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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.

BENLYSTA: 299 Adverse Event Reports & Safety Profile

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299
Total FAERS Reports
20 (6.7%)
Deaths Reported
65
Hospitalizations
299
As Primary/Secondary Suspect
8
Life-Threatening
7
Disabilities

First Report: 201105 · Latest Report: 201411

What Are the Most Common BENLYSTA Side Effects?

#1 Most Reported
Fatigue
35 reports (11.7%)
#2 Most Reported
Headache
31 reports (10.4%)
#3 Most Reported
Systemic lupus erythematosus
26 reports (8.7%)

All BENLYSTA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 35 11.7% 0 7
Headache 31 10.4% 0 7
Nausea 26 8.7% 0 5
Systemic lupus erythematosus 26 8.7% 1 7
Pyrexia 25 8.4% 1 13
Drug ineffective 21 7.0% 0 6
Malaise 21 7.0% 0 9
Arthralgia 17 5.7% 0 6
Dyspnoea 17 5.7% 0 9
Death 16 5.4% 16 2
Hypersensitivity 15 5.0% 0 5
Pain 15 5.0% 0 5
Vomiting 15 5.0% 0 6
Feeling abnormal 13 4.4% 0 2
Pain in extremity 13 4.4% 0 6
Rash 13 4.4% 0 3
Exposure during pregnancy 12 4.0% 0 2
Diarrhoea 11 3.7% 0 3
Infection 10 3.3% 0 5
Infusion related reaction 10 3.3% 0 0

Who Reports BENLYSTA Side Effects? Age & Gender Data

Average age: 44.0 years. Most reports from: US. View detailed demographics →

Is BENLYSTA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 3 0 0
2012 24 2 6
2013 90 7 25
2014 49 0 16

View full timeline →

What Is BENLYSTA Used For?

IndicationReports
Systemic lupus erythematosus 246
Product used for unknown indication 41

BENLYSTA vs Alternatives: Which Is Safer?

BENLYSTA vs BENRALIZUMAB BENLYSTA vs BENSERAZIDE BENLYSTA vs BENSERAZIDE\LEVODOPA BENLYSTA vs BENZALKONIUM BENLYSTA vs BENZOCAINE BENLYSTA vs BENZODIAZEPINE BENLYSTA vs BENZONATATE BENLYSTA vs BENZOYL PEROXIDE BENLYSTA vs BENZOYL PEROXIDE\CLINDAMYCIN BENLYSTA vs BENZOYLECGONINE

Official FDA Label for BENLYSTA

Official prescribing information from the FDA-approved drug label.