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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.

XYREM , /ML: 186 Adverse Event Reports & Safety Profile

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186
Total FAERS Reports
3 (1.6%)
Deaths Reported
66
Hospitalizations
186
As Primary/Secondary Suspect
1
Life-Threatening
3
Disabilities

First Report: 2005 · Latest Report: 201412

What Are the Most Common XYREM , /ML Side Effects?

#1 Most Reported
Off label use
30 reports (16.1%)
#2 Most Reported
Fall
15 reports (8.1%)
#3 Most Reported
Insomnia
13 reports (7.0%)

All XYREM , /ML Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 30 16.1% 0 16
Fall 15 8.1% 1 3
Insomnia 13 7.0% 1 7
Anxiety 12 6.5% 0 6
Fatigue 12 6.5% 0 3
Convulsion 11 5.9% 0 2
Surgery 11 5.9% 0 6
Headache 10 5.4% 0 6
Sleep apnoea syndrome 10 5.4% 0 0
Feeling abnormal 9 4.8% 0 3
Vomiting 9 4.8% 0 6
Confusional state 7 3.8% 1 3
Somnolence 7 3.8% 0 3
Cataplexy 6 3.2% 0 1
Condition aggravated 6 3.2% 0 3
Hospitalisation 6 3.2% 0 6
Hypertension 6 3.2% 0 3
Malaise 6 3.2% 0 1
Memory impairment 6 3.2% 0 1
Nausea 6 3.2% 0 4

Who Reports XYREM , /ML Side Effects? Age & Gender Data

Average age: 47.8 years. Most reports from: US. View detailed demographics →

Is XYREM , /ML Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 0
2006 1 0 0
2008 1 0 1
2009 2 0 1
2010 3 0 2
2011 4 0 3
2012 9 0 5
2013 55 2 20
2014 65 0 23

View full timeline →

What Is XYREM , /ML Used For?

IndicationReports
Narcolepsy 119
Cataplexy 47
Product used for unknown indication 18
Sleep disorder 16
Somnolence 11
Fibromyalgia 8
Insomnia 7

XYREM , /ML vs Alternatives: Which Is Safer?

XYREM , /ML vs YASMIN XYREM , /ML vs YAZ XYREM , /ML vs YTTRIUM Y-90 XYREM , /ML vs ZAFIRLUKAST XYREM , /ML vs ZALCITABINE XYREM , /ML vs ZALEPLON XYREM , /ML vs ZANAMIVIR XYREM , /ML vs ZANIDATAMAB XYREM , /ML vs ZANTAC XYREM , /ML vs ZANTAC 150

Official FDA Label for XYREM , /ML

Official prescribing information from the FDA-approved drug label.