Does APREMILAST Cause Paraesthesia? 996 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 996 reports of Paraesthesia have been filed in association with APREMILAST (Otezla). This represents 0.7% of all adverse event reports for APREMILAST.
996
Reports of Paraesthesia with APREMILAST
0.7%
of all APREMILAST reports
729
Deaths
672
Hospitalizations
How Dangerous Is Paraesthesia From APREMILAST?
Of the 996 reports, 729 (73.2%) resulted in death, 672 (67.5%) required hospitalization, and 667 (67.0%) were considered life-threatening.
Is Paraesthesia Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for APREMILAST. However, 996 reports have been filed with the FAERS database.