Recombitek 4 Lepto - 2668.00

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63 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.
63
Total Reports
6
Deaths Reported
950.0%
Death Rate

Active Ingredients

Recombitek 4 Lepto - 2668.00

Administration Routes

SubcutaneousUnknownIntramuscular

Species Affected

Dog 63

Most Affected Breeds

Retriever - Labrador 10
Shih Tzu 6
Crossbred Canine/dog 5
Retriever - Golden 4
Beagle 4
Chihuahua 4
Rottweiler 3
Bulldog - French 3
Ridgeback - Rhodesian 2
Terrier - Yorkshire 2

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 20
Vomiting 17
Anorexia 12
Other abnormal test result NOS 7
Seizure NOS 7
Not eating 6
Anaemia NOS 5
Elevated alanine aminotransferase (ALT) 5
Injection site swelling 4
Elevated serum alkaline phosphatase (SAP) 4
Diarrhoea 4
Behavioural disorder NOS 4

Outcome Breakdown

Recovered/Normal
25 (39.1%)
Outcome Unknown
23 (35.9%)
Ongoing
9 (14.1%)
Died
5 (7.8%)
Euthanized
2 (3.1%)

Data Summary

Metric Value
Total adverse event reports 63
Reports involving death 6
Case-fatality rate (reported events) 950.0%
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.

Recombitek 4 Lepto - 2668.00 Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 63 adverse event reports referencing Recombitek 4 Lepto - 2668.00, including 6 reports in which the animal died — a 950.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Recombitek 4 Lepto - 2668.00. Reported administration routes include Subcutaneous, Unknown, Intramuscular. 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 4 Lepto - 2668.00 reports are Dog (63 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (10), Shih Tzu (6), Crossbred Canine/dog (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 Recombitek 4 Lepto - 2668.00 are Lethargy (see also Central nervous system depression in 'Neurological') (20), Vomiting (17), Anorexia (12), Other abnormal test result NOS (7). Of the 64 reports with a coded outcome, Recovered/Normal is the leading category at 39.1%. 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 4 Lepto - 2668.00.

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