Does IBRUTINIB Cause Somnolence? 362 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 362 reports of Somnolence have been filed in association with IBRUTINIB (Imbruvica). This represents 0.5% of all adverse event reports for IBRUTINIB.
362
Reports of Somnolence with IBRUTINIB
0.5%
of all IBRUTINIB reports
27
Deaths
131
Hospitalizations
How Dangerous Is Somnolence From IBRUTINIB?
Of the 362 reports, 27 (7.5%) resulted in death, 131 (36.2%) required hospitalization, and 6 (1.7%) 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 IBRUTINIB. However, 362 reports have been filed with the FAERS database.
What Other Side Effects Does IBRUTINIB Cause?
Death (8,007)
Off label use (5,446)
Fatigue (4,479)
Diarrhoea (3,903)
Atrial fibrillation (3,671)
Pneumonia (3,015)
Incorrect dose administered (2,752)
Contusion (2,712)
Fall (2,375)
Asthenia (2,200)
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)