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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 NALTREXONE Cause Off label use? 1,077 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 1,077 reports of Off label use have been filed in association with NALTREXONE (NALTREXONE HYDROCHLORIDE). This represents 4.2% of all adverse event reports for NALTREXONE.

1,077
Reports of Off label use with NALTREXONE
4.2%
of all NALTREXONE reports
32
Deaths
77
Hospitalizations

How Dangerous Is Off label use From NALTREXONE?

Of the 1,077 reports, 32 (3.0%) resulted in death, 77 (7.1%) required hospitalization, and 13 (1.2%) 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 NALTREXONE. However, 1,077 reports have been filed with the FAERS database.

What Other Side Effects Does NALTREXONE Cause?

Injection site reaction (4,360) Injection site pain (2,990) Alcoholism (1,928) Injection site mass (1,849) Nausea (1,782) Fatigue (1,486) Pain (1,348) Drug dependence (1,334) Drug ineffective (1,250) Feeling abnormal (1,241)

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 NALTREXONE Alternatives Have Lower Off label use Risk?

NALTREXONE vs NAPHAZOLINE\PHENIRAMINE NALTREXONE vs NAPROXEN NALTREXONE vs NAPROXEN\NAPROXEN NALTREXONE vs NAPROXEN\PSEUDOEPHEDRINE NALTREXONE vs NAPROXEN\SUMATRIPTAN

Related Pages

NALTREXONE Full Profile All Off label use Reports All Drugs Causing Off label use NALTREXONE Demographics