Does OMEGA-3-ACID ETHYL ESTERS Cause Off label use? 72 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 72 reports of Off label use have been filed in association with OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS). This represents 3.3% of all adverse event reports for OMEGA-3-ACID ETHYL ESTERS.
72
Reports of Off label use with OMEGA-3-ACID ETHYL ESTERS
3.3%
of all OMEGA-3-ACID ETHYL ESTERS reports
3
Deaths
25
Hospitalizations
How Dangerous Is Off label use From OMEGA-3-ACID ETHYL ESTERS?
Of the 72 reports, 3 (4.2%) resulted in death, 25 (34.7%) required hospitalization, and 1 (1.4%) 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 OMEGA-3-ACID ETHYL ESTERS. However, 72 reports have been filed with the FAERS database.
What Other Side Effects Does OMEGA-3-ACID ETHYL ESTERS Cause?
Product odour abnormal (194)
Product quality issue (132)
Malaise (121)
Nausea (96)
Eructation (93)
Drug ineffective (91)
Chest pain (83)
Abdominal discomfort (77)
Diarrhoea (73)
Gastrooesophageal reflux disease (66)
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 OMEGA-3-ACID ETHYL ESTERS Alternatives Have Lower Off label use Risk?
OMEGA-3-ACID ETHYL ESTERS vs OMEGA-3-CARBOXYLIC ACIDS
OMEGA-3-ACID ETHYL ESTERS vs OMEGA-3 FATTY ACIDS
OMEGA-3-ACID ETHYL ESTERS vs OMEPRAZOLE
OMEGA-3-ACID ETHYL ESTERS vs OMEPRAZOLE\SODIUM BICARBONATE
OMEGA-3-ACID ETHYL ESTERS vs OMNIPAQUE