🇺🇸 LOVAZA Omega 3-acid ethyl esters in United States

17 US adverse-event reports

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

• Window: 22 April 2025 – 22 April 2026
• Total reports: 17

Most-reported reactions

1. Dyspnoea — 3 reports (17.65%)
2. Headache — 3 reports (17.65%)
3. Dizziness — 2 reports (11.76%)
4. Fatigue — 2 reports (11.76%)
5. Tremor — 2 reports (11.76%)
6. Anxiety — 1 report (5.88%)
7. Application Site Dermatitis — 1 report (5.88%)
8. Application Site Erythema — 1 report (5.88%)
9. Application Site Pain — 1 report (5.88%)
10. Application Site Pruritus — 1 report (5.88%)

Source database →

Frequently asked questions

Is LOVAZA Omega 3-acid ethyl esters approved in United States?

LOVAZA Omega 3-acid ethyl esters does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for LOVAZA Omega 3-acid ethyl esters in United States?

University of Michigan is the originator. The local marketing authorisation holder may differ — check the official source linked above.