Etanercept Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Feb 18, 2025.

Applies to etanercept: subcutaneous solution.

Precautions

It is very important that your doctor check you or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Your body's ability to fight infection may be reduced while you are being treated with etanercept. It is very important that you call your doctor at the first signs of any infection. Check with your doctor right away if you or your child have fever, chills, cough or hoarseness, flu-like symptoms, lower back or side pain, painful or difficult urination, or unusual tiredness or weakness.

While you are being treated with etanercept, do not have any immunizations (vaccines) without your doctor's approval. Your child's vaccines need to be current before he or she begins using etanercept. Be sure to ask your child's doctor if you have any questions about this.

This medicine may cause serious allergic reactions including anaphylaxis. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.

You or your child will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

This medicine may increase your risk of having a lupus-like syndrome or autoimmune hepatitis. Check with your doctor right away if you or your child have a fever or chills, a general feeling of discomfort, illness, or weakness, light-colored stools, nausea, vomiting, upper right-sided abdominal or stomach pain, or yellow eyes and skin.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, or white spots in your mouth or lips, or unusual tiredness or weakness.

Serious nervous system problems, including Guillain-Barré syndrome, multiple sclerosis, demyelinating disease, and seizures have occurred rarely in people using this medicine. Talk with your doctor if you have concerns about this.

A small number of people (including children and teenagers) who have used this medicine have developed certain types of cancer (eg, leukemia, lymphoma, skin cancer). Some patients also developed a rare type of cancer called lymphoma. Talk with your doctor if you or your child have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.

Check with your doctor right away if you have trouble breathing, swelling of the face, fingers, feet, or lower legs, or sudden weight gain. These may be signs of a heart condition called congestive heart failure (CHF).

Do not take other medicines unless they have been discussed with your doctor. This includes abatacept (Orencia®), anakinra (Kineret®), or cyclophosphamide (Cytoxan®). Using any of them together with this medicine may increase your risk of having serious side effects.

Serious side effects of etanercept

Along with its needed effects, etanercept 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:

Other side effects of etanercept

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:

For healthcare professionals

Applies to etanercept: subcutaneous kit, subcutaneous solution.

General adverse events

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]

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]

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]

See also:

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Further information

Etanercept side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer