What the label lists and what reports show
Etanercept side effects
Etanercept's FDA label: “Most common adverse reactions (incidence > 5%): infections and injection site reactions.” FAERS holds 595,129 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is injection site pain (56,796 reports).
- No generic listed
- Boxed warning
Check it at the source: the etanercept FDA label on DailyMed (effective May 11, 2026, Immunex Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Enbrel?Enbrel can cause serious side effects, including: See " What is the most important information I should know about Enbrel? " Infections. Enbrel can make you more likely to get infections or make any infection that you have worse. Call your healthcare provider right away if you have any symptoms of an infection. See " Before starting Enbrel, be sure to talk to your healthcare provider " for a list of symptoms of infection. Previous Hepatitis B infection. If you have been previously infected with the hepatitis B virus (a virus that affects the liver), the virus can become active while you use Enbrel. Your healthcare provider may do a blood test before you start treatment with Enbrel and while you use Enbrel. Nervous system problems. […]
Source: FDA drug label, Immunex Corporation, effective May 11, 2026 (SPL set a002b40c-097d-47a5-957f-7a7b1807af7f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence > 5%): infections and injection site reactions.
Table 3. Percent of Adult RA Patients Experiencing Adverse Reactions in Controlled Clinical Trials
| Reaction | Placebo (N = 152) | Enbrel Any dose. (N = 349) | MTX (N = 217) | Enbrel (N = 415) |
|---|---|---|---|---|
| Infection Includes bacterial, viral and fungal infections. (total) | 39 | 50 | 86 | 81 |
| Upper Respiratory Infections Most frequent Upper Respiratory Infections were upper… | 30 | 38 | 70 | 65 |
| Non-upper Respiratory Infections | 15 | 21 | 59 | 54 |
| Injection Site Reactions | 11 | 37 | 18 | 43 |
| Diarrhea | 9 | 8 | 16 | 16 |
| Rash | 2 | 3 | 19 | 13 |
| Pruritus | 1 | 2 | 5 | 5 |
| Urticaria | 1 | - | 4 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infections [see Warnings and Precautions (5.1) ] Neurologic Reactions [see Warnings and Precautions (5.2) ] Malignancies [see Warnings and Precautions (5.3) ] Patients with Heart Failure [see Warnings and Precautions (5.4) ] Hematologic Reactions [see Warnings and Precautions (5.5) ] Hepatitis B Reactivation [see Warnings and Precautions (5.6) ] Allergic Reactions [see Warnings and Precautions (5.7) ] Autoimmunity [see Warnings and Precautions (5.9) ] Immunosuppression [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence > 5%): infections and injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Across clinical studies and postmarketing experience, the most serious adverse reactions with Enbrel were infections, neurologic events, CHF, and hematologic events [see Warnings and Precautions (5) ]. The most common adverse reactions with Enbrel were infections and injection site reactions. …
Source: FDA drug label, Immunex Corporation, effective May 11, 2026 (SPL set a002b40c-097d-47a5-957f-7a7b1807af7f), via openFDA; the full label on DailyMed
What do FAERS reports show?
595,129 reports list etanercept among the medicines taken, each a report of something that happened, not proof the medicine caused it; 17,154 are coded as a death and 66,514 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2017 (59,690, against a median of 17,131 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Etanercept: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions