"Sept. 28, 2012 -- The FDA has approved Abbott's Humira for the treatment of moderate to severe ulcerative colitis.
Humira (adalimumab) now is approved for both forms of inflammatory bowel disease (IBD): ulcerative colitis and Crohn's "...
Humira Consumer (continued)
Redness, itching, pain, or swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: fast/irregular/pounding heartbeat, stomach pain, blood in the stools, mental/mood changes, severe headache, easy bruising or bleeding, dark urine, yellowing eyes and skin, leg pain or swelling, numbness or tingling of the arms/hands/legs/feet, unsteadiness, unexplained muscle weakness, difficulty with speaking/chewing/swallowing/facial movements, vision changes, extreme fatigue, joint pain, butterfly-shaped rash on the nose and cheeks.
Get medical help right away if you have any very serious side effects, including: seizures, chest pain.
Tell your doctor right away if you develop signs of infection while using this drug, such as: fever, chills, night sweats, persistent sore throat, trouble breathing, painful or frequent urination, persistent cough, unusual vaginal discharge, white patches in the mouth (oral thrush).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Humira (adalimumab) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Warning section.
Before using adalimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past/recurrent infections (such as hepatitis B, TB infection, histoplasmosis), decreased bone marrow function, seizures, certain brain/spinal cord/nerve disorders (demyelinating disorders such as multiple sclerosis, Guillain-Barre syndrome), history of cancer (e.g., lymphoma), a certain type of heart disease (heart failure), lupus.
Adalimumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be at greater risk for infections while using this drug.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This drug passes into breast milk in small amounts. Consult your doctor before breast-feeding.
Additional Humira Information
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Report Problems to the Food and Drug Administration
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.
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