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2026 FDA CVM data 3,074 reports on file official source

Spaniel (unspecified) — FDA Adverse Event Profile

Adverse-event records and label data for Spaniel (unspecified) (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. 323 242.25 161.5 80.75 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Spaniel (unspecified) drawn from FDA CVM filings.

Spaniel (unspecified) (Dog) has 3,074 FDA adverse event reports on record, with 150 deaths reported (490.0% death rate) — ranking #60 by report volume. The most frequently reported reaction is Vomiting (502 cases). The top associated drug is Pyrantel Pamoate;Sarolaner. Average age at report: 7.0 years.

Total Reports

3,074

FDA CVM filings

Deaths Reported

150

of 3,074 reports

Death Rate

490.0%

death-coded share

Avg Age at Report

7.0 yr

13.9 kg avg weight

Death-Coded Outcome Share

Spaniel (unspecified) death-coded reports 100.0%
Database median

490.0% of 3,074 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: 13.9 kg (30.6 lbs)

Top Reported Reactions

Vomiting 502
Lethargy (see also Central nervous system depression in 'Neurological') 291
Diarrhoea 262
Lack of efficacy - NOS 208
Lack of efficacy (endoparasite) - hookworm 187
Seizure NOS 173
Emesis 170
Lack of efficacy (endoparasite) - heartworm 120
Decreased appetite 107
Other abnormal test result NOS 106
Anorexia 98
INEFFECTIVE, HEARTWORM LARVAE 97
Lack of efficacy (bacteria) - Borrelia 96
Death by euthanasia 91
Lack of efficacy (ectoparasite) - flea 86

Most Referenced Drugs

Pyrantel Pamoate;Sarolaner 438
Trilostane 404
Oclacitinib Maleate 313
Ivermectin + Pyrantel As Pamoate Salt 281
Milbemycin Oxime + Spinosad 266
Moxidectin 246
Afoxolaner 163
Sarolaner 160
Bedinvetmab 149
Carprofen 130
Selamectin 94
Spinosad 80
Anti-Il31 Mab Mcs Lot #1283563 76
Maropitant Citrate 69
Gabapentin 51

Outcome Breakdown

Ongoing
1,069 (34.7%)
Outcome Unknown
984 (32.0%)
Recovered/Normal
794 (25.8%)
Euthanized
90 (2.9%)
Recovered with Sequela
80 (2.6%)
Died
60 (1.9%)

Gender Distribution

Female 1,524 (49.6%)
Male 1,484 (48.3%)
Unknown 55 (1.8%)
Mixed 11 (0.4%)

Reports by Year

Year Reports Trend
2010 3
2011 33
2012 134
2013 158
2014 236
2015 245
2016 258
2017 208
2018 210
2019 207
2020 209
2021 193
2022 226
2023 237
2024 323
2025 194
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 (unspecified) sits in the registered size-class taxonomy. Average reported weight: 13.9 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 (unspecified) Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Spaniel (unspecified) accounts for 3,074 submitted reports and currently ranks #60 by report volume within the dog population. Of those reports, 150 involved a death outcome — a 490.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 7.0 years, with an average recorded body weight of 13.9 kg (30.6 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 (unspecified) are Vomiting (502 reports), Lethargy (see also Central nervous system depression in 'Neurological') (291 reports), Diarrhoea (262 reports), together capturing a substantial share of the top-reaction traffic seen in this breed's record. On the product side, Pyrantel Pamoate;Sarolaner appears in 438 reports and is the single most-referenced drug, followed by Trilostane (404) and Oclacitinib Maleate (313). 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 3,077 reports with a recorded status is dominated by Ongoing (34.7% 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 (unspecified) Adverse Event Data

Spaniel (unspecified) has a moderate volume of adverse event reports (3,074). Report counts are influenced by breed popularity, owner awareness, and veterinary reporting practices.

The 490.0% 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 Pyrantel Pamoate;Sarolaner, appearing in 438 reports. This may indicate widespread use of the medication rather than a specific safety concern for Spaniel (unspecified).

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Spaniel (unspecified)?
There are 3,074 adverse event reports involving Spaniel (unspecified) in the FDA database, with 150 reports involving death (490.0% death rate). Spaniel (unspecified) ranks #60 by report volume.
What are the most common adverse reactions reported for Spaniel (unspecified)?
The most commonly reported adverse reactions for Spaniel (unspecified) are Vomiting (502 reports), Lethargy (see also Central nervous system depression in 'Neurological') (291 reports), Diarrhoea (262 reports), Lack of efficacy - NOS (208 reports), Lack of efficacy (endoparasite) - hookworm (187 reports).
What drugs are most frequently associated with Spaniel (unspecified) adverse events?
The drugs most frequently referenced in Spaniel (unspecified) adverse event reports are Pyrantel Pamoate;Sarolaner (438 reports), Trilostane (404 reports), Oclacitinib Maleate (313 reports), Ivermectin + Pyrantel As Pamoate Salt (281 reports), Milbemycin Oxime + Spinosad (266 reports).
What is the average age of Spaniel (unspecified) in adverse event reports?
The average age of Spaniel (unspecified) at the time of adverse event reports is 7.0 years, with an average weight of 13.9 kg (30.6 lbs).
Does a high number of adverse event reports mean Spaniel (unspecified) 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 (unspecified) 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 (unspecified) ranks #60 by total report volume. Death rate (490.0%) 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