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Humira Side Effects

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.

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.

Humira Side Effects Reported to FDA

The following 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.


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.
Crohn^s Disease, Anal Abscess, Anal Fistula
on Mar 12, 2014 Male from COUNTRY NOT SPECIFIED , 24 years of age, weighting 220.5 lb, was diagnosed with and was treated with Humira. Directly after, patient experienced the unwanted or unexpected Humira side effects: crohn^s disease, anal abscess, anal fistula. Humira dosage: N/A.
Associated medications used:
  • Budesonid
Patient was hospitalized.

Prostatomegaly, Alopecia, Red Blood Cell Count Decreased
Patient was taking Humira. Patient felt the following Humira side effects: prostatomegaly, alopecia, red blood cell count decreased on Mar 11, 2014 from COUNTRY NOT SPECIFIED Additional patient health information: Male , 55 years of age, weighting 174.2 lb, was diagnosed with and. Humira dosage: N/A.

Arthralgia, Neck Pain, Blood Glucose Increased, Cerebrovascular Accident, Pain In Extremity, Rheumatoid Arthritis
Adverse event was reported on Mar 11, 2014 by a Female taking Humira (Dosage: N/A) was diagnosed with and. Location: COUNTRY NOT SPECIFIED , 73 years of age, weighting 160.1 lb, After Humira was administered, patient encountered several Humira side effects: arthralgia, neck pain, blood glucose increased, cerebrovascular accident, pain in extremity, rheumatoid arthritis.
Multiple concurrent drugs taken:
  • Oyster Shell Calcium
  • Metformin
  • Nabumetone
  • Folic Acid
  • Methotrexate
  • Glipizide
  • Hydroxychloroquine
  • Anapril
Patient was hospitalized.

Gastrointestinal Infection, Bowel Movement Irregularity, Abdominal Pain, Nausea, Vomiting, Dehydration, Intestinal Resection, Ileostomy
on Mar 11, 2014 Male from COUNTRY NOT SPECIFIED , 22 years of age, was diagnosed with and was treated with Humira. Directly after, patient experienced the unwanted or unexpected Humira side effects: gastrointestinal infection, bowel movement irregularity, abdominal pain, nausea, vomiting, dehydration, intestinal resection, ileostomy. Humira dosage: N/A. Patient was hospitalized.


Nasal Congestion, Tooth Abscess
on Mar 11, 2014 Female from COUNTRY NOT SPECIFIED , 39 years of age, was diagnosed with and was treated with Humira. Patient felt the following Humira side effects: nasal congestion, tooth abscess. Humira dosage: Latest Dose: 22-feb-2014.

Renal Failure
Patient was taking Humira. After Humira was administered, patient encountered several Humira side effects: renal failure on Mar 11, 2014 from COUNTRY NOT SPECIFIED Additional patient health information: Female , 45 years of age, was diagnosed with and. Humira dosage: N/A.
Multiple concurrent drugs taken:
  • Olmesartan
  • Ferro Sanol Duodenal
  • Magnesium
  • Darbepoetin Alfa
  • Natriumhydrogencarbonat
  • Alfacalcidol
  • Metamizole
  • Cinacalcet
Patient was hospitalized.

Gastrointestinal Inflammation, Abdominal Pain
Adverse event was reported on Mar 11, 2014 by a Female taking Humira (Dosage: N/A) was diagnosed with and. Location: COUNTRY NOT SPECIFIED , 57 years of age, Directly after, patient experienced the unwanted or unexpected Humira side effects: gastrointestinal inflammation, abdominal pain.
Associated medications used:
  • Leflunomide
  • Prednisolone
  • Acetaminophen
Patient was hospitalized.

Arthralgia, Salmonella Sepsis
on Mar 11, 2014 Male from COUNTRY NOT SPECIFIED , 44 years of age, weighting 163.1 lb, was diagnosed with and was treated with Humira. Patient felt the following Humira side effects: arthralgia, salmonella sepsis. Humira dosage: N/A.
Multiple prescriptions taken:
  • Prednisolone
  • Enalapril
Patient was hospitalized.

Arthropathy
on Mar 11, 2014 Female from COUNTRY NOT SPECIFIED , 51 years of age, weighting 198.4 lb, was diagnosed with and was treated with Humira. After Humira was administered, patient encountered several Humira side effects: arthropathy. Humira dosage: N/A. Patient was hospitalized.

Urticaria
Patient was taking Humira Pen 40mg Abbvie. Directly after, patient experienced the unwanted or unexpected Humira side effects: urticaria on Mar 07, 2014 from US Additional patient health information: Female , 70 years of age, was diagnosed with and. Humira Pen 40mg Abbvie dosage: 40mg, Bi-monthly, Sub-q.

Joint Destruction, Asthenia, Inflammation, Pain, Rheumatoid Arthritis
Adverse event was reported on Mar 11, 2014 by a Female taking Humira (Dosage: N/A) was diagnosed with and. Location: COUNTRY NOT SPECIFIED , weighting 180.2 lb, Patient felt the following Humira side effects: joint destruction, asthenia, inflammation, pain, rheumatoid arthritis.
Multiple prescriptions taken:
  • Prednisone


Renal Failure
on Mar 10, 2014 Male from FR , 64 years of age, was diagnosed with and was treated with Humira. After Humira was administered, patient encountered several Humira side effects: renal failure. Humira dosage: N/A.

Joint Injury, Rheumatoid Arthritis, Knee Arthroplasty, Musculoskeletal Stiffness, Pain, Injection Site Pain
on Mar 10, 2014 Female from COUNTRY NOT SPECIFIED , 47 years of age, was diagnosed with and was treated with Humira. Directly after, patient experienced the unwanted or unexpected Humira side effects: joint injury, rheumatoid arthritis, knee arthroplasty, musculoskeletal stiffness, pain, injection site pain. Humira dosage: N/A.

Osteoarthritis, Staphylococcal Infection
Patient was taking Humira. Patient felt the following Humira side effects: osteoarthritis, staphylococcal infection on Mar 10, 2014 from COUNTRY NOT SPECIFIED Additional patient health information: Male , 58 years of age, was diagnosed with and. Humira dosage: N/A.
Multiple prescriptions taken:
  • Folic Acid
  • Losartan
  • Vitamin D
  • Calcium
  • Restoril
  • Aleve
  • Singulair
  • Fish Oil
Patient was hospitalized.

Paraesthesia, Hypoaesthesia, Vision Blurred, Thyroid Cancer
Adverse event was reported on Mar 10, 2014 by a Female taking Humira (Dosage: N/A) was diagnosed with and. Location: GB , 58 years of age, After Humira was administered, patient encountered several Humira side effects: paraesthesia, hypoaesthesia, vision blurred, thyroid cancer.
Multiple concurrent drugs taken:
  • Prednisolone


Heart Valve Stenosis, Neck Surgery, Chest Pain, Bone Cancer, Gastroenteritis, Monoclonal Gammopathy, Pain In Jaw
on Mar 24, 2014 Female from COUNTRY NOT SPECIFIED , 59 years of age, was diagnosed with and was treated with Humira. Directly after, patient experienced the unwanted or unexpected Humira side effects: heart valve stenosis, neck surgery, chest pain, bone cancer, gastroenteritis, monoclonal gammopathy, pain in jaw. Humira dosage: N/A.
Associated medications used:
  • Methotrexate
  • Aspirin
  • Atenolol
  • Atenolol
  • Folic Acid
  • Lisiniopril-hctz (20-12.5mg Daily)
  • Vit D3
  • Vit C
Patient was hospitalized.

Cell Marker Increased, Pancreatic Carcinoma, Infection
on Mar 13, 2014 Male from JP , 54 years of age, was diagnosed with and was treated with Humira. Patient felt the following Humira side effects: cell marker increased, pancreatic carcinoma, infection. Humira dosage: N/A.

Connective Tissue Disorder, Systemic Lupus Erythematosus, Obesity Surgery, Butterfly Rash, Arthritis, Off Label Use
Patient was taking Humira. After Humira was administered, patient encountered several Humira side effects: connective tissue disorder, systemic lupus erythematosus, obesity surgery, butterfly rash, arthritis, off label use on Mar 10, 2014 from COUNTRY NOT SPECIFIED Additional patient health information: Female , 35 years of age, weighting 213.2 lb, was diagnosed with and. Humira dosage: N/A.
Multiple concurrent drugs taken:
  • Plaquenil
  • Elavil
  • Prednisone
  • Xanax
  • Ambien
  • Multivitamin
  • Vitamin D
  • Biotin
Patient was hospitalized.

Pallor, Feeling Abnormal, Vulval Abscess, Unevaluable Event
Adverse event was reported on Mar 10, 2014 by a Female taking Humira (Dosage: N/A) was diagnosed with and. Location: COUNTRY NOT SPECIFIED , 16 years of age, weighting 98.08 lb, Directly after, patient experienced the unwanted or unexpected Humira side effects: pallor, feeling abnormal, vulval abscess, unevaluable event. Patient was hospitalized.

Arthropathy, Wound, Blood Pressure Decreased, Oral Herpes
on Mar 10, 2014 Female from COUNTRY NOT SPECIFIED , weighting 125.1 lb, was diagnosed with and was treated with Humira. Patient felt the following Humira side effects: arthropathy, wound, blood pressure decreased, oral herpes. Humira dosage: N/A.
Multiple prescriptions taken:
  • Indomethacin


Asthenia, Haematochezia, Haematemesis, Dysgeusia, Sleep Disorder
on Mar 20, 2014 Male from COUNTRY NOT SPECIFIED , 58 years of age, was diagnosed with and was treated with Humira. After Humira was administered, patient encountered several Humira side effects: asthenia, haematochezia, haematemesis, dysgeusia, sleep disorder. Humira dosage: N/A. Patient was hospitalized.

Infarction
Patient was taking Humira. Directly after, patient experienced the unwanted or unexpected Humira side effects: infarction on Mar 10, 2014 from COUNTRY NOT SPECIFIED Additional patient health information: Male , 58 years of age, weighting 187.4 lb, was diagnosed with and. Humira dosage: N/A.

Pulmonary Valve Incompetence, Chronic Obstructive Pulmonary Disease
Adverse event was reported on Mar 10, 2014 by a Female taking Humira 40 Mg/ 0.8 Ml Pre-filled Syringe (Dosage: N/A) was diagnosed with and. Location: COUNTRY NOT SPECIFIED , 69 years of age, Patient felt the following Humira side effects: pulmonary valve incompetence, chronic obstructive pulmonary disease.

Rhabdomyolysis, Muscular Weakness, Joint Swelling, Arthralgia
on Mar 10, 2014 Female from COUNTRY NOT SPECIFIED , 55 years of age, was diagnosed with and was treated with Humira. After Humira was administered, patient encountered several Humira side effects: rhabdomyolysis, muscular weakness, joint swelling, arthralgia. Humira dosage: N/A.
Multiple concurrent drugs taken:
  • Depakote
  • Depakote
  • Baclofen
  • Baclofen (5/325 Mg)
  • Baclofen


Bunion, Scar, Foot Deformity, Joint Dislocation, Hyperkeratosis, Synovitis
on Mar 27, 2014 Female from COUNTRY NOT SPECIFIED , weighting 137.1 lb, was diagnosed with and was treated with Humira. Directly after, patient experienced the unwanted or unexpected Humira side effects: bunion, scar, foot deformity, joint dislocation, hyperkeratosis, synovitis. Humira dosage: N/A.
Associated medications used:
  • Methotrexate
  • Arava (Every Other Day)
  • Vimovo
  • Plaquenil
  • Folic Acid
  • Elavil
  • Azithromycin
  • Nexium


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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Humira Side Effects

    Did You Have a Humira Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Humira for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    Alternative HUMIRA Names:ADALIMUMA

    Active Ingredient:

    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