What the label lists and what reports show
Fish oil side effects
Fish oil's FDA label: “Most common adverse drug reactions (>15%) are: vomiting, agitation, bradycardia, apnea and viral infection.” FAERS holds 89,898 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (8,356 reports).
- No generic listed
Check it at the source: the fish oil FDA label on DailyMed (effective September 5, 2025); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse drug reactions (>15%) are: vomiting, agitation, bradycardia, apnea and viral infection.
Table 2: Adverse Reactions in Greater Than 5% of Omegaven-Treated Pediatric Patients with PNAC
| Adverse Reaction | Omegaven (N=189) n (%) |
|---|---|
| Vomiting | 87 (46) |
| Agitation | 67 (35) |
| Bradycardia | 66 (35) |
| Apnea | 38 (20) |
| Viral Infection | 30 (16) |
| Erythema | 23 (12) |
| Rash | 15 (8) |
| Abscess | 14 (7) |
| Neutropenia | 13 (7) |
| Hypertonia | 11 (6) |
| Incision site erythema | 11 (6) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions ( 5.1 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] • Infections [see Warnings and Precautions ( 5.3 )] • Fat overload syndrome [see Warnings and Precautions ( 5.4 )] • Refeeding syndrome [see Warnings and Precautions ( 5.5 )] • Hypertriglyceridemia [see Warnings and Precautions ( 5.6 )] • Aluminum toxicity [see Warnings and Precautions ( 5.7 )] Most common adverse drug reactions (>15%) are: vomiting, agitation, bradycardia, apnea and viral infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety database for Omegaven reflects exposure in 189 pediatric patients (19 days to 15 years of age) treated for a median of 14 weeks (3 days to 8 years) in two clinical trials.
Source: FDA drug label, 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?
89,898 reports list fish oil among the medicines taken, 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. Of the 23 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Fish oil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions