XYREM: 466 Adverse Event Reports & Safety Profile
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466
Total FAERS Reports
20 (4.3%)
Deaths Reported
159
Hospitalizations
466
As Primary/Secondary Suspect
3
Life-Threatening
16
Disabilities
First Report: 2002 · Latest Report: 20140607
What Are the Most Common XYREM Side Effects?
#1 Most Reported
Off label use
76 reports (16.3%)
#2 Most Reported
Condition aggravated
50 reports (10.7%)
#3 Most Reported
Fall
48 reports (10.3%)
All XYREM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 76 | 16.3% | 3 | 22 |
| Condition aggravated | 50 | 10.7% | 0 | 21 |
| Fall | 48 | 10.3% | 2 | 21 |
| Insomnia | 35 | 7.5% | 0 | 12 |
| Convulsion | 31 | 6.7% | 1 | 5 |
| Somnolence | 31 | 6.7% | 1 | 11 |
| Weight decreased | 31 | 6.7% | 0 | 18 |
| Fatigue | 29 | 6.2% | 0 | 9 |
| Sleep apnoea syndrome | 28 | 6.0% | 0 | 2 |
| Anxiety | 27 | 5.8% | 0 | 14 |
| Confusional state | 24 | 5.2% | 0 | 11 |
| Depression | 24 | 5.2% | 0 | 12 |
| Nausea | 23 | 4.9% | 0 | 5 |
| Dizziness | 22 | 4.7% | 0 | 4 |
| Headache | 22 | 4.7% | 0 | 7 |
| Memory impairment | 20 | 4.3% | 0 | 5 |
| Tremor | 20 | 4.3% | 0 | 11 |
| Back pain | 19 | 4.1% | 1 | 11 |
| Cataplexy | 19 | 4.1% | 1 | 8 |
| Surgery | 19 | 4.1% | 0 | 6 |
Who Reports XYREM Side Effects? Age & Gender Data
Average age: 45.8 years. Most reports from: US. View detailed demographics →
Is XYREM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2002 | 1 | 0 | 0 |
| 2004 | 1 | 0 | 0 |
| 2005 | 3 | 0 | 3 |
| 2006 | 2 | 0 | 1 |
| 2007 | 3 | 0 | 1 |
| 2008 | 6 | 0 | 2 |
| 2009 | 8 | 0 | 3 |
| 2010 | 13 | 2 | 6 |
| 2011 | 15 | 0 | 7 |
| 2012 | 31 | 1 | 12 |
| 2013 | 151 | 8 | 57 |
| 2014 | 115 | 7 | 45 |
What Is XYREM Used For?
| Indication | Reports |
|---|---|
| Narcolepsy | 328 |
| Cataplexy | 144 |
| Product used for unknown indication | 34 |
| Sleep disorder | 32 |
| Somnolence | 29 |
| Insomnia | 23 |
| Fibromyalgia | 16 |
| Hypersomnia | 13 |
XYREM vs Alternatives: Which Is Safer?
XYREM vs XYREM , /ML
XYREM vs YASMIN
XYREM vs YAZ
XYREM vs YTTRIUM Y-90
XYREM vs ZAFIRLUKAST
XYREM vs ZALCITABINE
XYREM vs ZALEPLON
XYREM vs ZANAMIVIR
XYREM vs ZANIDATAMAB
XYREM vs ZANTAC
Official FDA Label for XYREM
Official prescribing information from the FDA-approved drug label.