The safety of Remicade has been studied in clinical trials across a range of indications reflecting drug exposure in 4,779 adult patients, 1,304 with RA. The most common side effect requiring discontinuation of treatment was infusion reaction, defined as any adverse effect occurring during infusion or within 1 hour afterward, and typically included shortness of breath, flushing, headache, and rash.1
Among patients with RA, the most common side effects or adverse reactions to Remicade included gastrointestinal (GI) effects (nausea, abdominal pain, diarrhea, and dyspepsia), respiratory effects including a variety of respiratory infections, headache, fatigue, and pain.1
Side effects occurring in 5% or more patients* in RA clinical trials
|Side effect||Remicade (N=1,129)||Placebo (N=350)|
|Dyspepsia (upset stomach)||10%||7%|
|Upper respiratory infection||32%||25%|
|Resistance mechanism disorders|
|Arthralgia (joint pain)||8%||7%|
|Urinary tract infection||8%||6%|
|*Among patients who received 4 or more infusions.|
Warnings and precautions with Remicade
There are several warnings and precautions you should know about before you start treatment with Remicade.
Serious infections. There is an increased risk for developing serious infections with Remicade, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (fungal infection inside the body) such as histoplasmosis, coccidioidomycosis, or blastomycosis (people who live in the Ohio or Mississippi River Valleys are at increased risk for these types of infections), and other opportunistic infections (infections that result from microorganisms that normally do not cause diseases in humans). The increased risk of infection with Remicade occurs because the drug can decrease the ability of the immune system to fight infections. If you develop a serious infection while taking Remicade, you should discontinue the treatment.1
Before starting treatment with Remicade, you should be tested for latent TB, and, if positive, you should receive treatment for TB before starting Remicade. All patients should be monitored for active TB during treatment with Remicade.1
The signs of TB include a cough that persists, a low-grade fever, weight loss, and loss of body fat and muscle.
If you carry the hepatitis B virus (HBV), a virus that affects the liver, HBV may become active during treatment with Remicade. Before you start treatment with Remicade, as well as during treatment and for several months after you stop treatment, your doctor will give you a blood test to see if you have HBV infection. The signs of HBV infection include muscle aches, fatigue, yellow-looking skin or eyes, dark urine, clay-colored bowel movements, vomiting, fever, chills, stomach ache, skin rash, and loss of appetite. Tell your doctor if you have any of these symptoms.1
Cancer. The risk for developing certain types of cancers, including lymphoma, increases if you are taking Remicade. In particular, cases of a type of lymphoma called fatal hepatosplenic T-cell lymphoma (HSTCL) have occurred in patients treated with anti-TNF drugs including Remicade, mostly in male adolescents and young adults with Crohn’s disease and ulcerative colitis who received Remicade. Remicade may increase the risk of developing two types of skin cancers, basal cell cancer and squamous cell cancer of the skin. While this risk these cancers is small, they do exist.1
Other health conditions. Remicade can cause a worsening of congestive heart failure (signs include shortness of breath, swelling of feet or ankles, and sudden weight gain), demyelinating disease (such as MS), a Lupus-like autoimmune disorder, cytopenia (a deficiency of cells that make up blood, with symptoms including bruising, bleeding, or persistent fever), liver toxicity (symptoms include jaundice and elevated liver enzymes), or severe hypersensitivity (allergic) reactions including anaphylaxis. If you experience any of these, contact your doctor immediately.1 Patients diagnosed with multiple sclerosis or other demyelinating disease should not use Remicade.
Pregnancy and nursing
Remicade is a pregnancy category B drug. There have been no well-controlled studies in pregnant women. Like other IgG antibodies, Remicade does cross the placental barrier and has been found in the serum of infants up to the age of 6 months and may increase risk of infection in new born infants. Therefore, Remicade should be used during pregnancy only if it is clearly needed.1
Remicade is excreted into human milk. Because of the risk of adverse effects, women who are taking Remicade should not breastfeed their children.1
Because of the increased risk for developing infections and the lack of any increased benefit, you should not take Remicade with other biologics used to treat the same conditions as Remicade, including Orencia (abatacept), Kineret (anakinra), Rituxan (rituximab), Actemra (tocilizumab).1
Taking Remicade may influence the way your body metabolizes other drugs. Therefore, the doses of these drugs may need to be changed. Drugs that are affected in this way include warfarin (Coumadin), cyclosporine, and theophylline.1