DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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 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

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014