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 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
Possible Enbrel side effects in 72 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 72 year old male
Reactions: Death, Heart Rate Increased, Lung Neoplasm Malignant
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Enbrel
Dosage: unk
Indication: Rheumatoid Arthritis
Start date: 2004-01-16
End date: 2009-01-01
Procrit
Dosage: unk
Possible Enbrel side effects in male
Reported by a consumer/non-health professional from Spain on 2012-08-27
Patient: male
Reactions: Sjogren's Syndrome
Drug(s) suspected as cause:
Enbrel
Possible Enbrel side effects in 71 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 71 year old female, weighing 53.5 kg (117.7 pounds)
Reactions: Breast Cancer
Drug(s) suspected as cause:
Enbrel
Other drugs received by patient: Plaquenil; Meloxicam
Possible Enbrel side effects in 69 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 69 year old female
Reactions: Joint Dislocation, Fall
Drug(s) suspected as cause:
Enbrel
Possible Enbrel side effects in 56 year old female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: 56 year old female
Reactions: Arthropod Bite, Infection
Drug(s) suspected as cause:
Enbrel
Possible Enbrel side effects in 77 year old male
Reported by a physician from United States on 2012-08-27
Patient: 77 year old male, weighing 102.5 kg (225.5 pounds)
Reactions: Visual Acuity Reduced, Macular Degeneration
Drug(s) suspected as cause:
Enbrel
Indication: Psoriasis
Enbrel
Dosage: 50 mg, unk
Indication: Psoriatic Arthropathy
Start date: 2009-05-27
Possible Enbrel side effects in 68 year old male
Reported by a consumer/non-health professional from Colombia on 2012-08-27
Patient: 68 year old male
Reactions: Anal Fistula, Spondylitis
Drug(s) suspected as cause:
Enbrel
Other drugs received by patient: Losartan Potassium; Dorixina / 00729301 /; Mobic; Galvus; Zolpidem; Medrol; Amlodipine / 00972402 /; Dorixina / 00729301 /
Possible Enbrel side effects in 43 year old female
Reported by a consumer/non-health professional from Colombia on 2012-08-27
Patient: 43 year old female
Reactions: Tuberculin Test Positive, Generalised Oedema
Drug(s) suspected as cause:
Enbrel
Possible Enbrel side effects in 30 year old female
Reported by a physician from United States on 2012-08-27
Patient: 30 year old female
Reactions: Abortion Spontaneous
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: Rheumatoid Arthritis, Lower Limb Fracture
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Enbrel
Possible Enbrel side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Rheumatoid Arthritis, Bursitis, Osteitis, Joint Destruction, Synovial Cyst
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Enbrel
Other drugs received by patient: Methotrexate
Possible Enbrel side effects in 47 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 47 year old female, weighing 93.0 kg (204.5 pounds)
Reactions: Optic Neuritis, Cheilitis, Oral Candidiasis, DRY Mouth, Saliva Altered, Irritable Bowel Syndrome, Multiple Sclerosis, Back Disorder, Demyelination, Obesity Surgery, Intervertebral Disc Protrusion, Gingival Disorder, Bursitis, Hypoaesthesia, Convulsion, Tongue Injury, Insomnia, Mental Disorder, Psoriatic Arthropathy, Speech Disorder, Foot Fracture, Myalgia, Neck Pain, Dizziness, Oedema, Abdominal Distension, Musculoskeletal Stiffness, Hypertonic Bladder, Depression, Gastrooesophageal Reflux Disease, Migraine, Drug Hypersensitivity, Muscular Weakness, Psoriasis, Hyponatraemia, Rash, Amnesia, Dental Discomfort, Burning Sensation, Diarrhoea, Oral Pain, Arthralgia, Dysuria, Alopecia, Vertigo, Gait Disturbance, Arthritis, Altered State of Consciousness, RED Blood Cell Sedimentation Rate Increased
Drug(s) suspected as cause:
Enbrel
Dosage: unk
Indication: Psoriatic Arthropathy
Start date: 2008-05-01
End date: 2010-11-01
Enbrel
Dosage: 50 mg, qwk
Start date: 2008-02-01
End date: 2011-01-01
Other drugs received by patient: Celebrex; Clobex / 00012002 /; Methotrexate; Clobetasol Propionate; Detrol LA; Claritin / 00413701 /; Cymbalta; Arava; Zolpidem Tartrate; Vitamin D; Methotrexate; Lyrica; Calcium + Vitamin D / 01483701 /; Prednisone TAB; Tramadol HCL; Multivitamin / 07504101 /; Prednisone TAB; Cyanocobalamin; Folic Acid; Baclofen
Possible Enbrel side effects in
Reported by a health professional (non-physician/pharmacist) from NEW Zealand on 2012-08-27
Patient:
Reactions: Progressive Multifocal Leukoencephalopathy
Drug(s) suspected as cause:
Enbrel
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
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