Total Reports
1,210
FDA CVM filings
Dog /
FDA CVM · 2025 release 1,210 reports on file
Setter - English - FDA Adverse Event Profile
Adverse-event records for Setter - English (Dog) from the FDA Center for Veterinary Medicine.
Data updated June 2026
The record at a glance
With 1,210 reports on file, Setter - English sits at #101 among dog breeds by volume; death-coded share is 3.6% (43 reports).
- #101
- most-reported dog breed
- 3.6%
- death-coded report share
- 164
- Vomiting - top reaction
- 6.4 yr
- average age at report
Read report counts next to breed popularity: a bigger number often just means more owners and more vet visits.
Deaths Reported
43
of 1,210 reports
Death Rate
3.6%
death-coded share
Avg Age at Report
6.4 yr
23.0 kg avg weight
Death-Coded Outcome Share
Setter - English death-coded reports 3.6%
Cross-breed median
3.6% of 1,210 setter - english reports involved a death outcome.
How to read this number
Read alongside breed popularity, veterinary access, and owner awareness, these shape how many events ever reach the FDA. The comparison line marks the cross-breed median death-coded share (about 4.8%) among breeds with 50 or more reports; values above it suggest higher reporting bias toward severe outcomes, not necessarily higher true mortality.
Average weight at time of report: 23.0 kg (50.7 lbs)
Top Reported Reactions
Vomiting 164
INEFFECTIVE, HEARTWORM LARVAE 110
Lack of efficacy (endoparasite) - hookworm 104
Diarrhoea 104
Lack of efficacy (endoparasite) - heartworm 99
Lethargy (see also Central nervous system depression in 'Neurological') 75
Lack of efficacy - NOS 68
Digestive tract disorder NOS 56
Emesis 46
Anorexia 45
INEFFECTIVE, ASCARIDS NOS 44
Lack of efficacy (ectoparasite) - tick NOS 44
Seizure NOS 36
Lack of efficacy (endoparasite) - whipworm 34
Cardiac disorder NOS 34
Most Referenced Drugs
Ivermectin + Pyrantel As Pamoate Salt 200
Milbemycin Oxime + Spinosad 113
Milbemycin Oxime + Praziquantel 97
Afoxolaner 90
Moxidectin 64
Pyrantel Pamoate;Sarolaner 64
Oclacitinib Maleate 50
Carprofen 45
Fluralaner Chew Tablets 41
Sarolaner 38
Spinosad 36
Fluralaner 13.64% 12-Week Chew 36
Milbemycin 29
Bedinvetmab 24
Ivermectin, Pyrantel 22
Outcome Breakdown
Outcome Unknown
401 (36.5%)
Ongoing
320 (29.1%)
Recovered/Normal
280 (25.5%)
Recovered with Sequela
55 (5.0%)
Died
24 (2.2%)
Euthanized
19 (1.7%)
Gender Distribution
Female 608 (50.2%)
Male 580 (47.9%)
Unknown 18 (1.5%)
Mixed 4 (0.3%)
Reports by Year
| Year | Reports | Trend |
|---|---|---|
| 2010 | 62 | |
| 2011 | 61 | |
| 2012 | 68 | |
| 2013 | 68 | |
| 2014 | 67 | |
| 2015 | 79 | |
| 2016 | 91 | |
| 2017 | 95 | |
| 2018 | 84 | |
| 2019 | 88 | |
| 2020 | 75 | |
| 2021 | 71 | |
| 2022 | 71 | |
| 2023 | 94 | |
| 2024 | 87 | |
| 2025 | 49 | |
Setter - English Pet Health Insights
Setter - English accounts for 1,210 FDA adverse event reports, ranking #101 by volume among dog breeds, with 43 reports (3.6%) coded as a death outcome. Mean age at report: 6.4 years, average weight 23.0 kg (50.7 lbs).
Top reported signs: Vomiting (164), INEFFECTIVE, HEARTWORM LARVAE (110), Lack of efficacy (endoparasite) - hookworm (104). Most-referenced drug: Ivermectin + Pyrantel As Pamoate Salt (200 reports), followed by Milbemycin Oxime + Spinosad (113) and Milbemycin Oxime + Praziquantel (97).
Outcome coding on 1,099 status-recorded reports is dominated by Outcome Unknown (36.5%). Annual submissions ranged 2,010-2,025 across 16 years on file.
Dog Breeds With a Similar Report Volume
Coonhound (unspecified)
1,210 reports · 3.0% death rate
Corgi - Welsh Cardigan
1,200 reports · 3.4% death rate
Spaniel - Cocker English
1,243 reports · 2.5% death rate
Saint Bernard Dog
1,253 reports · 7.8% death rate
Shar Pei
1,258 reports · 7.6% death rate
Newfoundland
1,261 reports · 7.2% death rate
Frequently Asked Questions
How many FDA adverse event reports involve Setter - English? ▼
There are 1,210 adverse event reports involving Setter - English in the FDA database, with 43 reports involving death (3.6% death rate). Setter - English ranks #101 by report volume.
What are the most common adverse reactions reported for Setter - English? ▼
The most commonly reported adverse reactions for Setter - English are Vomiting (164 reports), INEFFECTIVE, HEARTWORM LARVAE (110 reports), Lack of efficacy (endoparasite) - hookworm (104 reports), Diarrhoea (104 reports), Lack of efficacy (endoparasite) - heartworm (99 reports).
What drugs are most frequently associated with Setter - English adverse events? ▼
The drugs most frequently referenced in Setter - English adverse event reports are Ivermectin + Pyrantel As Pamoate Salt (200 reports), Milbemycin Oxime + Spinosad (113 reports), Milbemycin Oxime + Praziquantel (97 reports), Afoxolaner (90 reports), Moxidectin (64 reports).
What is the average age of Setter - English in adverse event reports? ▼
The average age of Setter - English at the time of adverse event reports is 6.4 years, with an average weight of 23.0 kg (50.7 lbs).
Does a high number of adverse event reports mean Setter - English is unhealthy? ▼
No. FDA adverse event reports are voluntarily submitted and do not prove causation. Popular breeds with more veterinary visits tend to have more reports. The data reflects reporting patterns, not actual incidence rates. Always consult a veterinarian for health decisions.
Where does this Setter - English safety data come from? ▼
All data comes from the FDA Center for Veterinary Medicine's adverse event reporting system. Pet owners, veterinarians, and manufacturers voluntarily submit reports about adverse events potentially linked to animal drugs and other products.
Compare a breed's report volume against how common the breed is before drawing conclusions. See our methodology for how death rate and rankings are computed.
Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. Breed figures are computed directly from 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.