Does IBRUTINIB Cause Mouth ulceration? 109 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 109 reports of Mouth ulceration have been filed in association with IBRUTINIB (Imbruvica). This represents 0.2% of all adverse event reports for IBRUTINIB.
109
Reports of Mouth ulceration with IBRUTINIB
0.2%
of all IBRUTINIB reports
15
Deaths
34
Hospitalizations
How Dangerous Is Mouth ulceration From IBRUTINIB?
Of the 109 reports, 15 (13.8%) resulted in death, 34 (31.2%) required hospitalization, and 3 (2.8%) were considered life-threatening.
Is Mouth ulceration Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for IBRUTINIB. However, 109 reports have been filed with the FAERS database.
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 Mouth ulceration?
METHOTREXATE (2,420)
ADALIMUMAB (860)
ETANERCEPT (618)
INFLIXIMAB (578)
RITUXIMAB (564)
EVEROLIMUS (522)
ABATACEPT (516)
TOCILIZUMAB (513)
LEFLUNOMIDE (488)
HYDROXYCHLOROQUINE (445)
Which IBRUTINIB Alternatives Have Lower Mouth ulceration Risk?
IBRUTINIB vs IBUPROFEN
IBRUTINIB vs IBUPROFEN LYSINE
IBRUTINIB vs IBUPROFEN UNKNOWN PRODUCT
IBRUTINIB vs IBUPROFEN\IBUPROFEN
IBRUTINIB vs IBUPROFEN\PHENYLEPHRINE