Safety Information and Side Effects of ENBREL
Common Side Effects of Enbrel® (etanercept)
- The most common side effects of ENBREL are infections and injection site reactions.
- Infections caused by viruses, fungi, or bacteria have happened in patients taking ENBREL and include the common cold, sinusitis, and the flu.
- Injection site reactions are mild to moderate (redness, itching, pain, swelling, bleeding, and bruising) and usually go away within 3 to 5 days. If you have pain, redness, or swelling around the injection site that doesn’t go away or gets worse, call your doctor.
Serious Side Effects of ENBREL
- Risk of infection. ENBREL can lower the ability of your immune system to fight infections. Some people have serious infections while taking ENBREL. These infections include tuberculosis (TB), and infections caused by viruses, fungi, or bacteria that spread throughout their body. Some people have died from these infections.
- Risk of cancer.
- There have been cases of unusual cancers in children and teenage patients who started using TNF blocking agents at less than 18 years of age.
- For children, teenagers, and adults taking TNF blocker medicines, including ENBREL, the chances of getting lymphoma or other cancers may increase.
- People with rheumatoid arthritis or psoriasis, especially those with very active disease, may be more likely to get lymphoma.
- Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ENBREL.
- Nervous system problems. Rarely, people who use TNF blocker medicines have developed nervous system problems such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes.
- Blood problems. Low blood counts have been seen with other TNF blocker medicines. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include fever, bruising or bleeding very easily, or looking pale.
- Heart failure including new heart failure or worsening of heart failure you already have. New or worsening heart failure can happen in people who use TNF blocker medicines, like ENBREL.
- Psoriasis. Some people using ENBREL developed new psoriasis or worsening of psoriasis they already had.
- Allergic reactions. Serious allergic reactions can happen to people who use TNF blocker medicines.
- Autoimmune reactions, including:
- Lupus-like syndrome. Symptoms include a rash on your face and arms that gets worse in the sun.
- Autoimmune hepatitis. Liver problems can happen in people who use TNF blocker medicines, including ENBREL. These problems can lead to liver failure and death.
Contact your doctor right away if you begin to experience any of the above symptoms or for medical advice about side effects.
These are not all the side effects associated with ENBREL. Please see Prescribing Information, Important Safety Information, and Medication Guide for complete details about ENBREL.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088.
"I mentioned ENBREL to my doctor, and he agreed that it was a good choice for me." Jack S., ENBREL user since 2004. Your results may vary.
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