Proheart

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18 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.
18
Total Reports
1
Deaths Reported
560.0%
Death Rate

Active Ingredients

Proheart

Administration Routes

SubcutaneousUnknown

Species Affected

Dog 18

Most Affected Breeds

Crossbred Canine/dog 5
Pekingese 2
Pit Bull 2
Retriever - Golden 1
Terrier - Yorkshire 1
Pinscher - Miniature 1
Schnauzer - Miniature 1
Siberian Husky 1
Terrier - Boston 1
Retriever - Labrador 1

Most Reported Reactions

Emesis (multiple) 4
Vomiting 3
Shaking 2
Lethargy (see also Central nervous system depression in 'Neurological') 2
Not eating 2
Seizure NOS 2
Lethargy (see also Central nervous system depression in Neurological) 2
Blood in vomit 1
Urine leakage 1
Urinary incontinence 1
Grand mal seizure 1
Reduced level of consciousness 1

Outcome Breakdown

Ongoing
9 (50.0%)
Recovered/Normal
8 (44.4%)
Died
1 (5.6%)

Data Summary

Metric Value
Total adverse event reports 18
Reports involving death 1
Case-fatality rate (reported events) 560.0%
Distinct species in reports 1
Distinct breeds in reports 12
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.

Proheart Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 18 adverse event reports referencing Proheart, including 1 reports in which the animal died — a 560.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Proheart. Reported administration routes include Subcutaneous, 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 Proheart reports are Dog (18 reports), with Dog accounting for the largest share. Within those species, Crossbred Canine/dog (5), Pekingese (2), Pit Bull (2) 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 Proheart are Emesis (multiple) (4), Vomiting (3), Shaking (2), Lethargy (see also Central nervous system depression in 'Neurological') (2). Of the 18 reports with a coded outcome, Ongoing is the leading category at 50.0%. 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 Proheart.

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