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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 OMAVELOXOLONE Cause Off label use? 11 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 11 reports of Off label use have been filed in association with OMAVELOXOLONE (SKYCLARYS). This represents 0.9% of all adverse event reports for OMAVELOXOLONE.

11
Reports of Off label use with OMAVELOXOLONE
0.9%
of all OMAVELOXOLONE reports
0
Deaths
2
Hospitalizations

How Dangerous Is Off label use From OMAVELOXOLONE?

Of the 11 reports, 2 (18.2%) required hospitalization, and 1 (9.1%) 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 OMAVELOXOLONE. However, 11 reports have been filed with the FAERS database.

What Other Side Effects Does OMAVELOXOLONE Cause?

Fatigue (118) Nausea (101) Hepatic enzyme increased (100) Product dose omission issue (92) Headache (83) Diarrhoea (77) Blood cholesterol increased (67) Muscle spasms (64) Abdominal pain upper (51) Atrial fibrillation (48)

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 OMAVELOXOLONE Alternatives Have Lower Off label use Risk?

OMAVELOXOLONE vs OMBITASVIR OMAVELOXOLONE vs OMBITASVIR\PARITAPREVIR\RITONAVIR OMAVELOXOLONE vs OMEGA-3-ACID ETHYL ESTERS OMAVELOXOLONE vs OMEGA-3-CARBOXYLIC ACIDS OMAVELOXOLONE vs OMEGA-3 FATTY ACIDS

Related Pages

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