Prescription medicine
Anastrozole Brand names: Arimidex
Anastrozole (Arimidex) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 24 generic labelers, and pharmacies paid $0.142 per anastrozole 1 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the anastrozole FDA label on DailyMed (effective March 2, 2026, ANI Pharmaceuticals, Inc.); the NDA 20541 record on Drugs@FDA; every anastrozole label on DailyMed.
Highlights of the record
FDA label of March 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageARIMIDEX is an aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 )
First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer ( 1.2 )
Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen
Forms and strengths
- 1 mg
Tablet; coated tablet; film-coated tablet.
On the market
- Earliest approval on file
- December 27, 1995 Arimidex, Ani Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first June 28, 2010; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 25 of which 24 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.142 per tablet Anastrozole 1 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2017 0 Class I among all firms' recalls; latest May 9, 2019; 2 more by firms not listed as its makers
- FAERS reports
- 36,521 through July 30, 2026
What is anastrozole used for?
From the label: indications and usageARIMIDEX is an aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 )
First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer ( 1.2 )
Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. […]
Conditions named in the indications of anastrozole's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Aromatase Inhibitor.
Source: FDA drug label (ARIMIDEX), NDA020541 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective March 2, 2026 (SPL set acbfaaa9-503c-4691-9828-76a7146ed6de), via openFDA; the full label on DailyMed
What does the patient leaflet for anastrozole say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ARIMIDEX?ARIMIDEX may cause serious side effects including: • heart disease. Women with early breast cancer, who have a history of blockage in their heart arteries (ischemic heart disease) and who take ARIMIDEX, may have an increase in symptoms of decreased blood flow to their heart compared to similar women who take tamoxifen. Get medical help right away if you have new or worsening chest pain or shortness of breath during treatment with ARIMIDEX.
From the patient leaflet: How should I store ARIMIDEX?Store ARIMIDEX at room temperature between 68°F to 77°F (20°C to 25°C). Keep ARIMIDEX and all medicines out of the reach of children.
Source: FDA drug label (ARIMIDEX), NDA020541 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective March 2, 2026 (SPL set acbfaaa9-503c-4691-9828-76a7146ed6de), via openFDA; the full label on DailyMed
Is there a generic for anastrozole (Arimidex)?
The FDA approved the first generic anastrozole on June 28, 2010. 18 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists anastrozole from 24 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.
- 1995 earliest approval on file
- 2010 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 anastrozole (Arimidex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.142 per Anastrozole 1 mg tablet, up 3% from $0.138 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.
- Anastrozole 1 mg tablet (generic)
- Arimidex 1 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Anastrozole 1 mg tablet | Generic | $0.142 per tablet | $4.25 | +3% |
| Arimidex 1 mg tablet | Brand | $52.86 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,585.85 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has anastrozole been recalled?
The FDA's Enforcement Report lists 6 recalls naming anastrozole since 2017: 0 Class I (the most serious), 6 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of anastrozole and that hold 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 |
|---|---|---|---|
| May 9, 2019 | Class II | American Health Packaging | GMP Deviations: Potential cross contamination due to cleaning procedure failure. |
| May 6, 2019 | Class II | Zydus Pharmaceuticals USA Inc | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. |
| November 16, 2017 | Class II | KRS Global Biotechnology, Inc not a listed maker | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the anastrozole label say about other medicines?
The anastrozole label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name anastrozole. 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 |
|---|---|---|
| Tamoxifen | drug interactions | Tamoxifen Co-administration of anastrozole and tamoxifen in breast cancer patients reduced anastrozole plasma concentration by 27%. |
Source: FDA drug label (ARIMIDEX), NDA020541 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective March 2, 2026 (SPL set acbfaaa9-503c-4691-9828-76a7146ed6de), via openFDA; the full label on DailyMed
What do FAERS reports show for anastrozole?
The FDA Adverse Event Reporting System holds 36,521 reports that list anastrozole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,430 are coded as a death and 7,951 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 anastrozole?
17 other medicines are given the same way (oral) and in the same FDA class as anastrozole 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 |
|---|---|---|---|---|
| Letrozole | Breast cancer | 19 labelers | $0.145 per tablet 2.5 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 |
Every medicine labeled for the same conditions as anastrozole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does anastrozole compare with medicines for the same use?
4 side-by-side pages set anastrozole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to anastrozole
- 17 medicines for the same use
- Other aromatase inhibitors
- the pharmacologic class, with prices and generics
- Anastrozole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other