Total Reports
56
FDA CVM filings
Adverse-event records and label data for Spaniel - American Water (Dog), sourced from the FDA Center for Veterinary Medicine. Refreshed as new reports are filed. Cite PlainBreed when reusing this analysis.
Spaniel - American Water (Dog) has 56 FDA adverse event reports on record, with 4 deaths reported (710.0% death rate) — ranking #264 by report volume. The most frequently reported reaction is Vomiting (8 cases). The top associated drug is Ivermectin + Pyrantel As Pamoate Salt. Average age at report: 5.7 years.
Total Reports
56
FDA CVM filings
Deaths Reported
4
of 56 reports
Death Rate
710.0%
death-coded share
Avg Age at Report
5.7 yr
17.4 kg avg weight
710.0% of 56 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.
| Year | Reports | Trend |
|---|---|---|
| 2010 | 2 | |
| 2011 | 1 | |
| 2012 | 5 | |
| 2013 | 7 | |
| 2014 | 4 | |
| 2015 | 4 | |
| 2016 | 4 | |
| 2017 | 3 | |
| 2018 | 6 | |
| 2019 | 3 | |
| 2020 | 3 | |
| 2021 | 4 | |
| 2022 | 1 | |
| 2023 | 1 | |
| 2024 | 6 | |
| 2025 | 2 | |
Across the FDA Center for Veterinary Medicine adverse event database, Spaniel - American Water accounts for 56 submitted reports and currently ranks #264 by report volume within the dog population. Of those reports, 4 involved a death outcome — a 710.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 5.7 years, with an average recorded body weight of 17.4 kg (38.4 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 - American Water are Vomiting (8 reports), Digestive tract disorder NOS (7 reports), Lack of efficacy (endoparasite) - hookworm (7 reports), together capturing a substantial share of the top-reaction traffic seen in this breed's record. On the product side, Ivermectin + Pyrantel As Pamoate Salt appears in 10 reports and is the single most-referenced drug, followed by Milbemycin Oxime + Spinosad (7) and Spinosad (5). 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 53 reports with a recorded status is dominated by Outcome Unknown (35.8% 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.
Spaniel - American Water has 56 adverse event reports on file. Lower report volumes may reflect a less common breed, lower reporting rates, or genuinely fewer adverse events.
The 710.0% 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 Ivermectin + Pyrantel As Pamoate Salt, appearing in 10 reports. This may indicate widespread use of the medication rather than a specific safety concern for Spaniel - American Water.
What FDA reports are and how they are collected
Why some breeds appear in more adverse event reports
Evaluating medication risks using FDA data
Drugs that appear most in adverse event reports
The reporting process and database limitations
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 - American Water ranks #264 by total report volume. Death rate (710.0%) 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.
Read our methodology — how this data is sourced, computed, and verified.