Does AZELAIC ACID Cause Hepatitis? 11 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 11 reports of Hepatitis have been filed in association with AZELAIC ACID (azelaic acid). This represents 0.9% of all adverse event reports for AZELAIC ACID.
11
Reports of Hepatitis with AZELAIC ACID
0.9%
of all AZELAIC ACID reports
11
Deaths
11
Hospitalizations
How Dangerous Is Hepatitis From AZELAIC ACID?
Of the 11 reports, 11 (100.0%) resulted in death, 11 (100.0%) required hospitalization, and 11 (100.0%) were considered life-threatening.
Is Hepatitis Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for AZELAIC ACID. However, 11 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 Hepatitis?
METHOTREXATE (1,835)
ACETAMINOPHEN (1,450)
TOCILIZUMAB (1,184)
HYDROXYCHLOROQUINE (1,133)
ADALIMUMAB (1,096)
RITUXIMAB (1,017)
ETANERCEPT (1,013)
LEFLUNOMIDE (997)
PEMBROLIZUMAB (935)
NIVOLUMAB (930)
Which AZELAIC ACID Alternatives Have Lower Hepatitis Risk?
AZELAIC ACID vs AZELASTINE
AZELAIC ACID vs AZELASTINE\FLUTICASONE
AZELAIC ACID vs AZELNIDIPINE
AZELAIC ACID vs AZILECT
AZELAIC ACID vs AZILSARTAN KAMEDOXOMIL