Does 5-FU Cause Stomatitis? 12 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 12 reports of Stomatitis have been filed in association with 5-FU. This represents 7.6% of all adverse event reports for 5-FU.
12
Reports of Stomatitis with 5-FU
7.6%
of all 5-FU reports
2
Deaths
6
Hospitalizations
How Dangerous Is Stomatitis From 5-FU?
Of the 12 reports, 2 (16.7%) resulted in death, 6 (50.0%) required hospitalization, and 1 (8.3%) 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 5-FU. However, 12 reports have been filed with the FAERS database.
What Other Side Effects Does 5-FU Cause?
Diarrhoea (21)
Disease progression (14)
Nausea (13)
Vomiting (12)
Dehydration (11)
Neutropenia (11)
Fatigue (9)
Hypertension (9)
Mucosal inflammation (9)
Pneumonia (9)
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 5-FU Alternatives Have Lower Stomatitis Risk?
5-FU vs 6-ACETYLMORPHINE
5-FU vs ABACAVIR
5-FU vs ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE
5-FU vs ABACAVIR\LAMIVUDINE
5-FU vs ABACAVIR\LAMIVUDINE\ZIDOVUDINE