Total Reports
26
FDA CVM filings
Dog /
FDA CVM · 2025 release 26 reports on file
Setter - Irish Red and White - FDA Adverse Event Profile
Adverse-event records for Setter - Irish Red and White (Dog) from the FDA Center for Veterinary Medicine.
Data updated June 2026
The record at a glance
Setter - Irish Red and White's FDA record: #334 most-reported dog breed, 26 total reports, 0.0% death-coded (0 reports).
- #334
- most-reported dog breed
- 0.0%
- death-coded report share
- 6
- Vomiting - top reaction
- 4.4 yr
- average age at report
Higher volume usually means a more popular breed, not a riskier one, compare against how common the breed is.
Deaths Reported
0
of 26 reports
Death Rate
0.0%
death-coded share
Avg Age at Report
4.4 yr
26.6 kg avg weight
Death-Coded Outcome Share
Setter - Irish Red and White death-coded reports 0.0%
Cross-breed median
0.0% of 26 setter - irish red and white 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: 26.6 kg (58.7 lbs)
Top Reported Reactions
Vomiting 6
Lethargy (see also Central nervous system depression in 'Neurological') 5
Emesis 4
Ataxia 2
Alopecia general 2
Most Referenced Drugs
Milbemycin Oxime + Spinosad 6
Spinosad 2
Milbemcyin Oxime, Lufenuron, Praziquantel 2
Fluralaner Chew Tablets 2
Milbemycin Oxime, Lufenuron 2
Outcome Breakdown
Recovered/Normal
14 (53.8%)
Ongoing
8 (30.8%)
Outcome Unknown
4 (15.4%)
Gender Distribution
Female 16 (61.5%)
Male 10 (38.5%)
Reports by Year
| Year | Reports | Trend |
|---|---|---|
| 2011 | 2 | |
| 2012 | 8 | |
| 2014 | 1 | |
| 2015 | 2 | |
| 2016 | 4 | |
| 2017 | 1 | |
| 2019 | 1 | |
| 2020 | 3 | |
| 2022 | 1 | |
| 2024 | 2 | |
| 2025 | 1 | |
Setter - Irish Red and White Pet Health Insights
Setter - Irish Red and White accounts for 26 FDA adverse event reports, ranking #334 by volume among dog breeds, with 0 reports (0.0%) coded as a death outcome. Mean age at report: 4.4 years, average weight 26.6 kg (58.7 lbs).
Top reported signs: Vomiting (6), Lethargy (see also Central nervous system depression in 'Neurological') (5), Emesis (4). Most-referenced drug: Milbemycin Oxime + Spinosad (6 reports), followed by Spinosad (2) and Milbemcyin Oxime, Lufenuron, Praziquantel (2).
Outcome coding on 26 status-recorded reports is dominated by Recovered/Normal (53.8%). Annual submissions ranged 2,011-2,025 across 11 years on file.
Dog Breeds With a Similar Report Volume
Coonhound - American English
26 reports · 0.0% death rate
Pointing Dog - English
26 reports · 11.5% death rate
Pudelpointer
25 reports · 0.0% death rate
Terrier - Dandie Dinmont
27 reports · 3.7% death rate
Terrier - Sealyham
27 reports · 7.4% death rate
Basset - Griffon Vendeen Small
28 reports · 7.1% death rate
Frequently Asked Questions
How many FDA adverse event reports involve Setter - Irish Red and White? ▼
There are 26 adverse event reports involving Setter - Irish Red and White in the FDA database, with 0 reports involving death (0.0% death rate). Setter - Irish Red and White ranks #334 by report volume.
What are the most common adverse reactions reported for Setter - Irish Red and White? ▼
The most commonly reported adverse reactions for Setter - Irish Red and White are Vomiting (6 reports), Lethargy (see also Central nervous system depression in 'Neurological') (5 reports), Emesis (4 reports), Ataxia (2 reports), Alopecia general (2 reports).
What drugs are most frequently associated with Setter - Irish Red and White adverse events? ▼
The drugs most frequently referenced in Setter - Irish Red and White adverse event reports are Milbemycin Oxime + Spinosad (6 reports), Spinosad (2 reports), Milbemcyin Oxime, Lufenuron, Praziquantel (2 reports), Fluralaner Chew Tablets (2 reports), Milbemycin Oxime, Lufenuron (2 reports).
What is the average age of Setter - Irish Red and White in adverse event reports? ▼
The average age of Setter - Irish Red and White at the time of adverse event reports is 4.4 years, with an average weight of 26.6 kg (58.7 lbs).
Does a high number of adverse event reports mean Setter - Irish Red and White 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 and White 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.