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Humira Side Effects

PatientsVille

Common Humira Side Effects


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

Injection Site Pain (15749)
Arthralgia (6869)
Incorrect Dose Administered (6829)
Pain (5859)
Fatigue (5095)
Headache (4721)
Injection Site Erythema (4659)
Pyrexia (4468)
Psoriasis (4239)
Diarrhoea (4177)
Nausea (4127)
Nasopharyngitis (3835)
Cough (3550)
Injection Site Haemorrhage (3472)
Abdominal Pain (3316)
Pain In Extremity (3298)
Rash (3183)
Injection Site Pruritus (2849)
Device Malfunction (2801)
Injection Site Bruising (2783)

➢ 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.

Humira Side Effects Reported to FDA



Humira Side Effect Report#9999649
Crohn^s Disease, Anal Abscess, Anal Fistula
This is a report of a 24-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Humira (dosage: NA, start time: 200708), combined with:
  • Budesonid
and developed a serious reaction and side effect(s): Crohn^s Disease, Anal Abscess, Anal Fistula after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Humira treatment in male patients, resulting in Crohn^s Disease side effect. The patient was hospitalized.
Humira Side Effect Report#9998197
Prostatomegaly, Alopecia, Red Blood Cell Count Decreased
This report suggests a potential Humira Prostatomegaly side effect(s) that can have serious consequences. A 55-year-old male patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: rheumatoid arthritis and used Humira (dosage: NA) starting
Jan 01, 2008. After starting Humira the patient began experiencing various side effects, including: Prostatomegaly, Alopecia, Red Blood Cell Count DecreasedAdditional drugs used concurrently: NA. Although Humira demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Prostatomegaly, may still occur.
Humira Side Effect Report#9998140
Arthralgia, Neck Pain, Pain, Blood Glucose Increased, Cerebrovascular Accident, Pain In Extremity, Rheumatoid Arthritis
This Arthralgia problem was reported by a consumer or non-health professional from Country Not Specified. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis,mineral supplementation,diabetes mellitus. On 2013 this consumer started treatment with Humira (dosage: NA). The following drugs were being taken at the same time:
  • Oyster Shell Calcium
  • Metformin
  • Nabumetone
  • Folic Acid
  • Methotrexate
  • Glipizide
  • Hydroxychloroquine
  • Anapril
When using Humira, the patient experienced the following unwanted symptoms/side effects: Arthralgia, Neck Pain, Pain, Blood Glucose Increased, Cerebrovascular Accident, Pain In Extremity, Rheumatoid ArthritisThe 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 Arthralgia, may become evident only after a product is in use by the general population.
Humira Side Effect Report#9998124
Gastrointestinal Infection, Bowel Movement Irregularity, Abdominal Pain, Nausea, Vomiting, Dehydration, Intestinal Resection, Ileostomy
This Gastrointestinal Infection side effect was reported by a consumer or non-health professional from Country Not Specified. A 22-year-old male patient (weight:NA) experienced the following symptoms/conditions: crohn^s disease.The patient was prescribed Humira (drug dosage: NA), which was initiated on
Mar 02, 2014. Concurrently used drugs: NA..After starting to take Humira the consumer reported adverse symptoms, such as: Gastrointestinal Infection, Bowel Movement Irregularity, Abdominal Pain, Nausea, Vomiting, Dehydration, Intestinal Resection, IleostomyThese side effects may potentially be related to Humira. The patient was hospitalized.
Humira Side Effect Report#9998091
Nasal Congestion, Tooth Abscess
This is a report of a 39-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Humira (dosage: Latest Dose: 22-feb-2014, start time:
May 17, 2011), combined with: NA. and developed a serious reaction and side effect(s): Nasal Congestion, Tooth Abscess after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Humira treatment in female patients, resulting in Nasal Congestion side effect.
Humira Side Effect Report#9998000
Renal Failure
This report suggests a potential Humira Renal Failure side effect(s) that can have serious consequences. A 45-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: psoriasis and used Humira (dosage: NA) starting 2011. After starting Humira the patient began experiencing various side effects, including: Renal FailureAdditional drugs used concurrently:
  • Olmesartan
  • Ferro Sanol Duodenal
  • Magnesium
  • Darbepoetin Alfa
  • Natriumhydrogencarbonat
  • Alfacalcidol
  • Metamizole
  • Cinacalcet
The patient was hospitalized. Although Humira demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure, may still occur.
Humira Side Effect Report#9997820
Gastrointestinal Inflammation, Abdominal Pain
This Gastrointestinal Inflammation problem was reported by a consumer or non-health professional from Country Not Specified. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On
Jun 04, 2013 this consumer started treatment with Humira (dosage: NA). The following drugs were being taken at the same time:
  • Leflunomide
  • Prednisolone
  • Acetaminophen
When using Humira, the patient experienced the following unwanted symptoms/side effects: Gastrointestinal Inflammation, Abdominal PainThe 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 Gastrointestinal Inflammation, may become evident only after a product is in use by the general population.
Humira Side Effect Report#9997812
Arthralgia, Salmonella Sepsis
This Arthralgia side effect was reported by a consumer or non-health professional from Country Not Specified. A 44-year-old male patient (weight:NA) experienced the following symptoms/conditions: ankylosing spondylitis.The patient was prescribed Humira (drug dosage: NA), which was initiated on
Feb 20, 2009. Concurrently used drugs:
  • Prednisolone
  • Enalapril
.After starting to take Humira the consumer reported adverse symptoms, such as: Arthralgia, Salmonella SepsisThese side effects may potentially be related to Humira. The patient was hospitalized.
Humira Side Effect Report#9997382
Arthropathy
This is a report of a 51-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Humira (dosage: NA, start time:
Jul 29, 2013), combined with: NA. and developed a serious reaction and side effect(s): Arthropathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Humira treatment in female patients, resulting in Arthropathy side effect. The patient was hospitalized.
Humira Side Effect Report#9994658
Urticaria
This report suggests a potential Humira Pen 40mg Abbvie Urticaria side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: psoriatic arthropathy and used Humira Pen 40mg Abbvie (dosage: 40mg, Bi-monthly, Sub-q) starting
Oct 04, 2013. After starting Humira Pen 40mg Abbvie the patient began experiencing various side effects, including: UrticariaAdditional drugs used concurrently: NA. Although Humira Pen 40mg Abbvie demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Urticaria, may still occur.
Humira Side Effect Report#9994290
Joint Destruction, Asthenia, Inflammation, Pain, Rheumatoid Arthritis
This Joint Destruction problem was reported by a consumer or non-health professional from Country Not Specified. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On NS this consumer started treatment with Humira (dosage: NA). The following drugs were being taken at the same time:
  • Prednisone
When using Humira, the patient experienced the following unwanted symptoms/side effects: Joint Destruction, Asthenia, Inflammation, Pain, Rheumatoid ArthritisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Joint Destruction, may become evident only after a product is in use by the general population.
Humira Side Effect Report#9994195
Renal Failure
This Renal Failure side effect was reported by a pharmacist from FR. A 64-year-old male patient (weight:NA) experienced the following symptoms/conditions: ankylosing spondylitis.The patient was prescribed Humira (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Humira the consumer reported adverse symptoms, such as: Renal FailureThese side effects may potentially be related to Humira.
Humira Side Effect Report#9994113
Joint Injury, Rheumatoid Arthritis, Knee Arthroplasty, Rheumatoid Arthritis, Musculoskeletal Stiffness, Pain, Injection Site Pain, Injection Site Pain
This is a report of a 47-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Humira (dosage: NA, start time: 2010), combined with: NA. and developed a serious reaction and side effect(s): Joint Injury, Rheumatoid Arthritis, Knee Arthroplasty, Rheumatoid Arthritis, Musculoskeletal Stiffness, Pain, Injection Site Pain, Injection Site Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Humira treatment in female patients, resulting in Joint Injury side effect.
Humira Side Effect Report#9993641
Osteoarthritis, Staphylococcal Infection
This report suggests a potential Humira Osteoarthritis side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: rheumatoid arthritis and used Humira (dosage: NA) starting 2006. After starting Humira the patient began experiencing various side effects, including: Osteoarthritis, Staphylococcal InfectionAdditional drugs used concurrently:
  • Folic Acid
  • Losartan
  • Vitamin D
  • Calcium
  • Restoril
  • Aleve
  • Singulair
  • Fish Oil
The patient was hospitalized. Although Humira demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Osteoarthritis, may still occur.
Humira Side Effect Report#9993585
Paraesthesia, Hypoaesthesia, Vision Blurred, Thyroid Cancer
This Paraesthesia problem was reported by a health professional from GB. A 58-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On NS this consumer started treatment with Humira (dosage: NA). The following drugs were being taken at the same time:
  • Prednisolone
When using Humira, the patient experienced the following unwanted symptoms/side effects: Paraesthesia, Hypoaesthesia, Vision Blurred, Thyroid CancerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Paraesthesia, may become evident only after a product is in use by the general population.
Humira Side Effect Report#9993557
Heart Valve Stenosis, Neck Surgery, Chest Pain, Chest Pain, Chest Pain, Bone Cancer, Gastroenteritis, Monoclonal Gammopathy, Pain In Jaw
This Heart Valve Stenosis side effect was reported by a physician from Country Not Specified. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis.The patient was prescribed Humira (drug dosage: NA), which was initiated on 2009. Concurrently used drugs:
  • Methotrexate
  • Aspirin
  • Atenolol
  • Atenolol
  • Folic Acid
  • Lisiniopril-hctz (20-12.5mg Daily)
  • Vit D3
  • Vit C
.After starting to take Humira the consumer reported adverse symptoms, such as: Heart Valve Stenosis, Neck Surgery, Chest Pain, Chest Pain, Chest Pain, Bone Cancer, Gastroenteritis, Monoclonal Gammopathy, Pain In JawThese side effects may potentially be related to Humira. The patient was hospitalized.
Humira Side Effect Report#9993536
Cell Marker Increased, Pancreatic Carcinoma, Infection
This is a report of a 54-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: psoriasis,psoriatic arthropathy, who was treated with Humira (dosage: NA, start time:
Feb 15, 2013), combined with: NA. and developed a serious reaction and side effect(s): Cell Marker Increased, Pancreatic Carcinoma, Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Humira treatment in male patients, resulting in Cell Marker Increased side effect.
Humira Side Effect Report#9993519
Connective Tissue Disorder, Systemic Lupus Erythematosus, Obesity Surgery, Butterfly Rash, Arthritis, Off Label Use
This report suggests a potential Humira Connective Tissue Disorder side effect(s) that can have serious consequences. A 35-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: arthritis and used Humira (dosage: NA) starting 201301. After starting Humira the patient began experiencing various side effects, including: Connective Tissue Disorder, Systemic Lupus Erythematosus, Obesity Surgery, Butterfly Rash, Arthritis, Off Label UseAdditional drugs used concurrently:
  • Plaquenil
  • Elavil
  • Prednisone
  • Xanax
  • Ambien
  • Multivitamin
  • Vitamin D
  • Biotin
The patient was hospitalized. Although Humira demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Connective Tissue Disorder, may still occur.
Humira Side Effect Report#9993461
Pallor, Feeling Abnormal, Vulval Abscess, Vulval Abscess, Unevaluable Event
This Pallor problem was reported by a health professional from Country Not Specified. A 16-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: crohn^s disease. On 201305 this consumer started treatment with Humira (dosage: NA). The following drugs were being taken at the same time: NA. When using Humira, the patient experienced the following unwanted symptoms/side effects: Pallor, Feeling Abnormal, Vulval Abscess, Vulval Abscess, Unevaluable EventThe 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 Pallor, may become evident only after a product is in use by the general population.
Humira Side Effect Report#9993410
Arthropathy, Wound, Blood Pressure Decreased, Oral Herpes
This Arthropathy side effect was reported by a consumer or non-health professional from Country Not Specified. A female patient (weight:NA) experienced the following symptoms/conditions: ankylosing spondylitis,arthritis.The patient was prescribed Humira (drug dosage: NA), which was initiated on
Oct 12, 2012. Concurrently used drugs:
  • Indomethacin
.After starting to take Humira the consumer reported adverse symptoms, such as: Arthropathy, Wound, Blood Pressure Decreased, Oral HerpesThese side effects may potentially be related to Humira.
Humira Side Effect Report#9993374
Asthenia, Haematochezia, Haematochezia, Haematemesis, Haematemesis, Haematemesis, Dysgeusia, Asthenia, Sleep Disorder
This is a report of a 58-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: psoriasis,blood pressure, who was treated with Humira (dosage: NA, start time: 2013), combined with: NA. and developed a serious reaction and side effect(s): Asthenia, Haematochezia, Haematochezia, Haematemesis, Haematemesis, Haematemesis, Dysgeusia, Asthenia, Sleep Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Humira treatment in male patients, resulting in Asthenia side effect. The patient was hospitalized.
Humira Side Effect Report#9993344
Infarction, Infarction
This report suggests a potential Humira Infarction side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: psoriatic arthropathy and used Humira (dosage: NA) starting NS. After starting Humira the patient began experiencing various side effects, including: Infarction, InfarctionAdditional drugs used concurrently: NA. Although Humira demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Infarction, may still occur.
Humira Side Effect Report#9993305
Pulmonary Valve Incompetence, Chronic Obstructive Pulmonary Disease
This Pulmonary Valve Incompetence problem was reported by a physician from Country Not Specified. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On 200907 this consumer started treatment with Humira 40 Mg/ 0.8 Ml Pre-filled Syringe (dosage: NA). The following drugs were being taken at the same time: NA. When using Humira 40 Mg/ 0.8 Ml Pre-filled Syringe, the patient experienced the following unwanted symptoms/side effects: Pulmonary Valve Incompetence, Chronic Obstructive Pulmonary DiseaseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Valve Incompetence, may become evident only after a product is in use by the general population.
Humira Side Effect Report#9993150
Rhabdomyolysis, Muscular Weakness, Joint Swelling, Arthralgia
This Rhabdomyolysis side effect was reported by a consumer or non-health professional from Country Not Specified. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: psoriatic arthropathy,convulsion,pruritus,muscle spasms,arthralgia.The patient was prescribed Humira (drug dosage: NA), which was initiated on
Jan 29, 2014. Concurrently used drugs:
  • Depakote
  • Depakote
  • Baclofen
  • Baclofen (5/325 Mg)
  • Baclofen
.After starting to take Humira the consumer reported adverse symptoms, such as: Rhabdomyolysis, Muscular Weakness, Joint Swelling, ArthralgiaThese side effects may potentially be related to Humira.
Humira Side Effect Report#9992641
Bunion, Scar, Foot Deformity, Foot Deformity, Joint Dislocation, Hyperkeratosis, Synovitis
This is a report of a female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Humira (dosage: NA, start time:
Nov 22, 2007), combined with:
  • Methotrexate
  • Arava (Every Other Day)
  • Vimovo
  • Plaquenil
  • Folic Acid
  • Elavil
  • Azithromycin
  • Nexium
and developed a serious reaction and side effect(s): Bunion, Scar, Foot Deformity, Foot Deformity, Joint Dislocation, Hyperkeratosis, Synovitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Humira treatment in female patients, resulting in Bunion side effect.


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The appearance of Humira 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 Humira Side Effects for Women?

Women Side EffectsReports
Injection Site Pain 11777
Arthralgia 4877
Incorrect Dose Administered 4856
Pain 4195
Injection Site Erythema 3841
Fatigue 3622
Headache 3527
Nausea 3070
Diarrhoea 2915
Pyrexia 2901

What are common Humira Side Effects for Men?

Men Side EffectsReports
Injection Site Pain 3858
Arthralgia 1938
Incorrect Dose Administered 1935
Psoriasis 1787
Pain 1616
Pyrexia 1537
Fatigue 1437
Diarrhoea 1243
Headache 1170
Nasopharyngitis 1112

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.

    Humira 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 Humira Side Effects

    Did You Have a Humira Side Effect?

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    How Effective is Humira for You?

    Exceeded Expectations
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    Humira Safety Alerts, Active Ingredients, Usage Information

    NDC0074-3797
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameHumira
    NameAdalimumab
    Dosage FormINJECTION, SOLUTION
    RouteSUBCUTANEOUS
    On market since20021230
    LabelerAbbVie Inc.
    Active Ingredient(s)ADALIMUMAB
    Strength(s)40
    Unit(s)mg/.8mL
    Pharma ClassTumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA]

    Humira Dosage, Warnings, Usage.

    Side Effects reported to FDA: 113760

    Humira safety alerts: 2009 2008 2004

    Reported deaths: 4394

    Reported hospitalizations: 27820

    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 Humira clinical trials