Breed · Dog

Setter: adverse event reports

FDA breed label "Setter (unspecified)" · single-breed animals only

Read this first · FDA's caveat, in its words

An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources. FDA Center for Veterinary Medicine

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

Not veterinary advice. This site lists what was reported to FDA. For an animal that is unwell, contact a veterinarian.

128reports, 2011–20260% of dog reports

11reports, 12 months to March 202618 in the 12 months before

37.5%classed serious, as reportedall dogs: 38.3%

13.3%name milbemycin oxime + spinosadall dogs: 13.1%

FDA's database holds 128 reports where the animal's breed is given as "Setter (unspecified)", shown here as Setter: 0% of reports about dogs. Reports on crossbred animals are left out of breed pages.

11 reports arrived in the 12 months to March 2026, down 39% from 18 in the 12 months before. A breed's count mostly mirrors how common the breed is; registration and ownership figures by breed are not public data, so no per-animal rate can be given.

By active ingredient, the drugs named most often are milbemycin oxime + spinosad, moxidectin and lufenuron + milbemycin oxime. Milbemycin Oxime + Spinosad is named in 13.3% of this breed's reports, about the same share as in reports about all dogs (13.1%).

The terms listed most often are lethargy (15.6%), vomiting (15.6%) and lack of efficacy - NOS (10.2%). Lethargy appears in 15.6% of reports, a larger share than in all dog reports (7.9%). 37.5% of reports stating seriousness were classed as serious, against 38.3% for dogs overall.

Drugs named most often, by active ingredient

Active ingredients recorded for the drug	Reports	Share of Setter reports	Share of all dog reports
Milbemycin Oxime + Spinosad	17	13.3%	13.1%
Moxidectin	14	10.9%	5%
Lufenuron + Milbemycin Oxime	13	10.2%	2.7%
Milbemycin Oxime + Praziquantel	9	7%	3.1%
Spinosad	9	7%	5.8%
Fluralaner	8	6.3%	6.7%
Imidacloprid + Moxidectin	8	6.3%	1.3%
Lotilaner	8	6.3%	1%
Lufenuron + Milbemycin Oxime + Praziquantel	7	5.5%	0.7%
Milbemycin Oxime	7	5.5%	3%
Febantel + Praziquantel + Pyrantel Pamoate	6	4.7%	0.7%
Carprofen	4	3.1%	4.8%
Florfenicol + Mometasone furoate + Terbinafine	4	3.1%	0.3%
Nitenpyram	4	3.1%	1.1%
Bedinvetmab	3	2.3%	1.9%
Grapiprant	3	2.3%	0.8%
Ivermectin + Praziquantel + Pyrantel Pamoate	3	2.3%	0.9%
Sarolaner	3	2.3%	1.7%
Doxycycline	2	1.6%	0.4%
Enrofloxacin	2	1.6%	0.4%

Ordered by report count. Differences from the species column often come from body size (which drugs a breed is prescribed) and from how common the breed was in the years a drug sold most. FDA states that these data cannot be used to estimate risk or to compare one product with another. Brand and manufacturer names are masked by FDA in these records.

Signs listed in reports

share of Setter reports listing the termall dog reports

Lethargy[unusually tired or inactive]15.6%20
Vomiting15.6%20
Lack of efficacy - NOS[the product did not have the expected effect]10.2%13
Diarrhoea[diarrhea]9.4%12
Emesis[vomiting]8.6%11
Behavioural disorder NOS[behaviour change, type not specified]6.3%8
Ineffective, heartworm larvae[legacy FDA term: the product did not have the expected effect (heartworm larvae)]5.5%7
Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]5.5%7
Lack of efficacy (endoparasite) - heartworm[the product did not have the expected effect: heartworm]4.7%6
Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]4.7%6
Panting4.7%6
Seizure NOS[seizure, type not specified]4.7%6
Anorexia[not eating]3.9%5
Death by euthanasia[the animal was euthanized]3.9%5
Drooling3.9%5
Lack of efficacy (ectoparasite) - tick NOS[the product did not have the expected effect: ticks]3.1%4
Other abnormal test result NOS[abnormal laboratory result, type not specified]3.1%4
Weight loss3.1%4
Emesis (multiple)[vomiting more than once]2.3%3
Ineffective, ascarids NOS[legacy FDA term: the product did not have the expected effect (ascarids nos)]2.3%3
Loose stool2.3%3
Pale mucous membrane[pale gums]2.3%3
Pruritus[itching]2.3%3
Anuria1.6%2
Breathing difficulty1.6%2

Age and weight

Age of the animal

Under 1 year5.5%7

1 to 3 years24.2%31

4 to 7 years25.8%33

8 to 11 years32%41

12 years and over11.7%15

Age not given0.8%1

Weight of the animal

Under 5 kg (11 lb)0.8%1

5 to 9.9 kg (11–22 lb)0%0

10 to 24.9 kg (22–55 lb)43%55

25 to 44.9 kg (55–99 lb)52.3%67

45 kg and over (99 lb+)0.8%1

Weight not given3.1%4

Coloured bar: Setter reports. Grey bar: all dog reports.

Trend and outcomes

Reports by month FDA received them. The newest months are incomplete because FDA posts reports with a delay of three to six months.

Outcome recorded in the report

Recovered/Normal32.8%42

Recovered with Sequela2.3%3

Ongoing28.1%36

Died1.6%2

Euthanized3.9%5

Outcome Unknown31.3%40

Beside all dogs

Measure	Setter	All dogs
Reports	128	985,675
Latest 12 months	11	53,292
Classed serious, of reports stating it	37.5%	38.3%
Death or euthanasia recorded, per 1,000 reports	54.7	55

Questions about Setter reports

How many FDA adverse event reports involve Setters?

128 reports through March 2026, 0% of reports about dogs; 11 in the latest 12 months.

Which drugs are named most often in Setter reports?

By active ingredient: milbemycin oxime + spinosad (17), moxidectin (14), lufenuron + milbemycin oxime (13), milbemycin oxime + praziquantel (9) and spinosad (9). Brands are masked in the public data.

What signs are reported most for this breed?

lethargy (15.6%), vomiting (15.6%), lack of efficacy - NOS (10.2%), diarrhoea (9.4%) and emesis (8.6%).

Is the Setter more sensitive to certain drugs?

Report counts cannot answer that. They show what was reported, not what a drug did, and they are not adjusted for how many Setter animals exist or were treated. Breed-related drug sensitivities that are established are described on FDA-approved labels; a veterinarian is the person to ask about an individual animal.

Why are crossbreds not included?

FDA records crossbred animals with one or more component breeds. Counting them under each component would double count, so breed pages use single-breed reports only. Crossbreds remain in the species totals.

How do I report a problem?

Call the drug company using the number on the label, or send Form FDA 1932a to FDA. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Animal & Veterinary adverse event bulk files released 28 Sep 2026, which hold reports FDA's Center for Veterinary Medicine received through 31 Mar 2026. openFDA masks brand and manufacturer names in these files, so drugs are counted by the active ingredients each record discloses and no figure is attributed to a brand, application or company. Ingredient names, and the separate reference lists of approved products, follow the FDA Green Book as of 1 Oct 2026. Breed names are FDA's labels rearranged into everyday order ("Setter (unspecified)" becomes "Setter"). No report text, lot numbers or reporter details are published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.