Known Side Effects and Uses of Enbrel (etanercept), treatment of Autoimmune Disorders

What is Enbrel?

Enbrel (etanercept), also known as tumor necrosis factor (TNF) blocker is a description medicine used in the treatment of certain autoimmune disorders. An autoimmune disorder is a condition where the immune system attacks parts of the body. Etanercept works by decreasing the protein (TNF), produced by the immune system in order to help one’s body fight infections. But the immune system of people with autoimmune disorder generates too much TNF that causes it to mistakenly attack healthy cells.

Enbrel has also been associated with the treatment of ankylosing spondylitis, psoriatic arthritis, or rheumatoid arthritis, and also in the prevention of joint damage caused by these conditions.

Enbrel (etanercept) is also effective in the treatment of polyarticular juvenile idiopathic arthritis in adolescent and children who are 2 years and older.

Enbrel has also been said to be used to treat plaque psoriasis in children who are 4 years and older, and adults.


Important Information

Enbrel is a drug that affects the immune system.

It may lower the ability of the immune system to fight infections. This has resulted in serious infections in patients taking Enbrel. Such serious infections comprise of infections caused by fungi, viruses, and bacteria that have spread rapidly throughout the body or tuberculosis (TB). These infections have resulted in the death of some of these patients. Your doctor or health care provider should test you for TB prior to initiating Enbrel therapy and monitor patients closely for TB before, during, and after Enbrel therapy, even if they have tested negative for TB.

There have been some cases of unusual cancers reported in children and teenage patients who started using tumor necrosis factor (TNF) blockers before the age of 18 years. Also, for some children, teenagers, and adults being given TNF blockers (such as Enbrel), the potential risk of them developing lymphoma or other cancers may increase. Patients with Rheumatoid Arthritis(RA) may be more likely to get lymphoma.

Prior to Enbrel treatment, inform your health care provider if:

  • You have any history or an existing medical condition
  • You are taking any medicines, including over the counter and herbal medicines
  • You are being treated for, think you have, are prone to or have signs of infection.
  • You do not have to take Enbrel if you have any kind of infection, unless otherwise stated by your health care provider that it’s okay
  • Have any sores or open cuts
  • Have HIV, diabetes, or a weak immune system
  • You have come in contact or close contact with someone who has had TB or have TB
  • You have ever traveled to, were born in, or lived in countries where there is a high risk of contracting TB. Ask your doctor if you are in any doubt
  • You have ever traveled to, live in, or have lived in certain parts of the country (like, the Mississippi River valleys, the Southwest, or Ohio) where there is a higher risk for certain kinds of fungal infections, including histoplasmosis. Such infections can develop or become more serious if you take Enbrel.
  • You have or have had hepatitis B
  • You have or have had heart failure
  • You develop symptoms like bruising, bleeding, paleness, or persistent fever while taking Enbrel
  • You are taking certain medicines such as Cytoxan (cyclophosphamide), Kineret(anakinra), or Orencia (abatacept)
  • You are taking anti-diabetic medicines
  • You have, have a history, or develop a serious nervous disorder, including numbness or tingling, seizures, or any disease that affects the nervous system such as Guillain-Barré syndrome or multiple sclerosis
  • You are scheduled for surgery
  • You are scheduled for or have recently received any vaccines. Patients on Enbrel therapy should not receive live vaccines. All vaccines should be brought up-to-date before initiating Enbrel.
  • You are allergic to latex or rubber
  • You are planning to become pregnant, you are pregnant, or you are breastfeeding
  • You have been around someone with chickenpox


Side effects of Enbrel

There have been some recorded adverse reactions associated with Enbrel intake. While some of these Enbrel side effects are severe and require immediate medical help, others are less severe. Also, some of the side effects of Enbrel are more common or more frequent as compared to others.

Severe but less common Side Effects Enbrel

Call the emergency medical help line once you notice any sign of an allergic reaction after you start taking Enbrel. Some of these signs include

  • Difficult breathing,
  • hives, and
  • swelling of the throat, lips, mouth, eyes, face, or tongue

If you notice signs or symptoms of an infection such as cough, chills, body aches, skin sores or redness (rash), fever, burning when you urinate, weight loss, diarrhea, shortness of breath, feeling very tired or weak, and coughing of blood, you should treat it as a matter of urgency and get to your doctor for immediate help. These are indications of a serious or sometimes fatal infection that develops, especially at the initiation of the Enbrel treatment.

Also get to your doctor as soon as you notice signs or symptoms of any of the following side effects of Enbrel:

  • Liver problems: Including vomiting, loss of appetite, tiredness, upper stomach pain, and jaundice (seen by yellowing of the eyes or skins)
  • Blood problems: Such as pale skin, easy bruising or bleeding, and fever
  • Nerve problems: Including tingling or numbness, feeling weak in the legs or arms, and problems with vision (blurred vision)
  • Lupus-like syndrome: Consisting of chest discomfort, feeling short of breath, joint pain or swelling, skin rash on the chest or arms (this condition grows worsens in sunlight)
  • Worsening or new psoriasis: Comprising of raised bumps that are filled with pus, and skin redness or patches
  • Lymphoma: Such as cough, fever, loss of appetite, feeling constant weak or tired, night sweat, and weigh loss
  • Heart failure: Consisting of sign such as rapid weight gain, feeling of shortness of breath, and swelling of the ankles or feet
  • Tuberculosis: Comprising of signs and symptoms like night sweats, loss of appetite, fever, cough, feeling constantly weak or tired, and weight loss


Common Enbrel Side Effects

Some of these side effects Enbrel occur more frequently. However, they’re easily disappearing as the body becomes used to the medicine or following withdrawal or discontinuation of Enbrel therapy. Your health care provider or pharmacist may be able to inform you about the various ways to prevent or reduce some of these side effects Enbrel. If any of these side effects are bothersome, continue, or if you have any doubt about them, talk with your health care provider. Some of these Enbrel side effects comprise the following:

  • Itching, pain, swelling, or redness at the spot or site where the drug was injected.
  • Cold symptoms, including stuffy nose, sore throat, and sneezing
  • Headache.
  • Abdominal or stomach pain
  • Nausea and vomiting
  • Pain or burning in the throat
  • Loss of energy or weakness
  • Itching, redness, pain, or swelling at the site of the injection (under the skin)
  • Stuffy or runny nose
  • Depression
  • Bumps below the skin
  • Dry mouth and eyes
  • Thinning or hair loss
  • Heartburn
  • Soreness or irritation of the mouth
  • Redness, tearing, or itching of the eye
  • Skin rash
  • Crawling, itching, prickling, numb, burning, or tingling feeling
  • Altered sense of taste
  • Feeling faint, lightheaded, or dizzy
  • Redness or flushing of the skin, especially at the neck and face
  • Weight gain
  • Sweating
  • Loss of appetite

There are some other side effects that have been recorded in subjects being treated with Enbrel whose incidence have been fully explained. However, they are recorded as some of the side effects Enbrel. These consist of:

Incidence not known:

  • Bladder pain
  • bloody, black, or tarry stools
  • blistering, peeling, or loosening of the skin
  • blue-yellow color blindness
  • chest discomfort or pain
  • blurred vision
  • difficulty with moving
  • dilated neck veins
  • cloudy or bloody urine
  • convulsions
  • confusion
  • decreased vision
  • diarrhea
  • darkened urine
  • decreased urine output
  • difficult, labored, troubled, or irregular breathing
  • eye pain
  • feeling sad or empty
  • double vision
  • extreme fatigue
  • fruit-like breath odor
  • general feeling of discomfort, illness, or weakness
  • inability to move the face, legs, or arm muscles
  • irregular heartbeat
  • generalized pain
  • heartburn or indigestion
  • high blood pressure
  • joint or muscle pain
  • lightheadedness
  • large, hive-like swelling of the eyelids, feet, hands, face, lips, throat, tongue, legs, or sex organs
  • loss of consciousness
  • pain or discomfort in the neck, arms, back, or jaw,
  • muscle tenderness
  • pain, redness, or swelling in the arm or leg
  • red skin lesions, often with a purple center
  • bowel or bladder problems
  • sore throat
  • severe and continuing nausea
  • red, scaling, or crusted skin
  • severe numbness, especially on one side of the face or body
  • swelling of the feet, lower legs, face, or fingers,
  • sores, ulcers, or white spots on the lips or in the mouth
  • tenderness
  • trouble concentrating
  • tightness in the chest
  • trouble sleeping
  • unusual bleeding or bruising
  • yellow eyes or skin
  • unexplained weight loss
  • unusual tiredness or weakness
  • weight loss
  • vomiting of blood

Bear in mind that this list is not a complete list of all the side effects of Enbrel. Call your health care provider for advice about the side effects of Enbrel. You can also report other side effects of Enbrel to FDA at 1-800-FDA-1088.


Dosage of Enbrel

Enbrel is taken through injection under the skin, at a rate of one injection per week.

Enbrel is distributed as a prefilled syringe, a vial, or an automatic device.

You will be directed by your doctor or health care provider about the proper way to take this injection.

Make sure you follow the advice and prescription of your doctor

Also, carefully read the instruction on how to take this drug from the instruction leaflet provided with this drug before taken this drug.

 Never take less or more of the medicine than is prescribed

Vials of Enbrel may contain more than one complete dose of this medicine. In which case, make sure you place the remaining drug in the refrigerator immediately, no later than four hours after you mixed it.

You can store vials of Enbrel for as long as 2 weeks (14 days) after mixing it, if it contains enough medicine for a complete dose.

Never combine two or more vials to make a complete dose.

If your Enbrel comes as an automatic injection device or prefilled syringe, use each device or syringe just once and inject all of the solution. Avoid using any extra solution again.

Remember to always make sure the liquid is clear and colorless and verify the expiration date before injecting the Enbrel.

Enbrel Overdose

Once you suspect an over dosage of Enbrel, you should contact the emergency health services or poison control center immediately.

Missed Dose of Enbrel

If you miss a dose of Enbrel, make sure you take it as soon as you remember.

However, if it's near the time for your next dose or about 4 days gone skip the missed dose and continue with your regular dosing schedule.

Never double dose or take an extra dose to make up for a missed one.


Uses of Enbrel

Rheumatoid Arthritis (RA): Enbrel is used in the treatment of rheumatoid arthritis. It is effective in reducing the symptom of this disease, inhibiting the advancement of structural damage, inducing major clinical response, and improving physical function in subjects with moderate to severely active RA. In which case, Enbrel may be used alone or in combination with MTX (methotrexate).

The usual prescribe adult dose of Enbrel for RA is 50 mg injected once a week (higher doses not recommended).

Psoriatic Arthritis (PsA): Enbrel is used alone or in combination with methotrexate (MTX) in subject with psoriatic arthritis to inhibit the progression of structural damage of the active arthritis, improve physical function in the subjects with PsA, and reduce symptoms.

The usual adult dose of Enbrel in psoriatic arthritis is 50 mg injected once a week (higher doses not recommended).

Ankylosing Spondylitis (AS): Enbrel is used alone to reduce the symptoms or effects of autoimmune disorder in patients with active ankylosing spondylitis (AS).

Plaque Psoriasis (PsO): One of the uses of Enbrel is in the treatment of moderate to chronic Plaque Psoriasis in patients who are 18 years and older.

Initial dose: The initial dose of Enbrel is 50 mg injected subcutaneously twice a week (administered either 3 or 4 days apart) for the first 3 months. A lower initial dose of 25 to 50 mg injected once a week has shown also to be effective.

For patients weighing less than 63 kg, a dose of 0.8 mg/kg once a week is recommended

Maintenance dose: A maintenance dose of Enbrel of 50 mg injected subcutaneously once a week.

Pediatric dose for Plaque Psoriasis:

Enbrel uses also include subject should be at least 4 years, suffering from chronic moderate to severe plaque psoriasis (PsO) and who are subjected to phototherapy or systemic therapy.

  • Less than 63 kg – 0.8 mg/kg once a week
  • Greater than 63 kg – 50 mg once a week
  • Maximum dose – 50 mg once a week

Idiopathic Arthritis: This is just one of the Enbrel uses, in reducing symptoms of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in subjects who are at least 2 years.

Dosage of Enbrel:

  • Less than 63 kg – 0.8 mg/kg once a week
  • Greater than 63 kg – 50 mg once a week
  • Maximum dose – 50 mg once a week


Use in Specific Populations


There are no significant evidence and well controlled studies carry out in pregnant women. However, etanercept has been detected in cord blood at the time of delivery. This indicates that etanercept passed through the placenta in small amounts. However, no harm to the fetus has been recorded.

Enbrel should therefore only be used during pregnancy only if its benefits out weight any adverse reaction.

Nursing Mothers

Limited data from clinical studies show that etanercept is passed in small amount in human milk and minimal amount is absorbed by a breastfed infant. Thus, caution should be taken when the Enbrel is given to a breastfeeding woman. Enbrel should only be given after the health benefits and development of breastfeeding have been considered along with the mother’s clinical record and any potential Enbrel side effects on the breastfed child from the medicine or from the underlying maternal condition.

Pediatric Use

Studies of the uses of Enbrel in children younger than 2 years of age with JIA and also children younger than 4 years of age with PsO have not been fully recorded.

Studies on the Enbrel uses has been documented in 69 children, age 2 to 17 years, with moderate to severe active polyarticular JIA and also in 211 pediatric patients, age 4 to 17 years, with moderate to severe PsO.

The effects of Enbrel to infant exposure in the uterus are not known. Also unknown is the safety of administering live or live attenuated vaccines in exposed infants.

Benefits and risks should be considered at all times prior to initiating the live or live-attenuated vaccines to expose infants.

Geriatric Use

In the studies of Enbrel in geriatric patients (patients age 65 years and older), there were no overall significant differences in safety or effectiveness observed between younger patients and these geriatric patients. But, the number of geriatric PsO patients tested is too small to be able to draw a definite conclusion whether they respond differently from younger patients. However, because of a higher incidence of infections in the older population, caution should be taken while treating the elderly.

Use in Diabetics

There have been a hand full of reports of hypoglycemia occurring following the initiation of Enbrel therapy in subjects receiving diabetes drugs. This has resulted in the need for a reduction in anti-diabetic drug in some of the patients.


Precautions with Enbrel

Serious Infections

There is increased risk of developing some serious infections involving different organs, and systems in patients treated with Enbrel. Some of these infections are reported to have led to hospitalization or death of these patients.

Other opportunistic infections cause by bacteria, invasive fungal, mycobacterial, parasitic, opportunistic pathogens, or viral consisting of candidiasis, histoplasmosis, coccidioidomycosis, blastomycosis, legionellosis, listeriosis, aspergillosis, tuberculosis, and pneumocystosis have been reported with TNF blockers.

Enbrel should not be given to patients with an active infection, such as those with localized infection. Geriatric (people older than 65) patients taking concomitant immunosuppressants (like corticosteroids or methotrexate), and/or with co-morbid conditions, may be at greater risk of infection. The benefits and risks of treatment should be considered before administering Enbrel in patients with:

  • Chronic or recurrent infection;
  • Any underlying conditions that may predispose them to infection, like poorly controlled or advanced diabetes 
  • A patient who has a history of any opportunistic infection
  • Who have in one way or the other been exposed to tuberculosis;
  • A history to have resided or traveled in an area of endemic Mycoses or endemic Tuberculosis, such as blastomycosis, and coccidioidomycosis;

Patients receiving Enbrel therapy should be closely monitored for the signs and symptoms of infection during and after treatment.

Enbrel should immediately be discontinued if any, subject is suspected or developed a serious infection or sepsis. If any patient develops a new infection during Enbrel therapy, he should be closely monitored, undergo an immediate and complete diagnostic appropriate for a patient whose immune system has been compromised or affected, and appropriate antimicrobial therapy should be initiated.


Cases of chronic and acute leukemia have been reported in association with postmarketing use of Enbrel (TNF-blocker) in rheumatoid arthritis and other indications. Even without a TNF-blocker therapy, subjects with rheumatoid arthritis may be at higher risk as compared to the general population for the development of leukemia.


There have been reports of cases of new tuberculosis or the recurrence of tuberculosis infections in some patients receiving Enbrel therapy. This includes patients who have previously received treatment for active or latent tuberculosis. Postmarketing tuberculosis reactivation has also been reported in cases of Enbrel usage.

Patients should be examined for tuberculosis risk factors and also for latent infection before initiating Enbrel and periodically during therapy.

Anti-tuberculosis therapy may also be considered before initiating Enbrel administration in patients with a history of active or latent tuberculosis and in patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection.

Tuberculosis should be considered in subjects who develop a new infection during Enbrel therapy, especially in those who have had close contact with a person with active tuberculosis, or who have recently or previously traveled to regions or countries with a high prevalence of tuberculosis.

Invasive Fungal Infections

Some cases of serious and even fatal fungal infections, such as histoplasmosis, have been reported with Enbrel therapy. For patients with a history to have travel or reside in regions where Mycoses are common, invasive fungal infection should be considered or suspected and appropriate anti-fungal therapy initiated while diagnoses is being carried out follow, if they develop a serious systemic illness.


Taking Enbrel may result in the development of autoimmune hepatitis or a lupus-like syndrome and in the production of autoantibodies, which may disappear following the discontinuation of Enbrel. If a subject develops symptoms and diagnosis suggests autoimmune hepatitis or a lupus-like syndrome following therapy with Enbrel, treatment should be withdrawn immediately and the patient should be carefully evaluated.


Enbrel mediates modulates and inflammation, cellular immune responses. Enbrel, affect (compromised or reduces) host defenses against infections. The effect of Enbrel on the development and course of malignancies has not been fully documented.

A disclaimer: This article is created as a guide, to provide you with information about certain aspects of Enbrel as an autoimmune medication and should for no reason be given preference over a doctor’s or pharmacist advice or description. 

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