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2026 FDA CVM data 5,775 reports on file official source

Spaniel - King Charles Cavalier — FDA Adverse Event Profile

Adverse-event records and label data for Spaniel - King Charles Cavalier (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. 541 405.75 270.5 135.25 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Spaniel - King Charles Cavalier drawn from FDA CVM filings.

Spaniel - King Charles Cavalier (Dog) has 5,775 FDA adverse event reports on record, with 248 deaths reported (430.0% death rate) — ranking #37 by report volume. The most frequently reported reaction is Vomiting (1,305 cases). The top associated drug is Milbemycin Oxime + Spinosad. Average age at report: 4.9 years.

Total Reports

5,775

FDA CVM filings

Deaths Reported

248

of 5,775 reports

Death Rate

430.0%

death-coded share

Avg Age at Report

4.9 yr

8.8 kg avg weight

Death-Coded Outcome Share

Spaniel - King Charles Cavalier death-coded reports 100.0%
Database median

430.0% of 5,775 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: 8.8 kg (19.4 lbs)

Top Reported Reactions

Vomiting 1,305
Diarrhoea 600
Lethargy (see also Central nervous system depression in 'Neurological') 533
Emesis 388
Lack of efficacy (endoparasite) - hookworm 356
Lack of efficacy (ectoparasite) - flea 337
Seizure NOS 263
Lack of efficacy - NOS 208
Digestive tract disorder NOS 166
Behavioural disorder NOS 154
Anorexia 150
Emesis (multiple) 146
Lack of efficacy (bacteria) - Borrelia 144
Not eating 137
Lethargy (see also Central nervous system depression in Neurological) 136

Most Referenced Drugs

Milbemycin Oxime + Spinosad 894
Pyrantel Pamoate;Sarolaner 696
Afoxolaner 469
Ivermectin + Pyrantel As Pamoate Salt 458
Pimobendan 389
Spinosad 312
Milbemycin Oxime + Praziquantel 249
Moxidectin 238
Sarolaner 198
Fluralaner Chew Tablets 186
Fluralaner 13.64% 12-Week Chew 180
Oclacitinib Maleate 178
Lotilaner 139
Carprofen 121
Selamectin 112

Outcome Breakdown

Recovered/Normal
2,064 (38.0%)
Outcome Unknown
1,598 (29.4%)
Ongoing
1,417 (26.1%)
Died
149 (2.7%)
Recovered with Sequela
105 (1.9%)
Euthanized
99 (1.8%)

Gender Distribution

Male 2,957 (51.2%)
Female 2,685 (46.5%)
Unknown 109 (1.9%)
Mixed 24 (0.4%)

Reports by Year

Year Reports Trend
2010 168
2011 221
2012 327
2013 350
2014 328
2015 354
2016 341
2017 377
2018 343
2019 336
2020 368
2021 379
2022 441
2023 532
2024 541
2025 369
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 Spaniel - King Charles Cavalier sits in the registered size-class taxonomy. Average reported weight: 8.8 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.

Spaniel - King Charles Cavalier Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Spaniel - King Charles Cavalier accounts for 5,775 submitted reports and currently ranks #37 by report volume within the dog population. Of those reports, 248 involved a death outcome — a 430.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 4.9 years, with an average recorded body weight of 8.8 kg (19.4 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 Spaniel - King Charles Cavalier are Vomiting (1,305 reports), Diarrhoea (600 reports), Lethargy (see also Central nervous system depression in 'Neurological') (533 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 894 reports and is the single most-referenced drug, followed by Pyrantel Pamoate;Sarolaner (696) and Afoxolaner (469). 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 5,432 reports with a recorded status is dominated by Recovered/Normal (38.0% 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 Spaniel - King Charles Cavalier Adverse Event Data

With 5,775 adverse event reports, Spaniel - King Charles Cavalier has one of the larger report volumes in the FDA database. This typically reflects breed popularity rather than inherent health risk — more pets of a breed means more veterinary encounters and more opportunity for adverse event reporting.

The 430.0% 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 894 reports. This may indicate widespread use of the medication rather than a specific safety concern for Spaniel - King Charles Cavalier.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Spaniel - King Charles Cavalier?
There are 5,775 adverse event reports involving Spaniel - King Charles Cavalier in the FDA database, with 248 reports involving death (430.0% death rate). Spaniel - King Charles Cavalier ranks #37 by report volume.
What are the most common adverse reactions reported for Spaniel - King Charles Cavalier?
The most commonly reported adverse reactions for Spaniel - King Charles Cavalier are Vomiting (1,305 reports), Diarrhoea (600 reports), Lethargy (see also Central nervous system depression in 'Neurological') (533 reports), Emesis (388 reports), Lack of efficacy (endoparasite) - hookworm (356 reports).
What drugs are most frequently associated with Spaniel - King Charles Cavalier adverse events?
The drugs most frequently referenced in Spaniel - King Charles Cavalier adverse event reports are Milbemycin Oxime + Spinosad (894 reports), Pyrantel Pamoate;Sarolaner (696 reports), Afoxolaner (469 reports), Ivermectin + Pyrantel As Pamoate Salt (458 reports), Pimobendan (389 reports).
What is the average age of Spaniel - King Charles Cavalier in adverse event reports?
The average age of Spaniel - King Charles Cavalier at the time of adverse event reports is 4.9 years, with an average weight of 8.8 kg (19.4 lbs).
Does a high number of adverse event reports mean Spaniel - King Charles Cavalier 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 Spaniel - King Charles Cavalier 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.

Spaniel - King Charles Cavalier ranks #37 by total report volume. Death rate (430.0%) 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