Enbrel Side Effects
Generic Name: etanercept
Note: This document contains side effect information about etanercept. Some of the dosage forms listed on this page may not apply to the brand name Enbrel.
Common side effects of Enbrel 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
Subcutaneous route (Solution; Powder for Solution)
Patients treated with etanercept 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 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.
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.
Side effects requiring immediate medical attention
Along with its needed effects, etanercept (the active ingredient contained in Enbrel) 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:
- sore throat
- Congestion in the chest
- 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
- dark urine
- decreased urine output
- decreased vision
- 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
- 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
- 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
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the face, fingers, feet, or lower legs
- 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
- yellow eyes or skin
Side effects not requiring immediate medical attention
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:
- Loss of energy or weakness
- 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
- 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
- weight gain
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
Very common (10% or more): Infections (including upper respiratory tract infections, bronchitis, cystitis, skin infections)
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
Very common (10% or more): Headache (17%)
Common (1% to 10%): Dizziness
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]
Uncommon (0.1% to 1%): Dry mouth
Rare (less than 0.1%): Anorexia
Frequency not reported: Intestinal perforation
Rare (less than 0.1%): Worsening of congestive heart failure
Postmarketing reports: Chest pain[Ref]
Common (1% to 10%): Pruritus, rash
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
Very rare (less than 0.01%): Aplastic anemia
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
Uncommon (0.1% to 1%): Non-melanoma skin cancers
Rare (less than 0.1%): Lymphoma, melanoma
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]
1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ():
2. "Product Information. Enbrel (etanercept)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
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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.
More about Enbrel (etanercept)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
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- En Español
- 240 Reviews
- Drug class: antirheumatics
- FDA Alerts (6)
- FDA Approval History
- Enbrel (Advanced Reading)
- Enbrel (Etanercept Prefilled Syringes)
- Enbrel (Etanercept Vials)
- Enbrel SureClick