Does ECULIZUMAB Cause Cholestasis? 49 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 49 reports of Cholestasis have been filed in association with ECULIZUMAB (SOLIRIS). This represents 0.1% of all adverse event reports for ECULIZUMAB.
49
Reports of Cholestasis with ECULIZUMAB
0.1%
of all ECULIZUMAB reports
10
Deaths
26
Hospitalizations
How Dangerous Is Cholestasis From ECULIZUMAB?
Of the 49 reports, 10 (20.4%) resulted in death, 26 (53.1%) required hospitalization, and 8 (16.3%) 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 ECULIZUMAB. However, 49 reports have been filed with the FAERS database.
What Other Side Effects Does ECULIZUMAB Cause?
Fatigue (4,858)
Off label use (4,228)
Haemoglobin decreased (3,028)
Headache (2,699)
Death (2,221)
Pyrexia (1,948)
Dyspnoea (1,819)
Asthenia (1,732)
Drug ineffective (1,644)
Nausea (1,579)
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 ECULIZUMAB Alternatives Have Lower Cholestasis Risk?
ECULIZUMAB vs EDARAVONE
ECULIZUMAB vs EDETATE
ECULIZUMAB vs EDOXABAN
ECULIZUMAB vs EDOXABAN TOSILATE
ECULIZUMAB vs EFALIZUMAB