Does DENOSUMAB Cause Stomatitis? 364 Reports in FDA Database

Q: Does DENOSUMAB cause Stomatitis?

364 reports of Stomatitis have been filed with the FDA for DENOSUMAB, representing 0.2% of all DENOSUMAB adverse event reports.

Q: How dangerous is Stomatitis from DENOSUMAB?

Of 364 reports, 22 (6.0%) resulted in death and 87 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 364 reports of Stomatitis have been filed in association with DENOSUMAB (Bilprevda). This represents 0.2% of all adverse event reports for DENOSUMAB.

364

Reports of Stomatitis with DENOSUMAB

0.2%

of all DENOSUMAB reports

Deaths

Hospitalizations

How Dangerous Is Stomatitis From DENOSUMAB?

Of the 364 reports, 22 (6.0%) resulted in death, 87 (23.9%) required hospitalization, and 3 (0.8%) were considered life-threatening.

Is Stomatitis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for DENOSUMAB. However, 364 reports have been filed with the FAERS database.

What Other Side Effects Does DENOSUMAB Cause?

Off label use (34,612) Death (16,545) Osteonecrosis of jaw (8,438) Arthralgia (5,890) Pain in extremity (4,541) Back pain (4,465) Pain (4,102) Product storage error (3,621) Fall (3,322) Fatigue (3,009)

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 DENOSUMAB Alternatives Have Lower Stomatitis Risk?

DENOSUMAB vs DEOXYCHOLIC ACID DENOSUMAB vs DEPAKINE CHRONO DENOSUMAB vs DEPAKOTE DENOSUMAB vs DEPO-PROVERA DENOSUMAB vs DERMATOPHAGOIDES FARINAE

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