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Enbrel Side Effects

PatientsVille

Common Enbrel Side Effects


The most commonly reported Enbrel side effects (click to view or check a box to report):

Injection Site Pain (14992)
Injection Site Erythema (12313)
Arthralgia (9457)
Injection Site Swelling (6906)
Psoriasis (6352)
Injection Site Pruritus (6280)
Pain In Extremity (5957)
Injection Site Reaction (5342)
Rheumatoid Arthritis (5068)
Pain (4880)
Headache (4873)
Fatigue (4600)
Nasopharyngitis (3963)
Injection Site Bruising (3481)
Sinusitis (3370)
Injection Site Warmth (3367)
Cough (3263)
Joint Swelling (2983)
Nausea (2821)
Pyrexia (2550)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Enbrel Side Effects Reported to FDA



Enbrel Side Effect Report#9999692
Depression, Pulmonary Embolism, Increased Upper Airway Secretion, Headache, Cough, Emotional Disorder, Psoriasis
This is a report of a 46-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: psoriasis, who was treated with Enbrel (dosage: 50 Mg, Qwk, start time:
Jan 01, 2008), combined with: NA. and developed a serious reaction and side effect(s): Depression, Pulmonary Embolism, Increased Upper Airway Secretion, Headache, Cough, Emotional Disorder, Psoriasis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enbrel treatment in male patients, resulting in Depression side effect.
Enbrel Side Effect Report#9999579
Osteoarthritis, Chondrolysis, Knee Deformity, Gait Disturbance, Cellulitis, Ulcer
This report suggests a potential Enbrel Osteoarthritis side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: psoriasis and used Enbrel (dosage: 50 Mg, Qwk) starting NS. After starting Enbrel the patient began experiencing various side effects, including: Osteoarthritis, Chondrolysis, Knee Deformity, Gait Disturbance, Cellulitis, UlcerAdditional drugs used concurrently: NA.The patient was hospitalized. Although Enbrel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Osteoarthritis, may still occur.
Enbrel Side Effect Report#9999542
Surgery
This Surgery problem was reported by a health professional from US. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On 201312 this consumer started treatment with Enbrel (dosage: 50 Mg, Qwk). The following drugs were being taken at the same time: NA. When using Enbrel, the patient experienced the following unwanted symptoms/side effects: SurgeryAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Surgery, may become evident only after a product is in use by the general population.
Enbrel Side Effect Report#9999308
Varicocele, Spermatozoa Morphology Abnormal
This Varicocele side effect was reported by a consumer or non-health professional from US. A 35-year-old male patient (weight:NA) experienced the following symptoms/conditions: psoriasis.The patient was prescribed Enbrel (drug dosage: 50 Mg, Every 7 To 10 Days), which was initiated on
Oct 31, 2007. Concurrently used drugs: NA..After starting to take Enbrel the consumer reported adverse symptoms, such as: Varicocele, Spermatozoa Morphology AbnormalThese side effects may potentially be related to Enbrel.
Enbrel Side Effect Report#9999250
Myelodysplastic Syndrome, Activities Of Daily Living Impaired, Tooth Abscess, Musculoskeletal Pain, Swelling, Epistaxis, Headache, Visual Impairment, Influenza Like Illness
This is a report of a 52-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: pustular psoriasis,psoriatic arthropathy, who was treated with Enbrel (dosage: 50 Mg, Qwk, start time: 201308), combined with: NA. and developed a serious reaction and side effect(s): Myelodysplastic Syndrome, Activities Of Daily Living Impaired, Tooth Abscess, Musculoskeletal Pain, Swelling, Epistaxis, Headache, Visual Impairment, Influenza Like Illness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enbrel treatment in female patients, resulting in Myelodysplastic Syndrome side effect.
Enbrel Side Effect Report#9999062
Renal Failure Acute
This report suggests a potential Enbrel Renal Failure Acute side effect(s) that can have serious consequences. A 77-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: rheumatoid arthritis and used Enbrel (dosage: 50 Mg, Qwk) starting NS. After starting Enbrel the patient began experiencing various side effects, including: Renal Failure AcuteAdditional drugs used concurrently:
  • Aciphex (Unk)
The patient was hospitalized. Although Enbrel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure Acute, may still occur.
Enbrel Side Effect Report#9999024
Diabetes Mellitus
This Diabetes Mellitus problem was reported by a physician from US. A 38-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: psoriasis. On NS this consumer started treatment with Enbrel (dosage: 50 Mg, 2 Times/wk). The following drugs were being taken at the same time: NA. When using Enbrel, the patient experienced the following unwanted symptoms/side effects: Diabetes MellitusAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Diabetes Mellitus, may become evident only after a product is in use by the general population.
Enbrel Side Effect Report#9999017
Eye Disorder, Eyelid Ptosis, Eye Movement Disorder
This Eye Disorder side effect was reported by a health professional from ES. A 68-year-old female patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis.The patient was prescribed Enbrel (drug dosage: 50 Mg, Unk), which was initiated on
Dec 01, 2013. Concurrently used drugs: NA..After starting to take Enbrel the consumer reported adverse symptoms, such as: Eye Disorder, Eyelid Ptosis, Eye Movement DisorderThese side effects may potentially be related to Enbrel. The patient was hospitalized.
Enbrel Side Effect Report#9998885
Breast Cancer, Injection Site Mass, Dyspnoea, Chest Discomfort
This is a report of a 51-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: ankylosing spondylitis, who was treated with Enbrel (dosage: 50 Mg, Qwk, start time: 2002), combined with: NA. and developed a serious reaction and side effect(s): Breast Cancer, Injection Site Mass, Dyspnoea, Chest Discomfort after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enbrel treatment in female patients, resulting in Breast Cancer side effect. The patient was hospitalized.
Enbrel Side Effect Report#9998485
Myocardial Infarction
This report suggests a potential Enbrel Myocardial Infarction side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Enbrel (dosage: Unk) starting NS. After starting Enbrel the patient began experiencing various side effects, including: Myocardial InfarctionAdditional drugs used concurrently: NA. Although Enbrel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myocardial Infarction, may still occur.
Enbrel Side Effect Report#9998285
Psoriasis
This Psoriasis problem was reported by a consumer or non-health professional from IT. A 26-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Enbrel (dosage: Unk). The following drugs were being taken at the same time: NA. When using Enbrel, the patient experienced the following unwanted symptoms/side effects: PsoriasisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Psoriasis, may become evident only after a product is in use by the general population.
Enbrel Side Effect Report#9998280
Blood Pressure Increased, Pre-eclampsia, Psoriasis, Prehypertension, Swelling
This Blood Pressure Increased side effect was reported by a consumer or non-health professional from US. A 30-year-old female patient (weight:NA) experienced the following symptoms/conditions: psoriasis.The patient was prescribed Enbrel (drug dosage: 50 Mg, Qwk), which was initiated on 2000. Concurrently used drugs: NA..After starting to take Enbrel the consumer reported adverse symptoms, such as: Blood Pressure Increased, Pre-eclampsia, Psoriasis, Prehypertension, SwellingThese side effects may potentially be related to Enbrel. The patient was hospitalized.
Enbrel Side Effect Report#9998029
Cellulitis, Diarrhoea
This is a report of a 70-year-old female patient (weight: NA) from CO, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Enbrel Myclic (dosage: 50 Mg, 2x/week, start time: 2012), combined with:
  • Clindamycin Hcl (300 Mg, 3x/day)
and developed a serious reaction and side effect(s): Cellulitis, Diarrhoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enbrel Myclic treatment in female patients, resulting in Cellulitis side effect.
Enbrel Side Effect Report#9995616
Cardiac Failure Congestive
This report suggests a potential Enbrel Cardiac Failure Congestive side effect(s) that can have serious consequences. A 83-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: rheumatoid arthritis and used Enbrel (dosage: NA) starting
Sep 01, 2013. After starting Enbrel the patient began experiencing various side effects, including: Cardiac Failure CongestiveAdditional drugs used concurrently: NA. Although Enbrel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Failure Congestive, may still occur.
Enbrel Side Effect Report#9995580
Hip Arthroplasty, Joint Stiffness, Arthralgia
This Hip Arthroplasty problem was reported by a physician from US. A 56-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On
Jan 01, 2011 this consumer started treatment with Enbrel (dosage: 25 Mg, 2 Times/wk). The following drugs were being taken at the same time: NA. When using Enbrel, the patient experienced the following unwanted symptoms/side effects: Hip Arthroplasty, Joint Stiffness, ArthralgiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hip Arthroplasty, may become evident only after a product is in use by the general population.
Enbrel Side Effect Report#9995541
Familial Mediterranean Fever, Arthralgia, Back Pain, Influenza, Product Quality Issue, Memory Impairment, Injection Site Erythema, Injection Site Pruritus
This Familial Mediterranean Fever side effect was reported by a consumer or non-health professional from TR. A 24-year-old female patient (weight:NA) experienced the following symptoms/conditions: ankylosing spondylitis.The patient was prescribed Enbrel (drug dosage: 50 Mg, Weekly), which was initiated on
Sep 27, 2012. Concurrently used drugs:
  • Endol /00003801/ (Unk Unk, As Necessary)
  • Colchicum-dispert (Unk, 3x/day)
  • Glifor (1000 Mg, 2x/day)
.After starting to take Enbrel the consumer reported adverse symptoms, such as: Familial Mediterranean Fever, Arthralgia, Back Pain, Influenza, Product Quality Issue, Memory Impairment, Injection Site Erythema, Injection Site PruritusThese side effects may potentially be related to Enbrel.
Enbrel Side Effect Report#9995453
This is a report of a 66-year-old male patient (weight: NA) from CA, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Enbrel (dosage: 50 Mg, Unk, start time:
Sep 23, 2013), combined with: NA. and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enbrel treatment in male patients, resulting in Death side effect.
Enbrel Side Effect Report#9994739
Cerebrovascular Accident, Hemiplegia, Viith Nerve Paralysis
This report suggests a potential Enbrel Cerebrovascular Accident side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from CO was diagnosed with the following symptoms/conditions: psoriasis and used Enbrel (dosage: 50 Mg, Weekly) starting
Feb 07, 2014. After starting Enbrel the patient began experiencing various side effects, including: Cerebrovascular Accident, Hemiplegia, Viith Nerve ParalysisAdditional drugs used concurrently: NA.The patient was hospitalized. Although Enbrel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cerebrovascular Accident, may still occur.
Enbrel Side Effect Report#9994728
Venous Occlusion, Off Label Use
This Venous Occlusion problem was reported by a consumer or non-health professional from CO. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: psoriasis. On 2006 this consumer started treatment with Enbrel (dosage: 50 Mg, Twice Weekly). The following drugs were being taken at the same time: NA. When using Enbrel, the patient experienced the following unwanted symptoms/side effects: Venous Occlusion, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Venous Occlusion, may become evident only after a product is in use by the general population.
Enbrel Side Effect Report#9994682
Paraesthesia, Muscle Spasms
This Paraesthesia side effect was reported by a pharmacist from US. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: psoriatic arthropathy.The patient was prescribed Enbrel 50mg Amgen (drug dosage: NA), which was initiated on
Oct 16, 2013. Concurrently used drugs: NA..After starting to take Enbrel 50mg Amgen the consumer reported adverse symptoms, such as: Paraesthesia, Muscle SpasmsThese side effects may potentially be related to Enbrel 50mg Amgen.
Enbrel Side Effect Report#9994636
Abasia, Arthralgia, Musculoskeletal Stiffness, Pain, Osteoarthritis
This is a report of a 37-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: ankylosing spondylitis, who was treated with Enbrel (dosage: 50 Mg, 1x/week, start time: 201310), combined with:
  • Cyclobenzaprine (Unk)
and developed a serious reaction and side effect(s): Abasia, Arthralgia, Musculoskeletal Stiffness, Pain, Osteoarthritis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enbrel treatment in female patients, resulting in Abasia side effect.
Enbrel Side Effect Report#9994635
Male Sexual Dysfunction, Semen Volume Decreased, Sinusitis, Upper-airway Cough Syndrome, Headache, Abdominal Distension, Fatigue, Neck Pain, Lymphadenopathy
This report suggests a potential Enbrel Male Sexual Dysfunction side effect(s) that can have serious consequences. A 56-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: psoriatic arthropathy and used Enbrel (dosage: 50 Mg, Qwk) starting
Jan 16, 2014. After starting Enbrel the patient began experiencing various side effects, including: Male Sexual Dysfunction, Semen Volume Decreased, Sinusitis, Upper-airway Cough Syndrome, Headache, Abdominal Distension, Fatigue, Neck Pain, LymphadenopathyAdditional drugs used concurrently: NA. Although Enbrel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Male Sexual Dysfunction, may still occur.
Enbrel Side Effect Report#9994632
Hypertension, Vomiting, Headache, Migraine, Paraesthesia, Hypoaesthesia
This Hypertension problem was reported by a consumer or non-health professional from CA. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On
Aug 15, 2012 this consumer started treatment with Enbrel (dosage: 50 Mg, Qwk). The following drugs were being taken at the same time:
  • Sulfasalazine (Unk)
  • Prednisone (Unk)
  • Plaquenil /00072602/ (Unk)
When using Enbrel, the patient experienced the following unwanted symptoms/side effects: Hypertension, Vomiting, Headache, Migraine, Paraesthesia, HypoaesthesiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypertension, may become evident only after a product is in use by the general population.
Enbrel Side Effect Report#9994602
Immunodeficiency, Joint Swelling, Nausea, Gastrooesophageal Reflux Disease, Vomiting, Arthritis Infective, Dyspnoea, Blood Folate Decreased, Injection Site Erythema
This Immunodeficiency side effect was reported by a health professional from US. A 62-year-old female patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis,fibromyalgia.The patient was prescribed Enbrel (drug dosage: Unk), which was initiated on 201302. Concurrently used drugs:
  • Savella (Unk)
  • Plaquenil /00072602/ (Unk)
  • Orencia (Unk)
.After starting to take Enbrel the consumer reported adverse symptoms, such as: Immunodeficiency, Joint Swelling, Nausea, Gastrooesophageal Reflux Disease, Vomiting, Arthritis Infective, Dyspnoea, Blood Folate Decreased, Injection Site ErythemaThese side effects may potentially be related to Enbrel. The patient was hospitalized.
Enbrel Side Effect Report#9994598
Hydronephrosis, Renal Cyst, Dysstasia, Arthralgia, Myalgia, Pancreatic Disorder, Nodule
This is a report of a 72-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Enbrel (dosage: 50 Mg, Qwk, start time:
Aug 12, 2013), combined with: NA. and developed a serious reaction and side effect(s): Hydronephrosis, Renal Cyst, Dysstasia, Arthralgia, Myalgia, Pancreatic Disorder, Nodule after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enbrel treatment in female patients, resulting in Hydronephrosis side effect.


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The appearance of Enbrel on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Enbrel Side Effects for Women?

Women Side EffectsReports
Injection Site Pain 12254
Injection Site Erythema 10648
Arthralgia 6934
Injection Site Swelling 5912
Injection Site Pruritus 5529
Injection Site Reaction 4580
Pain In Extremity 4527
Rheumatoid Arthritis 4142
Headache 3851
Pain 3709

What are common Enbrel Side Effects for Men?

Men Side EffectsReports
Psoriasis 2729
Injection Site Pain 2708
Arthralgia 2510
Injection Site Erythema 1637
Pain In Extremity 1425
Nasopharyngitis 1177
Pain 1160
Headache 1006
Fatigue 999
Injection Site Swelling 974

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Enbrel reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Enbrel Side Effects

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    How Effective is Enbrel for You?

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    Enbrel Safety Alerts, Active Ingredients, Usage Information

    NDC58406-425
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameENBREL
    Nameetanercept
    Dosage FormKIT
    Route
    On market since20030102
    LabelerImmunex Corporation
    Active Ingredient(s)
    Strength(s)
    Unit(s)
    Pharma Class

    More About Enbrel

    Side Effects reported to FDA: 110653

    Enbrel safety alerts: 2009 2008 2000

    Reported deaths: 2938

    Reported hospitalizations: 18714

    Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009

    Audience: Rheumatologists, gastroenterologists, oncologists, dermatologists

    [UPDATED 08/31/2009] Supplemental Q&As added

    [Posted 08/04/2009] FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.

    TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohnâ??s disease, and ankylosing spondylitis.

    [08/28/2009 - Q&As - FDA]
    [08/04/2009 - Information for Healthcare Professionals - FDA]
    [08/04/2009 - Follow-up to Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers - FDA]

    Previous MedWatch Alert:

    [06/03/2008]

     

    Latest Enbrel clinical trials