Does DEFIBROTIDE Cause Somnolence? 10 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 10 reports of Somnolence have been filed in association with DEFIBROTIDE (DEFITELIO). This represents 0.3% of all adverse event reports for DEFIBROTIDE.
10
Reports of Somnolence with DEFIBROTIDE
0.3%
of all DEFIBROTIDE reports
6
Deaths
9
Hospitalizations
How Dangerous Is Somnolence From DEFIBROTIDE?
Of the 10 reports, 6 (60.0%) resulted in death, 9 (90.0%) required hospitalization, and 1 (10.0%) were considered life-threatening.
Is Somnolence Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for DEFIBROTIDE. However, 10 reports have been filed with the FAERS database.
What Other Side Effects Does DEFIBROTIDE Cause?
Off label use (1,323)
Venoocclusive disease (576)
Death (463)
Multiple organ dysfunction syndrome (372)
Venoocclusive liver disease (355)
Intentional product use issue (201)
Hypotension (169)
Haemorrhage (156)
Sepsis (143)
Acute graft versus host disease (140)
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)
Which DEFIBROTIDE Alternatives Have Lower Somnolence Risk?
DEFIBROTIDE vs DEFLAZACORT
DEFIBROTIDE vs DEGARELIX
DEFIBROTIDE vs DELAFLOXACIN MEGLUMINE
DEFIBROTIDE vs DELAMANID
DEFIBROTIDE vs DELANDISTROGENE MOXEPARVOVEC-ROKL