Prescription medicine
Fish oil Brand names: Omegaven
Fish oil (Omegaven) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the fish oil FDA label on DailyMed (effective September 5, 2025); every fish oil label on DailyMed.
Highlights of the record
FDA label of September 5, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageOmegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).
Forms and strengths
- 0.1 g/ml
Injection (emulsion).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 89,898 through July 30, 2026
What is fish oil used for?
From the label: indications and usageOmegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). Limitations of Use:
Omegaven is not indicated for the prevention of PNAC. It has not been demonstrated that Omegaven prevents PNAC in parenteral nutrition (PN)-dependent patients [see Clinical Studies ( 14 )].
It has not been demonstrated that the clinical outcomes observed in patients treated with Omegaven are a result of the omega-6: omega-3 fatty acid ratio of the product [see Clinical Studies ( 14 )]. Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). […]
Source: FDA drug label (Omegaven), Fresenius Kabi USA, LLC, effective September 5, 2025 (SPL set 5d9d0b24-e139-48bf-ab2d-536fb59cf8e0), via openFDA; the full label on DailyMed
Is there a generic for fish oil (Omegaven)?
No generic fish oil is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the fish oil label say about other medicines?
The fish oil label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Thiamine | warnings and precautions | Thiamine deficiency and fluid retention may also develop. |
Source: FDA drug label (Omegaven), Fresenius Kabi USA, LLC, effective September 5, 2025 (SPL set 5d9d0b24-e139-48bf-ab2d-536fb59cf8e0), via openFDA; the full label on DailyMed
What do FAERS reports show for fish oil?
The FDA Adverse Event Reporting System holds 89,898 reports that list fish oil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,529 are coded as a death and 19,059 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Fish oil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other