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Breed profile · FDA CVM July 2026 extract

Setter (unspecified) adverse-event record

Adverse-event filings for Setter (unspecified) (Dog) in the FDA Center for Veterinary Medicine openFDA extract. Browse dog breeds, reactions, and outcomes below.

#197 of 510
by report volume (all breeds)
166
FDA CVM reports on file
4.8%
death-coded share of reports
#140 of 275
by death-coded share (≥50 reports)

How the 166 reports break down

By recorded gender -- every report on file for Setter (unspecified), no filtering.

Annual report volume

Annual adverse-event report trend Yearly FDA CVM adverse-event report counts for this breed. 23 17.25 11.5 5.75 0 2019 2020 2021 2022 2023 2024 2025 2026 Reports filed Death-coded reports
Annual report volume for Setter (unspecified) drawn from FDA CVM filings.

Data updated September 2026

The verdict

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Setter (unspecified) ranks #197 of 510 by total reports (166) and #139 of 275 by death-coded share (4.8%). National dual: Retriever - Labrador is #1 of 510 by total adverse-event reports (93,675) at death-coded-share rank 195 of 275 breeds with at least 50 reports (3.7%); separately, Atlantic Salmon (Salmo salar) is #1 highest death-coded share at 99.0% (report rank #233).

93,675
Retriever - Labrador reports (#1)
99.0%
Atlantic Salmon (Salmo salar) death share (#1)
#197
This breed, reports of 510
#139
This breed, death share of 275

Report volume reflects how common a breed or drug is and how often owners and vets file — not actual risk. Death-coded share ranks are limited to entries with enough reports to be meaningful. The two maps do not agree at #1.

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Setter (unspecified) has 166 reports now versus 164 in that prior snapshot: 2 more (1.2%).

Report change
+2
Death-coded reports
+1
Death-coded share
+0.6 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Setter (unspecified) changes

Total Reports

166

Above-median volume

Deaths Reported

8

of 166 reports

Death-coded share of reports

4.8%

Below-median death-coded share

Avg Age at Report

6.0 yr

25.9 kg avg weight

Death-Coded Outcome Share

Setter (unspecified) death-coded reports 4.8%
Cross-breed median

4.8% of 166 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 (4.8%) among breeds with 50 or more reports; values above it suggest higher reporting bias toward severe outcomes, not necessarily higher true mortality.

Where Setter (unspecified)'s death-coded share sits among indexed breeds

Death-coded share of FDA CVM reports, breeds with ≥50 reports (July 2026 extract)

5% 49th percentile Higher share than 49% of 275 indexed breeds

5%–10%: 1 indexed breeds (0%). This entry sits in this band. 20%–25%: 2 indexed breeds (1%). Above this entry. 25%–30%: 3 indexed breeds (1%). Above this entry. 30%–35%: 4 indexed breeds (1%). Above this entry. 35%–40%: 5 indexed breeds (2%). Above this entry. 40%–45%: 6 indexed breeds (2%). Above this entry. 45%–50%: 3 indexed breeds (1%). Above this entry. 50%–55%: 7 indexed breeds (3%). Above this entry. 55%–60%: 7 indexed breeds (3%). Above this entry. 60%–65%: 21 indexed breeds (8%). Above this entry. 65%–70%: 11 indexed breeds (4%). Above this entry. 70%–75%: 15 indexed breeds (5%). Above this entry. 75%–80%: 13 indexed breeds (5%). Above this entry. 80%–85%: 11 indexed breeds (4%). Above this entry. 85%–90%: 12 indexed breeds (4%). Above this entry. 90%–95%: 12 indexed breeds (4%). Above this entry. 95%–100%: 142 indexed breeds (52%). Above this entry. Setter (unspecified) 5% 100% every breed with ≥50 FDA reports, bucketed by value

Each bar is a band; taller bars hold more indexed breeds. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count, share, and where it sits relative to this entry.

Source FDA Center for Veterinary Medicine, openFDA adverse event extract (PlainBreed) · July 2026 extract

This histogram uses the same ≥50-report cohort as the highest death-coded share ranking. A higher share means more of this breed's reported events were death-coded, not a mortality rate for living animals.

Average weight at time of report: 25.9 kg (57.1 lbs)

Top Reported Reactions

Vomiting 23
Lethargy (see also Central nervous system depression in 'Neurological') 16
Emesis 16
Lack of efficacy - NOS 15
Diarrhoea 13
Lack of efficacy (endoparasite) - heartworm 10
Lack of efficacy (endoparasite) - hookworm 9
INEFFECTIVE, HEARTWORM LARVAE 8

Most Referenced Drugs

Milbemycin Oxime + Spinosad 23
Milbemycin Oxime + Praziquantel 21
Moxidectin 15
Lotilaner 13
Spinosad 10
Milbemycin Oxime 9
Lufenuron + Milbemycin Oxime 8
Fluralaner 13.64% 12-Week Chew 8

Outcome Breakdown

Outcome Unknown
56 (33.7%)
Recovered/Normal
52 (31.3%)
Ongoing
47 (28.3%)
Euthanized
5 (3.0%)
Recovered with Sequela
3 (1.8%)
Died
3 (1.8%)

Gender Distribution

Female 87 (52.4%)
Male 74 (44.6%)
Unknown 4 (2.4%)
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 10
2026 2

Setter (unspecified) FDA adverse-event insights

Signature read: mid-pack filing volume at 166 (#197 of 510) is the scale stamp on Setter (unspecified). According to FDA CVM filings indexed on PlainBreed as of July 2026 extract, Setter (unspecified) sits at #197 of 510 by report volume among all breeds and #152 of 298 among dog breeds, with 166 reports and 8 (4.8%) death-coded. On death-coded share among breeds with ≥50 reports, it ranks #140 of 275. Mean age at report: 6.0 years, average weight 25.9 kg (57.1 lbs).

Top reported signs: Vomiting (23), Lethargy (see also Central nervous system depression in 'Neurological') (16), Emesis (16). Most-referenced drug: Milbemycin Oxime + Spinosad (23 reports), followed by Milbemycin Oxime + Praziquantel (21) and Moxidectin (15).

Outcome coding on 166 status-recorded reports is dominated by Outcome Unknown (33.7%). Annual submissions ranged 1-2,026 across 17 years on file.

Dog Breeds With a Similar Report Volume

Showing 6 of 297 dog breeds in our dataset, ranked by closest report volume.

Nationwide breeds with similar profiles

Two openFDA-derived peer sets for Setter (unspecified), both outside the Dog family so the neighborhoods are not species containment (the similar-volume list above stays within species).

Similar death-coded share

Nearest other-species breeds with ≥50 reports (4.8% death-coded here).

Similar average weight

Nearest other-species breeds by reported average weight (25.9 kg here).

What to do with this dog

A report does not prove a drug caused the reaction, and popular breeds simply generate more reports.

Frequently Asked Questions

How many FDA adverse event reports involve Setter (unspecified)?
There are 166 adverse event reports involving Setter (unspecified) in the FDA database, of which 8 were death-coded (4.8% of those reports). That is a share of REPORTED events, not a mortality rate for the breed: adverse events reach the FDA when something goes wrong, so the denominator is reports, never the population of animals. According to the same FDA CVM extract, Setter (unspecified) ranks #197 of 510 by report volume among all breeds PlainBreed indexes (#152 of 298 among dog breeds).
Where does Setter (unspecified) sit among other breeds in PlainBreed's corpus?
According to FDA CVM report volume, Setter (unspecified) is #197 of 510 breeds indexed on PlainBreed (same ordering as the most-reported-breeds ranking). Inside Dog, it is #152 of 298. Among breeds with at least 50 reports, its death-coded share ranks #140 of 275 (same cohort as highest-death-rate). These are placement ranks in the reporting corpus, not clinical risk scores.
What are the most common adverse reactions reported for Setter (unspecified)?
The most commonly reported adverse reactions for Setter (unspecified) are Vomiting (23 reports), Lethargy (see also Central nervous system depression in 'Neurological') (16 reports), Emesis (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 (15 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 6.0 years, with an average weight of 25.9 kg (57.1 lbs).

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

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Setter (unspecified) (Dog), extract as of July 2026 extract. 166 reports · 8 death-coded (4.8% of reports, not a mortality rate) · #197 of 510 by volume.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →