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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.

TYSABRI: 8,210 Adverse Event Reports & Safety Profile

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8,210
Total FAERS Reports
156 (1.9%)
Deaths Reported
1,256
Hospitalizations
8,210
As Primary/Secondary Suspect
36
Life-Threatening
21
Disabilities

First Report: 2004 · Latest Report: 20140616

What Are the Most Common TYSABRI Side Effects?

#1 Most Reported
Multiple sclerosis relapse
811 reports (9.9%)
#2 Most Reported
Fatigue
759 reports (9.2%)
#3 Most Reported
Malaise
523 reports (6.4%)

All TYSABRI Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Multiple sclerosis relapse 811 9.9% 8 241
Fatigue 759 9.2% 0 56
Malaise 523 6.4% 1 37
Gait disturbance 445 5.4% 2 32
Multiple sclerosis 443 5.4% 9 57
Memory impairment 422 5.1% 0 26
Headache 368 4.5% 0 34
Drug ineffective 329 4.0% 2 25
Asthenia 328 4.0% 3 49
Fall 324 4.0% 8 99
Nasopharyngitis 310 3.8% 0 14
Urinary tract infection 308 3.8% 12 117
Pain 274 3.3% 1 37
Balance disorder 260 3.2% 1 25
Hypoaesthesia 259 3.2% 0 32
Stress 214 2.6% 0 15
Mobility decreased 213 2.6% 0 24
Cognitive disorder 211 2.6% 0 15
Pain in extremity 203 2.5% 1 25
Influenza 201 2.5% 0 27

Who Reports TYSABRI Side Effects? Age & Gender Data

Average age: 46.4 years. Most reports from: US. View detailed demographics →

Is TYSABRI Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 2 0 1
2005 5 0 0
2006 6 0 1
2007 33 0 7
2008 56 0 14
2009 59 1 13
2010 90 1 26
2011 145 7 48
2012 332 11 94
2013 1,728 51 447
2014 2,367 24 355

View full timeline →

What Is TYSABRI Used For?

IndicationReports
Multiple sclerosis 7,629
Relapsing-remitting multiple sclerosis 198
Product used for unknown indication 190
Crohn's disease 157
Maternal exposure timing unspecified 15
Exposure via father 5

TYSABRI vs Alternatives: Which Is Safer?

TYSABRI vs TYVASO TYSABRI vs UBIDECARENONE TYSABRI vs UBLITUXIMAB TYSABRI vs UBLITUXIMAB-XIIY TYSABRI vs UBROGEPANT TYSABRI vs ULIPRISTAL TYSABRI vs UMBRALISIB TYSABRI vs UMECLIDINIUM TYSABRI vs UMECLIDINIUM\VILANTEROL TRIFENATATE TYSABRI vs UMIFENOVIR

Official FDA Label for TYSABRI

Official prescribing information from the FDA-approved drug label.