Remicade Side Effects

Remicade (infliximab) reduces the effects of a substance in the body that can cause inflammation.

Remicade is used to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, and ankylosing spondylitis. It is also used to treat severe or disabling plaque psoriasis (raised, silvery flaking of the skin).

Remicade is often used when other medicines have not been effective.

You should not use Remicade if you are allergic to infliximab, or if you are also being treated with anakinra (Kineret) or abatacept (Orencia). Some people using Remicade 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 Remicade or similar medicines to treat Crohn’s disease or ulcerative colitis.

However, people with autoimmune disorders (including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.

Before using Remicade, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure you can safely take Remicade, tell your doctor if you have any of these other conditions:

  • severe heart failure, or other heart problems;
  • an active or recent infection, open sores or skin wounds;
  • diabetes;
  • liver disease (especially hepatitis B);
  • epilepsy or other seizure disorder;
  • chronic obstructive pulmonary disease (COPD);
  • a history of cancer;
  • a weak immune system;
  • numbness or tingling anywhere in your body;
  • a disease that affects the nerves or muscles, such as multiple sclerosis or Guillain-Barre syndrome;
  • if you have recently been vaccinated with BCG (Bacille Calmette-GuĂ©rin); or
  • if you are scheduled to receive any vaccines.

FDA pregnancy category B. It is not known whether Remicade will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Remicade. It is not known whether infliximab passes into breast milk. You should not breast-feed while you are receiving infliximab. Remicade is not for use in children younger than 6 years old.

Some people receiving an Remicade injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy or tingly, swollen, short of breath, or have a headache, fever, chills, flu symptoms, muscle or joint pain, pain or tightness in your throat, chest pain, or trouble swallowing during the injection. Infusion reactions may also occur within 1 or 2 hours after injection.

Get emergency medical help if you have any of these signs of an allergic reaction to Remicade: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using Remicade 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 or short of breath, rapid heart rate; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Call your doctor at once if you have any of these other serious side effects:

  • signs of infection (fever, chills, flu symptoms, confusion, or pain, warmth, or redness of your skin);
  • chest pain, ongoing cough, coughing up mucus or blood;
  • shortness of breath with swelling of your ankles or feet, rapid weight gain;
  • numbness or tingling;
  • easy bruising or bleeding, pale skin, unusual weakness;
  • weak feeling in your arms or legs;
  • problems with vision;
  • neck stiffness, seizure (convulsions);
  • pain or burning when you urinate; or
  • red, purple, or scaly skin rash, hair loss, joint or muscle pain, mouth sores.

Less serious Remicade side effects may include:

  • stuffy nose, sinus pain, headache;
  • mild stomach pain;
  • mild skin rash; or
  • flushing (warmth, redness, or tingly feeling).

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.