"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 Patient Information Including Side Effects
Brand Names: Humira, Humira Pen, Humira Pen Crohns Disease/Ulcerative Colitis Starter Package
Generic Name: adalimumab (Pronunciation: AY da LIM ue mab)
- What is adalimumab (Humira)?
- What are the possible side effects of adalimumab (Humira)?
- What is the most important information I should know about adalimumab (Humira)?
- What should I discuss with my healthcare provider before using adalimumab (Humira)?
- How should I use adalimumab (Humira)?
- What happens if I miss a dose (Humira)?
- What happens if I overdose (Humira)?
- What should I avoid while using adalimumab (Humira)?
- What other drugs will affect adalimumab (Humira)?
- Where can I get more information?
What is adalimumab (Humira)?
Adalimumab reduces the effects of a substance in the body that can cause inflammation.
Adalimumab is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. It is also used to treat Crohn's disease or ulcerative colitis in adults, after other drugs have been tried without successful treatment of symptoms.
Adalimumab may also be used for purposes not listed in this medication guide.
What are the possible side effects of adalimumab (Humira)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using adalimumab and call your doctor right away if you have any of these symptoms of lymphoma:
- fever, night sweats, weight loss, tiredness;
- feeling full after eating only a small amount;
- pain in your upper stomach that may spread to your shoulder;
- easy bruising or bleeding, pale skin, feeling light-headed, rapid heart rate; or
- liver problems--nausea, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Stop using adalimumab and call your doctor at once if you have any of these other serious side effects:
- signs of infection (fever, chills, sore throat, vomiting, diarrhea, flu symptoms);
- shortness of breath with swelling of your ankles or feet;
- confusion, neck stiffness, seizure (convulsions);
- pain or burning when you urinate;
- sudden numbness or weakness, sudden severe headache, problems with vision or balance;
- chest pain, sudden or ongoing cough, wheezing, rapid breathing, coughing up mucus or blood;
- tingly feeling, weakness or prickly feeling in your fingers or toes;
- problems with balance or eye movement, trouble speaking or swallowing;
- severe lower back pain, loss of bladder or bowel control;
- pain, swelling, warmth, or redness in one or both legs;
- red, purple, or scaly skin rash, hair loss, muscle pain, mouth sores;
- joint pain or swelling, swollen glands, muscle aches, unusual thoughts or behavior; or
- patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).
Other common side effects may include:
- stuffy nose, sinus pain;
- mild stomach pain; or
- pain, redness, itching, swelling, or bleeding where you injected the medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Humira (adalimumab) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about adalimumab (Humira)?
Some people using adalimumab have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using adalimumab or similar medicines to treat Crohn's disease or ulcerative colitis.
Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
Adalimumab can lower blood cells that help your body fight infections and help your blood to clot. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Serious and sometimes fatal infections may occur during treatment with adalimumab. Tell your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with adalimumab.
Additional Humira Information
- Humira Drug Interactions Center: adalimumab subq
- Humira Side Effects Center
- Humira Overview including Precautions
- Humira FDA Approved Prescribing Information including Dosage
Humira - User Reviews
Humira User Reviews
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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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