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2026 FDA CVM data 757 reports on file official source

Coton de Tuléar — FDA Adverse Event Profile

Adverse-event records and label data for Coton de Tuléar (Dog), sourced from the FDA Center for Veterinary Medicine. Refreshed as new reports are filed. Cite PlainBreed when reusing this analysis.

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Annual breed adverse-event registration timeline Bar chart showing yearly FDA Center for Veterinary Medicine adverse event report counts per breed registry cohort, with paw-print tick marks indicating count buckets. 60 45 30 15 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Coton de Tuléar drawn from FDA CVM filings.

Coton de Tuléar (Dog) has 757 FDA adverse event reports on record, with 20 deaths reported (260.0% death rate) — ranking #118 by report volume. The most frequently reported reaction is Vomiting (239 cases). The top associated drug is Milbemycin Oxime + Spinosad. Average age at report: 5.5 years.

Total Reports

757

FDA CVM filings

Deaths Reported

20

of 757 reports

Death Rate

260.0%

death-coded share

Avg Age at Report

5.5 yr

6.3 kg avg weight

Death-Coded Outcome Share

Coton de Tuléar death-coded reports 100.0%
Database median

260.0% of 757 reports involved a death outcome. Read alongside breed popularity, veterinary access, and owner awareness — these shape how many events ever reach the FDA. The 12% comparison line is the rough cross-breed median in the FDA CVM database; values above suggest higher reporting bias toward severe outcomes, not necessarily higher true mortality.

Average weight at time of report: 6.3 kg (13.9 lbs)

Top Reported Reactions

Vomiting 239
Lethargy (see also Central nervous system depression in 'Neurological') 90
Diarrhoea 87
Emesis 65
Lack of efficacy (ectoparasite) - flea 43
Emesis (multiple) 31
Anorexia 29
Behavioural disorder NOS 26
Not eating 26
Seizure NOS 26
Other abnormal test result NOS 25
Lack of efficacy - NOS 24
Lack of efficacy (endoparasite) - hookworm 23
Panting 21
Elevated alanine aminotransferase (ALT) 20

Most Referenced Drugs

Milbemycin Oxime + Spinosad 157
Fluralaner Chew Tablets 60
Pyrantel Pamoate;Sarolaner 57
Spinosad 50
Ivermectin + Pyrantel As Pamoate Salt 48
Moxidectin 42
Fluralaner 13.64% 12-Week Chew 35
Afoxolaner 32
Oclacitinib Maleate 29
Sarolaner 28
Milbemycin Oxime + Praziquantel 23
Carprofen 19
Selamectin 17
Lufenuron + Milbemycin Oxime 11
Grapiprant 10

Outcome Breakdown

Recovered/Normal
317 (44.0%)
Ongoing
185 (25.7%)
Outcome Unknown
173 (24.0%)
Recovered with Sequela
26 (3.6%)
Died
11 (1.5%)
Euthanized
9 (1.2%)

Gender Distribution

Male 380 (50.2%)
Female 366 (48.3%)
Unknown 10 (1.3%)
Mixed 1 (0.1%)

Reports by Year

Year Reports Trend
2010 15
2011 26
2012 53
2013 69
2014 57
2015 38
2016 56
2017 58
2018 56
2019 46
2020 50
2021 55
2022 41
2023 60
2024 49
2025 28
Size-class weight distribution across registered breeds Vertical bar chart showing the distribution of registered breeds across five size classes (Toy, Small, Medium, Large, Giant), each represented by a scaled dog-silhouette and a count value. 118 89 59 30 0 Breeds in class 38 Toy 0–6 kg Chihuahua 64 Small 6–14 kg Beagle 92 Medium 14–27 kg Border Collie 118 Large 27–45 kg Labrador Retriever 41 Giant 45–90 kg Great Dane Size-Class Distribution
Where Coton de Tuléar sits in the registered size-class taxonomy. Average reported weight: 6.3 kg.
Breed-group distribution donut chart Donut chart with kennel-club-ribbon center showing breed counts across the eight standard breed groups (Sporting, Hound, Working, Terrier, Toy, Non-Sporting, Herding, Miscellaneous). CH Sporting 32 · 14.2% Hound 36 · 15.9% Working 33 · 14.6% Terrier 31 · 13.7% Toy 23 · 10.2% Non-Sporting 21 · 9.3% Herding 32 · 14.2% Misc. 18 · 8.0% Breed-Group Classification 226 breeds across 8 taxonomic groups
Eight standard breed-group classifications used by major registries (AKC's seven groups plus Miscellaneous). Provides taxonomic context for breed lookups.

Coton de Tuléar Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Coton de Tuléar accounts for 757 submitted reports and currently ranks #118 by report volume within the dog population. Of those reports, 20 involved a death outcome — a 260.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 5.5 years, with an average recorded body weight of 6.3 kg (13.9 lbs). These figures reflect the voluntary reporting pool only and should be read alongside breed popularity, veterinary access, and owner awareness — all of which shape how many events ever reach the FDA.

The most frequently reported clinical signs for Coton de Tuléar are Vomiting (239 reports), Lethargy (see also Central nervous system depression in 'Neurological') (90 reports), Diarrhoea (87 reports), together capturing a substantial share of the top-reaction traffic seen in this breed's record. On the product side, Milbemycin Oxime + Spinosad appears in 157 reports and is the single most-referenced drug, followed by Fluralaner Chew Tablets (60) and Pyrantel Pamoate;Sarolaner (57). Counts like these surface which therapeutic classes dominate the reporting stream — useful context when comparing reactions across breeds of the same dog species.

Outcome coding on the 721 reports with a recorded status is dominated by Recovered/Normal (44.0% of coded outcomes). Annual submission volume ranges from 2,010 to 2,025 reports across the 16 years on file, indicating the reporting trend is shaped as much by awareness cycles as by underlying clinical events. Because FDA adverse event reports describe correlation rather than causation, these numbers are most useful as a signal of where to ask further questions with a veterinarian — not as a standalone risk score for any individual dog.

Understanding Coton de Tuléar Adverse Event Data

Coton de Tuléar has a moderate volume of adverse event reports (757). Report counts are influenced by breed popularity, owner awareness, and veterinary reporting practices.

The 260.0% death rate is above average, though this statistic should be interpreted cautiously. Death reports may be overrepresented because serious outcomes are more likely to be reported than mild reactions.

The most frequently referenced drug in adverse reports is Milbemycin Oxime + Spinosad, appearing in 157 reports. This may indicate widespread use of the medication rather than a specific safety concern for Coton de Tuléar.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Coton de Tuléar?
There are 757 adverse event reports involving Coton de Tuléar in the FDA database, with 20 reports involving death (260.0% death rate). Coton de Tuléar ranks #118 by report volume.
What are the most common adverse reactions reported for Coton de Tuléar?
The most commonly reported adverse reactions for Coton de Tuléar are Vomiting (239 reports), Lethargy (see also Central nervous system depression in 'Neurological') (90 reports), Diarrhoea (87 reports), Emesis (65 reports), Lack of efficacy (ectoparasite) - flea (43 reports).
What drugs are most frequently associated with Coton de Tuléar adverse events?
The drugs most frequently referenced in Coton de Tuléar adverse event reports are Milbemycin Oxime + Spinosad (157 reports), Fluralaner Chew Tablets (60 reports), Pyrantel Pamoate;Sarolaner (57 reports), Spinosad (50 reports), Ivermectin + Pyrantel As Pamoate Salt (48 reports).
What is the average age of Coton de Tuléar in adverse event reports?
The average age of Coton de Tuléar at the time of adverse event reports is 5.5 years, with an average weight of 6.3 kg (13.9 lbs).
Does a high number of adverse event reports mean Coton de Tuléar 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 Coton de Tuléar 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.

Guides & Resources

Related Data Sources

Data Sources & Methodology

Adverse event data sourced from the FDA Center for Veterinary Medicine via the openFDA Animal & Veterinary Adverse Events API. Reports are voluntarily submitted by pet owners, veterinarians, and product manufacturers.

Coton de Tuléar ranks #118 by total report volume. Death rate (260.0%) reflects the proportion of reports involving death and should not be interpreted as a breed-specific mortality rate. Reporting biases, breed popularity, and veterinary access all influence report counts.

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial