Infliximab Injection
Infliximab injection is a TNF blocker given by intravenous infusion to treat inflammatory conditions including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Infliximab carries a serious warning about life-threatening infections and certain cancers. Because it dampens part of the immune system, it significantly raises the risk of serious infections — including tuberculosis (TB), bacterial blood infections (sepsis), and invasive fungal infections like histoplasmosis. These infections can require hospitalization or be fatal. You must be tested for TB before starting, and the medication should be stopped if a serious infection develops.
Lymphoma and other cancers, some fatal, have been reported in children, adolescents, and young adults treated with infliximab and similar drugs. A rare, very aggressive blood cancer called hepatosplenic T-cell lymphoma (HSTCL) has occurred mostly in young males with Crohn's disease or ulcerative colitis who were also taking azathioprine or 6-mercaptopurine. Watch for unexplained weight loss, night sweats, fever, or swollen lymph nodes and report them to your doctor right away.
📖 Infliximab Injection: Patient Information Guide
A plain-language walkthrough of Infliximab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Infliximab injection treats a range of serious inflammatory conditions in adults and some in children. Here is the full list of supported uses:
- Moderately to severely active Crohn's disease in adults — to reduce symptoms, induce and maintain remission, and close draining fistulas
- Moderately to severely active Crohn's disease in children ages 6 and older — to reduce symptoms and maintain remission
- Moderately to severely active ulcerative colitis in adults — to reduce symptoms, achieve remission, promote mucosal healing, and reduce or eliminate corticosteroid use
- Moderately to severely active ulcerative colitis in children ages 6 and older — to reduce symptoms and maintain remission
- Moderately to severely active rheumatoid arthritis in adults — used in combination with methotrexate to reduce symptoms, slow joint damage, and improve physical function
- Active ankylosing spondylitis in adults — to reduce signs and symptoms
- Active psoriatic arthritis in adults — to reduce symptoms, slow structural joint damage, and improve physical function
- Chronic severe plaque psoriasis in adults who are candidates for systemic therapy and when other systemic therapies are less appropriate
⚙️How it works▾
Infliximab is a biologic medication that targets and blocks a protein called TNF-alpha (tumor necrosis factor-alpha). TNF-alpha is found at abnormally high levels in the joints, gut, skin, and other tissues of people with inflammatory diseases like rheumatoid arthritis, Crohn's disease, and psoriasis. By binding tightly to both the circulating and cell-surface forms of TNF-alpha, infliximab prevents it from triggering the chain reaction of inflammation — reducing the activity of inflammatory cells, lowering levels of inflammatory markers, and helping damaged tissues recover.
Importantly, infliximab does not block a closely related protein called TNF-beta, which uses the same receptors. This selectivity is part of how the drug is designed to target the right pathway.
💊How it's taken▾
Infliximab is always given as a slow intravenous (IV) infusion at a clinic or infusion center — never at home or by self-injection. Each infusion takes at least 2 hours and is administered through a vein by a trained healthcare professional.
- Treatment typically begins with a loading series of infusions at weeks 0, 2, and 6, then continues with regular maintenance infusions every 6 to 8 weeks, depending on the condition
- For rheumatoid arthritis, it is always given alongside methotrexate
- For ankylosing spondylitis, maintenance infusions are generally given every 6 weeks
- Your prescriber sets the exact schedule and monitors your response — follow their instructions and do not miss appointments
🤒Side effects — in detail▾
The most common side effects reported with infliximab include:
- Infections of the upper respiratory tract (colds, sinusitis, sore throat)
- Infusion reactions — such as flushing, headache, chills, rash, or shortness of breath — occurring during or within 1 hour after the infusion
- Headache
- Abdominal pain
- Fever or chills
- Elevated liver enzymes on blood tests
Serious reactions — including severe allergic reactions, life-threatening infections, and liver problems — can also occur. Contact your care team right away or go to an emergency room if you experience signs of a serious infection, difficulty breathing, chest pain, or jaundice (yellowing of the skin or eyes).
⚠️Warnings & precautions▾
Serious infections are the most urgent risk. Infliximab suppresses part of the immune system, which can allow dangerous infections to take hold — including tuberculosis, severe fungal infections (like histoplasmosis), and bacterial or viral infections. These can require hospitalization or be fatal. All patients must be tested for TB before starting and monitored throughout treatment. Infliximab must be stopped if a serious infection develops.
- Cancer risk: Lymphoma and other malignancies, including a rare fatal blood cancer (hepatosplenic T-cell lymphoma), have been reported — mostly in young males with Crohn's disease or ulcerative colitis also taking azathioprine or 6-mercaptopurine
- Liver damage: Severe liver reactions, some fatal or requiring liver transplant, have been reported; stop infliximab if jaundice or markedly elevated liver enzymes occur
- Hepatitis B reactivation: Patients must be tested for hepatitis B before starting; carriers must be monitored closely
- Heart failure: New or worsening heart failure symptoms may occur; higher doses are contraindicated in moderate to severe heart failure
- Nervous system effects: New or worsening demyelinating disease (damage to nerve sheaths, like multiple sclerosis) may occur
- Lupus-like syndrome: A drug-induced lupus-like reaction can develop; stop infliximab if this occurs
- Infusion reactions: Severe allergic reactions including anaphylaxis can occur during or after infusion; appropriate treatment must be on hand
- Skin cancers: Melanoma and Merkel cell carcinoma have been reported; periodic skin exams are recommended, especially for those with prior phototherapy
🔀What it interacts with▾
Infliximab can interact with several other medications, raising the risk of serious side effects:
- Anakinra or abatacept: Combining either of these with infliximab significantly increases the risk of serious infections — this combination is not recommended
- Tocilizumab: Using tocilizumab with infliximab increases the risk of over-suppression of the immune system and serious infection — avoid this combination
- Other biologics for the same conditions: Combining infliximab with other biologics used for the same diseases is not recommended
- Live vaccines: Should not be given while taking infliximab; infants exposed to infliximab in the womb should not receive live vaccines for at least 6 months after birth
- Warfarin, cyclosporine, theophylline: Infliximab may alter how the body processes these drugs; extra monitoring and possible dose adjustments are needed
- Methotrexate: Commonly used with infliximab; may reduce the body's immune response to the drug and increase infliximab levels in the blood
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Active infection: Do not start infliximab if you have any active infection, including a localized one — treatment must be delayed until the infection is resolved
- Tuberculosis: Must be tested for both latent (hidden) and active TB before starting; if the test is positive, TB treatment must begin first
- Hepatitis B: Must be tested before starting; carriers are monitored during and for several months after treatment
- Heart failure: Higher doses are contraindicated if you have moderate to severe heart failure; discuss all heart conditions with your doctor
- History of cancer: Use caution if you have a personal history of any malignancy, including lymphoma or skin cancers
- Pregnancy: Infliximab crosses the placenta in the third trimester and can be detected in infants for up to 6 months after birth; infants may face an increased risk of infection and should not receive live vaccines for at least 6 months — discuss the risks and benefits with your doctor
- Breastfeeding: Infliximab is present in breast milk at low levels; systemic exposure to the infant is expected to be low, but discuss with your doctor
- Children: Approved for Crohn's disease and ulcerative colitis in patients ages 6 and older; safety and effectiveness in younger children have not been established
- History of nerve disease: Tell your doctor if you have or have had demyelinating diseases such as multiple sclerosis
- Vaccinations: Pediatric patients should be brought up to date on all vaccinations before starting infliximab
🚑If you take too much▾
Single doses up to 20 mg/kg have been given in studies without direct toxic effects observed. If an overdose occurs, the patient should be monitored for any signs or symptoms of adverse reactions and given appropriate supportive care right away.
📡Pharmacodynamics — effects in the body▾
TNF-alpha is found at elevated levels in the tissues and fluids of people with rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. When infliximab blocks TNF-alpha, it reduces the infiltration of inflammatory cells into affected joints, gut lining, and skin. In clinical studies, treatment reduced inflammatory markers such as IL-6 and C-reactive protein (CRP) in rheumatoid arthritis and Crohn's disease patients. In psoriatic arthritis and plaque psoriasis, infliximab reduced the number of inflammatory T-cells and blood vessels in affected tissue, and may reduce the thickness of psoriatic skin plaques.
🔬Pharmacokinetics — how your body processes it▾
Infliximab is given directly into the bloodstream by IV infusion and distributes primarily within the vascular (blood vessel) compartment. Its median half-life — the time for the body to clear half of the drug — is approximately 7.7 to 9.5 days. Following the initial dose, infusions at weeks 2 and 6 produce consistent and predictable drug levels in the blood. If a patient's body develops antibodies against infliximab, the drug is cleared more quickly, which can reduce its effectiveness.
📦How to store it▾
Store unopened Infliximab vials in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F). stored at room temperatures up to a maximum of 30 °C (86 °F) for a single period of up to 6 months but not exceeding the original expiration date.
📄 Written from Infliximab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Infliximab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is infliximab and how is it given to me? ▾
What are the most common side effects I should expect? ▾
Should I be worried about serious infections while on infliximab? ▾
I've heard infliximab can cause cancer — how worried should I be? ▾
Can I get vaccinated while I'm on infliximab? ▾
Is it safe to take infliximab if I'm pregnant or breastfeeding? ▾
Is Infliximab Injection available over the counter? ▾
When was Infliximab Injection first available? ▾
Who makes Infliximab Injection? ▾
💬 Answers drafted from Infliximab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Infliximab Injection comes
Infliximab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Treats moderately to severely active Crohn's disease (including fistulizing disease) in adults, and in children ages 6 and older
- Treats moderately to severely active ulcerative colitis in adults and in children ages 6 and older
- Treats moderately to severely active rheumatoid arthritis in adults (used in combination with methotrexate), as well as ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis in adults
- Renflexis is administered by intravenous infusion over at least 2 hours using an in-line filter, prepared and given by a trained healthcare professional
- Renflexis is typically given as an initial induction series (at weeks 0, 2, and 6), then as maintenance infusions every 6 to 8 weeks depending on the condition
- Renflexis should not be infused through the same IV line as any other medication
- Before each Renflexis infusion, appropriate staff and medications to treat allergic or infusion reactions must be available
📊 Infliximab Injection across the U.S. market
How Infliximab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Infliximab Injection is used
A general measure of how commonly Infliximab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Infliximab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Infliximab Injection prescribed? Of the 1,596 medications we measure, Infliximab Injection ranks #510 by Medicaid prescriptions — more than 68% of them.
Utilization by Infliximab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
infliximab 100 MG Injection Most dispensed
Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310994
infliximab-dyyb 100 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790541
infliximab-abda 100 MG Injection
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1927285
infliximab-axxq 100 MG Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2266525
1 ML infliximab-dyyb 120 MG/ML Pen Injector
Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2675742
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Infliximab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 7 of 15 listed Infliximab Injection NDCs with Medicaid activity.
🔍 Compare Infliximab Injection products
A representative set of FDA-listed product records for Infliximab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 100 mg/10 mL | Intravenous | Janssen Biotech, Inc. × 4 listings | BLA | View NDC → |
| 100 mg | Intravenous | Merck Sharp & Dohme Corp. | BLA | View NDC → |
| 100 mg | Intravenous | Merck Sharp & Dohme LLC | BLA | View NDC → |
| 100 mg | Intravenous | Organon LLC × 4 listings | BLA | View NDC → |
| 100 mg/10 mL | — | Patheon Italia S.p.A. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 100 mg | — | SAMSUNG BIOLOGICS Co., Ltd. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 100 mg | — | Samsung BioLogics Co. LTD | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 13 of 13 products — FDA National Drug Code Directory. See every product, package size and price: browse all 13 Infliximab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Infliximab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Infliximab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Infliximab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 191831 3 dose forms · 6 strengths
-
Dose form (SCDF) Injection RxCUI 1655941In current FDA listingsClinical drug / strength (SCD) abda 100 MGRxCUI 1927285axxq 100 MGRxCUI 2266525dyyb 100 MGRxCUI 1790541100 MGRxCUI 310994 -
Dose form (SCDF) Pen Injector RxCUI 2675740In current FDA listingsClinical drug / strength (SCD) 1 ML infliximab-dyyb 120 MG/MLRxCUI 2675742 -
Dose form (SCDF) Prefilled Syringe RxCUI 2675751No current FDA listingClinical drug / strength (SCD) 1 ML infliximab-dyyb 120 MG/MLRxCUI 2675753
Look up RxCUI 191831 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Infliximab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Infliximab Injection belongs to the Tumor Necrosis Factor Blocker class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 4 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Merck Sharp & Dohme Corp. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.