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LABELS · 3bfeaa57-8d95-4bc9-8bb5-274271688470

INFLIXIMAB

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-02-11
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. 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. ( 5.1 ) Discontinue Infliximab if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting Infliximab. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ( 5.1 ) Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including Infliximab. ( 5.2 ) Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including Infliximab. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of Infliximab cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. ( 5.2 ) SERIOUS INFECTIONS Patients treated with Infliximab are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Infliximab should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Infliximab use and during therapy. Treatment for latent infection should be initiated prior to Infliximab use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with Infliximab should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Infliximab, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Infliximab [see Warnings and Precautions (5.2) ] . Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including Infliximab. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of reported Infliximab cases have occurred in patients with Crohn's disease or ulcerative colitis and most were in adolescent and young adult males.

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Infliximab is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.1 ) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. ( 1.1 ) Pediatric Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.2 ) Ulcerative Colitis : reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.3 ) Pediatric Ulcerative Colitis : reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.4 ) Rheumatoid Arthritis in combination with methotrexate : reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease. ( 1.5 ) Ankylosing Spondylitis : reducing signs and symptoms in adult patients with active disease. ( 1.6 ) Psoriatic Arthritis : reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients. ( 1.7 ) Plaque Psoriasis : treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. ( 1.8 ) 1.1 Crohn's Disease Infliximab 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. 1.2 Pediatric Crohn's Disease Infliximab 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. 1.3 Ulcerative Colitis Infliximab 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. 1.4 Pediatric Ulcerative Colitis Infliximab 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. 1.5 Rheumatoid Arthritis Infliximab, 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). 1.6 Ankylosing Spondylitis Infliximab is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). 1.7 Psoriatic Arthritis Infliximab 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). 1.8 Plaque Psoriasis Infliximab 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. Infliximab 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 (5) ] .
Full extracted label fields
application numbers
  1. BLA103772
boxed warning exact
  1. WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. 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. ( 5.1 ) Discontinue Infliximab if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting Infliximab. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ( 5.1 ) Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including Infliximab. ( 5.2 ) Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including Infliximab. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of Infliximab cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. ( 5.2 ) SERIOUS INFECTIONS Patients treated with Infliximab are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Infliximab should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Infliximab use and during therapy. Treatment for latent infection should be initiated prior to Infliximab use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with Infliximab should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Infliximab, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Infliximab [see Warnings and Precautions (5.2) ] . Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including Infliximab. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of reported Infliximab cases have occurred in patients with Crohn's disease or ulcerative colitis and most were in adolescent and young adult males.
brand names
  1. INFLIXIMAB
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b05c174f-832c-4321-b34f-2c4ad3742269
generic names
  1. INFLIXIMAB
id
3bfeaa57-8d95-4bc9-8bb5-274271688470
indications and usage exact
  1. 1 INDICATIONS AND USAGE Infliximab is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.1 ) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. ( 1.1 ) Pediatric Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.2 ) Ulcerative Colitis : reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.3 ) Pediatric Ulcerative Colitis : reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.4 ) Rheumatoid Arthritis in combination with methotrexate : reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease. ( 1.5 ) Ankylosing Spondylitis : reducing signs and symptoms in adult patients with active disease. ( 1.6 ) Psoriatic Arthritis : reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients. ( 1.7 ) Plaque Psoriasis : treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. ( 1.8 ) 1.1 Crohn's Disease Infliximab 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. 1.2 Pediatric Crohn's Disease Infliximab 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. 1.3 Ulcerative Colitis Infliximab 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. 1.4 Pediatric Ulcerative Colitis Infliximab 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. 1.5 Rheumatoid Arthritis Infliximab, 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). 1.6 Ankylosing Spondylitis Infliximab is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). 1.7 Psoriatic Arthritis Infliximab 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). 1.8 Plaque Psoriasis Infliximab 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. Infliximab 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 (5) ] .
indications and usage tables exact
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    1. Janssen Biotech, Inc.
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    1. 57894-160-01
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      substance names
      1. INFLIXIMAB
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      Drugs@FDA application source records
      1. application number
        BLA103772
        payload
        all indexed label documents
        1. Appl No
          103772
          Application Docs Date
          2004-03-26 00:00:00
          Application Docs ID
          18630
          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
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          Application Docs Date
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          Application Docs ID
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          103772
          Application Docs Date
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          103772
          Application Docs Date
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          0
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        5. Appl No
          103772
          Application Docs Date
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          0
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          103772
          Application Docs Date
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          0
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          103772
          Application Docs Date
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          18636
          Application Docs Title
          0
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          2
          Submission No
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        8. Appl No
          103772
          Application Docs Date
          2006-10-23 00:00:00
          Application Docs ID
          18637
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5145
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        9. Appl No
          103772
          Application Docs Date
          2007-01-08 00:00:00
          Application Docs ID
          18638
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5163
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          SUPPL
        10. Appl No
          103772
          Application Docs Date
          2006-08-18 00:00:00
          Application Docs ID
          18639
          Application Docs Title
          0
          Application Docs Type ID
          2
          Application Docs URL
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          Submission No
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          Submission Type
          SUPPL
        11. Appl No
          103772
          Application Docs Date
          2007-07-05 00:00:00
          Application Docs ID
          18640
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5189
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          SUPPL
        12. Appl No
          103772
          Application Docs Date
          2009-05-07 00:00:00
          Application Docs ID
          18641
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5234
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        all submission records
        1. Appl No
          103772
          Review Priority
          STANDARD
          Submission Class Code ID
          3
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          Submission Status
          AP
          Submission Status Date
          2008-12-22 00:00:00
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          Submissions Public Notes
        2. Appl No
          103772
          Review Priority
          Submission Class Code ID
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          Submission Type
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          Submissions Public Notes
        3. Appl No
          103772
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
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          Submission Status Date
          2009-11-18 00:00:00
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        4. Appl No
          103772
          Review Priority
          STANDARD
          Submission Class Code ID
          3
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          5259
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          Submission Status Date
          2010-12-28 00:00:00
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          Submissions Public Notes
        5. Appl No
          103772
          Review Priority
          STANDARD
          Submission Class Code ID
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          AP
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          Submissions Public Notes
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          103772
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          STANDARD
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          Submissions Public Notes
        7. Appl No
          103772
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5281
          Submission Status
          AP
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          2011-02-17 00:00:00
          Submission Type
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          Submissions Public Notes
        8. Appl No
          103772
          Review Priority
          STANDARD
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          Submissions Public Notes
        9. Appl No
          103772
          Review Priority
          STANDARD
          Submission Class Code ID
          3
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          AP
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          Submissions Public Notes
        10. Appl No
          103772
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          PRIORITY
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          Submission No
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          AP
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          2011-09-23 00:00:00
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          Submissions Public Notes
        11. Appl No
          103772
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submissions Public Notes
        12. Appl No
          103772
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          Submissions Public Notes
        application number
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          Application Docs Date
          2025-03-03 00:00:00
          Application Docs ID
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          0
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        products
        1. Active Ingredient
          INFLIXIMAB
          Appl No
          103772
          Drug Name
          REMICADE
          Form
          VIAL
          Product No
          001
          Reference Drug
          0
          Reference Standard
          Strength
          100MG
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
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      1 INDICATIONS AND USAGE Infliximab is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.1 ) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. ( 1.1 ) Pediatric Crohn's Disease : reduc
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                                                                                            Source null
                                                                                            biomarker and test
                                                                                            Source null
                                                                                            disease stage
                                                                                            Source null
                                                                                            limitations
                                                                                            Source null
                                                                                            line
                                                                                            Source null
                                                                                            prior therapy
                                                                                            Source null
                                                                                            regimen
                                                                                            Source null
                                                                                            tumor histology
                                                                                            Source null
                                                                                            use intent
                                                                                            non_oncology_or_unclear_candidate
                                                                                            Passage 21 · risk or warning
                                                                                            application numbers
                                                                                            1. BLA103772
                                                                                            brand names
                                                                                            1. INFLIXIMAB
                                                                                            classification reasons
                                                                                            1. risk_or_warning_words_without_positive_predicate
                                                                                            clinical review status
                                                                                            pending
                                                                                            content role
                                                                                            risk_or_warning
                                                                                            context span
                                                                                            end
                                                                                            4419
                                                                                            end exclusive
                                                                                            true
                                                                                            exact text
                                                                                            f 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. Infliximab 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 (5) ] .
                                                                                            label id
                                                                                            3bfeaa57-8d95-4bc9-8bb5-274271688470
                                                                                            offset unit
                                                                                            unicode_code_points
                                                                                            source array index
                                                                                            0
                                                                                            source field
                                                                                            indications_and_usage_exact
                                                                                            source text sha256
                                                                                            2dadf91605342e08312e14b3baefd154b683329106bd3b5361020a9a34e0989c
                                                                                            start
                                                                                            4032
                                                                                            current approval status
                                                                                            not_reconciled
                                                                                            duplicate text group
                                                                                            dup-762cefc01ac8afaa20ca
                                                                                            extraction review status
                                                                                            automated_candidate_pending_source_review
                                                                                            generic names
                                                                                            1. INFLIXIMAB
                                                                                            id
                                                                                            ind-span-9e911652de9ffcdad2be
                                                                                            label id
                                                                                            3bfeaa57-8d95-4bc9-8bb5-274271688470
                                                                                            positive predicate support span
                                                                                            Source null
                                                                                            qualifier mentions
                                                                                              regulatory links
                                                                                                schema version
                                                                                                0.1.0
                                                                                                source batch sha256
                                                                                                d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                                                                                source defined aliases
                                                                                                  source span
                                                                                                  end
                                                                                                  4419
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  Infliximab 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 (5) ] .
                                                                                                  label id
                                                                                                  3bfeaa57-8d95-4bc9-8bb5-274271688470
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                                                                                                  unicode_code_points
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                                                                                                  0
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                                                                                                  source text sha256
                                                                                                  2dadf91605342e08312e14b3baefd154b683329106bd3b5361020a9a34e0989c
                                                                                                  start
                                                                                                  4232
                                                                                                  source url
                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%223bfeaa57-8d95-4bc9-8bb5-274271688470%22
                                                                                                  spl effective date
                                                                                                  2026-02-11
                                                                                                  spl set id
                                                                                                  b05c174f-832c-4321-b34f-2c4ad3742269
                                                                                                  spl version
                                                                                                  5
                                                                                                  structured fields status
                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                  structured indication
                                                                                                  age
                                                                                                  Source null
                                                                                                  approval pathway
                                                                                                  Source null
                                                                                                  biomarker and test
                                                                                                  Source null
                                                                                                  disease stage
                                                                                                  Source null
                                                                                                  limitations
                                                                                                  Source null
                                                                                                  line
                                                                                                  Source null
                                                                                                  prior therapy
                                                                                                  Source null
                                                                                                  regimen
                                                                                                  Source null
                                                                                                  tumor histology
                                                                                                  Source null
                                                                                                  use intent
                                                                                                  not_applicable

                                                                                                  Preserved source evidence · Not medical advice