Does AMOXICILLIN Cause Off label use? 1,261 Reports in FDA Database

Q: Does AMOXICILLIN cause Off label use?

1,261 reports of Off label use have been filed with the FDA for AMOXICILLIN, representing 4.2% of all AMOXICILLIN adverse event reports.

Q: How dangerous is Off label use from AMOXICILLIN?

Of 1,261 reports, 64 (5.1%) resulted in death and 651 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 1,261 reports of Off label use have been filed in association with AMOXICILLIN (Amoxicillin and Clavulanate Potassium). This represents 4.2% of all adverse event reports for AMOXICILLIN.

1,261

Reports of Off label use with AMOXICILLIN

4.2%

of all AMOXICILLIN reports

Deaths

651

Hospitalizations

How Dangerous Is Off label use From AMOXICILLIN?

Of the 1,261 reports, 64 (5.1%) resulted in death, 651 (51.6%) required hospitalization, and 79 (6.3%) 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 AMOXICILLIN. However, 1,261 reports have been filed with the FAERS database.

What Other Side Effects Does AMOXICILLIN Cause?

Drug hypersensitivity (3,433) Rash (2,281) Pruritus (2,005) Drug ineffective (1,926) Urticaria (1,661) Dyspnoea (1,600) Diarrhoea (1,548)