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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 PEMBROLIZUMAB Cause Stomatitis? 893 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 893 reports of Stomatitis have been filed in association with PEMBROLIZUMAB (KEYTRUDA). This represents 1.1% of all adverse event reports for PEMBROLIZUMAB.

893
Reports of Stomatitis with PEMBROLIZUMAB
1.1%
of all PEMBROLIZUMAB reports
80
Deaths
387
Hospitalizations

How Dangerous Is Stomatitis From PEMBROLIZUMAB?

Of the 893 reports, 80 (9.0%) resulted in death, 387 (43.3%) required hospitalization, and 35 (3.9%) 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 PEMBROLIZUMAB.

What Other Side Effects Does PEMBROLIZUMAB Cause?

Malignant neoplasm progression (10,111) Death (4,744) Diarrhoea (4,251) Fatigue (3,833) Off label use (3,416) Product use in unapproved indication (3,191) Pyrexia (3,155) Rash (2,900) Nausea (2,670) Decreased appetite (2,486)

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 PEMBROLIZUMAB Alternatives Have Lower Stomatitis Risk?

PEMBROLIZUMAB vs PEMETREXED PEMBROLIZUMAB vs PEMIGATINIB PEMBROLIZUMAB vs PENICILLAMINE PEMBROLIZUMAB vs PENICILLIN PEMBROLIZUMAB vs PENICILLIN G

Related Pages

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