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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does NIVOLUMAB Cause Cholestasis? 342 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 342 reports of Cholestasis have been filed in association with NIVOLUMAB (OPDIVO). This represents 0.4% of all adverse event reports for NIVOLUMAB.

342
Reports of Cholestasis with NIVOLUMAB
0.4%
of all NIVOLUMAB reports
41
Deaths
202
Hospitalizations

How Dangerous Is Cholestasis From NIVOLUMAB?

Of the 342 reports, 41 (12.0%) resulted in death, 202 (59.1%) required hospitalization, and 10 (2.9%) were considered life-threatening.

Is Cholestasis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for NIVOLUMAB. However, 342 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 Cholestasis?

ACETAMINOPHEN (1,269) ATORVASTATIN (898) PANTOPRAZOLE (535) METHOTREXATE (507) AMOXICILLIN\CLAVULANATE (480) SULFAMETHOXAZOLE\TRIMETHOPRIM (462) ENOXAPARIN (404) PIPERACILLIN\TAZOBACTAM (394) ESOMEPRAZOLE (363) AMOXICILLIN (326)

Which NIVOLUMAB Alternatives Have Lower Cholestasis Risk?

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

Related Pages

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