Does NIVOLUMAB Cause Somnolence? 454 Reports in FDA Database

Q: Does NIVOLUMAB cause Somnolence?

454 reports of Somnolence have been filed with the FDA for NIVOLUMAB, representing 0.5% of all NIVOLUMAB adverse event reports.

Q: How dangerous is Somnolence from NIVOLUMAB?

Of 454 reports, 83 (18.3%) resulted in death and 237 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 454 reports of Somnolence have been filed in association with NIVOLUMAB (OPDIVO). This represents 0.5% of all adverse event reports for NIVOLUMAB.

454

Reports of Somnolence with NIVOLUMAB

0.5%

of all NIVOLUMAB reports

Deaths

237

Hospitalizations

How Dangerous Is Somnolence From NIVOLUMAB?

Of the 454 reports, 83 (18.3%) resulted in death, 237 (52.2%) required hospitalization, and 45 (9.9%) 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 NIVOLUMAB. However, 454 reports have been filed with the FAERS database.

What Other Side Effects Does NIVOLUMAB Cause?

Death (11,216) Malignant neoplasm progression (9,363) Off label use (5,208) Diarrhoea (4,692) Fatigue (3,709) Pyrexia (3,454) Intentional product use issue (3,297) Rash (2,816) Nausea (2,805) Decreased appetite (2,619)

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 NIVOLUMAB Alternatives Have Lower Somnolence Risk?

NIVOLUMAB vs NIVOLUMAB\RELATLIMAB-RMBW NIVOLUMAB vs NIZATIDINE NIVOLUMAB vs NOMEGESTROL NIVOLUMAB vs NORDAZEPAM NIVOLUMAB vs NOREPINEPHRINE

NIVOLUMAB Full Profile All Somnolence Reports All Drugs Causing Somnolence NIVOLUMAB Demographics