Last reviewed · How we verify
OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERS is a drug. It is currently FDA-approved (first approved 2004).
At a glance
| Generic name | OMEGA-3-ACID ETHYL ESTERS |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2004 |
Approved indications
Common side effects
- Taste perversion
- Eructation
- Dyspepsia
- Constipation
- Gastrointestinal disorder
- Vomiting
- Increased ALT
- Increased AST
- Pruritus
- Rash
Serious adverse events
- Anaphylactic reaction
- Hemorrhagic diathesis
- Urticaria
Key clinical trials
- Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction (PHASE2)
- The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery (PHASE2)
- Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers (PHASE2)
- Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers (NA)
- VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL) (NA)
- VITamin D and OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic Markers (NA)
- VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone (VITAL) (NA)
- Vitamin D and Omega-3 Hypertension Trial (VITAL Hypertension) (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- OMEGA-3-ACID ETHYL ESTERS CI brief — competitive landscape report
- OMEGA-3-ACID ETHYL ESTERS updates RSS · CI watch RSS
Frequently asked questions about OMEGA-3-ACID ETHYL ESTERS
What is OMEGA-3-ACID ETHYL ESTERS?
OMEGA-3-ACID ETHYL ESTERS is a Small molecule drug.
When was OMEGA-3-ACID ETHYL ESTERS approved?
OMEGA-3-ACID ETHYL ESTERS was first approved on 2004.
What development phase is OMEGA-3-ACID ETHYL ESTERS in?
OMEGA-3-ACID ETHYL ESTERS is FDA-approved (marketed).
What are the side effects of OMEGA-3-ACID ETHYL ESTERS?
Common side effects of OMEGA-3-ACID ETHYL ESTERS include Taste perversion, Eructation, Dyspepsia, Constipation, Gastrointestinal disorder, Vomiting. Serious adverse events: Anaphylactic reaction, Hemorrhagic diathesis, Urticaria.