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Erelzi Side Effects

Generic name: etanercept

Medically reviewed by Last updated on Apr 18, 2024.

Note: This document contains side effect information about etanercept. Some dosage forms listed on this page may not apply to the brand name Erelzi.

Applies to etanercept: subcutaneous solution.


Subcutaneous route (Solution; Powder for Solution)

Serious Infections: Patients treated with etanercept are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Etanercept should be discontinued if a patient develops a serious infection or sepsis.Reported Infections include: (1) Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patients for latent tuberculosis before etanercept use and during therapy. Initiate treatment for latent infection prior to etanercept use. (2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. (3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.The risks and benefits of treatment with etanercept should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with etanercept, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.Malignancies: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including etanercept.

Subcutaneous route (Solution)

Patients treated with etanercept products are at increased risk for infections, some progressing to serious infections leading to hospitalization or death. These infections have included bacterial sepsis, tuberculosis, invasive fungal and other opportunistic infections, including Legionella and Listeria. Evaluate for latent tuberculosis and treat if necessary prior to initiation of therapy. Discontinue etanercept-szzs if a serious infection or sepsis occurs during treatment. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including etanercept products.

Subcutaneous route (Solution)

Serious InfectionsIncreased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.Etanercept-ykro should be discontinued if a patient develops a serious infection or sepsis during treatment.Perform test for latent TB; if positive, start treatment for TB prior to starting etanercept-ykro.Monitor all patients for active TB during treatment, even if initial latent TB test is negative.MalignanciesLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including etanercept products.

Serious side effects of Erelzi

Along with its needed effects, etanercept (the active ingredient contained in Erelzi) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking etanercept:

More common

Less common

Incidence not known

Other side effects of Erelzi

Some side effects of etanercept may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Incidence not known

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%)

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

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


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]


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]


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

Postmarketing reports: Chest pain[Ref]


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]


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


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]


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

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


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]


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

Postmarketing reports: Hepatitis B reactivation[Ref]


Frequency not reported: Urinary tract infection[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.


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


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


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

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

3. Pharmaceutical Society of Australia (2006) APPGuide online. Australian prescription products guide online.

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.