Enbreletanercept
According to the FDA label: Enbrel 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…
592,886 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Enbrel in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
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Drug Ineffective 75,211 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Injection Site Pain 56,702 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →Rheumatoid Arthritis 46,374 reports
An autoimmune condition where the immune system attacks the joints, causing pain and swelling. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →Arthralgia 45,137 reports
Pain 43,199 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Injection Site Erythema 41,026 reports
Redness of the skin at the spot where a medication was injected. Erythema means skin redness.
Full definition in the glossary →Fatigue 30,415 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Joint Swelling 25,549 reports
Swelling in or around a joint.
Full definition in the glossary →Pain in Extremity 25,530 reports
Pain in an arm or leg.
Full definition in the glossary →Psoriasis 25,033 reports
A condition where skin cells build up and form itchy, scaly patches. It often appears in reports because it is a condition being treated.
Full definition in the glossary →Headache 24,802 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Injection Site Swelling 23,262 reports
Swelling at the spot where a medication was injected.
Full definition in the glossary →Off Label Use 22,314 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →- Injection Site Pruritus 22,094 reports
Injection Site Reaction 20,886 reports
A general report of a reaction at the spot where a medication was injected, such as redness, swelling, or pain.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 408,599 |
| Male | 139,298 |
| Unknown | 1,013 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 12,246 |
| 18-34 | 29,615 |
| 35-49 | 83,896 |
| 50-64 | 169,986 |
| 65-74 | 70,782 |
| 75+ | 30,294 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Enbrel. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 379,760 |
| Other Serious | 169,525 |
| Hospitalization | 65,973 |
| Death | 16,796 |
| Disability | 11,695 |
| Life-Threatening | 9,521 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Enbrel. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 1,196 |
| 2005 | 1,836 |
| 2006 | 8,807 |
| 2007 | 17,520 |
| 2008 | 16,649 |
| 2009 | 14,436 |
| 2010 | 22,274 |
| 2011 | 29,182 |
| 2012 | 42,297 |
| 2013 | 46,953 |
| 2014 | 41,070 |
| 2015 | 57,541 |
| 2016 | 58,757 |
| 2017 | 59,690 |
| 2018 | 49,137 |
| 2019 | 30,609 |
| 2020 | 26,238 |
| 2021 | 17,081 |
| 2022 | 17,133 |
| 2023 | 13,527 |
| 2024 | 11,927 |
| 2025 | 7,826 |
| 2026 (partial) | 1,200 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Enbrel
In FDA adverse event reports that mention Enbrel, these medications appeared most often in the same report.
- Methotrexate (115,824 reports)
- Adalimumab (60,284 reports)
- Leflunomide (45,464 reports)
- Prednisone (41,560 reports)
- Abatacept (38,149 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026