Etanercept Side Effects
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
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]
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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.