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2026 FDA CVM data 389 reports on file official source

Retriever - Flat-coated — FDA Adverse Event Profile

Adverse-event records and label data for Retriever - Flat-coated (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. 34 25.5 17 8.5 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Retriever - Flat-coated drawn from FDA CVM filings.

Retriever - Flat-coated (Dog) has 389 FDA adverse event reports on record, with 14 deaths reported (360.0% death rate) — ranking #152 by report volume. The most frequently reported reaction is Vomiting (57 cases). The top associated drug is Milbemycin Oxime + Spinosad. Average age at report: 5.3 years.

Total Reports

389

FDA CVM filings

Deaths Reported

14

of 389 reports

Death Rate

360.0%

death-coded share

Avg Age at Report

5.3 yr

29.7 kg avg weight

Death-Coded Outcome Share

Retriever - Flat-coated death-coded reports 100.0%
Database median

360.0% of 389 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: 29.7 kg (65.5 lbs)

Top Reported Reactions

Vomiting 57
Lethargy (see also Central nervous system depression in 'Neurological') 37
Diarrhoea 34
Lack of efficacy (endoparasite) - hookworm 29
Emesis 28
Digestive tract disorder NOS 24
Lack of efficacy - NOS 23
Lack of efficacy (endoparasite) - heartworm 23
INEFFECTIVE, ASCARIDS NOS 20
INEFFECTIVE, HEARTWORM LARVAE 17
Anorexia 17
INEFFECTIVE, HOOKS 16
Death by euthanasia 14
Elevated serum alkaline phosphatase (SAP) 13
Lethargy (see also Central nervous system depression in Neurological) 13

Most Referenced Drugs

Milbemycin Oxime + Spinosad 55
Ivermectin + Pyrantel As Pamoate Salt 55
Afoxolaner 26
Pyrantel Pamoate;Sarolaner 24
Spinosad 20
Carprofen 20
Milbemycin Oxime + Praziquantel 20
Oclacitinib Maleate 15
Fluralaner Chew Tablets 15
Bedinvetmab 13
Prednisone 12
Ivermectin/Pyrantel Pamoate Chewable 272Mcg/652Mg 11
Moxidectin 9
Lufenuron + Milbemycin Oxime 8
Gabapentin 8

Outcome Breakdown

Outcome Unknown
127 (35.2%)
Recovered/Normal
112 (31.0%)
Ongoing
95 (26.3%)
Recovered with Sequela
13 (3.6%)
Euthanized
8 (2.2%)
Died
6 (1.7%)

Gender Distribution

Male 229 (58.9%)
Female 154 (39.6%)
Unknown 4 (1.0%)
Mixed 2 (0.5%)

Reports by Year

Year Reports Trend
2010 8
2011 23
2012 22
2013 32
2014 34
2015 28
2016 32
2017 35
2018 32
2019 25
2020 26
2021 12
2022 16
2023 17
2024 34
2025 13
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 Retriever - Flat-coated sits in the registered size-class taxonomy. Average reported weight: 29.7 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.

Retriever - Flat-coated Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Retriever - Flat-coated accounts for 389 submitted reports and currently ranks #152 by report volume within the dog population. Of those reports, 14 involved a death outcome — a 360.0% 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 29.7 kg (65.5 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 Retriever - Flat-coated are Vomiting (57 reports), Lethargy (see also Central nervous system depression in 'Neurological') (37 reports), Diarrhoea (34 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 55 reports and is the single most-referenced drug, followed by Ivermectin + Pyrantel As Pamoate Salt (55) and Afoxolaner (26). 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 361 reports with a recorded status is dominated by Outcome Unknown (35.2% 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 Retriever - Flat-coated Adverse Event Data

Retriever - Flat-coated has 389 adverse event reports on file. Lower report volumes may reflect a less common breed, lower reporting rates, or genuinely fewer adverse events.

The 360.0% 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 55 reports. This may indicate widespread use of the medication rather than a specific safety concern for Retriever - Flat-coated.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Retriever - Flat-coated?
There are 389 adverse event reports involving Retriever - Flat-coated in the FDA database, with 14 reports involving death (360.0% death rate). Retriever - Flat-coated ranks #152 by report volume.
What are the most common adverse reactions reported for Retriever - Flat-coated?
The most commonly reported adverse reactions for Retriever - Flat-coated are Vomiting (57 reports), Lethargy (see also Central nervous system depression in 'Neurological') (37 reports), Diarrhoea (34 reports), Lack of efficacy (endoparasite) - hookworm (29 reports), Emesis (28 reports).
What drugs are most frequently associated with Retriever - Flat-coated adverse events?
The drugs most frequently referenced in Retriever - Flat-coated adverse event reports are Milbemycin Oxime + Spinosad (55 reports), Ivermectin + Pyrantel As Pamoate Salt (55 reports), Afoxolaner (26 reports), Pyrantel Pamoate;Sarolaner (24 reports), Spinosad (20 reports).
What is the average age of Retriever - Flat-coated in adverse event reports?
The average age of Retriever - Flat-coated at the time of adverse event reports is 5.3 years, with an average weight of 29.7 kg (65.5 lbs).
Does a high number of adverse event reports mean Retriever - Flat-coated 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 Retriever - Flat-coated 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.

Retriever - Flat-coated ranks #152 by total report volume. Death rate (360.0%) 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