Allergen-Specific Immunotherapy

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16 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.
16
Total Reports
4
Deaths Reported
2500.0%
Death Rate

Active Ingredients

Allergen-Specific Immunotherapy

Administration Routes

UnknownParenteralOtherSubcutaneous

Species Affected

Dog 14
Cat 2

Most Affected Breeds

Domestic Shorthair 2
Spaniel - Cocker American 2
Poodle - Toy 2
Retriever - Golden 2
Retriever - Labrador 1
Bulldog - American 1
Collie - Border 1
Mixed (Dog) 1
Hound (unspecified) 1
Collie (unspecified) 1

Most Reported Reactions

Death by euthanasia 3
Wheezing 2
Respiratory discomfort 2
Weight loss 2
Vomiting 2
Abnormal ultrasound finding 2
Digestive tract neoplasm NOS 2
Elevated serum alkaline phosphatase (SAP) 2
Lethargy (see also Central nervous system depression in 'Neurological') 2
Neutropenia 2
Anaemia NOS 2
Loss of hearing 2

Outcome Breakdown

Recovered/Normal
4 (25.0%)
Ongoing
4 (25.0%)
Outcome Unknown
4 (25.0%)
Euthanized
3 (18.8%)
Died
1 (6.3%)

Data Summary

Metric Value
Total adverse event reports 16
Reports involving death 4
Case-fatality rate (reported events) 2500.0%
Distinct species in reports 2
Distinct breeds in reports 12
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.

Allergen-Specific Immunotherapy Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 16 adverse event reports referencing Allergen-Specific Immunotherapy, including 4 reports in which the animal died — a 2500.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Allergen-Specific Immunotherapy. Reported administration routes include Unknown, Parenteral, Other, 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 Allergen-Specific Immunotherapy reports are Dog (14 reports), Cat (2 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (2), Spaniel - Cocker American (2), Poodle - Toy (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 Allergen-Specific Immunotherapy are Death by euthanasia (3), Wheezing (2), Respiratory discomfort (2), Weight loss (2). Of the 16 reports with a coded outcome, Recovered/Normal is the leading category at 25.0%. 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 Allergen-Specific Immunotherapy.

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