Does IBUPROFEN Cause Stomatitis? 423 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 423 reports of Stomatitis have been filed in association with IBUPROFEN (equate ibuprofen). This represents 0.5% of all adverse event reports for IBUPROFEN.
423
Reports of Stomatitis with IBUPROFEN
0.5%
of all IBUPROFEN reports
253
Deaths
334
Hospitalizations
How Dangerous Is Stomatitis From IBUPROFEN?
Of the 423 reports, 253 (59.8%) resulted in death, 334 (79.0%) required hospitalization, and 262 (61.9%) 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 IBUPROFEN. However, 423 reports have been filed with the FAERS database.
What Other Side Effects Does IBUPROFEN Cause?
Drug ineffective (9,352)
Drug hypersensitivity (5,269)
Nausea (4,129)
Vomiting (4,116)
Acute kidney injury (3,639)
Product use in unapproved indication (3,596)
Toxicity to various agents (3,584)
Off label use (3,556)
Intentional overdose (3,185)
Headache (3,010)
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 IBUPROFEN Alternatives Have Lower Stomatitis Risk?
IBUPROFEN vs IBUPROFEN LYSINE
IBUPROFEN vs IBUPROFEN UNKNOWN PRODUCT
IBUPROFEN vs IBUPROFEN\IBUPROFEN
IBUPROFEN vs IBUPROFEN\PHENYLEPHRINE
IBUPROFEN vs IBUPROFEN\PSEUDOEPHEDRINE