Infliximab: uses, dosing, side effects & brands
Infliximab is a tumor necrosis factor blocker sold in the U.S. under one brand, for rheumatoid arthritis, ulcerative colitis and crohn disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Tumor Necrosis Factor Blocker
- Treats
- Rheumatoid Arthritis, Ulcerative Colitis and Crohn Disease
- Available as
- Injectable
- Sold as
- Remicade
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How infliximab is dosed
From the FDA label for Remicade (application BLA103772). Other infliximab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Prior to treatment, ensure appropriate personnel and medication are available to treat reactions (e.g., hypersensitivity) that occur during infusion and shortly after infusion. ( 2.11 ) REMICADE is administered by intravenous infusion for at least 2 hours with an in-line filter ( 2.11 ) Crohn's Disease : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg every 8 weeks if they later lose their response. ( 2.1 ) Pediatric Crohn's Disease (≥ 6 years old) : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. ( 2.2 ) Ulcerative Colitis : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. ( 2.3 ) Pediatric Ulcerative Colitis (≥ 6 years old) : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. ( 2.4 ) Rheumatoid Arthritis : In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks. ( 2.5 ) Ankylosing Spondylitis : 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks. ( 2.6 ) Psoriatic Arthritis and Plaque Psoriasis : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. ( 2.7 , 2.8 ) 2.1 Dosage in Adult Crohn's Disease The recommended dosage of REMICADE is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen…
Infliximab side effects
Most common adverse reactions (>10%) – infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults The data described herein reflect exposure to REMICADE in 4779 adult patients (1304 patients with RA, 1106 patients with CD, 202 with AS, 293 with PsA, 484 with UC, 1373 with Ps, and 17 patients with other conditions), including 2625 patients exposed beyond 30 weeks and 374 exposed beyond 1 year. [For information on adverse reactions in pediatric patients see Adverse Reactions (6.1) ]. One of the most-common reasons for discontinuation of treatment was infusion-related reactions (e.g., dyspnea, flushing, headache and rash). Infusion-Related Reactions Adverse Reactions During or Shortly After Infusion An infusion reaction was defined in clinical trials as any adverse event occurring during an infusion or within 1 hour after an infusion. In all the clinical…
Who shouldn’t take infliximab
The use of REMICADE at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ] . REMICADE is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of REMICADE or any murine proteins [severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness] [see Warnings and Precautions (5.7) and Adverse Reactions (6.1) ]. REMICADE doses >5 mg/kg in moderate or severe heart failure. ( 4 ) Previous severe hypersensitivity reaction to infliximab or any inactive ingredients of REMICADE or to any murine proteins. ( 4 )
Infliximab drug interactions
Other Biological Products – increased risk of serious infections. ( 7.1 ) 7.1 Other Biological Products The combination of REMICADE with other biological products used to treat the same conditions as REMICADE is not recommended [see Warnings and Precautions (5.10) ] . 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. Because of the nature of the adverse reactions seen with these combinations with TNF blocker therapy, similar toxicities may also result from the combination of anakinra or abatacept with other TNF blockers. Therefore, the combination of REMICADE and anakinra or abatacept is not recommended [see Warnings and Precautions (5.10) ] . The concomitant use of tocilizumab with biological DMARDs such as TNF antagonists, including REMICADE, should be avoided because of the possibility of increased immunosuppression and increased risk of infection. 7.2 Methotrexate and Other Concomitant Medications Specific drug interaction studies, including interactions with methotrexate (MTX), have not been conducted. The majority of patients in RA or CD clinical studies received one or more concomitant medications. In RA, concomitant medications besides MTX were nonsteroidal anti-inflammatory agents (NSAIDs), folic acid, corticosteroids and/or narcotics. Concomitant CD medications were antibiotics, antivirals, corticosteroids, 6-MP/AZA and aminosalicylates. In PsA clinical trials, concomitant medications included MTX in approximately half of the patients as well as NSAIDs, folic acid and corticosteroids. Concomitant MTX use may decrease the incidence of anti-infliximab antibody production and increase infliximab concentrations. 7.3 Immunosuppressants Patients with CD who received immunosuppressants tended to experience fewer infusion reactions compared to patients on no immunosuppressants [see Adverse Reactions (6.1) ] . 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. 7.4 Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation. Therefore, it is expected that for a molecule that antagonizes cytokine activity, such as infliximab, the formation of CYP450 enzymes could be normalized. Upon initiation or discontinuation of REMICADE 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. 7.5 Live Vaccines/Therapeutic Infectious Agents It is recommended that live vaccines not be given concurrently with REMICADE. It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab for at least 6 months following birth [see Warnings and Precautions (5.13) ] . It is recommended that therapeutic infectious agents not be given concurrently with REMICADE [see Warnings and Precautions (5.13) ] .
Every infliximab product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Remicade.
Infliximab recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Infliximab and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for infliximab: levels in milk, effects in breastfed infants, and the drugs it would consider insteadInfliximab is usually either not detectable in breastmilk or detectable at very low levels in milk. Absorption of the drug from milk by the infant is minimal. The measurement of minute concentrations in the milk of some women raises the possibility of local immune suppression in the gastrointestinal tract, but levels were not high enough to be of concern for systemic immunosuppression. Follow-up of infants exposed in utero and breastfed during maternal infliximab therapy have found no adverse effects on the development of breastfed infants or increase the risk of infections. Waiting for at least 2 weeks postpartum to resume therapy suspended during pregnancy may minimize transfer to the infant. However, in infants of mothers who received infliximab during late pregnancy, continued use while breastfeeding does not prolong infliximab elimination by the infant. Numerous experts and professional guidelines have stated that infliximab is a low risk to the nursing infant and acceptable to use during breastfeeding. Anti-TNF agents appear to reduce the levels of tumor necrosis factor and IP-10 in the milk of mothers with inflammatory bowel disease in the early postpartum period. This reduction in TNF might lead to decreased milk production, so extra lactation support might be necessary in women taking infliximab.
National Institute of Child Health and Human Development, record revised June 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about infliximab
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 68,229 reports naming infliximab, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- intentional product use issue10,068 reports
- arthralgia8,247 reports
- fatigue6,597 reports
- inappropriate schedule of product administration6,070 reports
- nausea5,655 reports
- weight increased5,470 reports
- headache5,419 reports
- malaise5,287 reports
Read these as a signal, not a rate. A report does not mean infliximab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is infliximab?
Remicade (Infliximab) is a tumor necrosis factor blocker used to treat Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Ankylosing Spondylitis.
What kind of drug is infliximab?
The FDA classifies infliximab as a tumor necrosis factor blocker. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take infliximab with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run infliximab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does infliximab come in?
Across the brands we track, infliximab is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic infliximab?
We do not currently list a generic-labelled infliximab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has infliximab been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions infliximab. The most recent: Inflectra (infliximab-dyyb) (Jan 17, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Infliximab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/infliximab
- MLA
- “Infliximab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/infliximab.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for infliximab on DailyMed (NIH) ↗ — including its boxed warning in full.