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Etanercept Side Effects

In Summary

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

For the Consumer

Applies to etanercept: subcutaneous powder for solution, subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by etanercept. In the event that any of these side effects do occur, they may require medical attention.

Severity: Major

You should check with your doctor immediately if any of these side effects occur when taking etanercept:

More common
  • Chills
  • cough
  • fever
  • sneezing
  • sore throat
Less common
  • Congestion in the chest
  • depression
  • fast heartbeat
  • frequent or painful urination
  • itching, pain, redness, or swelling on the skin
  • joint or muscle stiffness, tightness, or rigidity
  • shortness of breath
  • stomach discomfort or pain
Incidence not known
  • bladder pain
  • blistering, peeling, or loosening of the skin
  • bloody, black, or tarry stools
  • blue-yellow color blindness
  • blurred vision
  • chest discomfort or pain
  • cloudy or bloody urine
  • confusion
  • convulsions
  • darkened urine
  • decreased urine output
  • decreased vision
  • diarrhea
  • difficult, irregular, troubled, or labored breathing (or difficulty in breathing gets worse)
  • difficulty with moving
  • dilated neck veins
  • double vision
  • extreme fatigue
  • eye pain
  • feeling sad or empty
  • fruit-like breath odor
  • general feeling of discomfort, illness, or weakness
  • generalized pain
  • heartburn or indigestion
  • high blood pressure
  • inability to move the arms, legs, or facial muscles
  • irregular heartbeat
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness
  • loss of consciousness
  • muscle tenderness
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, redness, or swelling in the arm or leg
  • problems with bowel or bladder function
  • red skin lesions, often with a purple center
  • red, scaling, or crusted skin
  • severe and continuing nausea
  • severe numbness, especially on one side of the face or body
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the face, fingers, feet, or lower legs
  • tenderness
  • tightness in the chest
  • trouble concentrating
  • trouble sleeping
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • weight loss
  • wheezing
  • yellow eyes or skin

Severity: Minor

Some of the side effects that can occur with etanercept may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abdominal or stomach pain
  • loss of energy or weakness
  • nausea and vomiting
  • pain or burning in the throat
  • redness or itching, pain, or swelling at the site of injection (under the skin)
  • runny or stuffy nose
Less common
  • Bumps below the skin
  • depression
  • dry eyes
  • dry mouth
  • hair loss or thinning
  • heartburn
  • irritation or soreness of the mouth
  • itching, redness, or tearing of the eye
  • skin rash
Incidence not known
  • Altered sense of taste
  • burning, crawling, itching, numb, prickling, “pins and needles”, or tingling feelings
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • loss of appetite
  • sweating
  • weight gain

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]

References

1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Enbrel (etanercept)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

Not all side effects for etanercept may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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