Does TOPIRAMATE Cause Stomatitis? 458 Reports in FDA Database

Q: Does TOPIRAMATE cause Stomatitis?

458 reports of Stomatitis have been filed with the FDA for TOPIRAMATE, representing 1.6% of all TOPIRAMATE adverse event reports.

Q: How dangerous is Stomatitis from TOPIRAMATE?

Of 458 reports, 440 (96.1%) resulted in death and 397 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 458 reports of Stomatitis have been filed in association with TOPIRAMATE (Topiramate). This represents 1.6% of all adverse event reports for TOPIRAMATE.

458

Reports of Stomatitis with TOPIRAMATE

1.6%

of all TOPIRAMATE reports

440

Deaths

397

Hospitalizations

How Dangerous Is Stomatitis From TOPIRAMATE?

Of the 458 reports, 440 (96.1%) resulted in death, 397 (86.7%) required hospitalization, and 397 (86.7%) 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 TOPIRAMATE. However, 458 reports have been filed with the FAERS database.

What Other Side Effects Does TOPIRAMATE Cause?

Drug ineffective (5,553) Off label use (4,248) Product use in unapproved indication (2,173) Headache (1,997) Drug intolerance (1,820) Migraine (1,796) Nausea (1,691) Seizure (1,535) Paraesthesia (1,506) Dizziness (1,466)

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 TOPIRAMATE Alternatives Have Lower Stomatitis Risk?

TOPIRAMATE vs TOPOTECAN TOPIRAMATE vs TOPOTECAN\TOPOTECAN TOPIRAMATE vs TOPROL TOPIRAMATE vs TOREMIFENE TOPIRAMATE vs TORIPALIMAB

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