Does BOTULINUM TOXIN TYPE A Cause Stomatitis? 467 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 467 reports of Stomatitis have been filed in association with BOTULINUM TOXIN TYPE A (Jeuveau). This represents 12.5% of all adverse event reports for BOTULINUM TOXIN TYPE A.
467
Reports of Stomatitis with BOTULINUM TOXIN TYPE A
12.5%
of all BOTULINUM TOXIN TYPE A reports
466
Deaths
386
Hospitalizations
How Dangerous Is Stomatitis From BOTULINUM TOXIN TYPE A?
Of the 467 reports, 466 (99.8%) resulted in death, 386 (82.7%) required hospitalization, and 396 (84.8%) 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 BOTULINUM TOXIN TYPE A. However, 467 reports have been filed with the FAERS database.
What Other Side Effects Does BOTULINUM TOXIN TYPE A Cause?
Off label use (1,785)
Drug ineffective (1,175)
Drug intolerance (1,004)
Product use in unapproved indication (950)
Headache (797)
Migraine (775)
Maternal exposure during pregnancy (716)
Pain (714)
Hypoaesthesia (703)
Nausea (665)
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 BOTULINUM TOXIN TYPE A Alternatives Have Lower Stomatitis Risk?
BOTULINUM TOXIN TYPE A vs BREMELANOTIDE
BOTULINUM TOXIN TYPE A vs BRENTUXIMAB
BOTULINUM TOXIN TYPE A vs BRENTUXIMAB VEDOTIN
BOTULINUM TOXIN TYPE A vs BREO ELLIPTA
BOTULINUM TOXIN TYPE A vs BREXANOLONE