65/100 · Elevated
Manufactured by Fresenius Kabi USA, LLC
Fish Oil Adverse Events: Moderate Safety Concerns
214,316 FDA adverse event reports analyzed
Last updated: 2026-05-12
FISH OIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. Based on analysis of 214,316 FDA adverse event reports, FISH OIL has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for FISH OIL include FATIGUE, DRUG INEFFECTIVE, NAUSEA, DIARRHOEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FISH OIL.
Fish Oil has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 214,316 adverse event reports for this medication, which is primarily manufactured by Fresenius Kabi Usa, Llc.
The most commonly reported adverse events include Fatigue, Drug Ineffective, Nausea. Of classified reports, 48.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and nausea are the most common adverse reactions, with over 5,000 reports each.
Serious adverse events, such as death and pneumonia, account for nearly 50% of all reports. The majority of adverse events are non-serious, but the diversity of reactions indicates a complex safety profile.
Patients taking Fish Oil should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Fish oil may interact with other medications, particularly those affecting blood clotting, and can cause drug hyper-sensitivity reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Fish Oil received a safety concern score of 65/100 (elevated concern). This is based on a 48.8% serious event ratio across 87,609 classified reports. The score accounts for 214,316 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 51,448, Male: 31,989, Unknown: 86. The most frequently reported age groups are age 64 (1,684 reports), age 65 (1,581 reports), age 67 (1,525 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 87,609 classified reports for FISH OIL:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Fish oil may interact with other medications, particularly those affecting blood clotting, and can cause drug hyper-sensitivity reactions.
If you are taking Fish Oil, here are important things to know. The most commonly reported side effects include fatigue, drug ineffective, nausea, diarrhoea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before starting fish oil supplements, especially if you have existing health conditions or are taking other medications. Monitor for any unusual symptoms and report them to your healthcare provider. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with the FDA monitoring adverse event reports to ensure public safety.
The FDA has received approximately 214,316 adverse event reports associated with Fish Oil. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Fish Oil include Fatigue, Drug Ineffective, Nausea, Diarrhoea, Headache. By volume, the top reported reactions are: Fatigue (8,138 reports), Drug Ineffective (6,011 reports), Nausea (5,912 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Fish Oil.
Out of 87,609 classified reports, 42,773 (48.8%) were classified as serious and 44,836 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Fish Oil break down by patient sex as follows: Female: 51,448, Male: 31,989, Unknown: 86. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Fish Oil adverse events are: age 64: 1,684 reports, age 65: 1,581 reports, age 67: 1,525 reports, age 62: 1,500 reports, age 63: 1,483 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Fish Oil adverse event reports is Fresenius Kabi Usa, Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Fish Oil include: Pain, Dizziness, Arthralgia, Dyspnoea, Pruritus. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Fish Oil to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Fish Oil has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Fatigue and nausea are the most common adverse reactions, with over 5,000 reports each.
Key safety signals identified in Fish Oil's adverse event data include: High frequency of gastrointestinal issues (nausea, diarrhea, abdominal pain).. Multiple reports of serious conditions like pneumonia and death.. A wide range of reactions, including neurological and musculoskeletal issues.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Fish oil may interact with other medications, particularly those affecting blood clotting, and can cause drug hyper-sensitivity reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Fish Oil.
Consult a healthcare provider before starting fish oil supplements, especially if you have existing health conditions or are taking other medications. Monitor for any unusual symptoms and report them to your healthcare provider.
Fish Oil has 214,316 adverse event reports on file with the FDA. Serious adverse events, such as death and pneumonia, account for nearly 50% of all reports. The volume of reports for Fish Oil reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with the FDA monitoring adverse event reports to ensure public safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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