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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is XYREM , /ML Used For?
| Indication | Reports |
|---|---|
| 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.