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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 DAROLUTAMIDE Cause Off label use? 133 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 133 reports of Off label use have been filed in association with DAROLUTAMIDE (NUBEQA). This represents 4.1% of all adverse event reports for DAROLUTAMIDE.

133
Reports of Off label use with DAROLUTAMIDE
4.1%
of all DAROLUTAMIDE reports
10
Deaths
30
Hospitalizations

How Dangerous Is Off label use From DAROLUTAMIDE?

Of the 133 reports, 10 (7.5%) resulted in death, 30 (22.6%) required hospitalization, and 2 (1.5%) 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 DAROLUTAMIDE. However, 133 reports have been filed with the FAERS database.

What Other Side Effects Does DAROLUTAMIDE Cause?

Fatigue (384) Death (361) Hot flush (203) Asthenia (173) Prostatic specific antigen increased (156) Neuropathy peripheral (127) Diarrhoea (122) Dizziness (122) Rash (116) Arthralgia (115)

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 DAROLUTAMIDE Alternatives Have Lower Off label use Risk?

DAROLUTAMIDE vs DARUNAVIR DAROLUTAMIDE vs DARUNAVIR ETHANOLATE DAROLUTAMIDE vs DARUNAVIR\RITONAVIR DAROLUTAMIDE vs DASABUVIR DAROLUTAMIDE vs DASABUVIR\OMBITASVIR HEMINONAHYDRATE\PARITAPREVIR\RITONAVIR

Related Pages

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