Prescription medicine
Letrozole Brand names: Femara
Letrozole (Femara) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 19 generic labelers, and pharmacies paid $0.145 per letrozole 2.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the letrozole FDA label on DailyMed (effective June 11, 2026, Novartis Pharmaceuticals Corporation); the NDA 20726 record on Drugs@FDA; every letrozole label on DailyMed.
Highlights of the record
FDA label of June 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFemara is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
Forms and strengths
- 2.5 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- July 25, 1997 Femara, Novartis Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first December 24, 2008; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 20 of which 19 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.145 per tablet Letrozole 2.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest April 3, 2018; 1 more by firms not listed as its makers
- FAERS reports
- 61,238 through July 30, 2026
What is letrozole used for?
From the label: indications and usageFemara is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. ( 1.1 ) Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. ( 1.2 ) First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. […]
Conditions named in the indications of letrozole's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Aromatase Inhibitor.
Source: FDA drug label (Femara), Novartis Pharmaceuticals Corporation, effective June 11, 2026 (SPL set 82b77d74-085f-45ac-a7dd-1f5c038bf406), via openFDA; the full label on DailyMed
Is there a generic for letrozole (Femara)?
The FDA approved the first generic letrozole on December 24, 2008. 20 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists letrozole from 19 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1997 earliest approval on file
- 2008 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for letrozole (Femara)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.145 per Letrozole 2.5 mg tablet, up 12% from $0.129 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.
- Letrozole 2.5 mg tablet (generic)
- Femara 2.5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Letrozole 2.5 mg tablet | Generic | $0.145 per tablet | $4.35 | +12% |
| Femara 2.5 mg tablet | Brand | $27.12 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $813.48 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has letrozole been recalled?
The FDA's Enforcement Report lists 2 recalls naming letrozole since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of letrozole and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 3, 2018 | Class II | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; LETROZOLE Tablet, 2.5 mg may be potentially mislabeled as METOPROLOL TARTRATE, Tablet, 50 mg, NDC 00093073301, Pedigree: W003848, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the letrozole label say about other medicines?
The letrozole label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name letrozole. 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 |
|---|---|---|
| Cimetidine | drug interactions | Cimetidine A pharmacokinetic interaction study with cimetidine (Study P004) showed no clinically significant effect on letrozole pharmacokinetics. |
| Tamoxifen | drug interactions | DRUG INTERACTIONS Tamoxifen Coadministration of Femara and tamoxifen 20 mg daily resulted in a reduction of letrozole plasma levels of 38% on average (Study P015). |
| Warfarin | drug interactions | Warfarin An interaction study (P017) with warfarin showed no clinically significant effect of letrozole on warfarin pharmacokinetics. |
Other labels that name letrozole
Source: FDA drug label (Femara), Novartis Pharmaceuticals Corporation, effective June 11, 2026 (SPL set 82b77d74-085f-45ac-a7dd-1f5c038bf406), via openFDA; the full label on DailyMed
What do FAERS reports show for letrozole?
The FDA Adverse Event Reporting System holds 61,238 reports that list letrozole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,036 are coded as a death and 15,648 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 letrozole?
17 other medicines are given the same way (oral) and in the same FDA class as letrozole or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 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 |
|---|---|---|---|---|
| Anastrozole | Breast cancer | 24 labelers | $0.142 per tablet 1 mg tablet | No current entry |
| Exemestane | Breast cancer | 10 labelers | $0.748 per tablet 25 mg tablet | No current entry |
| Everolimus | Breast cancer | 14 labelers | $26.32 per tablet 10 mg tablet | A presentation being discontinued |
| Tamoxifen | Breast cancer | 10 labelers | $0.277 per tablet 20 mg tablet | No current entry |
| Talazoparib | Breast cancer | none listed | n/a | No current entry |
| Palbociclib | Breast cancer | none listed | n/a | A presentation being discontinued |
| Abemaciclib | Breast cancer | none listed | n/a | No current entry |
| Lapatinib ditosylate | Breast cancer | 3 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does letrozole compare with medicines for the same use?
3 side-by-side pages set letrozole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to letrozole
- 17 medicines for the same use
- Other aromatase inhibitors
- the pharmacologic class, with prices and generics
- Letrozole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other