Does DUPILUMAB Cause Stomatitis? 450 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 450 reports of Stomatitis have been filed in association with DUPILUMAB (Dupixent). This represents 0.1% of all adverse event reports for DUPILUMAB.
450
Reports of Stomatitis with DUPILUMAB
0.1%
of all DUPILUMAB reports
1
Deaths
19
Hospitalizations
How Dangerous Is Stomatitis From DUPILUMAB?
Of the 450 reports, 1 (0.2%) resulted in death, 19 (4.2%) required hospitalization, and 1 (0.2%) 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 DUPILUMAB. However, 450 reports have been filed with the FAERS database.
What Other Side Effects Does DUPILUMAB Cause?
Pruritus (44,279)
Dermatitis atopic (33,670)
Product use in unapproved indication (33,452)
Rash (30,895)
Injection site pain (27,799)
Drug ineffective (23,712)
Dry skin (20,239)
Eczema (20,020)
Product dose omission issue (18,189)
Condition aggravated (16,459)
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 DUPILUMAB Alternatives Have Lower Stomatitis Risk?
DUPILUMAB vs DURAGESIC
DUPILUMAB vs DUROGESIC
DUPILUMAB vs DUROTEP MT
DUPILUMAB vs DURVALUMAB
DUPILUMAB vs DUTASTERIDE