Sulfadimethoxine;Ormetoprim

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44 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.
44
Total Reports
2
Deaths Reported
450.0%
Death Rate

Active Ingredients

Sulfadimethoxine;Ormetoprim

Administration Routes

OralUnknownSubcutaneous

Species Affected

Dog 39
Unknown 3
Turkey 1
Human 1

Most Affected Breeds

Retriever - Labrador 10
Unknown 4
Terrier - Bull - American Pit 3
Terrier - Yorkshire 2
Shih Tzu 2
Dog (unknown) 2
Bulldog 2
Crossbred Canine/dog 2
Terrier - Jack Russell 1
Terrier - Boston 1

Most Reported Reactions

Vomiting 9
Lethargy (see also Central nervous system depression in 'Neurological') 7
Ataxia 5
Panting 5
Lack of efficacy - NOS 4
Aggression 4
Behavioural disorder NOS 4
Fever 3
Not eating 3
Death 3
Diarrhoea 3
Elevated aspartate aminotransferase (AST) 3

Outcome Breakdown

Ongoing
24 (58.5%)
Recovered/Normal
9 (22.0%)
Outcome Unknown
6 (14.6%)
Died
2 (4.9%)

Data Summary

Metric Value
Total adverse event reports 44
Reports involving death 2
Case-fatality rate (reported events) 450.0%
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.

Sulfadimethoxine;Ormetoprim Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 44 adverse event reports referencing Sulfadimethoxine;Ormetoprim, including 2 reports in which the animal died — a 450.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Sulfadimethoxine;Ormetoprim. Reported administration routes include Oral, Unknown, 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 Sulfadimethoxine;Ormetoprim reports are Dog (39 reports), Unknown (3 reports), Turkey (1 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (10), Unknown (4), Terrier - Bull - American Pit (3) 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 Sulfadimethoxine;Ormetoprim are Vomiting (9), Lethargy (see also Central nervous system depression in 'Neurological') (7), Ataxia (5), Panting (5). Of the 41 reports with a coded outcome, Ongoing is the leading category at 58.5%. 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 Sulfadimethoxine;Ormetoprim.

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