Phenylpropanolamine (Unknown)

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113 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.
113
Total Reports
4
Deaths Reported
350.0%
Death Rate

Active Ingredients

Phenylpropanolamine (Unknown)

Administration Routes

UnknownOral

Species Affected

Dog 113

Most Affected Breeds

Retriever - Labrador 18
Crossbred Canine/dog 5
Shepherd Dog - Australian 5
Doberman Pinscher 5
Shepherd Dog - German 4
Spaniel - Cocker American 3
Boxer (German Boxer) 3
Pit Bull 3
Terrier - Yorkshire 3
Weimaraner 3

Most Reported Reactions

Emesis 29
Vomiting 25
Diarrhoea 12
Lack of efficacy - NOS 7
Not eating 7
Other abnormal test result NOS 7
Lethargy (see also Central nervous system depression in 'Neurological') 6
Lack of efficacy (endoparasite) - hookworm 6
Behavioural disorder NOS 5
Elevated serum alkaline phosphatase (SAP) 5
Urinary incontinence 5
Death by euthanasia 4

Outcome Breakdown

Recovered/Normal
57 (50.4%)
Outcome Unknown
28 (24.8%)
Ongoing
21 (18.6%)
Euthanized
4 (3.5%)
Recovered with Sequela
3 (2.7%)

Data Summary

Metric Value
Total adverse event reports 113
Reports involving death 4
Case-fatality rate (reported events) 350.0%
Distinct species in reports 1
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.

Phenylpropanolamine (Unknown) Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 113 adverse event reports referencing Phenylpropanolamine (Unknown), including 4 reports in which the animal died — a 350.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Phenylpropanolamine (Unknown). 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 Phenylpropanolamine (Unknown) reports are Dog (113 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (18), Crossbred Canine/dog (5), Shepherd Dog - Australian (5) 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 Phenylpropanolamine (Unknown) are Emesis (29), Vomiting (25), Diarrhoea (12), Lack of efficacy - NOS (7). Of the 113 reports with a coded outcome, Recovered/Normal is the leading category at 50.4%. 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 Phenylpropanolamine (Unknown).

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