Does AZELAIC ACID Cause Off label use? 267 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 267 reports of Off label use have been filed in association with AZELAIC ACID (azelaic acid). This represents 22.2% of all adverse event reports for AZELAIC ACID.
267
Reports of Off label use with AZELAIC ACID
22.2%
of all AZELAIC ACID reports
146
Deaths
95
Hospitalizations
How Dangerous Is Off label use From AZELAIC ACID?
Of the 267 reports, 146 (54.7%) resulted in death, 95 (35.6%) required hospitalization, and 96 (36.0%) were considered life-threatening.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for AZELAIC ACID. However, 267 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 Off label use?
RITUXIMAB (39,751)
INFLIXIMAB (34,801)
DENOSUMAB (34,612)
METHOTREXATE (24,020)
VEDOLIZUMAB (21,017)
ETANERCEPT (20,178)
TOCILIZUMAB (18,256)
PREDNISONE (17,867)
LENALIDOMIDE (17,017)
ADALIMUMAB (16,417)
Which AZELAIC ACID Alternatives Have Lower Off label use Risk?
AZELAIC ACID vs AZELASTINE
AZELAIC ACID vs AZELASTINE\FLUTICASONE
AZELAIC ACID vs AZELNIDIPINE
AZELAIC ACID vs AZILECT
AZELAIC ACID vs AZILSARTAN KAMEDOXOMIL