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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 Splenomegaly? 40 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 40 reports of Splenomegaly have been filed in association with NIVOLUMAB (OPDIVO). This represents 0.1% of all adverse event reports for NIVOLUMAB.

40
Reports of Splenomegaly with NIVOLUMAB
0.1%
of all NIVOLUMAB reports
6
Deaths
26
Hospitalizations

How Dangerous Is Splenomegaly From NIVOLUMAB?

Of the 40 reports, 6 (15.0%) resulted in death, 26 (65.0%) required hospitalization, and 6 (15.0%) were considered life-threatening.

Is Splenomegaly Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for NIVOLUMAB. However, 40 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 Splenomegaly?

RUXOLITINIB (1,995) RITUXIMAB (326) PREDNISONE (299) IBRUTINIB (279) CYCLOPHOSPHAMIDE (254) METHOTREXATE (253) OXALIPLATIN (253) ADALIMUMAB (245) TACROLIMUS (218) IMATINIB (216)

Which NIVOLUMAB Alternatives Have Lower Splenomegaly Risk?

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

Related Pages

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