Omega-3 Fatty Acids

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149 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.
149
Total Reports
10
Deaths Reported
670.0%
Death Rate

Active Ingredients

Omega-3 Fatty Acids

Administration Routes

UnknownOral

Species Affected

Dog 141
Cat 7
Human 1

Most Affected Breeds

Retriever - Labrador 21
Boxer (German Boxer) 9
Retriever - Golden 8
Terrier - Yorkshire 7
Maltese 6
Crossbred Canine/dog 6
Shepherd Dog - German 5
Terrier (unspecified) 5
Bichon Frise 4
Sheepdog - Shetland 4

Most Reported Reactions

Vomiting 24
Emesis 23
Diarrhoea 21
Lethargy (see also Central nervous system depression in 'Neurological') 19
Anorexia 15
Decreased appetite 15
Lack of efficacy - NOS 15
Elevated alanine aminotransferase (ALT) 11
Emesis (multiple) 9
Weight loss 9
Lethargy (see also Central nervous system depression in Neurological) 9
Other abnormal test result NOS 8

Outcome Breakdown

Recovered/Normal
54 (35.8%)
Ongoing
49 (32.5%)
Outcome Unknown
33 (21.9%)
Recovered with Sequela
5 (3.3%)
Died
5 (3.3%)
Euthanized
5 (3.3%)

Data Summary

Metric Value
Total adverse event reports 149
Reports involving death 10
Case-fatality rate (reported events) 670.0%
Distinct species in reports 3
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 149 adverse event reports referencing Omega-3 Fatty Acids, including 10 reports in which the animal died — a 670.0% 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 Unknown, Oral. 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 (141 reports), Cat (7 reports), Human (1 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (21), Boxer (German Boxer) (9), Retriever - Golden (8) 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 (24), Emesis (23), Diarrhoea (21), Lethargy (see also Central nervous system depression in 'Neurological') (19). Of the 151 reports with a coded outcome, Recovered/Normal is the leading category at 35.8%. 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