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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 DEGARELIX Cause Off label use? 128 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 128 reports of Off label use have been filed in association with DEGARELIX (FIRMAGON). This represents 3.4% of all adverse event reports for DEGARELIX.

128
Reports of Off label use with DEGARELIX
3.4%
of all DEGARELIX reports
16
Deaths
35
Hospitalizations

How Dangerous Is Off label use From DEGARELIX?

Of the 128 reports, 16 (12.5%) resulted in death, 35 (27.3%) required hospitalization, and 2 (1.6%) 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 DEGARELIX. However, 128 reports have been filed with the FAERS database.

What Other Side Effects Does DEGARELIX Cause?

Injection site pain (296) Injection site erythema (246) Hot flush (199) Fatigue (195) Injection site swelling (183) Product storage error (177) Pyrexia (170) Asthenia (1