Does MESALAMINE Cause Stomatitis? 374 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 374 reports of Stomatitis have been filed in association with MESALAMINE (Mesalamine). This represents 1.9% of all adverse event reports for MESALAMINE.
374
Reports of Stomatitis with MESALAMINE
1.9%
of all MESALAMINE reports
352
Deaths
320
Hospitalizations
How Dangerous Is Stomatitis From MESALAMINE?
Of the 374 reports, 352 (94.1%) resulted in death, 320 (85.6%) required hospitalization, and 311 (83.2%) 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 MESALAMINE.
What Other Side Effects Does MESALAMINE Cause?
Drug ineffective (4,753)
Off label use (2,450)
Colitis ulcerative (2,427)
Diarrhoea (1,874)
Condition aggravated (1,838)
Pyrexia (1,467)
Haematochezia (1,456)
Fatigue (1,442)
Headache (1,435)
Pain (1,395)
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 MESALAMINE Alternatives Have Lower Stomatitis Risk?
MESALAMINE vs MESNA
MESALAMINE vs METAMIZOLE
MESALAMINE vs METARAMINOL
MESALAMINE vs METAXALONE
MESALAMINE vs METFORMIN