Does MITOTANE Cause Abdominal pain? 16 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 16 reports of Abdominal pain have been filed in association with MITOTANE (Lysodren). This represents 1.6% of all adverse event reports for MITOTANE.
16
Reports of Abdominal pain with MITOTANE
1.6%
of all MITOTANE reports
0
Deaths
5
Hospitalizations
How Dangerous Is Abdominal pain From MITOTANE?
Of the 16 reports, 5 (31.3%) required hospitalization, and 2 (12.5%) were considered life-threatening.
Is Abdominal pain Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for MITOTANE. However, 16 reports have been filed with the FAERS database.