ICOSAPENT ETHYL
Generic: ICOSAPENT ETHYL
Northstar Rx LLCManufacturer
ORALRoute
ICOSAPENT ETHYLActive Substance
2023-12-07Original Approval
ICOSAPENT ETHYL is FDA application ANDA216811, sponsored by ASCENT PHARMS INC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2025-05-30
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza,Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules.
Class II2026-03-09
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., IndiaFailed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized
Top Reported Reactions
1
DRUG INEFFECTIVE
109 reports
2
OFF LABEL USE
104 reports
3
DIARRHOEA
73 reports
4
CONDITION AGGRAVATED
63 reports
5
NAUSEA
55 reports
6
MATERNAL EXPOSURE DURING PREGNANCY
52 reports
7
OVERLAP SYNDROME
46 reports
8
FATIGUE
40 reports
9
MYOCARDIAL INFARCTION
36 reports
10
PNEUMONIA
36 reports