This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.
Truxima is the brand name for rituximab, a cd20-directed cytolytic antibody. According to the FDA-approved label, TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. FAERS contains 210,163 submissions naming this drug from 1999 through 2026; the top three reactions cited are off label use, drug ineffective, and rheumatoid arthritis.
Most-Reported Reactions
Counts of the reactions most often cited in FAERS submissions that named Truxima. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.
Patient Demographics
Patient sex and age across the FAERS submissions that named Truxima. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.
By Sex
By Age Group
Severity Outcomes
Severity flags recorded across the 210,163 FAERS submissions that named Truxima. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.
Submissions Per Quarter
Quarterly count of FAERS submissions that named Truxima. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.
From the FDA-Approved Label
Excerpts from the official FDA-approved prescribing information for Truxima. This is the authoritative source on indications, warnings, and known adverse reactions.
Indications
1 INDICATIONS AND USAGE TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens. Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have ina...
Adverse Reactions (from label)
6 ADVERSE REACTIONS 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 ). 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 infu...
AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.
