Adalimumab is used alone or in combination with methotrexate to treat rheumatoid arthritis and juvenile idiopathic arthritis.

Adalimumab may also be used in adults and children to treat many inflammatory conditions such as Crohn's disease, juvenile idiopathic arthritis, uveitis, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and hidradenitis suppurativa. Some brand forms of adalimumab are used only in adults.

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

Before you start using adalimumab, tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

Tell your doctor if you've had or been exposed to tuberculosis or fungal infection, or if you recently traveled or plan to travel. Some infections are more common in certain parts of the world, and you may be exposed during travel.

Tell your doctor if you have or have ever had:

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

Make sure you are current on all vaccines before you start using adalimumab.

Using adalimumab may increase your risk of developing other cancers. Ask your doctor about this risk.

It is not known if adalimumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Tell your baby's doctor if you used adalimumab during pregnancy. It could affect your baby's vaccination schedule.

Ask a doctor if it is safe to breastfeed while using this medicine.

Use Idacio Prefilled 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 signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

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

• fever, swollen glands, body aches, night sweats, not feeling well;
• pale skin, rash, easy bruising or bleeding;
• cold hands and feet, feeling light-headed or short of breath;
• pain in your upper stomach that may spread to your shoulder; or
• feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

• skin changes such as red scaly patches or pus filled bumps;
• new or worsening heart problems--swelling, rapid weight gain, feeling short of breath;
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lupus-like symptoms--muscle or joint pain, flu symptoms, chest pain, and a rash or patchy skin color that worsens in sunlight;
• nervous system problems--numbness, tingling, dizziness, vision problems, weakness in your arms or legs; or
• signs of tuberculosis--fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Your treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• headache, skin rash;
• cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat; or
• pain, redness, rash, bruising, itching, or swelling where an 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.

Avoid injecting into skin that is hard, red, bruised, swollen, tender, has scars, or stretch marks.

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

Avoid receiving a "live" vaccine, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).