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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does SULFASALAZINE Cause Stomatitis? 3,424 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 3,424 reports of Stomatitis have been filed in association with SULFASALAZINE (Azulfidine EN-tabs). This represents 8.5% of all adverse event reports for SULFASALAZINE.

3,424
Reports of Stomatitis with SULFASALAZINE
8.5%
of all SULFASALAZINE reports
1,517
Deaths
2,051
Hospitalizations

How Dangerous Is Stomatitis From SULFASALAZINE?

Of the 3,424 reports, 1,517 (44.3%) resulted in death, 2,051 (59.9%) required hospitalization, and 1,748 (51.1%) 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 SULFASALAZINE.

What Other Side Effects Does SULFASALAZINE Cause?

Drug ineffective (22,365) Rheumatoid arthritis (15,136) Drug intolerance (11,530) Pain (11,309) Fatigue (9,684) Joint swelling (9,673) Rash (8,739) Contraindicated product administered (8,698) Arthralgia (8,527) Abdominal discomfort (8,404)

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 SULFASALAZINE Alternatives Have Lower Stomatitis Risk?

SULFASALAZINE vs SULFATHIAZOLE SULFASALAZINE vs SULFISOMIDINE SULFASALAZINE vs SULFUR SULFASALAZINE vs SULFUR HEXAFLUORIDE SULFASALAZINE vs SULINDAC

Related Pages

SULFASALAZINE Full Profile All Stomatitis Reports All Drugs Causing Stomatitis SULFASALAZINE Demographics