Prescription medicine
Etanercept Brand names: Enbrel
Etanercept (Enbrel) is a prescription medicine with an FDA approval on record since 1998. No generic is listed; pharmacies paid $2,084.14 per mL (Enbrel 25 mg/0.5 mL syringe) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the etanercept FDA label on DailyMed (effective May 11, 2026, Immunex Corporation); the BLA 103795 record on Drugs@FDA; every etanercept label on DailyMed.
Highlights of the record
FDA label of May 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS INFECTIONS and MALIGNANCIES WARNING: SERIOUS INFECTIONS and MALIGNANCIES See full prescribing information for complete boxed warning. SERIOUS INFECTIONS Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. ( 5.1 ) Enbrel should be discontinued if a patient develops a serious infection or sepsis during treatment. ( 5.1 ) Perform test for latent TB; if positive, start treatment for TB prior to starting Enbrel. ( 5.1 ) Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ( 5.1 ) MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including Enbrel. ( 5.3 ) SERIOUS INFECTIONS Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6) ]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Enbrel should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. […]
Used for
From the label: indications and usageEnbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA) ( 1.1 ) Psoriatic Arthritis (PsA) ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Plaque Psoriasis (PsO) ( 1.5 ) Pediatric patients with: Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or older ( 1.2 ) Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA) ( 1.6 ) Plaque
Forms and strengths
- 25 mg/.5ml
- 50 mg/ml
Solution.
On the market
- Earliest approval on file
- November 2, 1998 Enbrel, Immunex; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2,084.14 per mL Enbrel 25 mg/0.5 mL syringe
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 595,129 through July 30, 2026
What is etanercept used for?
From the label: indications and usageEnbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA) ( 1.1 ) Psoriatic Arthritis (PsA) ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Plaque Psoriasis (PsO) ( 1.5 ) Pediatric patients with: Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or older ( 1.2 ) Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA) ( 1.6 ) Plaque Psoriasis, 4 years of age or older ( 1.5 ) 1.1 Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). […]
Conditions named in the indications of etanercept's FDA labels, with every medicine labeled for each:
From other etanercept labelsPsoriasis: Enbrel is indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
FDA pharmacologic class: Tumor Necrosis Factor Blocker.
Source: FDA drug label (ENBREL), Immunex Corporation, effective May 11, 2026 (SPL set a002b40c-097d-47a5-957f-7a7b1807af7f), via openFDA; the full label on DailyMed
What does the patient leaflet for etanercept 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 Enbrel?Enbrel may cause serious side effects, including: 1. Risk of Infection 2. Risk of Cancer 1. Risk of infection Enbrel can lower the ability of your immune system to fight infections. Some people have serious infections while taking Enbrel. These infections include tuberculosis (TB), and infections caused by viruses, fungi, or bacteria that spread throughout their body. Some people have died from these infections. Your healthcare provider should test you for TB before starting Enbrel. Your healthcare provider should monitor you closely for symptoms of TB during treatment with Enbrel even if you tested negative for TB. Your healthcare provider should check you for symptoms of any type of infection before, during, and after your treatment with Enbrel. You should not start taking Enbrel if you have any kind of infection unless your healthcare provider says it is okay. 2. Risk of cancer There have been cases of unusual cancers, some resulting in death, in children and teenagers who started using TNF-blocking agents at less than 18 years of age. For children, teenagers, and adults taking TNF-blocker medicines, including Enbrel, the chances of getting lymphoma or other cancers may increase. People with rheumatoid arthritis, especially those with very active disease, may be more likely to get lymphoma. Before starting Enbrel, be sure to talk to your healthcare provider: Enbrel may not be right for you. Before starting Enbrel, tell your healthcare provider about all of your medical conditions, including: Infections. Tell your healthcare provider if you: have an infection. […]
From the patient leaflet: How should I store Enbrel?Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C). Store Enbrel in the original carton to protect from light or damage. If needed, you may store your dose tray for the multiple-dose vial at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days. - When the dose tray has reached room temperature, do not put it back in the refrigerator. - Throw away the dose tray that has been stored at room temperature after 14 days. Mixed Enbrel multiple-dose vials should be used right away or kept in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 14 days. […]
Source: FDA drug label (ENBREL), Immunex Corporation, effective May 11, 2026 (SPL set a002b40c-097d-47a5-957f-7a7b1807af7f), via openFDA; the full label on DailyMed
Is there a generic for etanercept (Enbrel)?
No generic etanercept is approved (Drugs@FDA, October 8, 2026).
- 1998 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for etanercept (Enbrel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2,084.14 per mL (Enbrel 25 mg/0.5 mL syringe), up 5% from $1,980.13 on October 8, 2025. 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.
- Enbrel 50 mg/mL syringe (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Enbrel 25 mg/0.5 mL syringe | Brand | $2,084.14 per mL | $1,042.07 per single-dose syringe | +5% |
| Enbrel 50 mg/mL mini cartridge | Brand | $2,080.99 per mL | n/a | +5% |
| Enbrel 50 mg/mL sureclick | Brand | $2,083.48 per mL | n/a | +5% |
| Enbrel 50 mg/mL syringe | Brand | $2,080.59 per mL | n/a | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the etanercept label say about other medicines?
The etanercept label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name etanercept. 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 |
|---|---|---|
| Abatacept | drug interactions | Live vaccines – Avoid concurrent administration with Enbrel ( 5.8 , 7.1 ) Anakinra – Increased risk of serious infection ( 5.12 , 7.2 ) Abatacept – Increased risk of serious adverse events, including infections ( 5.12 , 7.2 ) Cyclophosphamide – Not recommended for use with Enbrel. |
| Anakinra | drug interactions | Live vaccines – Avoid concurrent administration with Enbrel ( 5.8 , 7.1 ) Anakinra – Increased risk of serious infection ( 5.12 , 7.2 ) Abatacept – Increased risk of serious adverse events, including infections ( 5.12 , 7.2 ) Cyclophosphamide – Not recommended for use with Enbrel. |
| Cyclophosphamide | drug interactions | Live vaccines – Avoid concurrent administration with Enbrel ( 5.8 , 7.1 ) Anakinra – Increased risk of serious infection ( 5.12 , 7.2 ) Abatacept – Increased risk of serious adverse events, including infections ( 5.12 , 7.2 ) Cyclophosphamide – Not recommended for use with Enbrel. |
| Methotrexate | boxed warning | Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. |
| Sulfasalazine | drug interactions | Patients in a clinical study who were on established therapy with sulfasalazine, to which Enbrel was added, were noted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either Enbrel or sulfasalazine alone. |
Other labels that name etanercept
Source: FDA drug label (ENBREL), Immunex Corporation, effective May 11, 2026 (SPL set a002b40c-097d-47a5-957f-7a7b1807af7f), via openFDA; the full label on DailyMed
What do FAERS reports show for etanercept?
The FDA Adverse Event Reporting System holds 595,129 reports that list etanercept among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 17,154 are coded as a death and 66,514 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 rose sharply in 2017 (59,690, against a median of 17,131 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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 etanercept?
9 other medicines are given the same way (subcutaneous) and in the same FDA class as etanercept or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 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 (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Adalimumab | Rheumatoid arthritis, Psoriasis | none listed | $1,587.82 per mL 40 mg/0.4 mL | No current entry |
| Certolizumab | Rheumatoid arthritis, Psoriasis | none listed | $6,094.02 per syringe 2x200 mg/mL syringe kit | No current entry |
| Golimumab | Rheumatoid arthritis | none listed | $12,890.32 per mL 50 mg/0.5 mL pen injec | No current entry |
| Methotrexate | Rheumatoid arthritis, Psoriasis | none listed | $289.37 per mL 25 mg/0.5 mL autoinj | In shortage |
| Tocilizumab | Rheumatoid arthritis | none listed | $821.00 per mL 162 mg/0.9 mL autoinjct | No current entry |
| Adalimumab-ryvk | Rheumatoid arthritis, Psoriasis | none listed | $499.12 per unit 40 mg/0.4 mL autoinjector | A presentation being discontinued |
| Sarilumab | Rheumatoid arthritis | none listed | $2,075.30 per mL 200 mg/1.14 mL pen injection | No current entry |
| Abatacept | Rheumatoid arthritis | none listed | $1,469.23 per mL 125 mg/mL syringe | No current entry |
Every medicine labeled for the same conditions as etanercept
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does etanercept compare with medicines for the same use?
1 side-by-side page set etanercept beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to etanercept
- 9 medicines for the same use
- Other TNF blockers
- the pharmacologic class, with prices and generics
- Etanercept side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other