Breed · Dog

Rough-haired Collie: adverse event reports

FDA breed label "Collie - Rough-haired" · 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

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

348reports, 2003–20260% of dog reports

28reports, 12 months to March 202643 in the 12 months before

34.9%classed serious, as reportedall dogs: 38.3%

17.8%name milbemycin oxime + spinosadall dogs: 13.1%

348 adverse event reports received by FDA describe an animal recorded as Rough-haired Collie (FDA breed label "Collie - Rough-haired"). That is 0% of all reports about dogs. Crossbred animals are not counted here, only reports that give this single breed.

28 reports arrived in the 12 months to March 2026, down 35% from 43 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, milbemycin oxime + praziquantel and fluralaner. Milbemycin Oxime + Spinosad is named in 17.8% of this breed's reports, a larger share than in reports about all dogs (13.1%).

The terms listed most often are vomiting (21.3%), lethargy (12.1%) and diarrhoea (8.6%). Vomiting appears in 21.3% of reports, about the same share as in all dog reports (19.7%). 34.9% 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 Rough-haired Collie reports	Share of all dog reports
Milbemycin Oxime + Spinosad	62	17.8%	13.1%
Milbemycin Oxime + Praziquantel	55	15.8%	3.1%
Fluralaner	31	8.9%	6.7%
Pyrantel Pamoate + Sarolaner	27	7.8%	5.1%
Bedinvetmab	22	6.3%	1.9%
Lufenuron + Milbemycin Oxime	21	6%	2.7%
Lotilaner	16	4.6%	1%
Milbemycin Oxime	16	4.6%	3%
Sarolaner	16	4.6%	1.7%
Maropitant	15	4.3%	1.2%
Carprofen	14	4%	4.8%
Afoxolaner	12	3.4%	5.7%
Oclacitinib	11	3.2%	2.9%
Selamectin	10	2.9%	3%
Gabapentin	9	2.6%	0.9%
Grapiprant	9	2.6%	0.8%
Ivermectin + Pyrantel Pamoate	9	2.6%	14.9%
Lufenuron + Milbemycin Oxime + Praziquantel	8	2.3%	0.7%
Moxidectin	8	2.3%	5%
Nitenpyram	6	1.7%	1.1%

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 Rough-haired Collie reports listing the termall dog reports

Vomiting21.3%74
Lethargy[unusually tired or inactive]12.1%42
Diarrhoea[diarrhea]8.6%30
Seizure NOS[seizure, type not specified]7.2%25
Emesis[vomiting]6.9%24
Ataxia[unsteady, uncoordinated movement]4.6%16
Lack of efficacy - NOS[the product did not have the expected effect]4.6%16
Panting4.3%15
Anorexia[not eating]4%14
Emesis (multiple)[vomiting more than once]4%14
Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]3.4%12
Behavioural disorder NOS[behaviour change, type not specified]3.2%11
Lack of efficacy (bacteria) - Borrelia[the product did not have the expected effect: Borrelia (Lyme disease bacteria)]3.2%11
Lack of efficacy (endoparasite) - heartworm[the product did not have the expected effect: heartworm]3.2%11
Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]2.9%10
Not eating2.9%10
Other abnormal test result NOS[abnormal laboratory result, type not specified]2.9%10
Abnormal radiograph finding2.6%9
Death2.6%9
Weight loss2.6%9
Cough2.3%8
Drooling2.3%8
Lack of efficacy (ectoparasite) - tick NOS[the product did not have the expected effect: ticks]2.3%8
Lack of efficacy (endoparasite) - roundworm NOS[the product did not have the expected effect: roundworms]2.3%8
Loose stool2.3%8

Age and weight

Age of the animal

Under 1 year13.5%47

1 to 3 years29%101

4 to 7 years24.7%86

8 to 11 years23.3%81

12 years and over6.3%22

Age not given3.2%11

Weight of the animal

Under 5 kg (11 lb)0.3%1

5 to 9.9 kg (11–22 lb)3.2%11

10 to 24.9 kg (22–55 lb)25.9%90

25 to 44.9 kg (55–99 lb)62.9%219

45 kg and over (99 lb+)2.6%9

Weight not given5.2%18

Coloured bar: Rough-haired Collie 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/Normal37.1%129

Recovered with Sequela2.3%8

Ongoing31.6%110

Died3.4%12

Euthanized1.7%6

Outcome Unknown23.9%83

Beside all dogs

Measure	Rough-haired Collie	All dogs
Reports	348	985,675
Latest 12 months	28	53,292
Classed serious, of reports stating it	34.9%	38.3%
Death or euthanasia recorded, per 1,000 reports	51.7	55

Questions about Rough-haired Collie reports

How many FDA adverse event reports involve Rough-haired Collies?

348 reports through March 2026, 0% of reports about dogs; 28 in the latest 12 months.

Which drugs are named most often in Rough-haired Collie reports?

By active ingredient: milbemycin oxime + spinosad (62), milbemycin oxime + praziquantel (55), fluralaner (31), pyrantel pamoate + sarolaner (27) and bedinvetmab (22). Brands are masked in the public data.

What signs are reported most for this breed?

vomiting (21.3%), lethargy (12.1%), diarrhoea (8.6%), seizure NOS (7.2%) and emesis (6.9%).

Is the Rough-haired Collie 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 Rough-haired Collie 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 ("Collie - Rough-haired" becomes "Rough-haired Collie"). 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.