Does XYREM Cause Somnolence? 31 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 31 reports of Somnolence have been filed in association with XYREM. This represents 6.7% of all adverse event reports for XYREM.
31
Reports of Somnolence with XYREM
6.7%
of all XYREM reports
1
Deaths
11
Hospitalizations
How Dangerous Is Somnolence From XYREM?
Of the 31 reports, 1 (3.2%) resulted in death, 11 (35.5%) required hospitalization.
Is Somnolence Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for XYREM. However, 31 reports have been filed with the FAERS database.
What Other Side Effects Does XYREM Cause?
Off label use (76)
Condition aggravated (50)
Fall (48)
Insomnia (35)
Convulsion (31)
Weight decreased (31)
Fatigue (29)
Sleep apnoea syndrome (28)
Anxiety (27)
Confusional state (24)
What Other Drugs Cause Somnolence?
PREGABALIN (5,528)
QUETIAPINE (4,394)
ACETAMINOPHEN (3,923)
GABAPENTIN (3,798)
SODIUM OXYBATE (3,642)
CETIRIZINE (3,058)
OLANZAPINE (2,612)
DIAZEPAM (2,547)
RISPERIDONE (2,496)
OXYCODONE (2,494)