Does IBRUTINIB Cause Stomatitis? 867 Reports in FDA Database

Q: Does IBRUTINIB cause Stomatitis?

867 reports of Stomatitis have been filed with the FDA for IBRUTINIB, representing 1.2% of all IBRUTINIB adverse event reports.

Q: How dangerous is Stomatitis from IBRUTINIB?

Of 867 reports, 43 (5.0%) resulted in death and 231 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 867 reports of Stomatitis have been filed in association with IBRUTINIB (Imbruvica). This represents 1.2% of all adverse event reports for IBRUTINIB.

867

Reports of Stomatitis with IBRUTINIB

1.2%

of all IBRUTINIB reports

Deaths

231

Hospitalizations

How Dangerous Is Stomatitis From IBRUTINIB?

Of the 867 reports, 43 (5.0%) resulted in death, 231 (26.6%) required hospitalization, and 9 (1.0%) 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 IBRUTINIB.

What Other Side Effects Does IBRUTINIB Cause?

Death (8,007) Off label use (5,446) Fatigue (4,479) Diarrhoea (3,903) Atrial fibrillation (3,671) Pneumonia (3,015) Incorrect dose administered (2,752) Contusion (2,712) Fall (2,375) Asthenia (2,200)

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 IBRUTINIB Alternatives Have Lower Stomatitis Risk?

IBRUTINIB vs IBUPROFEN IBRUTINIB vs IBUPROFEN LYSINE IBRUTINIB vs IBUPROFEN UNKNOWN PRODUCT IBRUTINIB vs IBUPROFEN\IBUPROFEN IBRUTINIB vs IBUPROFEN\PHENYLEPHRINE

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