Does BENZALKONIUM Cause Off label use? 33 Reports in FDA Database

Q: Does BENZALKONIUM cause Off label use?

33 reports of Off label use have been filed with the FDA for BENZALKONIUM, representing 11.8% of all BENZALKONIUM adverse event reports.

Q: How dangerous is Off label use from BENZALKONIUM?

Of 33 reports, 7 (21.2%) resulted in death and 26 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 33 reports of Off label use have been filed in association with BENZALKONIUM (Benzalkonium Chloride). This represents 11.8% of all adverse event reports for BENZALKONIUM.

Reports of Off label use with BENZALKONIUM

11.8%

of all BENZALKONIUM reports

Deaths

Hospitalizations

How Dangerous Is Off label use From BENZALKONIUM?

Of the 33 reports, 7 (21.2%) resulted in death, 26 (78.8%) required hospitalization, and 7 (21.2%) 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 BENZALKONIUM. However, 33 reports have been filed with the FAERS database.

What Other Side Effects Does BENZALKONIUM Cause?

Drug hypersensitivity (112) Drug ineffective (109) Therapy non-responder (105) Condition aggravated (103) Arthralgia (100) Pain in extremity (100) Infection (99)