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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does ACETAMINOPHEN Cause Cholestasis? 1,269 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 1,269 reports of Cholestasis have been filed in association with ACETAMINOPHEN (Hydrocodone Bitartrate and Acetaminophen). This represents 0.9% of all adverse event reports for ACETAMINOPHEN.

1,269
Reports of Cholestasis with ACETAMINOPHEN
0.9%
of all ACETAMINOPHEN reports
57
Deaths
737
Hospitalizations

How Dangerous Is Cholestasis From ACETAMINOPHEN?

Of the 1,269 reports, 57 (4.5%) resulted in death, 737 (58.1%) required hospitalization, and 73 (5.8%) 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 ACETAMINOPHEN. However, 1,269 reports have been filed with the FAERS database.

What Other Side Effects Does ACETAMINOPHEN Cause?

Drug ineffective (17,522) Toxicity to various agents (16,128) Off label use (9,410) Vomiting (9,055) Pain (8,573) Fatigue (8,202) Overdose (7,917) Nausea (7,245) Rash (7,107) Headache (7,084)

What Other Drugs Cause Cholestasis?

ATORVASTATIN (898) PANTOPRAZOLE (535) METHOTREXATE (507) AMOXICILLIN\CLAVULANATE (480) SULFAMETHOXAZOLE\TRIMETHOPRIM (462) ENOXAPARIN (404) PIPERACILLIN\TAZOBACTAM (394) ESOMEPRAZOLE (363) NIVOLUMAB (342) AMOXICILLIN (326)

Which ACETAMINOPHEN Alternatives Have Lower Cholestasis Risk?

ACETAMINOPHEN vs ACETAMINOPHEN AND OR DEXTROMETHORPHAN AND OR DIPHENHYDRAMINE AND OR GUAIFENESIN AND OR PHENYLEPHRINE AND OR PSEUDOEPHEDRINE ACETAMINOPHEN vs ACETAMINOPHEN W/HYDROCODONE ACETAMINOPHEN vs ACETAMINOPHEN\ASPIRIN\CAFFEINE ACETAMINOPHEN vs ACETAMINOPHEN\ASPIRIN\CAFFEINE\SALICYLAMIDE ACETAMINOPHEN vs ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM

Related Pages

ACETAMINOPHEN Full Profile All Cholestasis Reports All Drugs Causing Cholestasis ACETAMINOPHEN Demographics