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etanercept

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Brand names: Enbrel

TNF-Alpha Inhibitor (Biologic) Rx

Enbrel is a medicine that blocks a protein called tumor necrosis factor (TNF). It is used to treat arthritis, psoriasis, and other similar conditions.

Drug Pricing (NADAC)

Brand Price

$1853.56/unit

Generic Available

No

Pricing data from NADAC (CMS), effective August 23, 2024. Compare all drug costs →

What it does

Enbrel treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in adults.

Common side effects

Infections, Injection site reactions (pain, redness, swelling, itching)

Key warnings

Enbrel can increase your risk of serious infections that may lead to hospitalization or death.

How It Works

Enbrel blocks a protein in your body called tumor necrosis factor (TNF). TNF can cause inflammation and damage in your joints and skin. By blocking TNF, Enbrel can reduce inflammation and improve your symptoms.

How to Take It

Enbrel is given as a shot under the skin (subcutaneous injection). For adults with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, the usual dose is 50 mg once a week. For adults with plaque psoriasis, the starting dose is 50 mg twice a week for 3 months, followed by 50 mg once a week. For children, the dose is based on weight.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. Studies suggest a slightly higher chance of birth defects in women exposed to Enbrel during pregnancy. Talk to your doctor about the risks and benefits of using Enbrel during pregnancy.

Missed Dose

If you miss a dose of Enbrel, take it as soon as you remember. Then, take your next dose at your regular scheduled time.

Storage

Store Enbrel in the refrigerator at 36°F to 46°F (2°C to 8°C) in its original carton to protect it from light. Do not freeze.

Side Effects (from patient reports)

Based on 413,008 FDA adverse event reports.

The medicine is not working
75,053
Pain where you got the shot
56,664
Rheumatoid arthritis
46,170
Joint pain
44,970
Pain
43,005
Redness where you got the shot
41,017
Tiredness
30,269
Pain in your arm or leg
25,461
Swollen joint
25,429
Psoriasis
24,970

FDA Adverse Event Report Analysis

Detailed analysis of 591,578 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

591,578

Death-Related Reports

16,504

Hospitalization Reports

65,552

Top Indication

Rheumatoid Arthritis

Gender Distribution

Female 407,745 (74%)
Male 139,055 (25%)

Age Distribution

0–17 12,226
18–44 77,830
45–64 205,107
65–74 70,618
75+ 30,149

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DRUG INEFFECTIVE 75,052
2 INJECTION SITE PAIN 56,664
3 RHEUMATOID ARTHRITIS 46,175
4 ARTHRALGIA 44,971
5 PAIN 43,004
6 INJECTION SITE ERYTHEMA 41,016
7 FATIGUE 30,269
8 PAIN IN EXTREMITY 25,460
9 JOINT SWELLING 25,430
10 PSORIASIS 24,970
11 HEADACHE 24,668
12 INJECTION SITE SWELLING 23,258
13 OFF LABEL USE 22,112
14 INJECTION SITE PRURITUS 22,089
15 INJECTION SITE REACTION 20,860

Reactions in Death Reports

DEATH 6,230
OFF LABEL USE 2,290
FATIGUE 2,250
RHEUMATOID ARTHRITIS 2,104
JOINT SWELLING 2,030
ARTHRALGIA 2,003
PAIN 1,998
RASH 1,975
HYPERTENSION 1,973
GENERAL PHYSICAL HEALTH DETERIORATION 1,935

Reactions in Hospitalization Reports

DRUG INEFFECTIVE 8,262
RHEUMATOID ARTHRITIS 8,061
ARTHRALGIA 7,585
PAIN 7,345
PNEUMONIA 5,567
FATIGUE 5,526
CONDITION AGGRAVATED 5,316
JOINT SWELLING 5,191
OFF LABEL USE 4,981
ARTHROPATHY 4,798

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Enbrel can increase your risk of serious infections that may lead to hospitalization or death. These include tuberculosis (TB) and fungal infections. You should be tested for TB before starting Enbrel. Enbrel may also increase your risk of certain cancers, including lymphoma. Children and adolescents taking TNF blockers like Enbrel have developed lymphoma and other malignancies, some of which were fatal.

Known Drug Interactions

moderate abatacept

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. In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events, including infections, and did not demonstrate increased clinical benefit [see Warnings and Precautions (5.12) ] .

Mechanism: Both drugs lower your body's ability to fight off germs. Using them together makes your immune system too weak and greatly increases your risk of getting a serious infection.

What to do: Avoid taking these two medications together. Your doctor will help you find a single treatment that works without increasing your risk of infection.

7.4 Sulfasalazine 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.

Mechanism: Taking these two medicines together can lower the number of white blood cells that help your body fight infections.

What to do: Your doctor should monitor your blood cell counts regularly while you are using both medications.

Common Questions

What should I do if I get an infection while taking Enbrel?
Tell your doctor right away if you develop any signs of infection, such as fever, cough, or flu-like symptoms.
Can I get vaccines while taking Enbrel?
Avoid live vaccines while taking Enbrel. Talk to your doctor about which vaccines are safe for you.
How long does it take for Enbrel to start working?
It may take several weeks or months to see the full benefits of Enbrel.
Can I take other medicines with Enbrel?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the signs of an allergic reaction to Enbrel?
Signs of an allergic reaction include hives, difficulty breathing, and swelling of the face, lips, tongue, or throat. Seek immediate medical attention if you experience these symptoms.
Can Enbrel cause heart problems?
Enbrel may worsen heart failure. Tell your doctor if you have heart problems.
Does Enbrel affect my blood?
Enbrel can affect your blood cell counts. Your doctor may do blood tests to monitor your blood cell counts.
Can Enbrel cause nerve problems?
Enbrel may cause or worsen nerve problems. Tell your doctor if you have any numbness, tingling, or vision problems.
What if I am exposed to chickenpox?
If you are exposed to chickenpox, talk to your doctor. You may need treatment to prevent chickenpox.
How is Enbrel supplied?
Enbrel comes in prefilled syringes, SureClick autoinjectors, and vials for injection.
What are the common side effects of etanercept?
The most commonly reported side effects of etanercept include Infections, Injection site reactions (pain, redness, swelling, itching). Based on 413,008 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does etanercept interact with other medications?
Yes, etanercept has 2 known drug interactions. Notable interactions include abatacept, sulfasalazine. Always inform your doctor about all medications you are taking.
What drug class is etanercept?
etanercept belongs to the TNF-Alpha Inhibitor (Biologic) drug class. It requires a prescription (Rx). Enbrel treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in adults.
Is etanercept safe during pregnancy?
Tell your doctor if you are pregnant or plan to become pregnant. Studies suggest a slightly higher chance of birth defects in women exposed to Enbrel during pregnancy. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Related Medications in TNF-Alpha Inhibitor (Biologic)

Other drugs grouped near etanercept — same-class peers and common alternatives.

Compare etanercept vs abatacept side-by-side →

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What the FDA Data Shows for etanercept

The FDA label for etanercept (sold under brand names such as Enbrel) classifies it as a prescription-only medication in the TNF-Alpha Inhibitor (Biologic) class. Enbrel treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in adults. Official labeling lists 2 commonly reported side effects, including Infections, Injection site reactions (pain, redness, swelling, itching).

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 413,008 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: December 9, 2025

All federal data sources used on this page