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Etanercept Side Effects

The most commonly reported side effects of etanercept include pain, arthralgia, and rheumatoid arthritis, based on 598,499 FDA adverse event reports from 2004 to 2025. 12.0% of reports found the drug to be ineffective.

Etanercept side effects

Percentages show how often each reaction appears relative to total reports for etanercept.

1
Drug Ineffective12.0%71,735
2
Pain6.9%41,064
3
Arthralgia6.7%39,805
4
Rheumatoid Arthritis6.6%39,738
5
Injection Site Pain6.2%37,009
6
Fatigue4.5%26,946
7
Injection Site Erythema4.5%26,877
8
Joint Swelling4.1%24,243
9
Off Label Use3.9%23,055
10
Pain In Extremity3.7%22,273
11
Headache3.4%20,344
12
Injection Site Pain3.4%20,054
13
Rash3.2%19,222
14
Condition Aggravated3.2%19,076
15
Nasopharyngitis3.0%17,784

These are voluntary reports and do not establish that etanercept caused these reactions.

Report severity

36.6%Serious218,813 reports
11.4%Hospitalizations68,201 reports
3.0%Fatal18,019 reports

Seriousness is determined by the reporter, not by OpenClaim.

Etanercept drug interactions

Other drugs that appear in adverse event reports alongside etanercept. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Methotrexate10.8%64,781
2
Adalimumab8.6%51,242
3
Leflunomide6.1%36,764
4
Abatacept6.0%36,165
5
Tocilizumab5.6%33,740
6
Hydroxychloroquine-sulfate5.5%32,950
7
Infliximab5.1%30,558
8
Rituximab4.7%28,411
9
Sulfasalazine4.1%24,736
10
Certolizumab-pegol3.5%21,095
11
Golimumab3.4%20,056
12
Prednisone3.1%18,685
13
Tofacitinib2.9%17,605
14
Diclofenac2.2%13,008
15
Folic-acid2.1%12,549

Taken alongside

1
Methotrexate9.9%59,482
2
Prednisone4.7%28,315
3
Folic-acid3.5%20,787
4
Hydroxychloroquine-sulfate3.2%19,339
5
Tofacitinib3.1%18,423
6
Acetaminophen2.8%16,593
7
Leflunomide2.4%14,270
8
Ergocalciferol2.3%13,610
9
Sulfasalazine2.1%12,729
10
Ibuprofen1.9%11,420
11
Adalimumab1.9%11,391
12
Levothyroxine-sodium1.6%9,850
13
Pantoprazole-sodium1.6%9,762
14
Naproxen1.4%8,142
15
Omeprazole1.4%8,126

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports etanercept side effects

68.9% of etanercept adverse event reports involve female patients and 23.5% involve male patients. The largest age group is adult at 72%. These figures reflect who reports side effects, not underlying risk.

Sex

Female68.9%
Male23.5%
Unknown7.6%

Age group

< 20.2%
2–111.2%
12–171.7%
18–6472.0%
65+24.9%

What is etanercept used for

Conditions and purposes for which patients were taking etanercept when the adverse event was reported.

Abdominal PainAbdominal Pain UpperAbortion ThreatenedAbscessAbscess IntestinalAbscess OralAccidentAcneAcne ConglobataAcne CysticAcrodermatitisActinic KeratosisAcute AbdomenAcute Febrile Neutrophilic DermatosisAcute Generalised Exanthematous Pustulosis

Showing 15 of 1,383 indications

Etanercept brand names and reporting trend

Etanercept is sold under brand names including Enbrel, Erelzi.

Brand names

Enbrel26,177
Erelzi1

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking etanercept with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.