Breed · Dog

Coton de Tuléar: adverse event reports

FDA breed label "Coton de Tuléar" · 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.

814reports, 1998–20260.1% of dog reports

42reports, 12 months to March 202655 in the 12 months before

35.9%classed serious, as reportedall dogs: 38.3%

17.4%name milbemycin oxime + spinosadall dogs: 13.1%

FDA's database holds 814 reports where the animal's breed is given as "Coton de Tuléar", shown here as Coton de Tuléar: 0.1% of reports about dogs. Reports on crossbred animals are left out of breed pages.

42 reports arrived in the 12 months to March 2026, down 24% from 55 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, fluralaner and ivermectin + pyrantel pamoate. Milbemycin Oxime + Spinosad is named in 17.4% of this breed's reports, a larger share than in reports about all dogs (13.1%).

The terms listed most often are vomiting (31.2%), lethargy (13%) and diarrhoea (11.9%). Vomiting appears in 31.2% of reports, a larger share than in all dog reports (19.7%). 35.9% 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 Coton de Tuléar reports	Share of all dog reports
Milbemycin Oxime + Spinosad	142	17.4%	13.1%
Fluralaner	103	12.7%	6.7%
Ivermectin + Pyrantel Pamoate	78	9.6%	14.9%
Pyrantel Pamoate + Sarolaner	58	7.1%	5.1%
Spinosad	51	6.3%	5.8%
Moxidectin	42	5.2%	5%
Afoxolaner	31	3.8%	5.7%
Oclacitinib	31	3.8%	2.9%
Sarolaner	29	3.6%	1.7%
Lufenuron + Milbemycin Oxime	27	3.3%	2.7%
Selamectin	27	3.3%	3%
Carprofen	25	3.1%	4.8%
Milbemycin Oxime + Praziquantel	21	2.6%	3.1%
Ivermectin + Praziquantel + Pyrantel Pamoate	17	2.1%	0.9%
Milbemycin Oxime	15	1.8%	3%
Maropitant	14	1.7%	1.2%
Cyclosporine	12	1.5%	1.5%
Pimobendan	12	1.5%	0.6%
Bedinvetmab	10	1.2%	1.9%
Grapiprant	10	1.2%	0.8%

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 Coton de Tuléar reports listing the termall dog reports

Vomiting31.2%254
Lethargy[unusually tired or inactive]13%106
Diarrhoea[diarrhea]11.9%97
Emesis[vomiting]7.6%62
Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]5.2%42
Anorexia[not eating]4.2%34
Emesis (multiple)[vomiting more than once]3.8%31
Behavioural disorder NOS[behaviour change, type not specified]3.6%29
Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]3.3%27
Lack of efficacy - NOS[the product did not have the expected effect]3.3%27
Seizure NOS[seizure, type not specified]3.3%27
Not eating3.2%26
Other abnormal test result NOS[abnormal laboratory result, type not specified]2.9%24
Panting2.8%23
Ataxia[unsteady, uncoordinated movement]2.7%22
Depression[dull, quiet or withdrawn]2.7%22
Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]2.7%22
Shaking2.5%20
Tremor2.2%18
Vocalisation[crying out or unusual noise]2.2%18
Inappetence[reduced appetite]2.1%17
Decreased appetite2%16
Loose stool2%16
Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]1.8%15
Death1.7%14

Age and weight

Age of the animal

Under 1 year12.5%102

1 to 3 years31.4%256

4 to 7 years23.1%188

8 to 11 years19.4%158

12 years and over10.8%88

Age not given2.7%22

Weight of the animal

Under 5 kg (11 lb)30.2%246

5 to 9.9 kg (11–22 lb)61.3%499

10 to 24.9 kg (22–55 lb)4.4%36

25 to 44.9 kg (55–99 lb)0.2%2

45 kg and over (99 lb+)0%0

Weight not given3.8%31

Coloured bar: Coton de Tuléar 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/Normal38.7%315

Recovered with Sequela3.2%26

Ongoing23%187

Died1.8%15

Euthanized1.4%11

Outcome Unknown21.3%173

Beside all dogs

Measure	Coton de Tuléar	All dogs
Reports	814	985,675
Latest 12 months	42	53,292
Classed serious, of reports stating it	35.9%	38.3%
Death or euthanasia recorded, per 1,000 reports	31.9	55

Questions about Coton de Tuléar reports

How many FDA adverse event reports involve Coton de Tuléars?

814 reports through March 2026, 0.1% of reports about dogs; 42 in the latest 12 months.

Which drugs are named most often in Coton de Tuléar reports?

By active ingredient: milbemycin oxime + spinosad (142), fluralaner (103), ivermectin + pyrantel pamoate (78), pyrantel pamoate + sarolaner (58) and spinosad (51). Brands are masked in the public data.

What signs are reported most for this breed?

vomiting (31.2%), lethargy (13%), diarrhoea (11.9%), emesis (7.6%) and lack of efficacy (ectoparasite) - flea (5.2%).

Is the Coton de Tuléar 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 Coton de Tuléar 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 ("Coton de Tuléar" becomes "Coton de Tuléar"). 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.