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Remicade
Infliximab
$865.00
100mg · 1 vial
Brand· By Janssen Cilag
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100mg
FDA boxed warningSerious infections and malignancy
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.
Discontinue REMICADE if a patient develops a serious infection.
Perform test for latent TB; if positive, start treatment for TB prior to starting REMICADE. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including REMICADE.
Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including REMICADE. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of REMICADE cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males.
About Remicade
Overview
Remicade is a prescription medicine containing infliximab, supplied in a vial for preparation as an intravenous infusion. It treats moderately to severely active Crohn’s disease and ulcerative colitis in adults and children aged 6 years and older when conventional treatment has not worked adequately. In adults, it also treats moderately to severely active rheumatoid arthritis with methotrexate, active ankylosing spondylitis, active psoriatic arthritis, and chronic severe plaque psoriasis when whole-body treatment is appropriate and other such treatments are medically less suitable. It works by binding to and blocking TNFα, a protein involved in inflammation.
What it treats
- Moderately to severely active Crohn’s disease in adults and children aged 6 years and older when conventional treatment has not worked adequately. - Fistulizing Crohn’s disease in adults. - Moderately to severely active ulcerative colitis in adults and children aged 6 years and older when conventional treatment has not worked adequately. - Moderately to severely active rheumatoid arthritis in adults, in combination with methotrexate. - Active ankylosing spondylitis in adults. - Active psoriatic arthritis in adults. - Chronic severe plaque psoriasis in adults who are candidates for systemic treatment and for whom other systemic treatments are medically less appropriate.
Safety information
Side effects
Common side effects include infections such as upper respiratory infections, sinusitis and throat infections, reactions during or after an infusion, headache and abdominal pain. Serious side effects require prompt medical attention. These include serious infections, including invasive fungal infections; reactivation of hepatitis B; severe liver injury, which can be fatal or require a liver transplant; new or worsening heart failure; low blood cell counts; new or worsening conditions that damage the protective covering of nerves; and a lupus-like syndrome. Contact your doctor promptly if an infection develops or you notice yellowing of the skin or eyes. Serious allergic or infusion reactions, including anaphylaxis and serum sickness-like reactions, can occur. Strokes, heart attacks, some fatal, and abnormal heart rhythms have been reported during an infusion or within 24 hours of its start. Seek immediate medical attention for a serious reaction or signs of low blood cell counts. Cancers, including invasive cervical cancer and lymphoma, occurred more often in people treated with Remicade than in those in the control groups. The risk of hepatosplenic T-cell lymphoma requires particular consideration in males with Crohn’s disease or ulcerative colitis who are also receiving azathioprine or 6-mercaptopurine. Discuss this risk with your doctor.
FDA boxed warning
Serious infections and malignancy
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.
Discontinue REMICADE if a patient develops a serious infection.
Perform test for latent TB; if positive, start treatment for TB prior to starting REMICADE. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including REMICADE.
Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including REMICADE. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of REMICADE cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not use Remicade if you have previously had a severe allergic reaction to infliximab, any of its inactive ingredients, or mouse proteins. Remicade should not be given during an active infection. Moderate or severe heart failure restricts which doses may be used; your prescriber must assess whether treatment is appropriate. Remicade can cause new or worsening heart failure. Conditions requiring particular caution include hepatitis B infection, liver problems, low blood cell counts, and demyelinating disease, which affects the protective covering of nerves. Testing for hepatitis B is required before treatment. Carriers need monitoring during treatment and for several months afterwards because the virus may reactivate. Serious infections, including invasive fungal infections, can occur. Tell your prescriber if you live in or travel to areas where these fungal infections are common. Remicade also carries a risk of cancer, including lymphoma and invasive cervical cancer. The risk of a rare lymphoma called HSTCL needs particular consideration in males with Crohn’s disease or ulcerative colitis who receive azathioprine or 6-mercaptopurine. Serious infusion reactions, severe liver injury, stroke, heart attack, abnormal heart rhythms and lupus-like reactions may occur. Monitoring during infusion is required. Seek immediate medical attention if signs or symptoms of low blood cell counts develop. Vaccinations should be up to date before treatment. Live vaccines and treatments containing infectious agents should not be given during Remicade treatment. Infants exposed to infliximab during pregnancy should wait at least six months after birth before receiving live vaccines.
Interactions
Tell your doctor if you use any other biological medicines. Using them with Remicade may increase the risk of serious infections.
Using Remicade
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label REMICADE (INFLIXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN BIOTECH, INC.] (DailyMed, retrieved 19 September 2026).
Patient information and references
Official and supporting information to read alongside advice from your prescriber or pharmacist.
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