FDA label
What is Remicade used for?
Remicade contains infliximab. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Remicade lists 8 uses: Crohn's Disease; Pediatric Crohn's Disease; Ulcerative Colitis; Pediatric Ulcerative Colitis; and 4 more.
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Indications and Usage, quoted from the label by Janssen Biotech, Inc. (BLA103772). Cross-references to other label sections are left out.
Crohn's Disease
REMICADE is indicated for:
- reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy.
- reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD.
Pediatric Crohn's Disease
REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy.
Ulcerative Colitis
REMICADE is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.
Pediatric Ulcerative Colitis
REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy.
Rheumatoid Arthritis
REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA).
Ankylosing Spondylitis
REMICADE is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS).
Psoriatic Arthritis
REMICADE is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA).
Plaque Psoriasis
REMICADE is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis (Ps) who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. REMICADE should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed Warning and Warnings and Precautions].
Source: DailyMed label, set id a0a046c1-056d-45a9-bfd9-13b47c24f257, version 37, effective June 3, 2025. NDC 57894-030, one of 1 listing for this product.
Questions
What is Remicade used for?
The FDA label for Remicade lists 8 uses: Crohn's Disease; Pediatric Crohn's Disease; Ulcerative Colitis; Pediatric Ulcerative Colitis; and 4 more.
What drug class is Remicade?
FDA lists infliximab in the Tumor Necrosis Factor Blocker established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.