, exp. date Nov-22 H002786, exp. date Jan-23 H101282, exp. date Feb-23 H001189, exp. date Nov-22 H002955, exp. date Jan-23 H101285, exp. date Feb-23 H001714, exp. date Dec-22 H000523, exp. date Jan-23 H101989, exp. date Mar-23 H0019… FDA record D-0838-2022 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Losartan RxCUI 52175 2 dose forms · 4 strengths
  1. Dose form (SCDF) Oral Suspension RxCUI 2709036 In current FDA listings
    Clinical drug / strength (SCD) potassium 10 MG/ML RxCUI 2709039

Look up RxCUI 52175 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Losartan costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 50 mg $0.033 per tablet NDC details & price history
Tablet · Oral 25 mg $0.022 per tablet NDC details & price history
Tablet · Oral 100 mg $0.045 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Losartan brand names

Losartan is sold under 2 brand names in the FDA directory — Cozaar, Arbli. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Cozaar Arbli

Who makes Losartan: manufacturers and labelers

41 companies list Losartan products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, NuCare Pharmaceuticals,Inc., A-S Medication Solutions. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 20 NuCare Pharmaceuticals,Inc. 16 A-S Medication Solutions 15 Proficient Rx LP 11 PD-Rx Pharmaceuticals, Inc. 10 Lupin Pharmaceuticals, Inc. 9 Remedyrepack Inc. 9 Aphena Pharma Solutions - Tennessee, LLC 8 Preferred Pharmaceuticals Inc. 8 Cardinal Health 107, LLC 6 Coupler LLC 5 Direct Rx 5 Northwind Health Company, LLC 5 QPharma, Inc. 5 AiPing Pharmaceutical, Inc. 3 Alembic Pharmaceuticals Inc. 3 Alembic Pharmaceuticals Limited 3 American Health Packaging 3 Aurobindo Pharma Limited 3 AvPAK 3 Camber Pharmaceuticals, Inc. 3 Granules India Ltd 3 Granules Pharmaceuticals Inc. 3 Jubilant Cadista Pharmaceuticals Inc. 3

…and 17 more on the FDA NDC directory.

Losartan drug class (RxNorm)

Losartan belongs to the Angiotensin 2 Receptor Blocker class.

Pharmacologic class Angiotensin 2 Receptor Blocker
Drug family (ATC) Angiotensin II receptor blockers (ARBs), plain
How it works Angiotensin 2 Receptor Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Losartan page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 16, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Losartan.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Losartan after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
158
Finished products in the current FDA directory
206
Companies listing them (makers, repackagers, distributors)
41
FDA labeler codes behind them ⓘ
45
Linked representative label ⓘ
Preferred Pharmaceuticals Inc.
Linked label effective
Jul 16, 2026
Composite sections available
23
Linked SPL Set ID
9501dfaa-c8cf-46d6-8bec-936c4fd8fe03
Linked SPL Document ID
9501dfaa-c8cf-46d6-8bec-936c4fd8fe03
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Preferred Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →