Does PEMBROLIZUMAB Cause Cholestasis? 273 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 273 reports of Cholestasis have been filed in association with PEMBROLIZUMAB (KEYTRUDA). This represents 0.3% of all adverse event reports for PEMBROLIZUMAB.
273
Reports of Cholestasis with PEMBROLIZUMAB
0.3%
of all PEMBROLIZUMAB reports
15
Deaths
141
Hospitalizations
How Dangerous Is Cholestasis From PEMBROLIZUMAB?
Of the 273 reports, 15 (5.5%) resulted in death, 141 (51.6%) required hospitalization, and 8 (2.9%) 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 PEMBROLIZUMAB. However, 273 reports have been filed with the FAERS database.
What Other Side Effects Does PEMBROLIZUMAB Cause?
Malignant neoplasm progression (10,111)
Death (4,744)
Diarrhoea (4,251)
Fatigue (3,833)
Off label use (3,416)
Product use in unapproved indication (3,191)
Pyrexia (3,155)
Rash (2,900)
Nausea (2,670)
Decreased appetite (2,486)
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 PEMBROLIZUMAB Alternatives Have Lower Cholestasis Risk?
PEMBROLIZUMAB vs PEMETREXED
PEMBROLIZUMAB vs PEMIGATINIB
PEMBROLIZUMAB vs PENICILLAMINE
PEMBROLIZUMAB vs PENICILLIN
PEMBROLIZUMAB vs PENICILLIN G