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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.

TECFIDERA: 10,394 Adverse Event Reports & Safety Profile

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10,394
Total FAERS Reports
40 (0.4%)
Deaths Reported
819
Hospitalizations
10,394
As Primary/Secondary Suspect
7
Life-Threatening
8
Disabilities

First Report: 021403 · Latest Report: 20140924

What Are the Most Common TECFIDERA Side Effects?

#1 Most Reported
Flushing
2,385 reports (22.9%)
#2 Most Reported
Nausea
1,325 reports (12.7%)
#3 Most Reported
Diarrhoea
1,209 reports (11.6%)

All TECFIDERA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Flushing 2,385 23.0% 0 75
Nausea 1,325 12.8% 0 75
Diarrhoea 1,209 11.6% 0 83
Fatigue 829 8.0% 0 27
Vomiting 777 7.5% 1 66
Abdominal pain upper 707 6.8% 0 37
Headache 667 6.4% 0 21
Pruritus 659 6.3% 0 13
Abdominal discomfort 463 4.5% 1 22
Multiple sclerosis relapse 461 4.4% 0 140
Asthenia 395 3.8% 1 34
Dizziness 383 3.7% 0 13
Malaise 370 3.6% 1 16
Prescribed underdose 362 3.5% 0 22
Gait disturbance 356 3.4% 0 27
Gastric disorder 353 3.4% 0 11
Memory impairment 352 3.4% 0 6
Paraesthesia 329 3.2% 0 9
Hypoaesthesia 320 3.1% 0 23
Rash 308 3.0% 0 9

Who Reports TECFIDERA Side Effects? Age & Gender Data

Average age: 49.1 years. Most reports from: US. View detailed demographics →

Is TECFIDERA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 1
2010 1 0 0
2011 2 0 0
2012 8 0 2
2013 2,783 12 225
2014 3,969 17 407

View full timeline →

What Is TECFIDERA Used For?

IndicationReports
Multiple sclerosis 8,747
Product used for unknown indication 806
Relapsing-remitting multiple sclerosis 806

TECFIDERA vs Alternatives: Which Is Safer?

TECFIDERA vs TECHNETIUM TC-99M TECFIDERA vs TECHNETIUM TC-99M MEDRONATE TECFIDERA vs TECHNETIUM TC-99M OXIDRONATE TECFIDERA vs TECHNETIUM TC-99M PERTECHNETATE TECFIDERA vs TECHNETIUM TC-99M SESTAMIBI TECFIDERA vs TECHNETIUM TC-99M TETROFOSMIN TECFIDERA vs TECLISTAMAB TECFIDERA vs TECLISTAMAB-CQYV TECFIDERA vs TEDIZOLID TECFIDERA vs TEDUGLUTIDE

Official FDA Label for TECFIDERA

Official prescribing information from the FDA-approved drug label.