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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.

MABTHERA: 627 Adverse Event Reports & Safety Profile

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627
Total FAERS Reports
154 (24.6%)
Deaths Reported
274
Hospitalizations
627
As Primary/Secondary Suspect
59
Life-Threatening
28
Disabilities

First Report: 2004 · Latest Report: 20140616

What Are the Most Common MABTHERA Side Effects?

#1 Most Reported
Death
71 reports (11.3%)
#2 Most Reported
Pyrexia
37 reports (5.9%)
#3 Most Reported
Progressive multifocal leukoencephalopathy
25 reports (4.0%)

All MABTHERA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Death 71 11.3% 71 3
Pyrexia 37 5.9% 5 24
Pain 25 4.0% 4 17
Progressive multifocal leukoencephalopathy 25 4.0% 6 10
Dyspnoea 23 3.7% 4 14
Vomiting 23 3.7% 1 22
Arthralgia 22 3.5% 0 17
Drug ineffective 22 3.5% 2 12
Infection 20 3.2% 1 15
Malaise 20 3.2% 0 12
Diarrhoea 19 3.0% 3 14
Headache 18 2.9% 2 15
Neutropenia 18 2.9% 2 9
Pain in extremity 18 2.9% 0 11
Pneumonia 18 2.9% 5 11
Hypertension 17 2.7% 1 12
Off label use 17 2.7% 2 4
Thrombocytopenia 17 2.7% 2 14
Nausea 16 2.6% 0 10
Chills 15 2.4% 3 4

Who Reports MABTHERA Side Effects? Age & Gender Data

Average age: 60.0 years. Most reports from: FR. View detailed demographics →

Is MABTHERA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 1 0 0
2006 3 1 2
2007 4 1 4
2008 7 0 3
2009 18 1 13
2010 22 3 15
2011 10 2 5
2012 34 8 21
2013 169 27 103
2014 131 19 62

View full timeline →

What Is MABTHERA Used For?

IndicationReports
Rheumatoid arthritis 169
Non-hodgkin's lymphoma 100
Product used for unknown indication 66
B-cell lymphoma 52
Chronic lymphocytic leukaemia 44
Diffuse large b-cell lymphoma 39
Lymphoma 27
Mantle cell lymphoma 16
Systemic lupus erythematosus 11
Non-hodgkin's lymphoma unspecified histology aggressive 9

MABTHERA vs Alternatives: Which Is Safer?

MABTHERA vs MACITENTAN MABTHERA vs MACITENTAN\TADALAFIL MABTHERA vs MAGNESIUM MABTHERA vs MAGNESIUM ASPARTATE MABTHERA vs MAGNESIUM ASPARTATE\POTASSIUM ASPARTATE MABTHERA vs MAGNESIUM HYDROXIDE MABTHERA vs MAGNESIUM OROTATE MABTHERA vs MAGNESIUM SALICYLATE MABTHERA vs MAGNESIUM\MAGNESIUM HEPTAHYDRATE MABTHERA vs MAGNESIUM\POTASSIUM\SODIUM

Official FDA Label for MABTHERA

Official prescribing information from the FDA-approved drug label.