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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\CODEINE Cause Off label use? 1,309 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 1,309 reports of Off label use have been filed in association with ACETAMINOPHEN\CODEINE. This represents 8.6% of all adverse event reports for ACETAMINOPHEN\CODEINE.

1,309
Reports of Off label use with ACETAMINOPHEN\CODEINE
8.6%
of all ACETAMINOPHEN\CODEINE reports
668
Deaths
904
Hospitalizations

How Dangerous Is Off label use From ACETAMINOPHEN\CODEINE?

Of the 1,309 reports, 668 (51.0%) resulted in death, 904 (69.1%) required hospitalization, and 683 (52.2%) 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\CODEINE. However, 1,309 reports have been filed with the FAERS database.

What Other Side Effects Does ACETAMINOPHEN\CODEINE Cause?

Dependence (3,857) Overdose (2,600) Pain (1,712) Drug ineffective (1,300) Nausea (1,291) Drug dependence (1,273) Fatigue (1,240) Vomiting (1,224) Depression (1,153) Dizziness (1,108)

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\CODEINE Alternatives Have Lower Off label use Risk?

ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE\PHENYLEPHRINE ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\GUAIFENESIN\PHENYLEPHRINE ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\PHENYLEPHRINE

Related Pages

ACETAMINOPHEN\CODEINE Full Profile All Off label use Reports All Drugs Causing Off label use ACETAMINOPHEN\CODEINE Demographics