Prednisolone; Trimeprazine Tartrate

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817 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.
817
Total Reports
64
Deaths Reported
780.0%
Death Rate

Active Ingredients

Prednisolone; Trimeprazine Tartrate

Administration Routes

OralUnknownOphthalmicSubcutaneous

Species Affected

Dog 786
Unknown 25
Cat 4
Human 2

Most Affected Breeds

Retriever - Labrador 79
Shih Tzu 59
Terrier - Yorkshire 42
Chihuahua 33
Unknown 27
Dog (unknown) 27
Retriever - Golden 26
Boxer (German Boxer) 23
Maltese 23
Terrier - Jack Russell 21

Most Reported Reactions

Lack of efficacy - NOS 148
Lethargy (see also Central nervous system depression in 'Neurological') 102
INEFFECTIVE, LOSS OF EFFECT 100
Vomiting 97
Elevated serum alkaline phosphatase (SAP) 83
Other abnormal test result NOS 75
INEFFECTIVE, ATOPY CONTROL 71
Polydipsia 64
Polyuria 58
Diarrhoea 53
Anorexia 53
Elevated alanine aminotransferase (ALT) 44

Outcome Breakdown

Ongoing
496 (62.6%)
Outcome Unknown
119 (15.0%)
Recovered/Normal
112 (14.1%)
Euthanized
35 (4.4%)
Died
29 (3.7%)
Recovered with Sequela
1 (0.1%)

Data Summary

Metric Value
Total adverse event reports 817
Reports involving death 64
Case-fatality rate (reported events) 780.0%
Distinct species in reports 4
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.

Prednisolone; Trimeprazine Tartrate Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 817 adverse event reports referencing Prednisolone; Trimeprazine Tartrate, including 64 reports in which the animal died — a 780.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Prednisolone; Trimeprazine Tartrate. Reported administration routes include Oral, Unknown, Ophthalmic, Subcutaneous. 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 Prednisolone; Trimeprazine Tartrate reports are Dog (786 reports), Unknown (25 reports), Cat (4 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (79), Shih Tzu (59), Terrier - Yorkshire (42) 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 Prednisolone; Trimeprazine Tartrate are Lack of efficacy - NOS (148), Lethargy (see also Central nervous system depression in 'Neurological') (102), INEFFECTIVE, LOSS OF EFFECT (100), Vomiting (97). Of the 792 reports with a coded outcome, Ongoing is the leading category at 62.6%. 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 Prednisolone; Trimeprazine Tartrate.

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