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2026 FDA CVM data 357 reports on file official source

Collie - Rough-haired — FDA Adverse Event Profile

Adverse-event records and label data for Collie - Rough-haired (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. 45 33.75 22.5 11.25 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Collie - Rough-haired drawn from FDA CVM filings.

Collie - Rough-haired (Dog) has 357 FDA adverse event reports on record, with 18 deaths reported (500.0% death rate) — ranking #156 by report volume. The most frequently reported reaction is Vomiting (78 cases). The top associated drug is Milbemycin Oxime + Spinosad. Average age at report: 5.3 years.

Total Reports

357

FDA CVM filings

Deaths Reported

18

of 357 reports

Death Rate

500.0%

death-coded share

Avg Age at Report

5.3 yr

28.2 kg avg weight

Death-Coded Outcome Share

Collie - Rough-haired death-coded reports 100.0%
Database median

500.0% of 357 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: 28.2 kg (62.2 lbs)

Top Reported Reactions

Vomiting 78
Lethargy (see also Central nervous system depression in 'Neurological') 41
Diarrhoea 32
Emesis 24
Seizure NOS 24
Lack of efficacy - NOS 19
Ataxia 18
Anorexia 16
Panting 15
Emesis (multiple) 13
Lack of efficacy (ectoparasite) - flea 12
Behavioural disorder NOS 11
Other abnormal test result NOS 11
Not eating 11
Lack of efficacy (bacteria) - Borrelia 11

Most Referenced Drugs

Milbemycin Oxime + Spinosad 64
Milbemycin Oxime + Praziquantel 53
Pyrantel Pamoate;Sarolaner 25
Bedinvetmab 23
Fluralaner 13.64% 12-Week Chew 21
Lotilaner 20
Milbemycin Oxime 19
Trilostane 17
Sarolaner 17
Carprofen 16
Maropitant Citrate 13
Afoxolaner 13
Lufenuron + Milbemycin Oxime 11
Oclacitinib Maleate 11
Gabapentin 11

Outcome Breakdown

Recovered/Normal
129 (35.9%)
Ongoing
112 (31.2%)
Outcome Unknown
92 (25.6%)
Died
12 (3.3%)
Recovered with Sequela
8 (2.2%)
Euthanized
6 (1.7%)

Gender Distribution

Male 182 (51.0%)
Female 163 (45.7%)
Unknown 10 (2.8%)
Mixed 2 (0.6%)

Reports by Year

Year Reports Trend
2011 2
2012 21
2013 23
2014 19
2015 19
2016 21
2017 23
2018 29
2019 23
2020 28
2021 30
2022 28
2023 23
2024 45
2025 23
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 Collie - Rough-haired sits in the registered size-class taxonomy. Average reported weight: 28.2 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.

Collie - Rough-haired Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Collie - Rough-haired accounts for 357 submitted reports and currently ranks #156 by report volume within the dog population. Of those reports, 18 involved a death outcome — a 500.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 5.3 years, with an average recorded body weight of 28.2 kg (62.2 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 Collie - Rough-haired are Vomiting (78 reports), Lethargy (see also Central nervous system depression in 'Neurological') (41 reports), Diarrhoea (32 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 64 reports and is the single most-referenced drug, followed by Milbemycin Oxime + Praziquantel (53) and Pyrantel Pamoate;Sarolaner (25). 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 359 reports with a recorded status is dominated by Recovered/Normal (35.9% of coded outcomes). Annual submission volume ranges from 2,011 to 2,025 reports across the 15 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 Collie - Rough-haired Adverse Event Data

Collie - Rough-haired has 357 adverse event reports on file. Lower report volumes may reflect a less common breed, lower reporting rates, or genuinely fewer adverse events.

The 500.0% 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 64 reports. This may indicate widespread use of the medication rather than a specific safety concern for Collie - Rough-haired.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Collie - Rough-haired?
There are 357 adverse event reports involving Collie - Rough-haired in the FDA database, with 18 reports involving death (500.0% death rate). Collie - Rough-haired ranks #156 by report volume.
What are the most common adverse reactions reported for Collie - Rough-haired?
The most commonly reported adverse reactions for Collie - Rough-haired are Vomiting (78 reports), Lethargy (see also Central nervous system depression in 'Neurological') (41 reports), Diarrhoea (32 reports), Emesis (24 reports), Seizure NOS (24 reports).
What drugs are most frequently associated with Collie - Rough-haired adverse events?
The drugs most frequently referenced in Collie - Rough-haired adverse event reports are Milbemycin Oxime + Spinosad (64 reports), Milbemycin Oxime + Praziquantel (53 reports), Pyrantel Pamoate;Sarolaner (25 reports), Bedinvetmab (23 reports), Fluralaner 13.64% 12-Week Chew (21 reports).
What is the average age of Collie - Rough-haired in adverse event reports?
The average age of Collie - Rough-haired at the time of adverse event reports is 5.3 years, with an average weight of 28.2 kg (62.2 lbs).
Does a high number of adverse event reports mean Collie - Rough-haired 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 Collie - Rough-haired 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.

Collie - Rough-haired ranks #156 by total report volume. Death rate (500.0%) 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