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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 NAPROXEN Cause Off label use? 4,434 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 4,434 reports of Off label use have been filed in association with NAPROXEN (Naproxen Sodium). This represents 8.4% of all adverse event reports for NAPROXEN.

4,434
Reports of Off label use with NAPROXEN
8.4%
of all NAPROXEN reports
1,323
Deaths
2,432
Hospitalizations

How Dangerous Is Off label use From NAPROXEN?

Of the 4,434 reports, 1,323 (29.8%) resulted in death, 2,432 (54.8%) required hospitalization, and 1,682 (37.9%) 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 NAPROXEN. However, 4,434 reports have been filed with the FAERS database.

What Other Side Effects Does NAPROXEN Cause?

Drug ineffective (12,416) Product use issue (4,865) Drug hypersensitivity (4,160) Pain (4,140) Nausea (4,139) Vomiting (3,889) Fatigue (3,659) Diarrhoea (3,498) Dizziness (3,460) Rash (3,401)

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 NAPROXEN Alternatives Have Lower Off label use Risk?

NAPROXEN vs NAPROXEN\NAPROXEN NAPROXEN vs NAPROXEN\PSEUDOEPHEDRINE NAPROXEN vs NAPROXEN\SUMATRIPTAN NAPROXEN vs NARATRIPTAN NAPROXEN vs NASONEX

Related Pages

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