Prescription medication · TNF-Alpha Inhibitor (Biologic)
etanercept
Also sold as Enbrel. Enbrel treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in adults.
Data updated 2026-05-15
- 591,578
- FDA reportsHeavily reported
- 2
- InteractionsFew interactions
- $1853.56
- Brand price (NADAC)
What the data shows
etanercept (Enbrel) is a prescription TNF-Alpha Inhibitor (Biologic), one of the most-reported medications in the FDA FAERS database (591,578 FDA reports), with 2 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
etanercept (Enbrel) is a prescription TNF-Alpha Inhibitor (Biologic). Enbrel treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in adults.
Enbrel is a medicine that blocks a protein called tumor necrosis factor (TNF). It is used to treat arthritis, psoriasis, and other similar conditions.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from etanercept's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of etanercept's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of etanercept's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of etanercept's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
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 591,578 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for etanercept, by number of reports
- Pain where you got the shot
Pain where you got the shot
56,664 reports
- Rheumatoid arthritis
Rheumatoid arthritis
46,170 reports
- Joint pain
Joint pain
44,970 reports
- Pain
Pain
43,005 reports
- Redness where you got the shot
Redness where you got the shot
41,017 reports
- Tiredness
Tiredness
30,269 reports
- Pain in your arm or leg
Pain in your arm or leg
25,461 reports
- Swollen joint
Swollen joint
25,429 reports
- Psoriasis
Psoriasis
24,970 reports
- Headache
Headache
24,667 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for etanercept each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where etanercept sits
etanercept has more FDA adverse-event reports than 100% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is etanercept; the line is the median (50th percentile).
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
Reports Mentioning Death
16,504
2.8% of reports — not proof of cause
Hospitalization Reports
65,552
Top Indication
Rheumatoid Arthritis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 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 |
| 14 | INJECTION SITE PRURITUS | 22,089 |
| 15 | INJECTION SITE REACTION | 20,860 |
| 16 | NASOPHARYNGITIS | 20,625 |
| 17 | CONDITION AGGRAVATED | 20,532 |
Reactions in Death Reports
Reactions in Hospitalization Reports
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
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I do if I get an infection while taking Enbrel?
Can I get vaccines while taking Enbrel?
How long does it take for Enbrel to start working?
Can I take other medicines with Enbrel?
What are the signs of an allergic reaction to Enbrel?
Can Enbrel cause heart problems?
Does Enbrel affect my blood?
Can Enbrel cause nerve problems?
What if I am exposed to chickenpox?
How is Enbrel supplied?
What are the common side effects of etanercept?
Does etanercept interact with other medications?
What drug class is etanercept?
Is etanercept safe during pregnancy?
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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 591,578 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
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages