Does NIVOLUMAB Cause Stomatitis? 749 Reports in FDA Database

Q: Does NIVOLUMAB cause Stomatitis?

749 reports of Stomatitis have been filed with the FDA for NIVOLUMAB, representing 0.9% of all NIVOLUMAB adverse event reports.

Q: How dangerous is Stomatitis from NIVOLUMAB?

Of 749 reports, 71 (9.5%) resulted in death and 306 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 749 reports of Stomatitis have been filed in association with NIVOLUMAB (OPDIVO). This represents 0.9% of all adverse event reports for NIVOLUMAB.

749

Reports of Stomatitis with NIVOLUMAB

0.9%

of all NIVOLUMAB reports

Deaths

306

Hospitalizations

How Dangerous Is Stomatitis From NIVOLUMAB?

Of the 749 reports, 71 (9.5%) resulted in death, 306 (40.9%) required hospitalization, and 28 (3.7%) were considered life-threatening.

Is Stomatitis Listed in the Official Label?

Yes, Stomatitis is listed as a known adverse reaction in the official FDA drug label for NIVOLUMAB.

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 Stomatitis?

METHOTREXATE (7,245) TOCILIZUMAB (4,761) ADALIMUMAB (4,500) LEFLUNOMIDE (4,492) ABATACEPT (4,481) ETANERCEPT (4,338) RITUXIMAB (4,335) CERTOLIZUMAB PEGOL (3,760) INFLIXIMAB (3,713) PREDNISONE (3,656)

Which NIVOLUMAB Alternatives Have Lower Stomatitis Risk?

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

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