Prescription medicine
Exemestane Brand names: Aromasin
Exemestane (Aromasin) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.748 per exemestane 25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the exemestane FDA label on DailyMed (effective September 12, 2024, Breckenridge Pharmaceutical, Inc.); the NDA 20753 record on Drugs@FDA; every exemestane label on DailyMed.
Highlights of the record
FDA label of September 12, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageExemestane tablets are an aromatase inhibitor indicated for: adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ).
Forms and strengths
- 25 mg
Tablet; film-coated tablet; sugar-coated tablet; coated tablet.
On the market
- Earliest approval on file
- October 21, 1999 Aromasin, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first April 1, 2011; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 10 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.748 per tablet Exemestane 25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 21,298 through July 30, 2026
What is exemestane used for?
From the label: indications and usageExemestane tablets are an aromatase inhibitor indicated for: adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ). treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). 1.1 Adjuvant Treatment of Postmenopausal Women Exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are […]
Conditions named in the indications of exemestane's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Aromatase Inhibitor.
Source: FDA drug label (Exemestane), Breckenridge Pharmaceutical, Inc., effective September 12, 2024 (SPL set 4e3fd382-19f5-4ded-ab22-39d5b1b2f366), via openFDA; the full label on DailyMed
Is there a generic for exemestane (Aromasin)?
The FDA approved the first generic exemestane on April 1, 2011. 11 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.
FDA's NDC Directory lists exemestane from 10 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.
- 1999 earliest approval on file
- 2011 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 exemestane (Aromasin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.748 per Exemestane 25 mg tablet, up 7% from $0.697 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.
- Exemestane 25 mg tablet (generic)
- Aromasin 25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Exemestane 25 mg tablet | Generic | $0.748 per tablet | $22.43 | +7% |
| Aromasin 25 mg tablet | Brand | $38.98 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,169.38 | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has exemestane been recalled?
The FDA's Enforcement Report lists 1 recall naming exemestane since 2013: 0 Class I (the most serious), 1 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 exemestane 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 |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: EXEMESTANE, Tablet, 25 mg may be potentially mislabeled as the following drug: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the exemestane label say about other medicines?
The exemestane label names 5 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Carbamazepine | drug interactions | Drugs That Induce CYP 3A4 Co-medications that induce CYP 3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's Wort) may significantly decrease exposure to exemestane. |
| Megestrol | warnings and precautions | In the comparative study in advanced breast cancer patients, CTC grade 3 or 4 elevation of gamma glutamyl transferase without documented evidence of liver metastasis was reported in 2.7% of patients treated with exemestane tablets and in 1.8% of patients treated with megestrol acetate. |
| Phenobarbital | drug interactions | Drugs That Induce CYP 3A4 Co-medications that induce CYP 3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's Wort) may significantly decrease exposure to exemestane. |
| Phenytoin | drug interactions | Drugs That Induce CYP 3A4 Co-medications that induce CYP 3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's Wort) may significantly decrease exposure to exemestane. |
| Tamoxifen | warnings and precautions | Percent Change in BMD from Baseline to 24 months, Exemestane vs. Control 1 IES 027 BMD Exemestane N=29 Tamoxifen 1 N=38 Exemestane N=59 Placebo 1 N=65 Lumbar spine (%) -3.1 -0.2 -3.5 -2.4 Femoral neck (%) -4.2 -0.3 -4.6 -2.6 During adjuvant treatment with exemestane, women with osteoporosis or at risk of osteoporosis … |
Source: FDA drug label (Exemestane), Breckenridge Pharmaceutical, Inc., effective September 12, 2024 (SPL set 4e3fd382-19f5-4ded-ab22-39d5b1b2f366), via openFDA; the full label on DailyMed
What do FAERS reports show for exemestane?
The FDA Adverse Event Reporting System holds 21,298 reports that list exemestane among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,512 are coded as a death and 5,287 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 exemestane?
17 other medicines are given the same way (oral) and in the same FDA class as exemestane 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 |
| Letrozole | Breast cancer | 19 labelers | $0.145 per tablet 2.5 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 exemestane
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does exemestane compare with medicines for the same use?
3 side-by-side pages set exemestane beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to exemestane
- 17 medicines for the same use
- Other aromatase inhibitors
- the pharmacologic class, with prices and generics
- Exemestane side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other