Omega 3 Fatty Acids

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190 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
190
Total Reports
12
Deaths Reported
630.0%
Death Rate

Active Ingredients

Omega 3 Fatty Acids

Administration Routes

OralUnknown

Species Affected

Dog 167
Cat 17
Human 4
Unknown 1
Other Canids 1

Most Affected Breeds

Retriever - Labrador 35
Domestic Shorthair 11
Retriever - Golden 10
Shepherd Dog - German 9
Dog (unknown) 8
Boxer (German Boxer) 7
Bulldog 6
Unknown 5
Chihuahua 5
Crossbred Canine/dog 5

Most Reported Reactions

Vomiting 42
Diarrhoea 25
Lack of efficacy - NOS 24
Lethargy (see also Central nervous system depression in 'Neurological') 19
Decreased appetite 15
Behavioural disorder NOS 15
Emesis 12
Weight loss 12
Other abnormal test result NOS 11
Not eating 11
Elevated alanine aminotransferase (ALT) 11
Lethargy (see also Central nervous system depression in Neurological) 10

Outcome Breakdown

Recovered/Normal
66 (34.9%)
Outcome Unknown
60 (31.7%)
Ongoing
49 (25.9%)
Euthanized
7 (3.7%)
Died
5 (2.6%)
Recovered with Sequela
2 (1.1%)

Data Summary

Metric Value
Total adverse event reports 190
Reports involving death 12
Case-fatality rate (reported events) 630.0%
Distinct species in reports 5
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Omega 3 Fatty Acids Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 190 adverse event reports referencing Omega 3 Fatty Acids, including 12 reports in which the animal died — a 630.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Omega 3 Fatty Acids. Reported administration routes include Oral, Unknown. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Omega 3 Fatty Acids reports are Dog (167 reports), Cat (17 reports), Human (4 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (35), Domestic Shorthair (11), Retriever - Golden (10) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Omega 3 Fatty Acids are Vomiting (42), Diarrhoea (25), Lack of efficacy - NOS (24), Lethargy (see also Central nervous system depression in 'Neurological') (19). Of the 189 reports with a coded outcome, Recovered/Normal is the leading category at 34.9%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Omega 3 Fatty Acids.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial