Hydrocodone Bitartrate + Homatropine Methylbromide

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17 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.
17
Total Reports
3
Deaths Reported
1760.0%
Death Rate

Active Ingredients

Hydrocodone Bitartrate + Homatropine Methylbromide

Administration Routes

UnknownOral

Species Affected

Dog 17

Most Affected Breeds

Retriever - Labrador 3
Spitz - German Pomeranian 2
Terrier - Yorkshire 2
Terrier - Rat 1
Spaniel - King Charles Cavalier 1
Greater Swiss Mountain Dog 1
Sheepdog - Shetland 1
Chihuahua 1
Corgi - Welsh Cardigan 1
Shih Tzu 1

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 4
Vomiting 4
Behavioural disorder NOS 3
Diarrhoea 3
Abnormal radiograph finding 3
Decreased appetite 3
Elevated alanine aminotransferase (ALT) 3
Elevated serum alkaline phosphatase (ALP) 3
Death 2
Ataxia 2
Pacing 2
Pale mucous membrane 2

Outcome Breakdown

Ongoing
5 (29.4%)
Outcome Unknown
5 (29.4%)
Recovered/Normal
4 (23.5%)
Died
2 (11.8%)
Euthanized
1 (5.9%)

Data Summary

Metric Value
Total adverse event reports 17
Reports involving death 3
Case-fatality rate (reported events) 1760.0%
Distinct species in reports 1
Distinct breeds in reports 13
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.

Hydrocodone Bitartrate + Homatropine Methylbromide Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 17 adverse event reports referencing Hydrocodone Bitartrate + Homatropine Methylbromide, including 3 reports in which the animal died — a 1760.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Hydrocodone Bitartrate + Homatropine Methylbromide. 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 Hydrocodone Bitartrate + Homatropine Methylbromide reports are Dog (17 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (3), Spitz - German Pomeranian (2), Terrier - Yorkshire (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 Hydrocodone Bitartrate + Homatropine Methylbromide are Lethargy (see also Central nervous system depression in 'Neurological') (4), Vomiting (4), Behavioural disorder NOS (3), Diarrhoea (3). Of the 17 reports with a coded outcome, Ongoing is the leading category at 29.4%. 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 Hydrocodone Bitartrate + Homatropine Methylbromide.

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