Adalimumab reduces the effects of a substance in the body that can cause inflammation.

Adalimumab is used to treat many inflammatory conditions in adults, such as ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and a skin condition called hidradenitis suppurativa.

Adalimumab is also used in adults and children to treat Crohn's disease, juvenile idiopathic arthritis, or uveitis.

Adalimumab may also be used for purposes not listed in this medication guide.

Before you start using adalimumab, tell your doctor if you have signs of infection--fever, chills, sweats, muscle aches, tiredness, cough, bloody mucus, skin sores, diarrhea, burning when you urinate, or feeling constantly tired.

Adalimumab should not be given to a child younger than 2 years old (or 6 years old if treating Crohn's disease). Children using adalimumab should be current on all childhood immunizations before starting treatment.

Tell your doctor if you have ever had:

• tuberculosis (or if anyone in your household has tuberculosis);
• a chronic infection;
• cancer;
• hepatitis B (adalimumab can cause hepatitis B to come back or get worse);
• diabetes;
• heart failure;
• any numbness or tingling, or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome;
• an allergy to latex rubber;
• if you are scheduled to have major surgery; or
• if you have recently received or are scheduled to receive any vaccine.

Tell your doctor where you live and if you have recently traveled or plan to travel. You may be exposed to infections that are common to certain areas of the world.

Adalimumab may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn's disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant. Make sure any doctor caring for your newborn baby knows if you used adalimumab while you were pregnant.

It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor about any risks.

Use Humira Pre-Filled Syringe (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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.

Call your doctor right away if you have any symptoms of lymphoma:

• fever, swollen glands, night sweats, general feeling of illness;
• joint and muscle pain, skin rash, easy bruising or bleeding;
• pale skin, feeling light-headed or short of breath, cold hands and feet;
• pain in your upper stomach that may spread to your shoulder; or
• loss of appetite, feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

• new or worsening psoriasis (raised, silvery flaking of the skin);
• a sore or bump on your skin that does not heal;
• symptoms of sepsis--confusion, chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
• liver problems--body aches, tiredness, stomach pain, right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lupus-like syndrome--joint pain or swelling, chest pain, shortness of breath, patchy skin color that worsens in sunlight;
• nerve problems--numbness, tingling, dizziness, vision problems, weakness in your arms or legs; or
• signs of tuberculosis--fever with ongoing cough, weight loss (fat or muscle).

Older adults may be more likely to develop infections or cancer while using adalimumab.

Common side effects may include:

• headache;
• cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat;
• rash; or
• redness, bruising, itching, or swelling where the injection was given.

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.

Do not inject adalimumab into skin that is bruised, red, tender, or hard.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using adalimumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).