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Rituximab: uses, dosing, side effects & brands

Rituximab is a cd20-directed cytolytic antibody sold in the U.S. under one brand, for rheumatoid arthritis, lymphoid leukemia and granulomatosis with polyangiitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class
Cd20-Directed Cytolytic Antibody
Treats
Rheumatoid Arthritis, Lymphoid Leukemia and Granulomatosis with Polyangiitis
Available as
Injectable
Sold as
Rituxan
Prescription?
Prescription only
Generic available?
Not in our catalog
Boxed warning
Boxed warning

How rituximab is dosed

From the FDA label for Rituxan (application BLA103705). Other rituximab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Administer only as an intravenous infusion ( 2.1 ). Do not administer as an intravenous push or bolus ( 2.1 ). RITUXAN should only be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions that can be fatal if they occur. ( 2.1 ). The dose for adult and pediatric B-cell NHL is 375 mg/m 2 ( 2.2 ). The dose for CLL is 375 mg/m 2 in the first cycle and 500 mg/m 2 in cycles 2–6, in combination with FC, administered every 28 days ( 2.3 ). The dose as a component of Zevalin ® (ibritumomab tiuxetan) Therapeutic Regimen is 250 mg/m 2 ( 2.4 ). The dose for RA in combination with methotrexate is two-1,000 mg intravenous infusions separated by 2 weeks (one course) every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks. Methylprednisolone 100 mg intravenous or equivalent glucocorticoid is recommended 30 minutes prior to each infusion ( 2.5 ). The induction dose for adult patients with active GPA and MPA in combination with glucocorticoids is 375 mg/m 2 once weekly for 4 weeks. The follow up dose for adult patients with GPA and MPA who have achieved disease control with induction treatment, in combination with glucocorticoids is two 500 mg intravenous infusions separated by two weeks, followed by a 500 mg intravenous infusion every 6 months thereafter based on clinical evaluation ( 2.6 ). The…

Rituximab side effects

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Infusion-related reactions [see Warnings and Precautions (5.1) ] Severe mucocutaneous reactions [see Warnings and Precautions (5.2) ] Hepatitis B reactivation with fulminant hepatitis [see Warnings and Precautions (5.3) ] Progressive multifocal leukoencephalopathy [see Warnings and Precautions (5.4) ] Tumor lysis syndrome [see Warnings and Precautions (5.5) ] Infections [see Warnings and Precautions (5.6) ] Cardiovascular adverse reactions [see Warnings and Precautions (5.7) ] Renal toxicity [see Warnings and Precautions (5.8) ] Bowel obstruction and perforation [see Warnings and Precautions (5.9) ] Most common adverse reactions in clinical trials were: NHL (greater than or equal to 25%): infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia ( 6.1 ). Pediatric B-NHL/B-AL with chemotherapy (Grade 3 or higher greater than 15%): febrile neutropenia, stomatitis, enteritis, sepsis, alanine aminotransferase increased and hypokalemia ( 6.1 ). CLL (greater than or equal to 25%): infusion-related reactions and neutropenia ( 6.1 ). RA (greater than or equal to 10%): upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis (other important adverse reactions include infusion-related reactions, serious…

Who shouldn’t take rituximab

None. None ( 4 )

Rituximab drug interactions

Formal drug interaction studies have not been performed with RITUXAN. In patients with CLL, RITUXAN did not alter systemic exposure to fludarabine or cyclophosphamide. In clinical trials of patients with RA, concomitant administration of methotrexate or cyclophosphamide did not alter the pharmacokinetics of rituximab. Renal toxicity when used in combination with cisplatin ( 5.8 ).

Every rituximab 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: Rituxan.

Combination products containing rituximab

A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.

How long rituximab keeps

The date on a sealed pack is not the only one: some rituximab labels start a second clock once the product is opened or mixed, as short as 24 hours.

Does rituximab expire? The in-use limits and storage rules from its labels

Rituximab and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Rituximab is a genetically engineered chimeric murine/human monoclonal antibody that targets CD20, a B-cell-specific surface antigen. The amount in milk is very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Numerous breastfed infants apparently experienced no adverse effects during maternal use of rituximab, including no adverse effect on the CD19 +B cell count. The manufacturer recommends that breastfeeding be discontinued during rituximab therapy and for 6 months after the last dose. However, professional guidelines consider rituximab to be acceptable for use during breastfeeding. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant. Breastfeeding can resume after the injection. One group recommends waiting for 4 hours after the pre-injection antihistamine dose before resuming breastfeeding.

Full LactMed record for rituximab: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised July 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about rituximab

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 173,359 reports naming rituximab, and the FDA flagged 95% 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:

  • rheumatoid arthritis16,338 reports
  • fatigue13,769 reports
  • pneumonia11,657 reports
  • rash11,082 reports
  • arthralgia10,950 reports
  • drug intolerance10,439 reports
  • infusion related reaction10,424 reports
  • pyrexia10,235 reports

Read these as a signal, not a rate. A report does not mean rituximab 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 26, 2026.

Related calculators

Frequently asked questions

What is rituximab?

Rituxan (Rituximab) is a cd20-directed cytolytic antibody used to treat Rheumatoid Arthritis, Lymphoid Leukemia, Granulomatosis with Polyangiitis, B-Cell Lymphoma.

What kind of drug is rituximab?

The FDA classifies rituximab as a cd20-directed cytolytic antibody. 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 rituximab 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 rituximab 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 rituximab come in?

Across the brands we track, rituximab 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 rituximab?

We do not currently list a generic-labelled rituximab 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.

Cite this page
APA
pharmaranks. (2026, July 24). Rituximab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/rituximab
MLA
“Rituximab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/rituximab.

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 rituximab on DailyMed (NIH) ↗ — including its boxed warning in full.