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2026 FDA CVM data 685 reports on file official source

Portuguese Water Dog — FDA Adverse Event Profile

Adverse-event records and label data for Portuguese Water Dog (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. 54 40.5 27 13.5 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Portuguese Water Dog drawn from FDA CVM filings.

Portuguese Water Dog (Dog) has 685 FDA adverse event reports on record, with 25 deaths reported (360.0% death rate) — ranking #122 by report volume. The most frequently reported reaction is Vomiting (156 cases). The top associated drug is Ivermectin + Pyrantel As Pamoate Salt. Average age at report: 5.0 years.

Total Reports

685

FDA CVM filings

Deaths Reported

25

of 685 reports

Death Rate

360.0%

death-coded share

Avg Age at Report

5.0 yr

22.7 kg avg weight

Death-Coded Outcome Share

Portuguese Water Dog death-coded reports 100.0%
Database median

360.0% of 685 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: 22.7 kg (50.1 lbs)

Top Reported Reactions

Vomiting 156
Lethargy (see also Central nervous system depression in 'Neurological') 55
Lack of efficacy (endoparasite) - hookworm 54
Diarrhoea 53
Digestive tract disorder NOS 41
Emesis 39
Lack of efficacy (bacteria) - Borrelia 33
Anorexia 31
Lack of efficacy - NOS 28
INEFFECTIVE, ASCARIDS NOS 26
Lack of efficacy (ectoparasite) - tick NOS 26
Lack of efficacy (bacteria) - NOS 22
Lack of efficacy (endoparasite) - roundworm NOS 22
Other abnormal test result NOS 21
Ataxia 20

Most Referenced Drugs

Ivermectin + Pyrantel As Pamoate Salt 90
Afoxolaner 72
Milbemycin Oxime + Spinosad 70
Pyrantel Pamoate;Sarolaner 69
Oclacitinib Maleate 35
Fluralaner Chew Tablets 33
Milbemycin Oxime + Praziquantel 30
Spinosad 24
Sarolaner 23
Carprofen 21
Fluralaner 13.64% 12-Week Chew 17
Selamectin 16
Bedinvetmab 16
Milbemycin Oxime 13
Moxidectin 12

Outcome Breakdown

Outcome Unknown
222 (35.0%)
Recovered/Normal
196 (30.9%)
Ongoing
178 (28.0%)
Recovered with Sequela
14 (2.2%)
Euthanized
13 (2.0%)
Died
12 (1.9%)

Gender Distribution

Male 355 (51.8%)
Female 317 (46.3%)
Unknown 9 (1.3%)
Mixed 4 (0.6%)

Reports by Year

Year Reports Trend
2010 24
2011 28
2012 45
2013 39
2014 42
2015 45
2016 59
2017 54
2018 54
2019 40
2020 39
2021 44
2022 38
2023 41
2024 48
2025 45
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 Portuguese Water Dog sits in the registered size-class taxonomy. Average reported weight: 22.7 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.

Portuguese Water Dog Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Portuguese Water Dog accounts for 685 submitted reports and currently ranks #122 by report volume within the dog population. Of those reports, 25 involved a death outcome — a 360.0% 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 22.7 kg (50.1 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 Portuguese Water Dog are Vomiting (156 reports), Lethargy (see also Central nervous system depression in 'Neurological') (55 reports), Lack of efficacy (endoparasite) - hookworm (54 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 90 reports and is the single most-referenced drug, followed by Afoxolaner (72) and Milbemycin Oxime + Spinosad (70). 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 635 reports with a recorded status is dominated by Outcome Unknown (35.0% 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 Portuguese Water Dog Adverse Event Data

Portuguese Water Dog has a moderate volume of adverse event reports (685). Report counts are influenced by breed popularity, owner awareness, and veterinary reporting practices.

The 360.0% 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 90 reports. This may indicate widespread use of the medication rather than a specific safety concern for Portuguese Water Dog.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Portuguese Water Dog?
There are 685 adverse event reports involving Portuguese Water Dog in the FDA database, with 25 reports involving death (360.0% death rate). Portuguese Water Dog ranks #122 by report volume.
What are the most common adverse reactions reported for Portuguese Water Dog?
The most commonly reported adverse reactions for Portuguese Water Dog are Vomiting (156 reports), Lethargy (see also Central nervous system depression in 'Neurological') (55 reports), Lack of efficacy (endoparasite) - hookworm (54 reports), Diarrhoea (53 reports), Digestive tract disorder NOS (41 reports).
What drugs are most frequently associated with Portuguese Water Dog adverse events?
The drugs most frequently referenced in Portuguese Water Dog adverse event reports are Ivermectin + Pyrantel As Pamoate Salt (90 reports), Afoxolaner (72 reports), Milbemycin Oxime + Spinosad (70 reports), Pyrantel Pamoate;Sarolaner (69 reports), Oclacitinib Maleate (35 reports).
What is the average age of Portuguese Water Dog in adverse event reports?
The average age of Portuguese Water Dog at the time of adverse event reports is 5.0 years, with an average weight of 22.7 kg (50.1 lbs).
Does a high number of adverse event reports mean Portuguese Water Dog 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 Portuguese Water Dog 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.

Portuguese Water Dog ranks #122 by total report volume. Death rate (360.0%) 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