Does MIDOSTAURIN Cause Cholestasis? 10 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 10 reports of Cholestasis have been filed in association with MIDOSTAURIN (RYDAPT). This represents 0.3% of all adverse event reports for MIDOSTAURIN.
10
Reports of Cholestasis with MIDOSTAURIN
0.3%
of all MIDOSTAURIN reports
3
Deaths
3
Hospitalizations
How Dangerous Is Cholestasis From MIDOSTAURIN?
Of the 10 reports, 3 (30.0%) resulted in death, 3 (30.0%) required hospitalization, and 2 (20.0%) were considered life-threatening.
Is Cholestasis Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for MIDOSTAURIN. However, 10 reports have been filed with the FAERS database.
What Other Side Effects Does MIDOSTAURIN Cause?
Death (397)
Nausea (252)
Febrile neutropenia (223)
Diarrhoea (194)
Pyrexia (188)
Acute myeloid leukaemia recurrent (171)
Pancytopenia (152)
Vomiting (152)
Drug ineffective (151)
Thrombocytopenia (140)
What Other Drugs Cause Cholestasis?
ACETAMINOPHEN (1,269)
ATORVASTATIN (898)
PANTOPRAZOLE (535)
METHOTREXATE (507)
AMOXICILLIN\CLAVULANATE (480)
SULFAMETHOXAZOLE\TRIMETHOPRIM (462)
ENOXAPARIN (404)
PIPERACILLIN\TAZOBACTAM (394)
ESOMEPRAZOLE (363)
NIVOLUMAB (342)
Which MIDOSTAURIN Alternatives Have Lower Cholestasis Risk?
MIDOSTAURIN vs MIFEPRISTONE
MIDOSTAURIN vs MIGALASTAT
MIDOSTAURIN vs MIGLITOL
MIDOSTAURIN vs MIGLUSTAT
MIDOSTAURIN vs MILNACIPRAN