Total Reports
640
FDA CVM filings
Dog /
FDA CVM · 2025 release 640 reports on file
Setter - Irish Red - FDA Adverse Event Profile
Adverse-event records for Setter - Irish Red (Dog) from the FDA Center for Veterinary Medicine.
Data updated June 2026
The record at a glance
Setter - Irish Red's FDA record: #125 most-reported dog breed, 640 total reports, 3.9% death-coded (25 reports).
- #125
- most-reported dog breed
- 3.9%
- death-coded report share
- 134
- Vomiting - top reaction
- 5.2 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
25
of 640 reports
Death Rate
3.9%
death-coded share
Avg Age at Report
5.2 yr
27.8 kg avg weight
Death-Coded Outcome Share
Setter - Irish Red death-coded reports 3.9%
Cross-breed median
3.9% of 640 setter - irish red 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: 27.8 kg (61.3 lbs)
Top Reported Reactions
Vomiting 134
Diarrhoea 44
Lethargy (see also Central nervous system depression in 'Neurological') 41
Lack of efficacy (endoparasite) - hookworm 38
Lack of efficacy - NOS 34
Seizure NOS 34
Lack of efficacy (ectoparasite) - tick NOS 29
Emesis 27
Most Referenced Drugs
Ivermectin + Pyrantel As Pamoate Salt 80
Milbemycin Oxime + Spinosad 75
Afoxolaner 66
Pyrantel Pamoate;Sarolaner 57
Fluralaner Chew Tablets 40
Moxidectin 31
Milbemycin Oxime + Praziquantel 29
Carprofen 26
Outcome Breakdown
Outcome Unknown
201 (34.1%)
Ongoing
172 (29.2%)
Recovered/Normal
165 (28.0%)
Recovered with Sequela
27 (4.6%)
Euthanized
13 (2.2%)
Died
12 (2.0%)
Gender Distribution
Male 332 (51.9%)
Female 296 (46.3%)
Unknown 11 (1.7%)
Mixed 1 (0.2%)
Reports by Year
| Year | Reports | Trend |
|---|---|---|
| 2010 | 26 | |
| 2011 | 23 | |
| 2012 | 30 | |
| 2013 | 29 | |
| 2014 | 34 | |
| 2015 | 37 | |
| 2016 | 43 | |
| 2017 | 50 | |
| 2018 | 51 | |
| 2019 | 43 | |
| 2020 | 52 | |
| 2021 | 42 | |
| 2022 | 49 | |
| 2023 | 37 | |
| 2024 | 61 | |
| 2025 | 33 | |
Setter - Irish Red Pet Health Insights
Setter - Irish Red accounts for 640 FDA adverse event reports, ranking #125 by volume among dog breeds, with 25 reports (3.9%) coded as a death outcome. Mean age at report: 5.2 years, average weight 27.8 kg (61.3 lbs).
Top reported signs: Vomiting (134), Diarrhoea (44), Lethargy (see also Central nervous system depression in 'Neurological') (41). Most-referenced drug: Ivermectin + Pyrantel As Pamoate Salt (80 reports), followed by Milbemycin Oxime + Spinosad (75) and Afoxolaner (66).
Outcome coding on 590 status-recorded reports is dominated by Outcome Unknown (34.1%). Annual submissions ranged 2,010-2,025 across 16 years on file.
Dog Breeds With a Similar Report Volume
Coonhound - Black and Tan
654 reports · 3.1% death rate
Dachshund - Standard Smooth-haired
621 reports · 8.2% death rate
Griffon - Brussels
615 reports · 5.0% death rate
Portuguese Water Dog
685 reports · 3.6% death rate
Spaniel - Boykin
704 reports · 1.6% death rate
Sheepdog - Old English
569 reports · 4.0% death rate
Frequently Asked Questions
How many FDA adverse event reports involve Setter - Irish Red? ▼
There are 640 adverse event reports involving Setter - Irish Red in the FDA database, with 25 reports involving death (3.9% death rate). Setter - Irish Red ranks #125 by report volume.
What are the most common adverse reactions reported for Setter - Irish Red? ▼
The most commonly reported adverse reactions for Setter - Irish Red are Vomiting (134 reports), Diarrhoea (44 reports), Lethargy (see also Central nervous system depression in 'Neurological') (41 reports), Lack of efficacy (endoparasite) - hookworm (38 reports), Lack of efficacy - NOS (34 reports).
What drugs are most frequently associated with Setter - Irish Red adverse events? ▼
The drugs most frequently referenced in Setter - Irish Red adverse event reports are Ivermectin + Pyrantel As Pamoate Salt (80 reports), Milbemycin Oxime + Spinosad (75 reports), Afoxolaner (66 reports), Pyrantel Pamoate;Sarolaner (57 reports), Fluralaner Chew Tablets (40 reports).
What is the average age of Setter - Irish Red in adverse event reports? ▼
The average age of Setter - Irish Red at the time of adverse event reports is 5.2 years, with an average weight of 27.8 kg (61.3 lbs).
Does a high number of adverse event reports mean Setter - Irish Red 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 - Irish Red 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.