Enbrel Side Effects

Black Box Warning

In addition to the Enbrel side effects mentioned below, people who use Enbrel have a higher risk of developing serious infections that may lead to hospitalization or even death. Note though, that most of the people who developed these infections were also taking other medications known as immunosuppressants, and they include such medications as methotrexate or corticosteroids.

Enbrel Side Effects
High Frequency of Occurrence

• Development of autoantibodies - in particular, users developed antinuclear antibodies (ANA), anti-double-stranded DNA antibodies and anticardiolipin antibodies. The development of antibodies may indicate that one could develop an autoimmune disease.
• Immune system reactions
• Infections - including upper respiratory infections, pyelonephritis (i.e. kidney infection/inflammation), bronchitis, septic arthritis, abdominal abscess, cellulitis (i.e. skin infection), osteomyelitis (i.e. bone infection), wound infection, pneumonia, foot abscess, leg ulcer, diarrhea, sinusitis, and sepsis (i.e. an infection in the blood), gastroenteritis (i.e. infection of the stomach and intestines), tuberculosis
• Injection site reactions - includes mild to moderate erythema (i.e. redness) and/or itching, pain or swelling; bleeding and bruising at the injection site
• Malignancies (Cancers) - including lymphomas such as non-Hodgkin's lymphoma, colon cancer, breast cancer, lung cancer, prostate cancer, non-cutaneous solid tumors, basal cell skin cancer and squamous cell skin cancer

Enbrel Side Effects
Medium Frequency of Occurrence

• Abdominal pain
• Alopecia
• Asthenia - general weakness/loss of strength
• Cough
• Dizziness
• Dyspepsia
• Headache
• Mouth ulcer
• Nausea
• Peripheral edema - swelling in the arms and legs
• Pharyngitis - sore throat
• Rash
• Respiratory disorder
• Rhinitis - runny nose
• Sinusitis - sinus infection/inflammation
• Vomiting

Enbrel Side Effects
Low Frequency of Occurrence

• Appendicitis
• Bursitis - inflammation of the bursae
• Cerebral ischemia - insufficient blood flow to the brain
• Cholecystitis - inflammation of the gallbladder
• Deep vein thrombosis
• Depression
• Dyspnea - difficulty breathing
• Gastrointestinal bleeding
• Heart failure
• Hypertension - high blood pressure
• Hypotension - low blood pressure
• Kidney calculus - kidney stones
• Lymphadenopathy - enlarged lymph nodes ("swollen glands")
• Membranous glomerulonephropathy - a type of kidney disorder
• Multiple sclerosis
• Myocardial infarction
• Myocardial ischemia
• Normal pressure hydrocephalus - an increase in pressure in the brain caused by excessive fluid in the brain
• Pancreatitis - inflammation of the pancreas
• Polymyositis - weakness and inflammation of the muscles
• Pulmonary embolism - blood clot in the lungs
• Sarcoidosis
• Seizure
• Stroke
• Thrombophlebitis - a blood clot in a vein
• Worsening psoriasis

Adverse in Children with Juvenile Idiopathic Arthritis (JIA)

Frequently Occur:

• Abdominal pain
• Headache
• Nausea
• Vomiting

Sometimes Occur:

• Cutaneous ulcer - skin ulcer
• Depression/personality disorder
• Esophagitis/gastritis
• Gastroenteritis
• Group A streptococcal septic shock
• Soft tissue and post-operative wound infection
• Type 1 diabetes mellitus
• Varicella - chicken pox

Post-Marketing Enbrel Side Effects

The following Enbrel side effects were reported AFTER Enbrel was approved and being used by the general population. You should note though that they were reported voluntarily by folks in the general population so there is therefore no way to determine how often they occur or if there is even really a true connection between them and Enbrel.

Adults

• Adenopathy - enlarged/swollen lymph nodes
• Altered sense of taste
• Anemia
• Angioedema
• Anorexia - loss of appetite
• Aplastic anemia - failure of the bone marrow to produce blood cells
• Autoimmune hepatitis
• Central nervous system events suggestive of multiple sclerosis or isolated demyelinating conditions such as transverse myelitis inflammation of the nerves of the spinal cord or optic neuritisinflammation of the optic nerve i.e. the nerve that (simply put) connects the eye to the brain
• Chest pain
• Cutaneous vasculitis - inflammation of the blood vessels in the skin
• Diarrhea
• Dry eyes
• Dry mouth
• Dyspnea - difficulty breathing
• Erythema multiforme - red, blistery rash
• Fatigue
• Fever
• Flu syndrome
• Generalized pain
• Interstitial lung disease - inflammation/swelling of the lungs that can cause scarring
• Intestinal perforation
• Joint pain
• Leukopenia - a type of low white blood cell count
• Lupus-like syndrome with manifestations including rash consistent with subacute or discoid lupus
• Neutropenia a type of low white blood cell count
• New-onset congestive heart failure
• Ocular inflammation - eye inflammation
• Pancytopenia abnormally low levels of all types of blood cells
• Paresthesias - numbness or tingling of the skin
• Pruritus - itching
• Pulmonary disease - lung disease
• Seizures
• Stevens-Johnson syndrome
• Stroke
• Subcutaneous nodules - lump/lesion/mass under the skin
• Thrombocytopenia - low blood platelet count
• Toxic epidermal necrolysis - blistering/peeling of the top layer of the skin (can be life-threatening)
• Urticaria - hives; itchy rash
• Vasodilation (flushing)
• Weight gain
• Worsening of prior lung disorder

Children

• Abscess with bacteremia - abscess with a bacterial infection of the blood
• Coagulopathy - a condition that affects the normal clotting of the blood
• Cutaneous vasculitis - inflammation of the blood vessels in the skin
• Optic neuritis - inflammation of the optic nerve i.e. the nerve that (simply put) connects the eye to the brain
• Pancytopenia - abnormally low levels of all types of blood cells
• Seizures
• Transaminase elevations - there are enzymes produced by the liver
• Tuberculous arthritis - infection of the joints due to tuberculosis
• Urinary tract infection

No profit whatever can possibly be made but at the expense of another...
A physician takes no pleasure in the health even of his friends.
- Michel de Montaigne

Drug Manufacturer Information

Immunex Corporation
Thousand Oaks, CA 91320-1799
805-447-1000
Marketed by Amgen Inc. and Wyeth Pharmaceuticals

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August 15, 2009

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