Prescription medicine
Fulvestrant Brand names: Faslodex, Cligavyx
Fulvestrant (Faslodex) is a prescription medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 19 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the fulvestrant FDA label on DailyMed (effective September 25, 2020, AstraZeneca Pharmaceuticals LP); the NDA 21344 record on Drugs@FDA; every fulvestrant label on DailyMed.
Highlights of the record
FDA label of September 25, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageMonotherapy FASLODEX is indicated for the treatment of:
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or
HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
Forms and strengths
- 50 mg/ml
- 250 mg/5ml
Injection; injection (solution).
On the market
- Earliest approval on file
- April 25, 2002 Faslodex, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first March 4, 2019; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 22 of which 19 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- May 17, 2034 Fulvestrant injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 2 since 2021 0 Class I among all firms' recalls; latest July 15, 2022
- FAERS reports
- 32,841 through July 30, 2026
What is fulvestrant used for?
From the label: indications and usageMonotherapy FASLODEX is indicated for the treatment of:
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or
HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy FASLODEX is indicated for the treatment of:
HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy. […]
Conditions named in the indications of fulvestrant's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Estrogen Receptor Antagonist.
Source: FDA drug label (FASLODEX), AstraZeneca Pharmaceuticals LP, effective September 25, 2020 (SPL set 83d7a440-e904-4e36-afb5-cb02b1c919f7), via openFDA; the full label on DailyMed
Is there a generic for fulvestrant (Faslodex)?
The FDA approved the first generic fulvestrant on March 4, 2019. 15 generic applications are approved; 12 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 fulvestrant from 19 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Faslodex injection; a patent listed only for Fulvestrant injection runs to May 17, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2002 earliest approval on file
- 2019 first generic approved
- 2034 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is fulvestrant in shortage?
No fulvestrant presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated August 14, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Fulvestrant, Injection, 250 mg per 5mL (NDC 63323-715-05) | Fresenius Kabi USA, LLC | To Be Discontinued | August 14, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has fulvestrant been recalled?
The FDA's Enforcement Report lists 2 recalls naming fulvestrant since 2021: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 15, 2022 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed Impurities/Degradation Specifications |
| August 27, 2021 | Class II | Glenmark Pharmaceuticals Inc., USA | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fulvestrant label say about other medicines?
The fulvestrant label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name fulvestrant. 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 |
|---|---|---|
| Estradiol | warnings and precautions | Immunoassay Measurement of Serum Estradiol: FASLODEX can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels. |
| Ketoconazole | drug interactions | Although, fulvestrant is metabolized by CYP 3A4 in vitro, drug interactions studies with ketoconazole or rifampin did not alter fulvestrant pharmacokinetics. |
| Rifampin | drug interactions | Although, fulvestrant is metabolized by CYP 3A4 in vitro, drug interactions studies with ketoconazole or rifampin did not alter fulvestrant pharmacokinetics. |
Other labels that name fulvestrant
Source: FDA drug label (FASLODEX), AstraZeneca Pharmaceuticals LP, effective September 25, 2020 (SPL set 83d7a440-e904-4e36-afb5-cb02b1c919f7), via openFDA; the full label on DailyMed
What do FAERS reports show for fulvestrant?
The FDA Adverse Event Reporting System holds 32,841 reports that list fulvestrant among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,960 are coded as a death and 7,497 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 fulvestrant?
1 other medicine is given the same way (intramuscular) and in the same FDA class as fulvestrant 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. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intramuscular) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Testosterone | Breast cancer | 22 labelers | $11.39 per mL 200 mg/mL | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other estrogen receptor antagonists
- the pharmacologic class, with prices and generics
- Fulvestrant side effects
- the label's list beside FAERS reports
- Fulvestrant shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other