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Etanercept Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 11, 2023.

Summary

Commonly reported side effects of etanercept include: infection and injection site reaction. Continue reading for a comprehensive list of adverse effects.

Applies to etanercept: parenteral powder for injection, parenteral single-use vial prefilled syringe prefilled auto-injector prefilled auto-injector cartridge.

Warning

    Serious Infections
  • Increased risk of serious infections involving various organ systems and sites that may require hospitalization or result in death; tuberculosis (frequently disseminated or extrapulmonary), invasive fungal infections (may be disseminated), bacterial (e.g., legionellosis, listeriosis) and viral infections, and other opportunistic infections reported.1 129 137 (See Infectious Complications under Cautions.)

  • Carefully consider risks and benefits prior to initiating etanercept therapy in patients with chronic or recurring infections.1 137

  • Evaluate patients for latent tuberculosis infection prior to and periodically during etanercept therapy; if indicated, initiate appropriate antimycobacterial regimen prior to initiating etanercept therapy.1 137

  • Closely monitor patients for infection, including active tuberculosis in those with a negative tuberculin skin test, during and after treatment.1 129 137 Discontinue etanercept if serious infection or sepsis occurs.1 129 Consider empiric antifungal therapy if serious systemic illness occurs in a patient at risk for invasive fungal infections.1 129 137

    Malignancy
  • Lymphoma and other malignancies (some fatal) reported in children and adolescents receiving TNF blocking agents.1 128 138 (See Malignancies and Lymphoproliferative Disorders under Cautions.)

Side effects include:

Adverse effects reported in >5% of patients receiving etanercept include infections and injection site reactions.

For Healthcare Professionals

Applies to etanercept: subcutaneous kit, subcutaneous solution.

Respiratory

Very common (10% or more): Non-upper respiratory infection (38%), upper respiratory infection (29%), rhinitis (12%)

Common (1% to 10%): Pharyngitis, cough, respiratory disorder, sinusitis

Uncommon (0.1% to 1%): Interstitial lung disease (including pneumonitis and pulmonary fibrosis)[Ref]

Immunologic

Very common (10% or more): Infections (including upper respiratory tract infections, bronchitis, cystitis, skin infections)

Uncommon (0.1% to 1%): Serious infections (including pneumonia, cellulitis, septic arthritis, sepsis, parasitic infection)

Rare (less than 0.1%): Tuberculosis, opportunistic infections (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, Legionella), subacute cutaneous lupus erythematosus, discoid lupus erythematosus, lupus-like syndrome

Frequency not reported: Listeria, hepatitis B reactivation

Postmarketing reports: Macrophage activation syndrome, systemic vasculitis, sarcoidosis[Ref]

Nervous system

Very common (10% or more): Headache (17%)

Common (1% to 10%): Dizziness

Rare (less than 0.1%): Seizures, CNS demyelinating events suggestive of multiple sclerosis or localized demyelinating conditions, such as optic neuritis and transverse myelitis

Very rare (less than 0.01%): Peripheral demyelinating events (including Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, multifocal motor neuropathy)

Postmarketing reports: Paresthesias[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, dyspepsia, diarrhea, nausea, vomiting, mouth ulcers, altered sense of taste, esophagitis, gastritis

Uncommon (0.1% to 1%): Dry mouth

Rare (less than 0.1%): Anorexia

Frequency not reported: Intestinal perforation

Postmarketing reports: Inflammatory bowel disease (IBD)[Ref]

Cardiovascular

Rare (less than 0.1%): Worsening of congestive heart failure

Postmarketing reports: Chest pain[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash

Uncommon (0.1% to 1%): Angioedema, urticaria, rash, psoriasiform rash, psoriasis (including new onset or worsening and pustular, primarily palms and soles)

Rare (less than 0.1%): Cutaneous vasculitis (including leukocytoclastic vasculitis), Stevens-Johnson syndrome, erythema multiforme

Very rare (less than 0.01%): Toxic epidermal necrolysis

Postmarketing reports: Angioedema[Ref]

Local

Very common (10% or more): Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)[Ref]

Hematologic

Uncommon (0.1% to 1%): Thrombocytopenia

Rare (less than 0.1%): Anemia, leukopenia, neutropenia, pancytopenia

Very rare (less than 0.01%): Aplastic anemia

Postmarketing reports: Lymphadenopathy[Ref]

Ocular

Uncommon (0.1% to 1%): Uveitis, scleritis

Rare (less than 0.1%): Inflammation, dry eyes[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reactions, autoantibody formation

Uncommon (0.1% to 1%): Systemic vasculitis (including anti-neutrophilic cytoplasmic antibody positive vasculitis)

Rare (less than 0.1%): Serious allergic/anaphylactic reactions (including angioedema, bronchospasm), sarcoidosis

Frequency not reported: Macrophage activation syndrome, worsening of symptoms of dermatomyositis[Ref]

Oncologic

Uncommon (0.1% to 1%): Non-melanoma skin cancers

Rare (less than 0.1%): Lymphoma, melanoma

Frequency not reported: Leukemia, Merkel cell carcinoma, leukemia[Ref]

Hepatic

Rare (less than 0.1%): Elevated liver enzymes, autoimmune hepatitis

Postmarketing reports: Hepatitis B reactivation[Ref]

Genitourinary

Frequency not reported: Urinary tract infection[Ref]

Renal

Renal side effects including pyelonephritis have been reported. At least one case of necrotizing crescentic glomerulonephritis has been reported, in addition to a case of proliferative lupus nephritis.

Other

Common (1% to 10%): Fever, asthenia[Ref]

General

The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever.[Ref]

Frequently asked questions

References

1. Product Information. Enbrel (etanercept). Wyeth-Ayerst Laboratories. 2001.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Pharmaceutical Society of Australia. APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp 2006.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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