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Enbrel (Etanercept) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Enbrel (Etanercept) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (40923)
Death (484)
Life Threatening Events (281)
Disability (196)

Reports by Reaction Type

Injection Site Pain (6662)Injection Site Erythema (5633)Injection Site Swelling (3183)Rheumatoid Arthritis (3001)Injection Site Pruritus (2899)Psoriasis (2632)Arthralgia (2574)Injection Site Reaction (2480)Drug Ineffective (2422)Injection Site Haematoma (2251)Fatigue (1765)Headache (1744)

Below are a few examples of reports where side effects / adverse reactions may be related to Enbrel (Etanercept). For a complete list or a specific selection of reports, please use the links above.

Possible Enbrel side effects in 51 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: 51 year old female, weighing 76.0 kg (167.2 pounds)

Reactions: Hypersensitivity, Dyspnoea, Glossodynia, Tongue DRY, Anaphylactic Shock, Nasal Congestion, Swollen Tongue, Headache, Injection Site Erythema, Throat Irritation, DRY Throat, Injection Site Warmth, Cough

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Acetaminophen



Possible Enbrel side effects in

Reported by a physician from Japan on 2012-08-27

Patient:

Reactions: Chest X-RAY Abnormal

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 68 year old female

Reactions: Diarrhoea, Injection Site Haematoma, Dehydration, Arthropod Bite

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 53 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: 53 year old male

Reactions: Aesthesioneuroblastoma

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, weekly
    Indication: Ankylosing Spondylitis
    Start date: 2005-11-01
    End date: 2006-05-01

Humira
    Dosage: 40 mg, every other week
    Indication: Ankylosing Spondylitis
    Start date: 2006-10-01
    End date: 2011-02-18

Remicade
    Dosage: 3 mg/kg, single
    Indication: Ankylosing Spondylitis
    Start date: 2011-03-23
    End date: 2011-04-07



Possible Enbrel side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female, weighing 106.6 kg (234.5 pounds)

Reactions: Pruritus, Chest Discomfort, Hypersensitivity, Drug Ineffective, Diabetes Mellitus, Chills, Urticaria, Headache, Osteoarthritis, Vitamin D Decreased, Alopecia, Insomnia, Animal Scratch, Skin Atrophy

Drug(s) suspected as cause:
Cortisone Acetate
    Indication: Rheumatoid Arthritis

Enbrel
    Indication: Rheumatoid Arthritis

Prednisone TAB
    Indication: Rheumatoid Arthritis

Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2012-07-01

Remicade
    Dosage: every 6 to 8 weeks
    Start date: 2003-01-01
    End date: 2006-01-01

Other drugs received by patient: Methotrexate; Prednisone TAB; Norco



Possible Enbrel side effects in 49 year old female

Reported by a consumer/non-health professional from Netherlands on 2012-08-27

Patient: 49 year old female

Reactions: Injection Site Reaction, Coagulopathy, Respiratory Tract Infection, Inflammation

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 71 year old female

Reactions: Bedridden, Contusion, Depression, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in

Reported by a physician from Canada on 2012-08-27

Patient:

Reactions: Mycobacterium Avium Complex Infection

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 26 year old male

Reported by a physician from United States on 2012-08-27

Patient: 26 year old male

Reactions: Limb Crushing Injury, Drug Ineffective

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 12 year old male

Reported by a physician from United States on 2012-08-27

Patient: 12 year old male

Reactions: Rheumatoid Arthritis, Slow Response To Stimuli, Neuropathy Peripheral, Sleep Disorder, Feeling Abnormal, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel
    Indication: Tendonitis

Enbrel
    Dosage: 25 mg, 2 times/wk
    Indication: Juvenile Arthritis
    Start date: 2004-04-01

Other drugs received by patient: Naproxen



Possible Enbrel side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Beta Haemolytic Streptococcal Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 31 year old female

Reported by a physician from United States on 2012-08-27

Patient: 31 year old female

Reactions: Abortion Spontaneous

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 73 year old female

Reported by a physician from United States on 2012-08-27

Patient: 73 year old female

Reactions: Food Poisoning, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 50 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: 50 year old female, weighing 93.0 kg (204.6 pounds)

Reactions: Breast Cancer

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Prednisone TAB



Possible Enbrel side effects in 51 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: 51 year old female, weighing 50.0 kg (110.0 pounds)

Reactions: Viral Infection, Diabetic Foot, Anaemia, Pyrexia, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Alendronate Sodium; Insulin Human; Arava



Possible Enbrel side effects in 71 year old female

Reported by a physician from United States on 2012-08-27

Patient: 71 year old female

Reactions: Pulmonary Hypertension, Peptic Ulcer, Osteoporosis, Urinary Tract Infection, Atrial Fibrillation, Hyperlipidaemia, Rheumatoid Arthritis, Cardiac Failure, Mitral Valve Incompetence, Depression, Hypertension, Sjogren's Syndrome, Viral Cardiomyopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Methotrexate; Coumadin; Flonase; Potassium Chloride; Multi-Vitamins; Aspirin; Folic Acid; Simvastatin; Calcium Carbonate; Furosemide; Percocet; Prednisone TAB; Zoloft; Lovenox; Metoprolol Tartrate; Prilosec; Reclast; Vitamin D; Evoxac; Amiodarone HCL



Possible Enbrel side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 54 year old female, weighing 67.6 kg (148.7 pounds)

Reactions: Pain in Extremity, Osteomyelitis, Gangrene, Staphylococcal Sepsis, Mobility Decreased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Prednisone TAB



Possible Enbrel side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 47 year old female

Reactions: Nephrolithiasis, Urinary Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 73 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 73 year old male

Reactions: Pancreaticoduodenectomy, Cervical Spinal Stenosis, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient:

Reactions: Pancreatitis

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 30 year old female

Reported by a consumer/non-health professional from Germany on 2012-08-27

Patient: 30 year old female

Reactions: Cervical Dysplasia, Cervix Carcinoma

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 63 year old female

Reported by a physician from United States on 2012-08-27

Patient: 63 year old female

Reactions: Osteonecrosis, Injection Site Erythema, Injection Site Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 59 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 59 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 76 year old male

Reported by a consumer/non-health professional from Argentina on 2012-08-27

Patient: 76 year old male

Reactions: Asthma, Oedema Peripheral

Drug(s) suspected as cause:
Enbrel
    Dosage: unk
    Start date: 2012-08-01

Enbrel
    Dosage: 25 mg, 2x/week
    Indication: Psoriatic Arthropathy
    Start date: 2011-02-28
    End date: 2012-04-01



Possible Enbrel side effects in 50 year old female

Reported by a consumer/non-health professional from Argentina on 2012-08-27

Patient: 50 year old female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Cilostazol; Sintrom



Possible Enbrel side effects in 48 year old female

Reported by a physician from United States on 2012-08-27

Patient: 48 year old female

Reactions: Confusional State, Amnesia

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 58 year old female

Reported by a consumer/non-health professional from Argentina on 2012-08-27

Patient: 58 year old female

Reactions: Arthralgia, Drug Ineffective

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Methotrexate; Folic Acid; Arcoxia



Possible Enbrel side effects in 23 year old female

Reported by a health professional (non-physician/pharmacist) from NEW Zealand on 2012-08-27

Patient: 23 year old female

Reactions: Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: death

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, qwk
    Indication: Rheumatoid Arthritis

Prednisone TAB
    Dosage: 10-20mg a day



Possible Enbrel side effects in 58 year old female

Reported by a physician from Netherlands on 2012-08-27

Patient: 58 year old female, weighing 56.0 kg (123.2 pounds)

Reactions: Adenocarcinoma Pancreas, Weight Decreased, Rheumatoid Arthritis, Pancreatic Disorder, Metastases To Lymph Nodes

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: 25 mg, weekly
    Start date: 2012-06-27

Enbrel
    Dosage: 50 mg, weekly
    Indication: Rheumatoid Arthritis
    Start date: 2009-10-01
    End date: 2011-01-01

Other drugs received by patient: Prednisone TAB



Possible Enbrel side effects in 62 year old female

Reported by a physician from United States on 2012-08-27

Patient: 62 year old female

Reactions: Therapeutic Response Decreased, Vertebroplasty, Adverse Drug Reaction, Knee Arthroplasty

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel

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