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2026 FDA CVM data 36 reports on file official source

Spaniel - Irish Water — FDA Adverse Event Profile

Adverse-event records and label data for Spaniel - Irish Water (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. 5 3.75 2.5 1.25 0 2016 2017 2019 2020 2021 2022 2023 2024 Reports filed Death-coded reports
Annual report volume for Spaniel - Irish Water drawn from FDA CVM filings.

Spaniel - Irish Water (Dog) has 36 FDA adverse event reports on record, with 2 deaths reported (560.0% death rate) — ranking #300 by report volume. The most frequently reported reaction is Vomiting (10 cases). The top associated drug is Afoxolaner. Average age at report: 6.0 years.

Total Reports

36

FDA CVM filings

Deaths Reported

2

of 36 reports

Death Rate

560.0%

death-coded share

Avg Age at Report

6.0 yr

27.5 kg avg weight

Death-Coded Outcome Share

Spaniel - Irish Water death-coded reports 100.0%
Database median

560.0% of 36 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: 27.5 kg (60.6 lbs)

Top Reported Reactions

Vomiting 10
Lethargy (see also Central nervous system depression in 'Neurological') 7
Digestive tract disorder NOS 4
Diarrhoea 3
Overdose 3
INEFFECTIVE, HEARTWORM LARVAE 2
Polydipsia 2
Polyuria 2
Depression 2
Anorexia 2
Itching 2
INEFFECTIVE, ASCARIDS NOS 2
Behavioural disorder NOS 2
Drooling 2
Lack of efficacy (endoparasite) - hookworm 2

Most Referenced Drugs

Afoxolaner 5
Ivermectin + Pyrantel As Pamoate Salt 4
Ivermectin/Pyrantel Pamoate Chewable 136Mcg/326Mg 3
Fluralaner Chew Tablets 3
Spinosad 2
Milbemycin Oxime + Spinosad 2
Selamectin 2
Ivermectin 272Mcg, Pyrantel Pamoate 228Mg, Praziquantel 228Mg 2
Milbemycin, Lufenuron 1
Desoxycorticosterone Pivalate 1
Glycosaminoglycan Polysulfate 1
Cyclosporine A 1
Fipronil 1
Ivermectin 1
Dimethylglycine 1

Outcome Breakdown

Recovered/Normal
14 (42.4%)
Ongoing
10 (30.3%)
Outcome Unknown
6 (18.2%)
Died
1 (3.0%)
Recovered with Sequela
1 (3.0%)
Euthanized
1 (3.0%)

Gender Distribution

Male 23 (63.9%)
Female 13 (36.1%)

Reports by Year

Year Reports Trend
2010 4
2011 1
2012 5
2013 2
2014 3
2015 2
2016 2
2017 2
2019 5
2020 2
2021 2
2022 3
2023 1
2024 2
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 - Irish Water sits in the registered size-class taxonomy. Average reported weight: 27.5 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 - Irish Water Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Spaniel - Irish Water accounts for 36 submitted reports and currently ranks #300 by report volume within the dog population. Of those reports, 2 involved a death outcome — a 560.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 6.0 years, with an average recorded body weight of 27.5 kg (60.6 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 - Irish Water are Vomiting (10 reports), Lethargy (see also Central nervous system depression in 'Neurological') (7 reports), Digestive tract disorder NOS (4 reports), together capturing a substantial share of the top-reaction traffic seen in this breed's record. On the product side, Afoxolaner appears in 5 reports and is the single most-referenced drug, followed by Ivermectin + Pyrantel As Pamoate Salt (4) and Ivermectin/Pyrantel Pamoate Chewable 136Mcg/326Mg (3). 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 33 reports with a recorded status is dominated by Recovered/Normal (42.4% of coded outcomes). Annual submission volume ranges from 2,010 to 2,024 reports across the 14 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 - Irish Water Adverse Event Data

Spaniel - Irish Water has 36 adverse event reports on file. Lower report volumes may reflect a less common breed, lower reporting rates, or genuinely fewer adverse events.

The 560.0% 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 Afoxolaner, appearing in 5 reports. This may indicate widespread use of the medication rather than a specific safety concern for Spaniel - Irish Water.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Spaniel - Irish Water?
There are 36 adverse event reports involving Spaniel - Irish Water in the FDA database, with 2 reports involving death (560.0% death rate). Spaniel - Irish Water ranks #300 by report volume.
What are the most common adverse reactions reported for Spaniel - Irish Water?
The most commonly reported adverse reactions for Spaniel - Irish Water are Vomiting (10 reports), Lethargy (see also Central nervous system depression in 'Neurological') (7 reports), Digestive tract disorder NOS (4 reports), Diarrhoea (3 reports), Overdose (3 reports).
What drugs are most frequently associated with Spaniel - Irish Water adverse events?
The drugs most frequently referenced in Spaniel - Irish Water adverse event reports are Afoxolaner (5 reports), Ivermectin + Pyrantel As Pamoate Salt (4 reports), Ivermectin/Pyrantel Pamoate Chewable 136Mcg/326Mg (3 reports), Fluralaner Chew Tablets (3 reports), Spinosad (2 reports).
What is the average age of Spaniel - Irish Water in adverse event reports?
The average age of Spaniel - Irish Water at the time of adverse event reports is 6.0 years, with an average weight of 27.5 kg (60.6 lbs).
Does a high number of adverse event reports mean Spaniel - Irish Water 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 - Irish Water 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 - Irish Water ranks #300 by total report volume. Death rate (560.0%) 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