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What is the Most Commonly Reported Side Effect of Enbrel?

3 min read

In placebo-controlled trials for rheumatologic indications, approximately 37% of patients treated with Enbrel developed injection site reactions [1.2.2]. This article explores what is the most commonly reported side effect of Enbrel and provides further details on other potential reactions.

Quick Summary

The most frequently reported side effects of Enbrel are infections and injection site reactions [1.2.2]. These local reactions include redness, itching, pain, and swelling at the injection spot.

Key Points

  • Most Common Side Effect: The most commonly reported side effects of Enbrel are injection site reactions (redness, pain, swelling) and infections [1.2.2].

  • Injection Site Reactions: Approximately 37% of patients in rheumatology clinical trials experienced mild-to-moderate injection site reactions, which usually lessen over time [1.2.2].

  • FDA Boxed Warnings: Enbrel has serious warnings for an increased risk of severe infections (like tuberculosis) and malignancies (like lymphoma) [1.4.2, 1.4.3].

  • Mechanism of Action: Enbrel is a TNF inhibitor that works by blocking the activity of tumor necrosis factor, a protein that causes inflammation in autoimmune diseases [1.8.1, 1.8.2].

  • Serious Risks: Other serious potential side effects include neurologic disorders, new or worsening heart failure, blood disorders, and hepatitis B reactivation [1.4.3].

  • Management: Managing injection site reactions involves rotating injection sites, using cold compresses, and allowing the medication to warm to room temperature before use [1.5.1, 1.5.5].

  • Contraindications: Enbrel should not be given to patients with sepsis and should be used with caution in those with active infections, heart failure, or certain neurologic disorders [1.10.1, 1.10.4].

In This Article

Understanding Enbrel (Etanercept)

Enbrel, with the generic name etanercept, is a biologic medication prescribed to treat several autoimmune conditions [1.8.1, 1.8.4]. It is a type of drug known as a tumor necrosis factor (TNF) inhibitor [1.8.2]. In autoimmune diseases like rheumatoid arthritis, the immune system mistakenly attacks healthy cells, producing an excess of proteins like TNF, which causes inflammation and damage [1.8.1]. Etanercept works by binding to this excess TNF, blocking its activity and thereby reducing inflammation, pain, and joint damage [1.8.1, 1.8.4].

Enbrel is FDA-approved for various conditions, including:

  • Moderately to severely active rheumatoid arthritis (RA) in adults [1.3.1].
  • Moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in children aged 2 and older [1.3.1].
  • Psoriatic arthritis (PsA) in adults [1.3.3].
  • Ankylosing spondylitis (AS) in adults [1.3.3].
  • Chronic moderate to severe plaque psoriasis (PsO) in adults and children 4 years and older [1.3.4, 1.8.1].

What is the Most Commonly Reported Side Effect of Enbrel?

The most common adverse reactions associated with Enbrel are infections and injection site reactions [1.2.2, 1.9.3]. In clinical trials for rheumatologic conditions, about 37% of patients using Enbrel experienced injection site reactions, compared to 11% in the placebo group [1.2.2]. For plaque psoriasis patients, 15% of adults and 7% of pediatric patients reported these reactions [1.2.2].

These reactions are typically mild to moderate and include symptoms at the spot of the injection such as:

  • Redness [1.2.2]
  • Itching [1.2.2]
  • Pain [1.2.2]
  • Swelling [1.2.2]
  • Bruising or bleeding [1.2.2]

These reactions most often occur within the first month of treatment and tend to decrease in frequency over time [1.2.2]. The average duration is 3 to 5 days, and they generally do not require discontinuation of the medication [1.2.2, 1.5.1].

Other Common and Serious Side Effects

Beyond injection site reactions, the other most common side effect is infection, particularly upper respiratory infections like sinusitis, colds, and the flu [1.2.2, 1.10.3]. While many infections are mild, Enbrel carries a boxed warning from the FDA for the risk of serious infections that can lead to hospitalization or death [1.4.2, 1.4.3]. These include tuberculosis (TB), bacterial sepsis, and invasive fungal infections [1.4.3]. Patients are tested for latent TB before starting Enbrel and monitored during treatment [1.3.1].

Another boxed warning highlights the risk of malignancies, including lymphoma and skin cancers, especially in children and adolescents [1.4.2, 1.4.3]. Other potential serious side effects include:

  • Neurologic reactions like multiple sclerosis or seizures [1.4.3].
  • New or worsening congestive heart failure [1.4.3].
  • Blood disorders such as pancytopenia (low levels of all blood cells) [1.4.2].
  • Reactivation of a previous hepatitis B infection [1.4.3].
  • Allergic reactions [1.4.3].
  • Autoimmune reactions like a lupus-like syndrome [1.4.2].

Managing Enbrel Side Effects

For mild injection site reactions, several strategies can provide relief:

  • Rotate injection sites: Regularly changing where you inject the medication can prevent irritation [1.5.1].
  • Use a cold compress: Applying an ice pack to the area before and after the injection can help numb the skin and reduce swelling and pain [1.5.1, 1.5.2].
  • Allow medication to reach room temperature: Injecting Enbrel cold from the refrigerator can be more painful. Letting it sit at room temperature for 15-30 minutes first is recommended [1.5.5, 1.10.5].
  • Over-the-counter pain relievers: Medications like acetaminophen or ibuprofen can help with pain and swelling, but you should check with a healthcare provider first [1.5.1].

It is crucial to contact a doctor immediately for any signs of a serious infection (e.g., persistent fever, cough, unexplained weight loss) or any other severe symptoms [1.2.3, 1.4.5].

Enbrel vs. Other TNF Blockers: A Side Effect Comparison

Enbrel is one of several TNF inhibitors used to treat autoimmune diseases. Others include Humira (adalimumab) and Remicade (infliximab).

Feature Enbrel (etanercept) Humira (adalimumab) Remicade (infliximab)
Administration Subcutaneous Injection [1.3.1] Subcutaneous Injection [1.6.1] Intravenous Infusion [1.7.2]
Most Common Side Effects Infections, Injection site reactions [1.2.2] Infections, Injection site reactions, headache, rash [1.6.1] Infections, Infusion-related reactions, headache, stomach pain [1.6.1]
Specific Risks Noted in Studies Not associated with increased risk of herpes zoster reactivation compared to monoclonal antibodies [1.7.4] Associated with higher risk of herpes zoster and developing certain autoantibodies [1.7.4] Associated with the greatest risk of serious infections and infusion reactions [1.6.2, 1.7.4, 1.7.5]

Conclusion

While a powerful tool for managing several debilitating autoimmune diseases, Enbrel is not without risks. The most common and mildest side effect is a reaction at the injection site, which affects a significant number of users but is typically manageable and temporary [1.2.2]. However, all patients and physicians must remain vigilant for signs of more serious side effects, particularly severe infections and malignancies, for which Enbrel has FDA boxed warnings [1.4.2]. Open communication with a healthcare provider about any new or worsening symptoms is essential for safely managing treatment with Enbrel.


For more detailed information, you can review the official FDA prescribing information. An authoritative outbound link is not available from the search results provided.

Frequently Asked Questions

The most common side effects of Enbrel are infections (such as upper respiratory infections) and injection site reactions, which include redness, itching, pain, and swelling at the injection spot [1.2.2, 1.10.3].

Injection site reactions from Enbrel typically last for 3 to 5 days. They occur most frequently within the first month of treatment and tend to decrease over time [1.2.2, 1.5.1].

Yes, Enbrel has FDA-issued boxed warnings for an increased risk of serious infections that may lead to hospitalization or death, and for malignancies like lymphoma and other cancers, particularly in children and adolescents [1.4.2, 1.4.3].

You should not start taking Enbrel if you have an active infection, including clinically important localized infections. If you develop a serious infection while on Enbrel, the treatment should be discontinued [1.4.3, 1.10.2].

If you develop a fever or other signs of infection while taking Enbrel, such as a persistent cough or bruising, you should contact your doctor immediately [1.2.3, 1.10.3].

It is recommended that your immunizations be up-to-date before starting Enbrel. You should not receive live vaccines while taking Enbrel. Consult your doctor before getting any vaccines [1.4.5, 1.10.3].

Rarely, treatment with Enbrel has been associated with new onset or worsening of nervous system disorders like multiple sclerosis (MS), seizures, optic neuritis (inflammation of the eye nerves), and Guillain-Barré syndrome [1.4.3, 1.10.4].

To make the injection more comfortable, you can take the Enbrel prefilled syringe or vial out of the refrigerator for about 15-30 minutes to let it reach room temperature before injecting. You can also apply a cold compress to the site before and after the injection [1.5.1, 1.10.5].

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.