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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.

SOLIRIS: 2,401 Adverse Event Reports & Safety Profile

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2,401
Total FAERS Reports
227 (9.5%)
Deaths Reported
838
Hospitalizations
2,401
As Primary/Secondary Suspect
28
Life-Threatening
13
Disabilities

First Report: 2007 · Latest Report: 20140613

What Are the Most Common SOLIRIS Side Effects?

#1 Most Reported
Fatigue
341 reports (14.2%)
#2 Most Reported
Haemoglobin decreased
254 reports (10.6%)
#3 Most Reported
Transfusion
183 reports (7.6%)

All SOLIRIS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 341 14.2% 14 95
Haemoglobin decreased 254 10.6% 12 122
Transfusion 183 7.6% 8 67
Abdominal pain 141 5.9% 8 69
Unevaluable event 140 5.8% 17 129
Dyspnoea 129 5.4% 10 57
Headache 126 5.3% 3 49
Aplastic anaemia 120 5.0% 4 27
Death 118 4.9% 118 38
Platelet count decreased 106 4.4% 12 60
Haemolysis 103 4.3% 2 53
Pyrexia 103 4.3% 11 78
Haemoglobinuria 100 4.2% 5 34
Off label use 96 4.0% 26 22
Vomiting 95 4.0% 8 54
Nausea 91 3.8% 5 41
Back pain 78 3.3% 4 28
Anaemia 75 3.1% 10 41
Asthenia 75 3.1% 7 48
Pain 73 3.0% 6 37

Who Reports SOLIRIS Side Effects? Age & Gender Data

Average age: 47.0 years. Most reports from: US. View detailed demographics →

Is SOLIRIS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 49 10 32
2008 57 4 36
2009 80 8 50
2010 59 3 31
2011 76 8 40
2012 149 17 82
2013 244 41 114
2014 305 63 113

View full timeline →

What Is SOLIRIS Used For?

IndicationReports
Paroxysmal nocturnal haemoglobinuria 1,478
Haemolytic uraemic syndrome 811
Off label use 102
Product used for unknown indication 30
Neuromyelitis optica 17
Thrombotic microangiopathy 10
Transplant rejection 8
Glomerulonephritis membranoproliferative 5

SOLIRIS vs Alternatives: Which Is Safer?

SOLIRIS vs SOLOSTAR SOLIRIS vs SOLRIAMFETOL SOLIRIS vs SOLU-MEDROL SOLIRIS vs SOMATREM SOLIRIS vs SOMATROGON-GHLA SOLIRIS vs SOMATROPIN SOLIRIS vs SONIDEGIB SOLIRIS vs SORAFENIB SOLIRIS vs SORGHUM HALEPENSE POLLEN SOLIRIS vs SOTAGLIFLOZIN

Official FDA Label for SOLIRIS

Official prescribing information from the FDA-approved drug label.