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Fulvestrant

Fulvestrant is an injectable estrogen blocker used to treat hormone receptor-positive advanced or metastatic breast cancer, alone or together with certain other cancer medicines.

Brand names CligavyxFaslodex
Drug class Estrogen Receptor Antagonist
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

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 →

Other forms & routes:
Injection
Fulvestrant 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

Fulvestrant (Faslodex) is a hormone-blocking injection for hormone receptor-positive advanced breast cancer that blocks the estrogen receptor on cancer cells and lowers the amount of it, a standard option often paired with an oral drug such as palbociclib, available generically and on the market since about 2006. Most people handle it well, and the usual complaints are injection site soreness, hot flashes, joint or bone aches and tiredness. Report pain, numbness or tingling shooting down the buttock or leg after a shot (possible sciatic nerve irritation), or hives and facial swelling. Mention any bleeding disorder, blood thinner or liver disease first, since these affect how safely and how much it is given.

Clinical pearls

  • Doses come more often in the first month, then about once a month, so keeping those early appointments matters.
  • It can falsely raise some estradiol blood tests, so remind anyone checking your hormone levels that you receive it.
  • Pregnancy testing is advised before starting, and effective contraception and no breastfeeding continue for a full year after the last dose.
  • If it is paired with palbociclib, take that medicine with food; abemaciclib can be taken with or without food.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection
Earliest FDA record2002
Companies listing it with the FDA21
FDA label last updatedSep 25, 2020
FDA’s strongest warning (boxed)None on the label

Patient Information Guide A plain-language walkthrough of Fulvestrant, written from its FDA label.

What Fulvestrant Is Used For

▾

Fulvestrant treats HR-positive breast cancer in these settings:

  • Alone for HR-positive, HER2-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy
  • Alone for HR-positive advanced breast cancer in postmenopausal women whose disease progressed after endocrine therapy
  • With ribociclib for HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women, as first endocrine-based therapy or after progression
  • With palbociclib or abemaciclib for HR-positive, HER2-negative advanced or metastatic breast cancer in women whose disease progressed after endocrine therapy

Faslodex, Cligavyx and fulvestrant injection labels list these same uses.

How Fulvestrant Works

▾

Fulvestrant is an estrogen receptor antagonist. It binds to estrogen receptors on breast cancer cells, blocking estrogen from stimulating them. It also reduces the amount of receptor protein in the cells.

In lab studies it slowed growth of both estrogen-sensitive and tamoxifen-resistant breast cancer cells.

Fulvestrant Dosage

▾

Fulvestrant is given by a healthcare professional as an intramuscular injection into the buttocks, slowly over 1 to 2 minutes. Doses are given in the first month at set intervals, then about monthly.

  • People with moderate liver impairment get a lower dose.
  • If combined with palbociclib, abemaciclib or ribociclib, those are taken by mouth on their own schedules.
  • If you miss an appointment, contact your clinic to reschedule.

Dosing details from the FDA-approved label

From the Fulvestrant 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.

  • Monotherapy (Faslodex and Cligavyx recommended dose)
    • 500 mg intramuscularly into the buttocks (gluteal area) slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29, and once monthly thereafter
  • Combination therapy with palbociclib, abemaciclib, or ribociclib (fulvestrant dose)
    • 500 mg intramuscularly into the buttocks (gluteal area) slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29, and once monthly thereafter
    • Pre/perimenopausal women should be treated with LHRH agonists according to current clinical practice standards
  • Moderate hepatic impairment (Child-Pugh class B)
    • 250 mg intramuscularly into the buttock (gluteal area) slowly (1 - 2 minutes) as one 5 mL injection on Days 1, 15, 29, and once monthly thereafter
    • Not evaluated in severe hepatic impairment (Child-Pugh class C)
  • Palbociclib when used in combination with Faslodex
    • 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days
    • Palbociclib should be taken with food
  • Abemaciclib when used in combination with Faslodex
    • 150 mg orally, twice daily
    • May be taken with or without food
  • Ribociclib when used in combination with Faslodex
    • 600 mg taken orally, once daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days
    • Can be taken with or without food
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Fulvestrant injection 500 mg should be administered intramuscularly into the buttocks (gluteal area) slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29, and once monthly thereafter. ( 2.1 , 14 ) A dose of 250 mg is recommended in patients with moderate hepatic impairment to be administered intramuscularly into the buttock (gluteal area) slowly (1 - 2 minutes) as one 5 mL injection on Days 1, 15, 29, and once monthly thereafter. ( 2.2 , 5.2 , 8.6 ) 2.1 Recommended Dose Monotherapy The recommended dose of fulvestrant injection is 500 mg to be administered intramuscularly into the buttocks (gluteal area) slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29, and once monthly thereafter [see Clinical Studies (14) ]. Combination Therapy When fulvestrant injection is used in combination with palbociclib, abemaciclib, or ribociclib, the recommended dose of fulvestrant injection is 500 mg to be administered intramuscularly into the buttocks (gluteal area) slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29, and once monthly thereafter. When fulvestrant injection is used in combination with palbociclib, the recommended dose of palbociclib is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib should be taken with food. Refer to the Full Prescribing Information for palbociclib. When fulvestrant injection is used in combination with abemaciclib, the recommended dose of abemaciclib is 150 mg orally, twice daily. Abemaciclib may be taken with or without food. Refer to the Full Prescribing Information for abemaciclib. When fulvestrant injection is used in combination with ribociclib, the recommended dose of ribociclib is 600 mg taken orally, once daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days. Ribociclib can be taken with or without food. Refer to the Full Prescribing Information for ribociclib.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Fulvestrant Side Effects

▾

The most common side effects include:

Common side effects

  • Injection site pain
  • Nausea
  • Bone pain
  • Joint pain (arthralgia)
  • Headache
  • Back pain
  • Tiredness or weakness
  • Hot flashes
  • Nausea and vomiting
  • Bone pain, joint pain, back pain and pain in the arms or legs
  • Loss of appetite, constipation, cough and shortness of breath

When to get medical help

  • Call your doctor if you have an allergic reaction such as hives or swelling of the face, lips or throat.
  • Tell your care team about pain, numbness or tingling that shoots down the buttock or leg after an injection, which could be nerve irritation.
  • Report unusual bleeding or bruising.
  • Tell your doctor right away if you become pregnant or think you might be.
  • Liver enzyme increases can occur, so your doctor may check your liver tests.

Fulvestrant Warnings and Precautions

▾
  • Embryo-fetal harm: it can harm an unborn baby. Use effective contraception during treatment and for one year after the last dose.
  • Bleeding risk: use caution with bleeding disorders, low platelets or anticoagulants.
  • Liver impairment: exposure is higher in moderate impairment, so a lower dose is used.
  • Injection site nerve problems: sciatica, neuralgia and neuropathy have been reported.
  • Lab tests: it can falsely raise estradiol results on some tests.

Fulvestrant Interactions

▾

The label lists no known drug-drug interactions.

  • CYP 3A4 inhibitors or inducers (such as ketoconazole and rifampin) did not change fulvestrant levels.
  • Palbociclib, abemaciclib and ribociclib showed no clinically relevant interaction with it.
  • It can interfere with immunoassay estradiol tests because it is structurally similar to estradiol.

Interactions listed in the FDA-approved label

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

  • Ketoconazole or rifampin (CYP 3A4 inhibitor/inducer): Fulvestrant is metabolized by CYP 3A4 in vitro, but drug interaction studies with ketoconazole or rifampin did not alter fulvestrant pharmacokinetics; there are no known drug-drug interactions. Dose adjustment is not needed in patients co-prescribed CYP 3A4 inhibitors or inducers.
Read the label’s full interactions text

7 DRUG INTERACTIONS There are no known drug-drug interactions. Although, fulvestrant is metabolized by CYP 3A4 in vitro , drug interactions studies with ketoconazole or rifampin did not alter fulvestrant pharmacokinetics. Dose adjustment is not needed in patients co-prescribed CYP 3A4 inhibitors or inducers [see Clinical Pharmacology ( 12.3 )]. • There are no known drug-drug interactions. ( 7 )

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.

Check Fulvestrant against a supplement or herb →

Before Taking Fulvestrant

▾
  • Do not use it if you are allergic to fulvestrant or its ingredients.
  • Tell your doctor about bleeding disorders, low platelets or blood thinner use.
  • Tell your doctor about liver problems.
  • Pregnancy testing is recommended within seven days before starting for those who could become pregnant.
  • Do not breastfeed during treatment and for one year after the last dose.
  • It may affect fertility.
  • Safety and effectiveness in children have not been established.
  • No kidney dose change is needed. Levels were similar with creatinine clearance as low as 30 mL/min.

Fulvestrant Overdose

▾

Human overdose experience is limited. Healthy volunteers given IV fulvestrant with peak levels about 10 to 15 times those from intramuscular injection had no adverse reactions. There is no specific treatment, and symptoms of overdose are not established, so care is supportive and symptom-based.

What Fulvestrant Does in the Body

▾

In postmenopausal women with breast cancer given single doses before surgery, higher doses lowered estrogen receptor levels more. This came with a dose-related drop in progesterone receptor, an estrogen-regulated protein. Ki67, a marker of cell growth, also decreased.

How Your Body Processes Fulvestrant

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An extra dose two weeks after the first lets the drug reach steady levels within the first month. Fulvestrant is 99% bound to plasma proteins and is partly broken down in the liver, including by CYP 3A4. It leaves the body mainly in the feces (about 90%), with under 1% through the kidneys. Its half-life is about 40 days after an intramuscular injection.

How to Store Fulvestrant

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REFRIGERATE, 2° to 8°C (36° to 46°F). PROTECT FROM LIGHT, STORE IN THE ORIGINAL CARTON UNTIL TIME OF USE.

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

Fulvestrant: Pharmacist Answers to Common Questions

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

What is fulvestrant used for?

▾
It treats HR-positive advanced or metastatic breast cancer, mainly in postmenopausal women. It can be used alone or with palbociclib, abemaciclib or ribociclib, depending on your situation. Your oncologist chooses the plan that fits you.

How is it given, and how often?

▾
A healthcare professional injects it into the muscle of your buttocks, slowly over 1 to 2 minutes. You get doses closely spaced in the first month, then about once a month. Your clinic will give you the exact schedule.

What side effects should I expect?

▾
The most common are pain where you were injected, nausea, bone or joint pain, headache, tiredness and hot flashes. Most are manageable, but tell your care team if they bother you. Call right away for hives, swelling, or shooting pain, numbness or tingling in the buttock or leg.

Do I need to worry about other medicines I take?

▾
The label lists no known drug interactions, and common enzyme-affecting drugs did not change its levels. Still, tell us about everything you take, especially blood thinners, because the shot goes into muscle. It can also falsely raise some estradiol blood tests.

Is it safe in pregnancy or while breastfeeding?

▾
No. It can harm an unborn baby, so use effective contraception during treatment and for one year after your last dose. A pregnancy test is advised beforehand. Do not breastfeed during treatment or for one year after.

Does liver disease change my dose?

▾
Yes. With moderate liver impairment your body has more exposure, so a lower dose is recommended. It has not been studied in severe liver impairment, so make sure your doctor knows your liver history.

Is Fulvestrant available over the counter?

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

▾
The earliest FDA record we hold for Fulvestrant is from 2002: 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 Fulvestrant was first used.

Who makes Fulvestrant?

▾
21 companies currently list Fulvestrant products in the FDA's NDC Directory, including BluePoint Laboratories, Sandoz Inc, Accord Healthcare 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 Fulvestrant on HelloPharmacist

🌿Drug & Supplement CheckerFulvestrant vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Fulvestrant NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed Data & References for Fulvestrant 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.

Fulvestrant Forms and Strengths (How It Comes)

Fulvestrant 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Fulvestrant inactive ingredients by manufacturer.

Injection

Into a muscle · Into a vein
Brands Cligavyx Faslodex
How this form is used
What it may be used for
  • Faslodex is used for HR-positive advanced breast cancer in postmenopausal women, alone or with ribociclib, palbociclib or abemaciclib.
  • Cligavyx is used for the same HR-positive advanced or metastatic breast cancer uses, alone or in combination.
  • Fulvestrant injection is used for the same breast cancer uses, alone or in combination.
Important instructions
  • Faslodex is given into the buttocks as an intramuscular injection, slowly over 1 to 2 minutes per injection.
  • Cligavyx is given into the buttocks as an intramuscular injection, slowly over 1 to 2 minutes per injection.
  • Cligavyx: pre- or perimenopausal women using it with palbociclib, abemaciclib or ribociclib should also be treated with an LHRH agonist.
  • Fulvestrant injection products are given into the buttocks by intramuscular injection, with a lower dose for moderate liver impairment.
Available strengths 2 strengths
50 mg/mL 250 mg/5 mL
50 FDA-listed product records ⓘ

Fulvestrant on the U.S. Market: Products, Makers and Brands

How Fulvestrant 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.

21 companies list 24 Fulvestrant product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2002. Brand names on the directory include Cligavyx, Faslodex; the rest are generics.

1
Dose forms ⓘ
21
Labelers (makers, repackagers, distributors)
3
Brand names
24
FDA-listed product records ⓘ
2002
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (12) · Unfinished injection (1) — bulk drug substance and unfinished product sold to compounders and other manufacturers to finish, and multi-item kits. These aren’t counted in the dose-form total above.

BluePoint Laboratories13%
Sandoz Inc8%
Accord Healthcare Inc.4%
Alembic Pharmaceuticals Inc.4%
Amneal Pharmaceuticals LLC4%
AstraZeneca Pharmaceuticals LP4%
Other makers63%

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

How Widely Fulvestrant Is Used (Medicaid Data)

A general measure of how commonly Fulvestrant 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 Fulvestrant 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.

8,707
Medicaid prescriptions filled (Q1–Q4 2025)
$2.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Fulvestrant prescribed? Of the 1,603 medications we measure, Fulvestrant ranks #953 by Medicaid prescriptions — more than 41% of them.

Where Fulvestrant ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #953 of 1,603
#948 Eptinezumab-jjmr Injec... 8,909 Rx #949 Pitavastatin 8,812 Rx #950 Balsalazide 8,799 Rx #951 Selexipag 8,761 Rx #952 Nitroglycerin Topical 8,740 Rx #953 Fulvestrant Injection 8,707 Rx #954 Fulvestrant 8,707 Rx #955 Beclomethasone Nasal S... 8,632 Rx #956 Cetuximab Injection 8,583 Rx #957 Diflorasone Topical 8,568 Rx #958 Ephedrine 8,557 Rx

Utilization by Fulvestrant 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.

5 ML fulvestrant 50 MG/ML Prefilled Syringe

8,707 Medicaid prescriptions (Q1–Q4 2025) 100% of Fulvestrant prescriptions shown $2.7M gross reimbursement (before rebates) ≈ $312 per prescription (gross)

Summed across the 19 of 57 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 727762

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 Fulvestrant, 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 19 of 57 listed Fulvestrant NDCs with Medicaid activity.

Compare Fulvestrant Products

A representative set of FDA-listed product records for Fulvestrant — 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 Fulvestrant NDCs →

Fulvestrant Side Effects Reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Fulvestrant — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Fulvestrant are malignant neoplasm progression, fatigue, nausea; about 81% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

32,841
Reports mentioning it
81%
Reported as serious
12
Distinct effects shown
Most reported effects
Malignant Neoplasm Progression
4,229
Fatigue
4,182
Nausea
3,029
Death
2,742
Diarrhoea
2,623
Neutropenia
2,485
White Blood Cell Count Decreased
2,199
Metastases To Bone
2,131
Neoplasm Progression
2,129
Asthenia
1,771
Age groups
Adult · 2,923Elderly · 2,496Child · 3Adolescent · 3Neonate · 1

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Fulvestrant in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Fulvestrant FDA Approval History

How Fulvestrant went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Fulvestrant was first approved by the FDA in 2002 (Brand: FASLODEX · Astrazeneca); the first generic version was approved in 2019. It remains available in U.S. pharmacies today.

2002
Brand approved
Brand: FASLODEX · Astrazeneca
2019
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Fulvestrant 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 2 Fulvestrant recalls since July 2021. None of them is still listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class II Jul 15, 2022 · Terminated · Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications
  • Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus P… Lots: Lot # B200076; Exp 31 JAN 2024 FDA record D-1351-2022 →
Class II Aug 27, 2021 · Terminated · Glenmark Pharmaceuticals Inc., USA
Lack of Assurance of Sterility
  • Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32 Lots: Lots: 30200014 Exp. 04/30/2022; 30200015 Exp. 05/31/2022; 30200015 Exp. 05/31/2022; 30200016 Exp. 05/31/2022; 30200036 Exp. 09/30/2022; 30200038 Exp. 09/30/2022; 30200039 Exp. 09/30/2022; 30200040 Exp. 09/30/2022; 30210001 Exp. 12/31/2022;… FDA record D-0820-2021 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 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) Fulvestrant RxCUI 282357 1 dose form · 1 strength
  1. Dose form (SCDF) Prefilled Syringe RxCUI 727760 In current FDA listings
    Clinical drug / strength (SCD) 5 ML fulvestrant 50 MG/ML RxCUI 727762

Look up RxCUI 282357 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.

Fulvestrant Supply and Shortage Status

Whether Fulvestrant is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.

Fulvestrant is not in shortage right now; the FDA has 1 past shortage record for it.

✅No current shortage of Fulvestrant on record

Read the full Fulvestrant shortage page — affected NDCs, other makers, and what to do →

To be discontinued Fulvestrant, Injection, 250 mg per 5mL (NDC 63323-715-05)
Fresenius Kabi USA, LLC · Since 08/14/2026 · Updated 08/14/2026

Source: openFDA, from the FDA Drug Shortages database.

Fulvestrant Brand Names

Fulvestrant is sold under 2 brand names in the FDA directory — Cligavyx, Faslodex. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Cligavyx Faslodex

Who Makes Fulvestrant: Manufacturers and Labelers

21 companies list Fulvestrant products with the FDA. By number of product records, the largest are BluePoint Laboratories, Sandoz Inc, Accord Healthcare Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

BluePoint Laboratories 3 Sandoz Inc 2 Accord Healthcare Inc. 1 Alembic Pharmaceuticals Inc. 1 Amneal Pharmaceuticals LLC 1 AstraZeneca Pharmaceuticals LP 1 Athenex Pharmaceutical Division, LLC. 1 Avenacy, Inc. 1 Avyxa Pharma, LLC 1 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. 1 Dr.Reddy's Laboratories Inc 1 Eugia US LLC 1 Fresenius Kabi USA, LLC 1 Glenmark Pharmaceuticals Inc., Usa 1 Hikma Pharmaceuticals USA Inc. 1 Meitheal Pharmaceuticals Inc 1 Northstar Rx, LLC, 1 Sagent Pharmaceuticals 1 Xiromed, LLC 1 Zydus Lifesciences Limited 1 Zydus Pharmaceuticals USA Inc. 1

Sources for This Fulvestrant 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 Sep 25, 2020
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fulvestrant.
📈
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 Fulvestrant 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)
21
FDA labeler codes behind them ⓘ
21
Linked representative label ⓘ
AstraZeneca Pharmaceuticals LP
Linked label effective
Sep 25, 2020
Composite sections available
23
Linked SPL Set ID
83d7a440-e904-4e36-afb5-cb02b1c919f7
Linked SPL Document ID
9541dd80-09f9-4d3c-bb2a-fc354e198a2e
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. AstraZeneca Pharmaceuticals LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →