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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.

COPAXONE: 1,268 Adverse Event Reports & Safety Profile

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1,268
Total FAERS Reports
59 (4.7%)
Deaths Reported
165
Hospitalizations
1,268
As Primary/Secondary Suspect
5
Life-Threatening
13
Disabilities

First Report: 1993 · Latest Report: 20140626

What Are the Most Common COPAXONE Side Effects?

#1 Most Reported
Injection site pain
163 reports (12.9%)
#2 Most Reported
Multiple sclerosis relapse
136 reports (10.7%)
#3 Most Reported
Injection site reaction
116 reports (9.1%)

All COPAXONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Injection site pain 163 12.9% 0 4
Multiple sclerosis relapse 136 10.7% 2 31
Injection site reaction 116 9.2% 0 1
Injection site mass 69 5.4% 0 0
Injection site erythema 61 4.8% 0 2
Dyspnoea 58 4.6% 2 11
Death 50 3.9% 50 1
Drug ineffective 45 3.6% 0 5
Fatigue 42 3.3% 0 3
Pain 40 3.2% 1 6
Injection site swelling 36 2.8% 0 1
Multiple sclerosis 35 2.8% 0 4
Asthenia 33 2.6% 1 11
Injection site bruising 33 2.6% 0 1
Fall 31 2.4% 0 11
Hypoaesthesia 31 2.4% 0 5
Malaise 30 2.4% 0 5
Injection site pruritus 29 2.3% 0 1
Pruritus 29 2.3% 0 4
Urticaria 29 2.3% 0 0

Who Reports COPAXONE Side Effects? Age & Gender Data

Average age: 47.6 years. Most reports from: US. View detailed demographics →

Is COPAXONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 2 0 1
2002 2 0 2
2004 3 0 1
2005 1 0 1
2006 5 1 0
2007 4 0 0
2008 7 0 4
2009 8 0 1
2010 9 0 1
2011 11 0 1
2012 30 1 9
2013 177 4 56
2014 280 3 65

View full timeline →

What Is COPAXONE Used For?

IndicationReports
Multiple sclerosis 792
Relapsing-remitting multiple sclerosis 48
Product used for unknown indication 35

COPAXONE vs Alternatives: Which Is Safer?

COPAXONE vs COPEGUS COPAXONE vs COPPER COPAXONE vs CORDARONE COPAXONE vs CORICIDIN HBP COLD AND FLU COPAXONE vs CORTICOSTEROID NOS COPAXONE vs CORTICOTROPIN COPAXONE vs CORTISONE COPAXONE vs CORTISONE\HYDROCORTISONE COPAXONE vs COSMETICS COPAXONE vs COUMADIN

Official FDA Label for COPAXONE

Official prescribing information from the FDA-approved drug label.