Does IBUPROFEN Cause Cholestasis? 202 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 202 reports of Cholestasis have been filed in association with IBUPROFEN (equate ibuprofen). This represents 0.2% of all adverse event reports for IBUPROFEN.
202
Reports of Cholestasis with IBUPROFEN
0.2%
of all IBUPROFEN reports
3
Deaths
140
Hospitalizations
How Dangerous Is Cholestasis From IBUPROFEN?
Of the 202 reports, 3 (1.5%) resulted in death, 140 (69.3%) required hospitalization, and 26 (12.9%) 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 IBUPROFEN. However, 202 reports have been filed with the FAERS database.
What Other Side Effects Does IBUPROFEN Cause?
Drug ineffective (9,352)
Drug hypersensitivity (5,269)
Nausea (4,129)
Vomiting (4,116)
Acute kidney injury (3,639)
Product use in unapproved indication (3,596)
Toxicity to various agents (3,584)
Off label use (3,556)
Intentional overdose (3,185)
Headache (3,010)
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 IBUPROFEN Alternatives Have Lower Cholestasis Risk?
IBUPROFEN vs IBUPROFEN LYSINE
IBUPROFEN vs IBUPROFEN UNKNOWN PRODUCT
IBUPROFEN vs IBUPROFEN\IBUPROFEN
IBUPROFEN vs IBUPROFEN\PHENYLEPHRINE
IBUPROFEN vs IBUPROFEN\PSEUDOEPHEDRINE