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Fatigue (105)
Depression (67)
Mental Fog (53)
Blurry Vision (46)
Dry Eyes (46)
Diarrhea (24)
Dry Eyes, Blurry Vision (23)
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Humira Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 59650 

Ocular Discomfort, Vision Blurred, Foreign Body In Eye, Arthralgia, Retinal Detachment, Visual Impairment (8477871-5)
on Jun 20, 2012 Male from MEXICO , weighting 196.2 lb, was diagnosed with
  • ankylosing spondylitis
and was treated with Humira. Directly after, patient experienced the unwanted or unexpected Humira side effects: ocular discomfort, vision blurred, foreign body in eye, arthralgia, retinal detachment, visual impairment. Humira dosage: N/A.
Associated medications used:
  • Antalgin


Crohn's Disease (8477695-9)
Patient was taking Humira. Patient felt the following Humira side effects: crohn's disease on Jun 19, 2012 from FRANCE Additional patient health information: Male , weighting 140.7 lb, was diagnosed with
  • crohn's disease
and. Humira dosage: N/A.
Multiple prescriptions taken:
  • Prednisone
  • Methotrexate
  • Remicade
Patient was hospitalized.

Gastrostomy (8477682-0)
Adverse event was reported on Jun 18, 2012 by a Male taking Humira (Dosage: N/A) . Location: FRANCE , weighting 88.18 lb, After Humira was administered, patient encountered several Humira side effects: gastrostomy.
Multiple concurrent drugs taken:
  • Infliximab, Recombinant
  • Vancomycin
Patient was hospitalized.

Insomnia, Gastrointestinal Oedema, Intestinal Obstruction, Abdominal Pain (8477594-2)
on Jun 20, 2012 Male from UNITED STATES , weighting 151.1 lb, was diagnosed with
  • crohn's disease
and was treated with Humira. Directly after, patient experienced the unwanted or unexpected Humira side effects: insomnia, gastrointestinal oedema, intestinal obstruction, abdominal pain. Humira dosage: N/A.
Associated medications used:
  • Iron
Patient was hospitalized.


Painful Respiration, Pulmonary Embolism, Pneumonia, Angina Pectoris, Extrasystoles, Oedema Peripheral, Renal Failure (8477533-4)
on Jun 22, 2012 Female from GERMANY , weighting 152.1 lb, was diagnosed with
  • rheumatoid arthritis
and was treated with Humira. Patient felt the following Humira side effects: painful respiration, pulmonary embolism, pneumonia, angina pectoris, extrasystoles, oedema peripheral, renal failure. Humira dosage: N/A.
Multiple prescriptions taken:
  • Pantoprazole
  • Ergocalciferol
  • Xarelto
  • Atohexal
  • Tilidin
Patient was hospitalized.

Neuropathy Peripheral (8477197-X)
Patient was taking Humira. After Humira was administered, patient encountered several Humira side effects: neuropathy peripheral on Jun 25, 2012 from UNITED STATES Additional patient health information: Male , 64 years of age, weighting 190.0 lb, was diagnosed with
  • rheumatoid arthritis
and. Humira dosage: 40mg Every 2 Weeks Sq 4 Doses.

Intestinal Stenosis, Arthralgia, Abdominal Pain, Anal Fissure, Fistula, Abscess, Ileus, Colonic Stenosis (8476795-7)
Adverse event was reported on Jun 28, 2012 by a Female taking Humira (Dosage: N/A) was diagnosed with
  • crohn's disease
and. Location: GERMANY , weighting 158.7 lb, Directly after, patient experienced the unwanted or unexpected Humira side effects: intestinal stenosis, arthralgia, abdominal pain, anal fissure, fistula, abscess, ileus, colonic stenosis.
Associated medications used:
  • Budesonide
  • Systemic Steriods (Six Times During Past Three Years, Dailyyears)
Patient was hospitalized.

Spinal Decompression, Tendon Rupture, Fall, Hysterectomy, Arthralgia, Hip Arthroplasty, Fat Tissue Increased, Atrial Fibrillation, Pelvic Fracture (8476794-5)
on Jun 18, 2012 Female from UNITED STATES , 76 years of age, was diagnosed with
  • rheumatoid arthritis
and was treated with Humira. Patient felt the following Humira side effects: spinal decompression, tendon rupture, fall, hysterectomy, arthralgia, hip arthroplasty, fat tissue increased, atrial fibrillation, pelvic fracture. Humira dosage: Saturday.
Multiple prescriptions taken:
  • Restasis (1 Drop To Each Eye)
  • Vitron C
  • Lutein
  • Mucinex
  • Aspirin (Daily)
  • Boniva
  • Colace
  • Levothyroxine
Patient was hospitalized.

Intracranial Aneurysm (8476732-5)
on Jun 28, 2012 Male from COLOMBIA , weighting 136.7 lb, was diagnosed with
  • ankylosing spondylitis
and was treated with Humira. After Humira was administered, patient encountered several Humira side effects: intracranial aneurysm. Humira dosage: N/A.

Malignant Melanoma (8476726-X)
Patient was taking Humira. Directly after, patient experienced the unwanted or unexpected Humira side effects: malignant melanoma on Jun 20, 2012 from FRANCE Additional patient health information: Male , weighting 172.0 lb, . Humira dosage: N/A.
Associated medications used:
  • Urea (1 Application)


Injection Site Warmth, Injection Site Pain, Injection Site Pruritus, Injection Site Reaction, Injection Site Erythema, Hypersensitivity (8476713-1)
Adverse event was reported on Jun 18, 2012 by a Male taking Humira (Dosage: 4 Injections (induction Phase)) was diagnosed with
  • crohn's disease
and. Location: BELGIUM , 33 years of age, Patient felt the following Humira side effects: injection site warmth, injection site pain, injection site pruritus, injection site reaction, injection site erythema, hypersensitivity.

Vomiting, Nausea, Herpes Zoster Ophthalmic, Eyelid Oedema, Herpes Simplex (8476709-X)
on Jun 21, 2012 Female from CANADA , weighting 106.1 lb, was treated with Humira. After Humira was administered, patient encountered several Humira side effects: vomiting, nausea, herpes zoster ophthalmic, eyelid oedema, herpes simplex. Humira dosage: N/A.
Multiple concurrent drugs taken:
  • Prednisone Tab
  • Vitamin D
Patient was hospitalized.

Cervical Dysplasia (8476707-6)
on Jun 21, 2012 Female from NETHERLANDS , weighting 165.3 lb, was diagnosed with
  • psoriasis
and was treated with Humira. Directly after, patient experienced the unwanted or unexpected Humira side effects: cervical dysplasia. Humira dosage: Initial Dose 80 Mg Then 40 Mg.
Associated medications used:
  • Ustekinumab


Frequent Bowel Movements, Intestinal Resection, Crohn's Disease (8476704-0)
Patient was taking Humira. Patient felt the following Humira side effects: frequent bowel movements, intestinal resection, crohn's disease on Jun 20, 2012 from CANADA Additional patient health information: Male , weighting 92.08 lb, was diagnosed with
  • crohn's disease
and. Humira dosage: N/A.

Crohn's Disease, Intestinal Resection, Frequent Bowel Movements (8476703-9)
Adverse event was reported on Jun 20, 2012 by a Male taking Humira (Dosage: N/A) was diagnosed with
  • crohn's disease
and. Location: CANADA , weighting 92.08 lb, After Humira was administered, patient encountered several Humira side effects: crohn's disease, intestinal resection, frequent bowel movements.

Subileus, Crohn's Disease, Intestinal Stenosis (8476311-X)
on Jun 18, 2012 Female from FRANCE , 41 years of age, was diagnosed with
  • crohn's disease
and was treated with Humira. Directly after, patient experienced the unwanted or unexpected Humira side effects: subileus, crohn's disease, intestinal stenosis. Humira dosage: N/A. Patient was hospitalized.

Foetal Exposure During Pregnancy, Heart Rate Decreased (8475964-X)
on Jun 19, 2012 Male from GERMANY , weighting 6.04 lb, was treated with Humira. Patient felt the following Humira side effects: foetal exposure during pregnancy, heart rate decreased. Humira dosage: N/A.

Arthritis Bacterial, Staphylococcal Infection, Device Dislocation (8475843-8)
Patient was taking Humira. After Humira was administered, patient encountered several Humira side effects: arthritis bacterial, staphylococcal infection, device dislocation on Jun 19, 2012 from GERMANY Additional patient health information: Female , 48 years of age, weighting 189.6 lb, was diagnosed with
  • rheumatoid arthritis
and. Humira dosage: N/A.
Multiple concurrent drugs taken:
  • Leflunomide (20mg Daily)
  • Prednisolone (5mg Daily)
  • Metoprolol Tartrate (200mg Daily)
  • Sulfasalazine (1000mg Daily)
Patient was hospitalized.

Colitis Ischaemic (8475642-7)
Adverse event was reported on Jun 27, 2012 by a Female taking Humira (Dosage: N/A) was diagnosed with
  • rheumatoid arthritis
and. Location: UNITED KINGDOM , weighting 119.0 lb, Directly after, patient experienced the unwanted or unexpected Humira side effects: colitis ischaemic.

Toxic Skin Eruption (8475573-2)
on Jun 19, 2012 Female from JAPAN , 58 years of age, was diagnosed with
  • rheumatoid arthritis
and was treated with Humira. Patient felt the following Humira side effects: toxic skin eruption. Humira dosage: N/A.

Colitis, Gastrointestinal Inflammation, Dehydration, Diarrhoea, Sensory Disturbance, Injection Site Pain, Crohn's Disease, Cystitis, Arthralgia (8475571-9)
on Jun 21, 2012 Female from UNITED STATES , weighting 135.1 lb, was diagnosed with
  • crohn's disease
and was treated with Humira. After Humira was administered, patient encountered several Humira side effects: colitis, gastrointestinal inflammation, dehydration, diarrhoea, sensory disturbance, injection site pain, crohn's disease, cystitis, arthralgia. Humira dosage: N/A. Patient was hospitalized.

Transaminases Abnormal (8475481-7)
Patient was taking Humira. Directly after, patient experienced the unwanted or unexpected Humira side effects: transaminases abnormal on Jun 21, 2012 from GERMANY Additional patient health information: Female , weighting 207.2 lb, was diagnosed with
  • rheumatoid arthritis
and. Humira dosage: N/A. Patient was hospitalized.

Application Site Erosion, Product Quality Issue, Adrenal Disorder, Thyroid Disorder, Application Site Reaction (8474232-X)
Adverse event was reported on Jun 18, 2012 by a Female taking Humira (Dosage: N/A) was diagnosed with
  • psoriatic arthropathy
and. Location: UNITED STATES , weighting 190.0 lb, Patient felt the following Humira side effects: application site erosion, product quality issue, adrenal disorder, thyroid disorder, application site reaction.
Multiple prescriptions taken:
  • Duragesic-100
  • Duragesic-100


Hyperhidrosis, Unevaluable Event, Mobility Decreased, Nausea, Retching, Feeling Hot (8474209-4)
on Jun 26, 2012 Female from UNITED STATES , 57 years of age, weighting 127.0 lb, was treated with Humira. After Humira was administered, patient encountered several Humira side effects: hyperhidrosis, unevaluable event, mobility decreased, nausea, retching, feeling hot. Humira dosage: 40 Mg, Unk.
Multiple concurrent drugs taken:
  • Gadavist (7.5 Ml, Once)
  • Metoprolol Tartrate (50 Mg, Bid)


Myocarditis, Pleurisy (8473229-3)
on Jun 22, 2012 Male from FRANCE , weighting 172.0 lb, was diagnosed with
  • psoriasis
  • ankylosing spondylitis
and was treated with Humira. Directly after, patient experienced the unwanted or unexpected Humira side effects: myocarditis, pleurisy. Humira dosage: N/A.
Associated medications used:
  • Arava (20mg Daily)
  • Piroxicam (20 Mg Daily)
Patient was hospitalized.

Showing 1-25 of 59650 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

Alternative HUMIRA Names:ADALIMUMA

Active Ingredient:

Humira Dosage, Warnings, Usage.

Side Effects reported to FDA: 59650. View Humira Adverse Reports

Humira safety alerts: 2009 2008 2004

Reported deaths: 2782

Reported hospitalizations: 17828

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]

 

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