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Letrozole

Letrozole is an aromatase inhibitor tablet used to treat hormone receptor positive early and advanced breast cancer in postmenopausal women.

Brand name Femara
Drug class Aromatase Inhibitor
Rx Form 1
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 24 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
Letrozole 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

Letrozole (Femara) is a hormone therapy, not chemotherapy, for hormone receptor positive breast cancer after menopause, blocking aromatase, the enzyme that keeps making estrogen, so the cancer loses its fuel; a usual first choice, it has been around since about 1997 and is available as a generic. Most people tolerate it well, but hot flashes and achy, stiff joints are common and worth raising before you think about stopping. Its quiet risk is thinner bones, so expect bone density scans and cholesterol checks along the way. It must never be used in pregnancy, and anyone who could still conceive needs effective contraception.

Clinical pearls

  • Food does not change absorption, so take it once daily at whatever time you will remember it best.
  • Tamoxifen taken at the same time lowers letrozole levels, but starting letrozole right after finishing tamoxifen is fine.
  • Ask whether you need calcium and vitamin D, and get a baseline bone density scan early in treatment.
  • Some versions contain tartrazine (Yellow No. 5 dye), so mention any aspirin or tartrazine allergy when filling it.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record1997
Companies listing it with the FDA20
FDA label last updatedJun 11, 2026
FDA’s strongest warning (boxed)None on the label

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

What Letrozole is used for

▾

Letrozole tablets are an aromatase inhibitor approved for several breast cancer situations in postmenopausal women, available as the brand Femara or as generic letrozole tablets.

  • Adjuvant treatment of early breast cancer: Femara and letrozole tablets are used after primary treatment in postmenopausal women with hormone receptor positive early breast cancer to reduce the risk of recurrence.
  • Extended adjuvant treatment of early breast cancer: Femara and letrozole tablets are used in postmenopausal women who have already completed 5 years of tamoxifen therapy, to continue reducing relapse risk.
  • First-line treatment of advanced breast cancer: Femara and letrozole tablets are used as initial therapy for postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic (spread beyond the original site) breast cancer.
  • Second-line treatment of advanced breast cancer: Femara and letrozole tablets are used in postmenopausal women whose advanced breast cancer has progressed after prior anti-estrogen (antiestrogen) therapy.

How Letrozole works

▾

After menopause, the ovaries no longer produce estrogen, but the body still makes small amounts via an enzyme called aromatase, which converts androgens (male-type hormones present in everyone) into estrogens in fat tissue, muscle, and even within the tumor itself. Letrozole competitively blocks the aromatase enzyme — specifically by binding to the heme component of its cytochrome P450 unit — which sharply reduces estrogen production in all body tissues. With much less estrogen available, hormone-sensitive breast cancer cells are deprived of a key growth signal.

Importantly, letrozole does not meaningfully affect the adrenal gland's production of cortisol, aldosterone, or other essential hormones, so no supplementation of these is needed during treatment.

Letrozole dosage

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Letrozole tablets are taken once daily by mouth, and you can take them with or without food — your meal schedule won't affect how the medication works. Treatment length depends on your situation: for early or extended adjuvant therapy, the typical study duration was around 5 years, but your prescriber will set the right course for you. For advanced breast cancer, treatment generally continues as long as the tumor is responding.

  • If you have severe liver disease or cirrhosis, your prescriber will likely reduce your dosing to every other day rather than daily.
  • No dose adjustment is generally needed for kidney disease if your kidney function is above a certain threshold — your prescriber will assess this.
  • Always follow your prescriber's instructions, and do not stop or adjust your dose on your own.

Dosing details from the FDA-approved label

From the Letrozole 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.

  • Recommended dose
    • One 2.5 mg tablet administered once a day, without regard to meals
  • Adjuvant Treatment of Early Breast Cancer
    • 2.5 mg once a day
    • The optimal duration of treatment is unknown
    • Median treatment duration was 5 years in both the adjuvant study and the post approval adjuvant study
    • Discontinue at relapse
  • Extended Adjuvant Treatment of Early Breast Cancer
    • 2.5 mg once a day
    • The optimal treatment duration is not known
    • Planned duration of treatment in the study was 5 years
    • Discontinue at tumor relapse
  • First and Second-Line Treatment of Advanced Breast Cancer
    • 2.5 mg once a day
    • Continue until tumor progression is evident
  • Patients with cirrhosis and severe hepatic dysfunction
    • 2.5 mg administered every other day (dose reduced by 50%)
    • No dosage adjustment for mild to moderate hepatic impairment
  • Renal impairment
    • No dosage adjustment is required if creatinine clearance is greater than or equal to 10 mL/min
    • Applies to creatinine clearance greater than or equal to 10 mL/min
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Letrozole tablets are taken orally without regard to meals ( 2 ): Recommended dose: 2.5 mg once daily. ( 2.1 ) Patients with cirrhosis or severe hepatic impairment: 2.5 mg every other day. ( 2.5 , 5.3 ) 2.1 Recommended Dose The recommended dose of letrozole tablets is one 2.5 mg tablet administered once a day, without regard to meals. 2.2 Use in Adjuvant Treatment of Early Breast Cancer In the adjuvant setting, the optimal duration of treatment with letrozole is unknown. In both the adjuvant study and the post approval adjuvant study, median treatment duration was 5 years. Treatment should be discontinued at relapse [see Clinical Studies (14.1) ]. 2.3 Use in Extended Adjuvant Treatment of Early Breast Cancer In the extended adjuvant setting, the optimal treatment duration with letrozole tablets are not known. The planned duration of treatment in the study was 5 years. In the final updated analysis, conducted at a median follow-up of 62 months, the median treatment duration for letrozole tablets was 60 months. Seventy-one percent (71%) of patients were treated for at least 3 years and 58% of patients completed at least 4.5 years of extended adjuvant treatment. The treatment should be discontinued at tumor relapse [see Clinical Studies (14.2) ]. 2.4 Use in First and Second-Line Treatment of Advanced Breast Cancer In patients with advanced disease, treatment with letrozole tablets should continue until tumor progression is evident [see Clinical Studies (14.4 , 14.5) ] . 2.5 Use in Hepatic Impairment No dosage adjustment is recommended for patients with mild to moderate hepatic impairment, although letrozole tablets blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of letrozole tablets in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50% [see Warnings and Precautions (5.3)] . The recommended dose of letrozole tablets for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on letrozole tablets exposure in noncirrhotic cancer patients with elevated bilirubin levels has not been determined. 2.6 Use in Renal Impairment No dosage adjustment is required for patients with renal impairment if creatinine clearance is greater than or equal to 10 mL/min [see Clinical Pharmacology (12.3) ] .

Read the full Dosage and Administration section on DailyMed →

Letrozole side effects

▾

The most commonly reported side effects with letrozole include:

Common side effects

  • Hot flashes
  • Joint pain or arthritis (arthralgia)
  • Flushing and increased sweating
  • Fatigue, weakness, or feeling generally unwell
  • Headache and dizziness
  • High cholesterol (hypercholesterolemia)
  • Bone pain and musculoskeletal discomfort
  • Swelling (edema)
  • Nausea

When to get medical help

  • Call your doctor if you notice signs of bone pain, fractures, or significant loss of height — letrozole can reduce bone density over time
  • Tell your doctor if you develop muscle weakness, unusual fatigue, or signs of very high cholesterol, since cholesterol monitoring may be needed
  • Seek care immediately if you think you might be pregnant — letrozole can cause serious fetal harm and is contraindicated in pregnancy
  • Tell your doctor if you feel very dizzy or drowsy, especially before driving or operating machinery
  • Contact your doctor if you experience signs of a serious allergic reaction, including difficulty breathing or swelling — especially if you are sensitive to aspirin or tartrazine (a yellow dye in some formulations)

More serious concerns include significant bone density loss leading to fractures or osteoporosis, and markedly elevated cholesterol — both require monitoring. Dizziness and fatigue can also affect your ability to drive or operate machinery safely, especially at first.

Letrozole warnings and precautions

▾
  • Bone density loss: Letrozole can reduce bone mineral density, raising the risk of fractures and osteoporosis. Bone density monitoring is recommended, and your doctor may discuss supplements or other measures.
  • High cholesterol: Letrozole is associated with significant increases in cholesterol. Monitoring and, in some cases, cholesterol-lowering medication may be needed.
  • Pregnancy — do not use: Letrozole can cause serious fetal harm, including miscarriage and birth defects. It is contraindicated in pregnancy. Women who could still become pregnant must use effective contraception during treatment and for at least 3 weeks after the last dose.
  • Fatigue and dizziness: These side effects have been reported and can impair your ability to drive or use machinery — use caution until you know how letrozole affects you.
  • Severe liver disease: If you have cirrhosis or severe hepatic (liver) impairment, letrozole builds up to higher levels in your body, and your dose must be reduced.
  • Tartrazine dye allergy: Some formulations contain FD&C Yellow No. 5 (tartrazine), which can trigger allergic reactions — particularly in people who are sensitive to aspirin.

Letrozole interactions

▾

Letrozole has a few known drug interactions to be aware of — always share your complete medication list with your prescriber and pharmacist.

  • Tamoxifen: Taking both at the same time reduces letrozole blood levels by about 38% on average. Clinical evidence suggests letrozole's effectiveness is not impaired when it is started immediately after finishing tamoxifen, but concurrent use is a concern.
  • Cimetidine (a stomach acid reducer): No clinically significant interaction was found, but always disclose all medications.
  • Warfarin (a blood thinner): No clinically significant effect on warfarin levels was found in a study, but notify your prescriber if you take blood thinners.
  • Other anticancer agents: There is no established clinical data on combining letrozole with other cancer drugs — your oncologist will determine what is safe in your case.

Interactions listed in the FDA-approved label

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

  • Tamoxifen: Coadministration with tamoxifen 20 mg daily reduced letrozole plasma levels by 38% on average (study P015). Therapeutic effect of letrozole is not impaired if letrozole is administered immediately after tamoxifen, per second-line breast cancer trials (AR/BC2 and AR/BC3).
  • Cimetidine: Study P0004 showed no clinically significant effect on letrozole pharmacokinetics.
  • Warfarin: Study P017 showed no clinically significant effect of letrozole on warfarin pharmacokinetics.
  • Other anticancer agents: There is no clinical experience to date on the use of letrozole in combination with other anticancer agents.
Read the label’s full interactions text

7 DRUG INTERACTIONS Tamoxifen Coadministration of letrozole tablets and tamoxifen 20 mg daily resulted in a reduction of letrozole plasma levels of 38% on average (study P015). Clinical experience in the second-line breast cancer trials (AR/BC2 and AR/BC3) indicates that the therapeutic effect of letrozole tablets therapy is not impaired if letrozole tablets is administered immediately after tamoxifen. Cimetidine A pharmacokinetic interaction study with cimetidine (study P0004) showed no clinically significant effect on letrozole pharmacokinetics. Warfarin An interaction study (P017) with warfarin showed no clinically significant effect of letrozole on warfarin pharmacokinetics. Other anticancer agents There is no clinical experience to date on the use of letrozole tablets in combination with other anticancer agents.

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.

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

Before taking Letrozole

▾
  • Pregnancy: Do not take letrozole if you are pregnant — it is contraindicated and can cause fetal harm, birth defects, and miscarriage.
  • Reproductive potential: If you could become pregnant, get a pregnancy test before starting and use effective contraception during treatment and for at least 3 weeks after your last dose.
  • Breastfeeding: Do not breastfeed while taking letrozole or for at least 3 weeks after stopping — potential harm to a nursing infant is a concern.
  • Severe liver disease or cirrhosis: Tell your doctor — your dose will need to be reduced.
  • Bone density concerns: If you have a history of osteoporosis or risk factors for bone loss, discuss monitoring and preventive strategies with your doctor.
  • Aspirin or tartrazine allergy: Some letrozole formulations contain tartrazine dye, which can cause allergic reactions in susceptible people, particularly those with aspirin hypersensitivity.
  • Children: Letrozole is not approved for pediatric patients — safety and effectiveness have not been established in children.
  • Older adults: Letrozole has been studied extensively in women over 65 and over 75 — no significant overall differences in safety or effectiveness were found, though some older individuals may be more sensitive to effects.
  • Kidney disease: If your kidney function is above the minimum threshold your doctor checks, no dose adjustment is typically needed.

Letrozole overdose

▾

There are limited reports of letrozole overdose in people. In the cases reported, no serious adverse reactions occurred, but recommendations for treatment are not firmly established due to the small amount of data available. If an overdose is suspected, general supportive care and close monitoring of vital signs are appropriate — seek emergency medical attention immediately.

What Letrozole does in the body

▾

Letrozole powerfully suppresses the body's estrogen levels. In postmenopausal patients, it reduces blood concentrations of estradiol, estrone, and estrone sulfate by 75% to 95% from baseline, with maximum suppression typically reached within two to three days of starting treatment. This estrogen suppression is sustained throughout therapy. Importantly, letrozole does not disrupt the body's production of cortisol, aldosterone, or other adrenal hormones, and it does not affect thyroid function or androgen levels — meaning no steroid hormone supplementation is needed during treatment.

How your body processes Letrozole

▾

Letrozole is rapidly and completely absorbed when taken by mouth, and food does not affect how well it's absorbed. It is broken down slowly by the liver — primarily through enzymes CYP3A4 and CYP2A6 — into an inactive metabolite that is then excreted mainly in the urine. The drug has a half-life of about 2 days (meaning it takes about 2 days for half of a dose to leave the body), and steady-state blood levels are typically reached within 2 to 6 weeks of daily dosing. People with severe liver disease (cirrhosis) experience about twice the drug exposure of those with normal liver function, which is why a dose reduction is recommended for them.

How to store Letrozole

▾

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

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

142

Supplements & herbs that interact with Letrozole

142 supplements and herbal products have documented interactions with Letrozole 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 · 3
  • Moderate · 99
  • Minor · 40
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major 7-METHOXYFLAVONE Moderate ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate AMERICAN ELDER Moderate +134 more
Every supplement checked against Letrozole — ranked by severity The full interaction hub: 3 major · 99 moderate · 40 minor · every one linked to its full report. Check Letrozole 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.

Letrozole: pharmacist answers to common questions

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

What exactly is letrozole being used to treat — is it chemotherapy?

▾
Letrozole is not chemotherapy. It's a hormone therapy, specifically an aromatase inhibitor — it works by dramatically lowering estrogen levels in your body. Some breast cancers are fueled by estrogen, so cutting off that fuel supply helps slow or stop the cancer. It's used in postmenopausal women with hormone receptor positive breast cancer, whether that's early-stage (to reduce the chance of the cancer coming back) or more advanced disease.

Can I take letrozole with food, and does it matter what time of day I take it?

▾
Good news — you can take letrozole with or without food, whichever is easiest for you. Meals don't affect how the medication is absorbed. As for timing, pick a time of day you'll remember and stick to it. Consistency helps keep your levels steady. Your prescription label or prescriber will confirm your specific schedule.

What side effects should I actually expect, and which ones should make me call my doctor?

▾
The most common side effects are hot flashes, joint pain, fatigue, headaches, dizziness, and increased sweating — many of these are related to having lower estrogen levels. Over time, letrozole can also raise your cholesterol and reduce your bone density, which is why your doctor may monitor those things with blood tests and bone scans. Call your doctor promptly if you experience a bone fracture, signs of very high cholesterol, or severe dizziness. And if you feel dizzy or drowsy, be careful with driving or using machinery until you know how letrozole affects you.

I'm past menopause — do I still need to worry about getting pregnant while on letrozole?

▾
This is an important question. Even though letrozole is designed for postmenopausal women, if there's any chance you could still become pregnant, it's essential to use effective contraception during treatment and for at least 3 weeks after your last dose. Letrozole can cause serious harm to a developing baby, including birth defects and miscarriage. Your doctor should do a pregnancy test before you start, and you should use reliable birth control throughout. If you think you may be pregnant at any point during treatment, contact your doctor right away.

Is it safe to breastfeed while taking letrozole?

▾
No — it's not recommended. We don't know for certain if letrozole passes into breast milk in humans, but animal studies raised concerns about harm to nursing offspring. Because of the potential risk to a breastfeeding baby, the guidance is to avoid breastfeeding while you're on letrozole and for at least 3 weeks after your last dose. Talk to your doctor if you have questions about this.

I have some liver problems — can I still take letrozole?

▾
Possibly yes, but it depends on how severe your liver condition is. Mild to moderate liver problems generally don't require a dose change. However, if you have cirrhosis or severe liver disease, letrozole can build up to about twice the normal level in your body, which raises the risk of side effects. In that case, your prescriber will likely cut your dosing frequency to every other day instead of daily. Make sure your doctor knows your full liver history before you start.

Is Letrozole available over the counter?

▾
No. Letrozole is a prescription medicine: every Letrozole 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 Letrozole first available?

▾
The earliest FDA record we hold for Letrozole is from 1997: 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 Letrozole was first used.

Who makes Letrozole?

▾
20 companies currently list Letrozole products in the FDA's NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, NuCare Pharmaceuticals,Inc.. 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 Letrozole on HelloPharmacist

📊Letrozole supplement interactions142 checked — ranked by severity 🌿Drug & Supplement CheckerLetrozole vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Letrozole NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Letrozole 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.

Letrozole forms and strengths (how it comes)

Letrozole is available in 1 form. 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.

Tablet

By mouth
Brands Femara
How this form is used
What it may be used for
  • Femara tablets are used for adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
  • Femara tablets are used for extended adjuvant treatment of early breast cancer after 5 years of tamoxifen therapy
  • Femara tablets are used as first- and second-line treatment for locally advanced or metastatic breast cancer in postmenopausal women
  • Letrozole tablets are indicated for the same adjuvant, extended adjuvant, and advanced breast cancer uses in postmenopausal women
Important instructions
  • Femara and letrozole tablets are taken orally once a day, with or without food
  • Femara tablets should be discontinued if the tumor relapses in the adjuvant or extended adjuvant setting; in advanced disease, continue until tumor progression
  • Femara: patients with cirrhosis or severe liver impairment should take the tablet every other day rather than daily, as directed by their prescriber
  • Letrozole tablets: patients with cirrhosis or severe liver impairment also require every-other-day dosing — follow your prescriber's guidance
Available strengths 1 strength
2.5 mg
50 FDA-listed product records ⓘ

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

How Letrozole 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.

20 companies list 24 Letrozole product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1997. Brand names on the directory include Femara; the rest are generics.

1
Dose forms ⓘ
20
Labelers (makers, repackagers, distributors)
2
Brand names
24
FDA-listed product records ⓘ
1997
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (11) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack13%
A-S Medication Solutions8%
NuCare Pharmaceuticals,Inc.8%
Atlantic Biologicals Corp.4%
Accord Healthcare, Inc.4%
Aurobindo Pharma Limited4%
Other makers58%

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

How widely Letrozole is used (Medicaid data)

A general measure of how commonly Letrozole 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 Letrozole 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.

140,810
Medicaid prescriptions filled (Q1–Q4 2025)
$1.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Letrozole prescribed? Of the 1,601 medications we measure, Letrozole ranks #451 by Medicaid prescriptions — more than 72% of them.

Where Letrozole ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #451 of 1,601
#446 Lovastatin 141,955 Rx #447 Regadenoson 141,955 Rx #448 Dexlansoprazole 141,938 Rx #449 Levocarnitine 141,917 Rx #450 Acetazolamide 141,794 Rx #451 Letrozole 140,810 Rx #452 Cenobamate 139,992 Rx #453 Empagliflozin / Metfor... 139,145 Rx #454 Ramelteon 138,690 Rx #455 Umeclidinium Oral Inha... 137,953 Rx #456 Dexamethasone / Tobram... 137,322 Rx

Utilization by Letrozole 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.

letrozole 2.5 MG Oral Tablet

140,810 Medicaid prescriptions (Q1–Q4 2025) 100% of Letrozole prescriptions shown $1.8M gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 12 of 62 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 200064

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 Letrozole, 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 12 of 62 listed Letrozole NDCs with Medicaid activity.

Compare Letrozole products

A representative set of FDA-listed product records for Letrozole — 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 24 of 24 products — FDA National Drug Code Directory. See every product, package size and price: browse all 24 Letrozole NDCs →

Letrozole 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 no Letrozole recalls since July 2021.

✅No Letrozole recalls on record since July 2021

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) Letrozole RxCUI 72965 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Tablet RxCUI 372571 In current FDA listings
    Clinical drug / strength (SCD) 2.5 MG RxCUI 200064

Look up RxCUI 72965 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 Letrozole 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, Film Coated · Oral 2.5 mg $27.12 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.

Letrozole brand names

Letrozole is sold under one brand name in the FDA directory — Femara. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Femara

Who makes Letrozole: manufacturers and labelers

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

Bryant Ranch Prepack 3 A-S Medication Solutions 2 NuCare Pharmaceuticals,Inc. 2 Atlantic Biologicals Corp. 1 Accord Healthcare, Inc. 1 Aurobindo Pharma Limited 1 AvKARE 1 AvPAK 1 Avet Pharmaceuticals Inc. 1 Breckenridge Pharmaceutical, Inc. 1 Carnegie Pharmaceuticals LLC 1 Chartwell RX, LLC 1 Dr. Reddy's Laboratories Limited 1 Golden State Medical Supply, Inc. 1 Natco Pharma Limited 1 Novartis Pharmaceuticals Corporation 1 Proficient Rx LP 1 Teva Pharmaceuticals USA, Inc. 1 Upsher-Smith Laboratories, LLC 1 Yiling Pharmaceutical, Inc. 1

Letrozole drug class (RxNorm)

Letrozole belongs to the Aromatase Inhibitor class.

Pharmacologic class Aromatase Inhibitor
Drug family (ATC) Aromatase inhibitors
How it works Aromatase Inhibitors

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 Letrozole 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 Jun 11, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Letrozole.
📈
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 Letrozole after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
24
Finished products in the current FDA directory
24
Companies listing them (makers, repackagers, distributors)
20
FDA labeler codes behind them ⓘ
21
Linked representative label ⓘ
Novartis Pharmaceuticals Corporation
Linked label effective
Jun 11, 2026
Composite sections available
22
Linked SPL Set ID
82b77d74-085f-45ac-a7dd-1f5c038bf406
Linked SPL Document ID
28456311-e797-457f-8a9e-54dca5a7a336
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

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