Etanercept Side Effects
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.
- 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
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.
Very common (10% or more): Non-upper respiratory infection (38%), upper respiratory infection (29%), rhinitis (12%)
Very common (10% or more): Infections (including upper respiratory tract infections, bronchitis, cystitis, skin infections)
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
Very common (10% or more): Headache (17%)
Common (1% to 10%): Dizziness
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]
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]
Rare (less than 0.1%): Worsening of congestive heart failure
Postmarketing reports: Chest pain[Ref]
Very rare (less than 0.01%): Toxic epidermal necrolysis
Postmarketing reports: Angioedema[Ref]
Uncommon (0.1% to 1%): Thrombocytopenia
Very rare (less than 0.01%): Aplastic anemia
Uncommon (0.1% to 1%): Uveitis, scleritis
Rare (less than 0.1%): Inflammation, dry eyes[Ref]
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
Uncommon (0.1% to 1%): Non-melanoma skin cancers
Rare (less than 0.1%): Lymphoma, melanoma
Rare (less than 0.1%): Elevated liver enzymes, autoimmune hepatitis
Postmarketing reports: Hepatitis B reactivation[Ref]
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.
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]
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More about etanercept
- Check interactions
- Compare alternatives
- Reviews (320)
- Dosage information
- During pregnancy
- Support group
- Drug class: antirheumatics
- Etanercept drug information
- Etanercept-szzs (Advanced Reading)
- Etanercept-ykro (Advanced Reading)
- Etanercept Auto-Injectors
- Etanercept Prefilled Syringes
Related treatment guides
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.
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.