Total Reports
161
FDA CVM filings
Dog /
FDA CVM · 2025 release 161 reports on file
Setter (unspecified) - FDA Adverse Event Profile
Adverse-event records for Setter (unspecified) (Dog) from the FDA Center for Veterinary Medicine.
Data updated June 2026
The record at a glance
Setter (unspecified) ranks #196 by report volume among dog breeds - 7 of 161 reports (4.3%) recorded a death outcome.
- #196
- most-reported dog breed
- 4.3%
- death-coded report share
- 23
- Vomiting - top reaction
- 5.9 yr
- average age at report
Report counts track breed popularity and reporting activity, not real-world risk, read this alongside how common the breed is.
Deaths Reported
7
of 161 reports
Death Rate
4.3%
death-coded share
Avg Age at Report
5.9 yr
25.8 kg avg weight
Death-Coded Outcome Share
Setter (unspecified) death-coded reports 4.3%
Cross-breed median
4.3% of 161 setter (unspecified) 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: 25.8 kg (56.9 lbs)
Top Reported Reactions
Vomiting 23
Emesis 16
Lethargy (see also Central nervous system depression in 'Neurological') 16
Lack of efficacy - NOS 15
Diarrhoea 13
Lack of efficacy (endoparasite) - heartworm 10
INEFFECTIVE, HEARTWORM LARVAE 8
Behavioural disorder NOS 8
Most Referenced Drugs
Milbemycin Oxime + Spinosad 23
Milbemycin Oxime + Praziquantel 21
Moxidectin 13
Lotilaner 13
Spinosad 10
Milbemycin Oxime 9
Lufenuron + Milbemycin Oxime 8
Fluralaner 13.64% 12-Week Chew 8
Outcome Breakdown
Outcome Unknown
55 (34.2%)
Recovered/Normal
52 (32.3%)
Ongoing
44 (27.3%)
Euthanized
5 (3.1%)
Recovered with Sequela
3 (1.9%)
Died
2 (1.2%)
Gender Distribution
Female 86 (53.4%)
Male 70 (43.5%)
Unknown 4 (2.5%)
Mixed 1 (0.6%)
Reports by Year
| Year | Reports | Trend |
|---|---|---|
| 2010 | 1 | |
| 2011 | 4 | |
| 2012 | 16 | |
| 2013 | 16 | |
| 2014 | 21 | |
| 2015 | 7 | |
| 2016 | 6 | |
| 2017 | 8 | |
| 2018 | 4 | |
| 2019 | 10 | |
| 2020 | 7 | |
| 2021 | 6 | |
| 2022 | 10 | |
| 2023 | 15 | |
| 2024 | 23 | |
| 2025 | 7 | |
Setter (unspecified) Pet Health Insights
Setter (unspecified) accounts for 161 FDA adverse event reports, ranking #196 by volume among dog breeds, with 7 reports (4.3%) coded as a death outcome. Mean age at report: 5.9 years, average weight 25.8 kg (56.9 lbs).
Top reported signs: Vomiting (23), Emesis (16), Lethargy (see also Central nervous system depression in 'Neurological') (16). Most-referenced drug: Milbemycin Oxime + Spinosad (23 reports), followed by Milbemycin Oxime + Praziquantel (21) and Moxidectin (13).
Outcome coding on 161 status-recorded reports is dominated by Outcome Unknown (34.2%). Annual submissions ranged 2,010-2,025 across 16 years on file.
Dog Breeds With a Similar Report Volume
Terrier - Manchester
159 reports · 5.0% death rate
Australian Kelpie
156 reports · 1.9% death rate
Spaniel - Springer Welsh
155 reports · 3.2% death rate
Foxhound (unspecified)
168 reports · 4.8% death rate
Collie - Smooth-haired
152 reports · 11.2% death rate
Dachshund - Standard Wire-haired
152 reports · 2.6% death rate
Frequently Asked Questions
How many FDA adverse event reports involve Setter (unspecified)? ▼
There are 161 adverse event reports involving Setter (unspecified) in the FDA database, with 7 reports involving death (4.3% death rate). Setter (unspecified) ranks #196 by report volume.
What are the most common adverse reactions reported for Setter (unspecified)? ▼
The most commonly reported adverse reactions for Setter (unspecified) are Vomiting (23 reports), Emesis (16 reports), Lethargy (see also Central nervous system depression in 'Neurological') (16 reports), Lack of efficacy - NOS (15 reports), Diarrhoea (13 reports).
What drugs are most frequently associated with Setter (unspecified) adverse events? ▼
The drugs most frequently referenced in Setter (unspecified) adverse event reports are Milbemycin Oxime + Spinosad (23 reports), Milbemycin Oxime + Praziquantel (21 reports), Moxidectin (13 reports), Lotilaner (13 reports), Spinosad (10 reports).
What is the average age of Setter (unspecified) in adverse event reports? ▼
The average age of Setter (unspecified) at the time of adverse event reports is 5.9 years, with an average weight of 25.8 kg (56.9 lbs).
Does a high number of adverse event reports mean Setter (unspecified) 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 (unspecified) 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.