Recombitek C6 - 4639.R1

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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
1
Deaths Reported
590.0%
Death Rate

Active Ingredients

Recombitek C6 - 4639.R1

Administration Routes

SubcutaneousUnknown

Species Affected

Dog 17

Most Affected Breeds

Shih Tzu 2
Crossbred Canine/dog 2
Pointing Dog - Hungarian Short-haired (Vizsla) 2
Bloodhound 1
Bulldog 1
Dog (unknown) 1
Retriever - Golden 1
Mastiff 1
Terrier - Yorkshire 1
Terrier (unspecified) 1

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 7
Diarrhoea 4
Injection site lump 3
Vomiting 3
Ataxia 2
Pain NOS 2
Injection site pain 2
Inappetence 2
Shivering 2
Digestive tract disorder NOS 2
Fever 2
Vocalisation 2

Outcome Breakdown

Outcome Unknown
13 (72.2%)
Recovered/Normal
3 (16.7%)
Ongoing
1 (5.6%)
Died
1 (5.6%)

Data Summary

Metric Value
Total adverse event reports 17
Reports involving death 1
Case-fatality rate (reported events) 590.0%
Distinct species in reports 1
Distinct breeds in reports 14
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.

Recombitek C6 - 4639.R1 Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 17 adverse event reports referencing Recombitek C6 - 4639.R1, including 1 reports in which the animal died — a 590.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Recombitek C6 - 4639.R1. 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 Recombitek C6 - 4639.R1 reports are Dog (17 reports), with Dog accounting for the largest share. Within those species, Shih Tzu (2), Crossbred Canine/dog (2), Pointing Dog - Hungarian Short-haired (Vizsla) (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 Recombitek C6 - 4639.R1 are Lethargy (see also Central nervous system depression in 'Neurological') (7), Diarrhoea (4), Injection site lump (3), Vomiting (3). Of the 18 reports with a coded outcome, Outcome Unknown is the leading category at 72.2%. 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 Recombitek C6 - 4639.R1.

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