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: subcutaneous solution.

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:

More common

• Chills
• cough
• fever
• sneezing
• sore throat

Less common

• Chest tightness
• depression
• fast heartbeat
• frequent or painful urination
• itching, pain, redness, or swelling on the skin
• joint or muscle stiffness, tightness, or rigidity
• 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
• dark urine
• decreased urine output
• decreased vision
• diarrhea
• difficult, irregular, troubled, or labored breathing (or difficulty with 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
• high blood pressure
• inability to move the arms, legs, or facial muscles
• indigestion
• 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
• seizures
• severe and continuing nausea
• severe numbness, especially on one side of the face or body
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, fingers, feet, or lower legs
• tenderness
• 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
• yellow eyes or skin

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:

More common

• Loss of energy or weakness
• nausea
• pain or burning in the throat
• redness or itching, pain, or swelling at the injection site (under the skin)
• runny or stuffy nose
• stomach pain
• vomiting

Less common

• Bumps below the skin
• dry eyes
• dry mouth
• hair loss or thinning
• 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]