🇺🇸 n-3 PUFA in United States

10 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: 28 March 2025 – 28 March 2026
• Total reports: 10

Most-reported reactions

1. Anaemia — 1 report (10%)
2. Blood Creatinine Increased — 1 report (10%)
3. Calculus Bladder — 1 report (10%)
4. Disseminated Intravascular Coagulation — 1 report (10%)
5. Dyspnoea — 1 report (10%)
6. Fatigue — 1 report (10%)
7. Gallbladder Enlargement — 1 report (10%)
8. Haemoglobin Decreased — 1 report (10%)
9. Hepatic Cyst — 1 report (10%)
10. Hepatic Failure — 1 report (10%)

Source database →

Frequently asked questions

Is n-3 PUFA approved in United States?

n-3 PUFA does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for n-3 PUFA in United States?

Gruppo di Ricerca GISSI is the originator. The local marketing authorisation holder may differ — check the official source linked above.