Drug profile

The FDA adverse-event record for Immunotherapy

414 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Immunotherapy. See the species affected, top reactions, and outcomes below.

414
adverse-event reports
5.8%
death-coded share
Dog
most-reported species
61
Lack of efficacy - NOS - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
414
Total Reports
24
Deaths Reported
5.8%
Death Rate

Active Ingredients

Immunotherapy

Administration Routes

UnknownOralSublingualParenteralSubcutaneousOtherIntradermalTransdermal

Species Affected

Dog 394
Cat 20

Most Affected Breeds

Retriever - Labrador 55
Retriever - Golden 29
Shepherd Dog - German 23
Terrier - Bull - American Pit 21
Bulldog - French 16
Bulldog 14
Terrier - Yorkshire 14
Domestic Shorthair 12
Terrier - West Highland White 11
Shih Tzu 10

Most Reported Reactions

Lack of efficacy - NOS 61
Other abnormal test result NOS 43
Vomiting 38
INEFFECTIVE, ATOPY CONTROL 37
INEFFECTIVE, LOSS OF EFFECT 35
Lethargy (see also Central nervous system depression in 'Neurological') 34
Diarrhoea 28
Leucopenia NOS 23
Neutropenia 22
Elevated alanine aminotransferase (ALT) 19
Skin disorders NOS 18
Death by euthanasia 17

Outcome Breakdown

Ongoing
256 (61.8%)
Outcome Unknown
70 (16.9%)
Recovered/Normal
60 (14.5%)
Euthanized
17 (4.1%)
Died
7 (1.7%)
Recovered with Sequela
4 (1.0%)

Immunotherapy Adverse Event Insights

414 reports name Immunotherapy; 24 recorded a death outcome (5.8% of reported events, not a population-level mortality rate). Active ingredient: Immunotherapy. Administration routes: Unknown, Oral, Sublingual, Parenteral.

By species: Dog (394 reports), Cat (20 reports). By breed: Retriever - Labrador (55), Retriever - Golden (29), Shepherd Dog - German (23).

Leading clinical signs: Lack of efficacy - NOS (61), Other abnormal test result NOS (43), Vomiting (38), INEFFECTIVE, ATOPY CONTROL (37). Outcome, 414 coded reports: Ongoing leads at 61.8%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.