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.
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
- Injection Site Pain
Injection Site Pain
56,664 reports
- Rheumatoid Arthritis
Rheumatoid Arthritis
46,175 reports
- Arthralgia
Arthralgia
44,971 reports
- Pain
Pain
43,004 reports
- Injection Site Erythema
Injection Site Erythema
41,016 reports
- Fatigue
Fatigue
30,269 reports
- Pain In Extremity
Pain In Extremity
25,460 reports
- Joint Swelling
Joint Swelling
25,430 reports
- Psoriasis
Psoriasis
24,970 reports
- Headache
Headache
24,668 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) 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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for etanercept?
Related Medications in TNF-Alpha Inhibitor (Biologic)
Other drugs grouped near etanercept - same-class peers and common alternatives.
abatacept
Orencia
Orencia is a medicine that helps to reduce inflammation.
Compare with etanercept →
acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
Compare with etanercept →
acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
Compare with etanercept →
acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
Compare with etanercept →
adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
Compare with etanercept →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for etanercept: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 591,578.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 2.79%.
- fexofenadine Δ 0.02 pts · 19,831 reports · Second-Generation Antihistamine 2.77%death share
- lurasidone Δ 0.04 pts · 20,544 reports · Atypical Antipsychotic 2.75%death share
- inclisiran Δ 0.07 pts · 6,989 reports · PCSK9 siRNA 2.72%death share
- bimatoprost Δ 0.08 pts · 28,128 reports · Prostaglandin Analog (Ophthalmic) 2.71%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: December 9, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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