"The US Food and Drug Administration (FDA) has approved a supplemental biologics license application for use of etanercept (Enbrel, Amgen) in children aged 4 years and older with chronic moderate-to-severe plaque psoriasis who are candidate"...
Enbrel Patient Information Including Side Effects
Brand Names: Enbrel, Enbrel Prefilled Syringe, Enbrel SureClick
Generic Name: etanercept (Pronunciation: ee TAN er sept)
- What is etanercept (Enbrel)?
- What are the possible side effects of etanercept (Enbrel)?
- What is the most important information I should know about etanercept (Enbrel)?
- What should I discuss with my healthcare provider before using etanercept (Enbrel)?
- How should I use etanercept (Enbrel)?
- What happens if I miss a dose (Enbrel)?
- What happens if I overdose (Enbrel)?
- What should I avoid while using etanercept (Enbrel)?
- What other drugs will affect etanercept (Enbrel)?
- Where can I get more information?
What is etanercept (Enbrel)?
Etanercept works by decreasing a certain protein produced by the immune system. The immune system helps the body fight infections. In people with autoimmune disorders, the immune system mistakes the body's own cells for invaders and attacks them.
Etanercept is used to treat the symptoms of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, and to prevent joint damage caused by these conditions. It is also used to treat plaque psoriasis in adults and polyarticular juvenile idiopathic arthritis in children who are at least 2 years old.
Etanercept may also be used for purposes not listed in this medication guide.
What are the possible side effects of etanercept (Enbrel)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using etanercept and call your doctor right away if you have any of these symptoms of lymphoma:
- fever, night sweats, weight loss, tiredness;
- feeling full after eating only a small amount;
- pain in your upper stomach that may spread to your shoulder;
- easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Stop using etanercept and call your doctor at once if you have any of these other serious side effects:
- signs of infection (fever, chills, sore throat, body aches, confusion, neck stiffness, flu symptoms);
- shortness of breath with swelling, rapid weight gain;
- chest pain, ongoing cough, coughing up mucus or blood;
- signs of skin infection such as itching, swelling, warmth, redness, or oozing;
- black, bloody, or tarry stools;
- changes in mood or personality (in children);
- numbness, burning, pain, or tingly feeling;
- joint pain or swelling with fever, swollen glands, muscle aches, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or
- patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).
Less serious side effects may include:
- mild nausea, vomiting, mild diarrhea, mild stomach pain;
- runny or stuffy nose, cold symptoms; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Enbrel (etanercept) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about etanercept (Enbrel)?
Some people using etanercept have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using etanercept or similar medicines to treat Crohn's disease or ulcerative colitis.
Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
Etanercept can lower blood cells that help your body fight infections. Your blood may need to be tested often. Serious and sometimes fatal infections may occur during treatment with etanercept. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or if you feel short of breath.
Children using this medication should be current on all childhood immunizations before starting treatment with etanercept.
Additional Enbrel Information
- Enbrel Drug Interactions Center: etanercept subq
- Enbrel Side Effects Center
- Enbrel Overview including Precautions
- Enbrel FDA Approved Prescribing Information including Dosage
Enbrel - User Reviews
Enbrel User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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