Does APREMILAST Cause Hepatitis? 326 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 326 reports of Hepatitis have been filed in association with APREMILAST (Otezla). This represents 0.2% of all adverse event reports for APREMILAST.
326
Reports of Hepatitis with APREMILAST
0.2%
of all APREMILAST reports
246
Deaths
299
Hospitalizations
How Dangerous Is Hepatitis From APREMILAST?
Of the 326 reports, 246 (75.5%) resulted in death, 299 (91.7%) required hospitalization, and 240 (73.6%) 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 APREMILAST. However, 326 reports have been filed with the FAERS database.
What Other Side Effects Does APREMILAST Cause?
Diarrhoea (23,752)
Nausea (21,352)
Psoriasis (19,255)
Headache (17,024)
Drug ineffective (14,121)
Abdominal discomfort (7,653)
Psoriatic arthropathy (7,035)
Vomiting (5,959)
Rash (5,883)
Pain (5,676)
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 APREMILAST Alternatives Have Lower Hepatitis Risk?
APREMILAST vs APREPITANT
APREMILAST vs APROTININ
APREMILAST vs ARANESP
APREMILAST vs ARAVA
APREMILAST vs AREDIA