Prescription medicine
Infliximab Brand names: Remicade, Inflectra, Renflexis, Avsola
Infliximab (Remicade) is a prescription medicine with an FDA approval on record since 1998. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the infliximab FDA label on DailyMed (effective August 28, 2026); the BLA 103772 record on Drugs@FDA; every infliximab label on DailyMed.
Highlights of the record
FDA label of August 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 RENFLEXIS if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting RENFLEXIS. 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 products. ( 5.2 ) Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received azathioprine or 6- mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. […]
Used for
From the label: indications and usageRENFLEXIS 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.
Forms and strengths
- 100 mg
- 100 mg/10ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- August 24, 1998 Remicade, Centocor Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 4 of which 0 under generic applications, 4 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2019 0 Class I among all firms' recalls; latest January 17, 2025
- FAERS reports
- 243,740 through July 30, 2026
What is infliximab used for?
From the label: indications and usageRENFLEXIS 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. […]
Conditions named in the indications of infliximab's FDA labels, with every medicine labeled for each:
From other infliximab labelsRheumatoid arthritis: Rheumatoid Arthritis RENFLEXIS, 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 …
Crohn's disease and ulcerative colitis: Crohn's Disease ( 1.1 ):
FDA pharmacologic class: Tumor Necrosis Factor Blocker.
Source: FDA drug label (Renflexis), Organon LLC, effective August 28, 2026 (SPL set dbf738c4-3fac-4422-a9d8-51d9c83a8789), via openFDA; the full label on DailyMed
What does the patient leaflet for infliximab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about RENFLEXIS?RENFLEXIS may cause serious side effects, including: 1. Risk of infection RENFLEXIS is a medicine that affects your immune system. RENFLEXIS can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving RENFLEXIS. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections. Your doctor should test you for TB before starting RENFLEXIS. Your doctor should monitor you closely for signs and symptoms of TB during treatment with RENFLEXIS. Before starting RENFLEXIS, tell your doctor if you: think you have an infection. You should not start receiving RENFLEXIS if you have any kind of infection. are being treated for an infection. have signs of an infection, such as a fever, cough, flu-like symptoms. have any open cuts or sores on your body. get a lot of infections or have infections that keep coming back. have diabetes or an immune system problem. People with these conditions have a higher chance for infections. have TB, or have been in close contact with someone with TB. live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may develop or become more severe if you receive RENFLEXIS. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor. have or have had hepatitis B. use the medicines KINERET (anakinra), ORENCIA (abatacept), ACTEMRA (tocilizumab), or other medicines called biologics used to treat the same conditions as RENFLEXIS. […]
From the patient leaflet: What should I avoid while receiving RENFLEXIS?Do not take RENFLEXIS together with medicines such as KINERET (anakinra), ORENCIA (abatacept), ACTEMRA (tocilizumab), or other medicines called biologics that are used to treat the same conditions as RENFLEXIS. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These include any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis. Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine.
Source: FDA drug label (Renflexis), Organon LLC, effective August 28, 2026 (SPL set dbf738c4-3fac-4422-a9d8-51d9c83a8789), via openFDA; the full label on DailyMed
Is there a generic for infliximab (Remicade)?
No generic infliximab is approved (Drugs@FDA, October 8, 2026).
- 1998 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has infliximab been recalled?
The FDA's Enforcement Report lists 2 recalls naming infliximab since 2019: 0 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 17, 2025 | Class II | McKesson | cGMP Deviations: Product intended for quarantine was inadvertently distributed. |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the infliximab label say about other medicines?
The infliximab label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name infliximab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Abatacept | drug interactions | An increased risk of serious infections was seen in clinical studies of other TNF blockers used in combination with anakinra or abatacept, with no added clinical benefit. |
| Acetaminophen | warnings and precautions | Medications for the treatment of hypersensitivity reactions (e.g., acetaminophen, antihistamines, corticosteroids and/or epinephrine) should be available for immediate use in the event of a reaction [see Dosage and Administration (2.10) and Adverse Reactions (6.1) ]. |
| Anakinra | drug interactions | An increased risk of serious infections was seen in clinical studies of other TNF blockers used in combination with anakinra or abatacept, with no added clinical benefit. |
| Azathioprine | boxed warning | Almost all had received azathioprine or 6- mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. |
| Ciprofloxacin | drug interactions | Serum infliximab concentrations appeared to be unaffected by baseline use of medications for the treatment of CD including corticosteroids, antibiotics (metronidazole or ciprofloxacin) and aminosalicylates. |
| Cyclosporine | drug interactions | Upon initiation or discontinuation of RENFLEXIS in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. |
| Epinephrine | warnings and precautions | Medications for the treatment of hypersensitivity reactions (e.g., acetaminophen, antihistamines, corticosteroids and/or epinephrine) should be available for immediate use in the event of a reaction [see Dosage and Administration (2.10) and Adverse Reactions (6.1) ]. |
| Etanercept | warnings and precautions | Because of the nature of the adverse reactions seen with the concurrent use of etanercept and anakinra therapy, similar toxicities may also result from the concurrent use of anakinra and other TNF blockers. |
| Mercaptopurine | boxed warning | Almost all had received azathioprine or 6- mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. |
| Methotrexate | boxed warning | Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. |
| Metronidazole | drug interactions | Serum infliximab concentrations appeared to be unaffected by baseline use of medications for the treatment of CD including corticosteroids, antibiotics (metronidazole or ciprofloxacin) and aminosalicylates. |
| Theophylline | drug interactions | Upon initiation or discontinuation of RENFLEXIS in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. |
| Tocilizumab | drug interactions | The concomitant use of tocilizumab with biological DMARDs such as TNF antagonists, including RENFLEXIS, should be avoided because of the possibility of increased immunosuppression and increased risk of infection. |
| Warfarin | drug interactions | Upon initiation or discontinuation of RENFLEXIS in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. |
Other labels that name infliximab
Source: FDA drug label (Renflexis), Organon LLC, effective August 28, 2026 (SPL set dbf738c4-3fac-4422-a9d8-51d9c83a8789), via openFDA; the full label on DailyMed
What do FAERS reports show for infliximab?
The FDA Adverse Event Reporting System holds 243,740 reports that list infliximab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14,395 are coded as a death and 70,690 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as infliximab?
3 other medicines are given the same way (intravenous) and in the same FDA class as infliximab or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Golimumab | Rheumatoid arthritis, Crohn's disease and ulcerative colitis | none listed | $12,890.32 per mL 50 mg/0.5 mL pen injec | No current entry |
| Tocilizumab | Rheumatoid arthritis | none listed | $821.00 per mL 162 mg/0.9 mL autoinjct | No current entry |
| Abatacept | Rheumatoid arthritis | none listed | $1,469.23 per mL 125 mg/mL syringe | No current entry |
Every medicine labeled for the same conditions as infliximab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to infliximab
- 3 medicines for the same use
- Other TNF blockers
- the pharmacologic class, with prices and generics
- Infliximab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other