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2026 FDA CVM data 517 reports on file official source

Spaniel - King Charles — FDA Adverse Event Profile

Adverse-event records and label data for Spaniel - King Charles (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 Spaniel - King Charles drawn from FDA CVM filings.

Spaniel - King Charles (Dog) has 517 FDA adverse event reports on record, with 16 deaths reported (310.0% death rate) — ranking #137 by report volume. The most frequently reported reaction is Vomiting (121 cases). The top associated drug is Milbemycin Oxime + Spinosad. Average age at report: 5.0 years.

Total Reports

517

FDA CVM filings

Deaths Reported

16

of 517 reports

Death Rate

310.0%

death-coded share

Avg Age at Report

5.0 yr

9.0 kg avg weight

Death-Coded Outcome Share

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

310.0% of 517 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: 9.0 kg (19.8 lbs)

Top Reported Reactions

Vomiting 121
Emesis 81
Lethargy (see also Central nervous system depression in 'Neurological') 77
Diarrhoea 68
Digestive tract disorder NOS 36
Lack of efficacy - NOS 29
Lack of efficacy (ectoparasite) - flea 27
Seizure NOS 27
Lack of efficacy (endoparasite) - hookworm 27
Not eating 18
INEFFECTIVE, HOOKS 14
Death 12
Behavioural disorder NOS 12
Pruritus 12
INEFFECTIVE, ASCARIDS NOS 12

Most Referenced Drugs

Milbemycin Oxime + Spinosad 142
Ivermectin + Pyrantel As Pamoate Salt 69
Afoxolaner 65
Spinosad 46
Fluralaner Chew Tablets 25
Pimobendan 21
Trilostane 21
Polysulfated Glycosaminoglycan 21
Fluralaner 13.64% 12-Week Chew 19
Ivermectin/Pyrantel Pamoate Chewable 68Mcg/163Mg 10
Milbemycin Oxime + Praziquantel 10
Milbemycin Oxime 8
Nitenpyram 8
Ivermectin 7
Lufenuron + Milbemycin Oxime 7

Outcome Breakdown

Recovered/Normal
259 (50.5%)
Outcome Unknown
169 (32.9%)
Ongoing
52 (10.1%)
Recovered with Sequela
17 (3.3%)
Died
12 (2.3%)
Euthanized
4 (0.8%)

Gender Distribution

Female 249 (48.2%)
Male 244 (47.2%)
Unknown 19 (3.7%)
Mixed 5 (1.0%)

Reports by Year

Year Reports Trend
2010 3
2011 24
2012 48
2013 63
2014 59
2015 61
2016 46
2017 42
2018 31
2019 45
2020 29
2021 19
2022 9
2023 11
2024 21
2025 6
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 sits in the registered size-class taxonomy. Average reported weight: 9.0 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 Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Spaniel - King Charles accounts for 517 submitted reports and currently ranks #137 by report volume within the dog population. Of those reports, 16 involved a death outcome — a 310.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 5.0 years, with an average recorded body weight of 9.0 kg (19.8 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 are Vomiting (121 reports), Emesis (81 reports), Lethargy (see also Central nervous system depression in 'Neurological') (77 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 142 reports and is the single most-referenced drug, followed by Ivermectin + Pyrantel As Pamoate Salt (69) and Afoxolaner (65). 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 513 reports with a recorded status is dominated by Recovered/Normal (50.5% 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 Adverse Event Data

Spaniel - King Charles has a moderate volume of adverse event reports (517). Report counts are influenced by breed popularity, owner awareness, and veterinary reporting practices.

The 310.0% 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 142 reports. This may indicate widespread use of the medication rather than a specific safety concern for Spaniel - King Charles.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Spaniel - King Charles?
There are 517 adverse event reports involving Spaniel - King Charles in the FDA database, with 16 reports involving death (310.0% death rate). Spaniel - King Charles ranks #137 by report volume.
What are the most common adverse reactions reported for Spaniel - King Charles?
The most commonly reported adverse reactions for Spaniel - King Charles are Vomiting (121 reports), Emesis (81 reports), Lethargy (see also Central nervous system depression in 'Neurological') (77 reports), Diarrhoea (68 reports), Digestive tract disorder NOS (36 reports).
What drugs are most frequently associated with Spaniel - King Charles adverse events?
The drugs most frequently referenced in Spaniel - King Charles adverse event reports are Milbemycin Oxime + Spinosad (142 reports), Ivermectin + Pyrantel As Pamoate Salt (69 reports), Afoxolaner (65 reports), Spinosad (46 reports), Fluralaner Chew Tablets (25 reports).
What is the average age of Spaniel - King Charles in adverse event reports?
The average age of Spaniel - King Charles at the time of adverse event reports is 5.0 years, with an average weight of 9.0 kg (19.8 lbs).
Does a high number of adverse event reports mean Spaniel - King Charles 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 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 ranks #137 by total report volume. Death rate (310.0%) 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