Does AZELAIC ACID Cause Stomatitis? 172 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 172 reports of Stomatitis have been filed in association with AZELAIC ACID (azelaic acid). This represents 14.3% of all adverse event reports for AZELAIC ACID.
172
Reports of Stomatitis with AZELAIC ACID
14.3%
of all AZELAIC ACID reports
172
Deaths
102
Hospitalizations
How Dangerous Is Stomatitis From AZELAIC ACID?
Of the 172 reports, 172 (100.0%) resulted in death, 102 (59.3%) required hospitalization, and 104 (60.5%) 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 AZELAIC ACID. However, 172 reports have been filed with the FAERS database.
What Other Side Effects Does AZELAIC ACID Cause?
Drug ineffective (344)
Hypoaesthesia (311)
Gastrooesophageal reflux disease (308)
Abdominal pain upper (300)
Paraesthesia (300)
Blepharospasm (298)
Epilepsy (294)
Drug intolerance (286)
Taste disorder (286)
Product use in unapproved indication (271)
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 AZELAIC ACID Alternatives Have Lower Stomatitis Risk?
AZELAIC ACID vs AZELASTINE
AZELAIC ACID vs AZELASTINE\FLUTICASONE
AZELAIC ACID vs AZELNIDIPINE
AZELAIC ACID vs AZILECT
AZELAIC ACID vs AZILSARTAN KAMEDOXOMIL