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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 Off label use? 9,410 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 9,410 reports of Off label use have been filed in association with ACETAMINOPHEN (Hydrocodone Bitartrate and Acetaminophen). This represents 6.9% of all adverse event reports for ACETAMINOPHEN.

9,410
Reports of Off label use with ACETAMINOPHEN
6.9%
of all ACETAMINOPHEN reports
2,262
Deaths
3,754
Hospitalizations

How Dangerous Is Off label use From ACETAMINOPHEN?

Of the 9,410 reports, 2,262 (24.0%) resulted in death, 3,754 (39.9%) required hospitalization, and 2,429 (25.8%) were considered life-threatening.

Is Off label use Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for ACETAMINOPHEN. However, 9,410 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) Vomiting (9,055) Pain (8,573) Fatigue (8,202) Overdose (7,917) Nausea (7,245) Rash (7,107) Headache (7,084) Intentional overdose (6,869)

What Other Drugs Cause Off label use?

RITUXIMAB (39,751) INFLIXIMAB (34,801) DENOSUMAB (34,612) METHOTREXATE (24,020) VEDOLIZUMAB (21,017) ETANERCEPT (20,178) TOCILIZUMAB (18,256) PREDNISONE (17,867) LENALIDOMIDE (17,017) ADALIMUMAB (16,417)

Which ACETAMINOPHEN Alternatives Have Lower Off label use 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 Off label use Reports All Drugs Causing Off label use ACETAMINOPHEN Demographics