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2026 FDA CVM data 44 reports on file official source

Puli — FDA Adverse Event Profile

Adverse-event records and label data for Puli (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. 4 3 2 1 0 2017 2018 2019 2020 2021 2022 2023 2024 Reports filed Death-coded reports
Annual report volume for Puli drawn from FDA CVM filings.

Puli (Dog) has 44 FDA adverse event reports on record, with 0 deaths reported (0.0% death rate) — ranking #276 by report volume. The most frequently reported reaction is Vomiting (11 cases). The top associated drug is Milbemycin Oxime + Spinosad. Average age at report: 5.9 years.

Total Reports

44

FDA CVM filings

Deaths Reported

0

of 44 reports

Death Rate

0.0%

death-coded share

Avg Age at Report

5.9 yr

13.7 kg avg weight

Death-Coded Outcome Share

Puli death-coded reports 0.0%
Database median

0.0% of 44 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: 13.7 kg (30.2 lbs)

Top Reported Reactions

Vomiting 11
Diarrhoea 8
Lack of efficacy (ectoparasite) - flea 6
Restlessness 5
Lethargy (see also Central nervous system depression in 'Neurological') 5
Behavioural disorder NOS 4
Emesis 3
Infertility NOS 3
INEFFECTIVE, HEARTWORM LARVAE 2
Head shake - ear disorder 2
Shaking 2
Underdose 2
Vocalisation 2
Seizure NOS 2
Barking 2

Most Referenced Drugs

Milbemycin Oxime + Spinosad 10
Spinosad 6
Milbemycin Oxime 4
Ivermectin + Pyrantel As Pamoate Salt 4
Cyclosporine 2
Carprofen 2
Oclacitinib Maleate 2
Milbemycin Oxime, Lufenuron 2
Fluralaner Chew Tablets 2
Afoxolaner 2
Fluralaner 13.64% 12-Week Chew 2
Milbemycin Oxime + Praziquantel 2
Selamectin 1
Ivermectin 136Mcg, Pyrantel 114Mg 1
Cyphenothrin 40.0 %,Pyriproxyfen 2.0% 1

Outcome Breakdown

Outcome Unknown
20 (47.6%)
Recovered/Normal
14 (33.3%)
Ongoing
6 (14.3%)
Recovered with Sequela
2 (4.8%)

Gender Distribution

Female 22 (50.0%)
Male 21 (47.7%)
Unknown 1 (2.3%)

Reports by Year

Year Reports Trend
2010 2
2011 1
2012 1
2013 2
2014 5
2015 6
2016 9
2017 1
2018 1
2019 2
2020 3
2021 4
2022 2
2023 1
2024 4
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 Puli sits in the registered size-class taxonomy. Average reported weight: 13.7 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.

Puli Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Puli accounts for 44 submitted reports and currently ranks #276 by report volume within the dog population. Of those reports, 0 involved a death outcome — a 0.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 5.9 years, with an average recorded body weight of 13.7 kg (30.2 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 Puli are Vomiting (11 reports), Diarrhoea (8 reports), Lack of efficacy (ectoparasite) - flea (6 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 10 reports and is the single most-referenced drug, followed by Spinosad (6) and Milbemycin Oxime (4). 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 42 reports with a recorded status is dominated by Outcome Unknown (47.6% of coded outcomes). Annual submission volume ranges from 2,010 to 2,024 reports across the 15 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 Puli Adverse Event Data

Puli has 44 adverse event reports on file. Lower report volumes may reflect a less common breed, lower reporting rates, or genuinely fewer adverse events.

A 0.0% death rate is below average in the FDA adverse event database, suggesting reported events tend toward less severe outcomes.

The most frequently referenced drug in adverse reports is Milbemycin Oxime + Spinosad, appearing in 10 reports. This may indicate widespread use of the medication rather than a specific safety concern for Puli.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Puli?
There are 44 adverse event reports involving Puli in the FDA database, with 0 reports involving death (0.0% death rate). Puli ranks #276 by report volume.
What are the most common adverse reactions reported for Puli?
The most commonly reported adverse reactions for Puli are Vomiting (11 reports), Diarrhoea (8 reports), Lack of efficacy (ectoparasite) - flea (6 reports), Restlessness (5 reports), Lethargy (see also Central nervous system depression in 'Neurological') (5 reports).
What drugs are most frequently associated with Puli adverse events?
The drugs most frequently referenced in Puli adverse event reports are Milbemycin Oxime + Spinosad (10 reports), Spinosad (6 reports), Milbemycin Oxime (4 reports), Ivermectin + Pyrantel As Pamoate Salt (4 reports), Cyclosporine (2 reports).
What is the average age of Puli in adverse event reports?
The average age of Puli at the time of adverse event reports is 5.9 years, with an average weight of 13.7 kg (30.2 lbs).
Does a high number of adverse event reports mean Puli 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 Puli 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.

Puli ranks #276 by total report volume. Death rate (0.0%) 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