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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

RITUXAN: 487 Adverse Event Reports & Safety Profile

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487
Total FAERS Reports
71 (14.6%)
Deaths Reported
160
Hospitalizations
487
As Primary/Secondary Suspect
23
Life-Threatening
7
Disabilities

First Report: 2004 · Latest Report: 20140611

What Are the Most Common RITUXAN Side Effects?

#1 Most Reported
Arthralgia
39 reports (8.0%)
#2 Most Reported
Drug ineffective
37 reports (7.6%)
#3 Most Reported
Death
37 reports (7.6%)

All RITUXAN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Arthralgia 39 8.0% 1 19
Death 37 7.6% 37 4
Drug ineffective 37 7.6% 2 10
Off label use 34 7.0% 3 20
Infusion related reaction 33 6.8% 0 11
Pyrexia 33 6.8% 1 22
Dyspnoea 30 6.2% 0 16
Nausea 26 5.3% 0 11
Fatigue 25 5.1% 1 15
Rash 24 4.9% 1 11
Weight decreased 24 4.9% 1 9
Hypotension 23 4.7% 0 11
Pain 22 4.5% 2 8
Blood pressure increased 21 4.3% 0 3
Pneumonia 21 4.3% 3 14
Chills 20 4.1% 0 4
Headache 20 4.1% 1 8
Asthenia 19 3.9% 1 11
Anaphylactic reaction 18 3.7% 1 2
Cough 18 3.7% 0 10

Who Reports RITUXAN Side Effects? Age & Gender Data

Average age: 60.1 years. Most reports from: US. View detailed demographics →

Is RITUXAN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 1 0 0
2005 1 0 1
2006 1 0 1
2007 1 0 0
2008 2 0 1
2009 4 0 2
2010 9 1 7
2011 12 1 8
2012 46 1 24
2013 107 16 36
2014 57 12 20

View full timeline →

What Is RITUXAN Used For?

IndicationReports
Rheumatoid arthritis 130
Product used for unknown indication 104
Chronic lymphocytic leukaemia 56
Non-hodgkin's lymphoma 25
B-cell lymphoma 24
Granulomatosis with polyangiitis 23
Lymphoma 13
Vasculitis 13
Immune thrombocytopenic purpura 12
Waldenstrom's macroglobulinaemia 9

RITUXAN vs Alternatives: Which Is Safer?

RITUXAN vs RITUXIMAB RITUXAN vs RITUXIMAB-ABBS RITUXAN vs RITUXIMAB-ARRX RITUXAN vs RITUXIMAB-PVVR RITUXAN vs RIVAROXABAN RITUXAN vs RIVASTIGMINE RITUXAN vs RIVOTRIL RITUXAN vs RIZATRIPTAN RITUXAN vs ROACTEMRA RITUXAN vs ROCURONIUM

Official FDA Label for RITUXAN

Official prescribing information from the FDA-approved drug label.