Total Reports
4,292
FDA CVM filings
Dog /
FDA CVM · 2025 release 4,292 reports on file
Great Pyrenees - FDA Adverse Event Profile
Adverse-event records for Great Pyrenees (Dog) from the FDA Center for Veterinary Medicine.
Data updated June 2026
The record at a glance
With 4,292 reports on file, Great Pyrenees sits at #45 among dog breeds by volume; death-coded share is 3.8% (164 reports).
- #45
- most-reported dog breed
- 3.8%
- death-coded report share
- 871
- Lack of efficacy (endoparasite) - heartworm - top reaction
- 3.8 yr
- average age at report
Read report counts next to breed popularity: a bigger number often just means more owners and more vet visits.
Deaths Reported
164
of 4,292 reports
Death Rate
3.8%
death-coded share
Avg Age at Report
3.8 yr
39.7 kg avg weight
Death-Coded Outcome Share
Great Pyrenees death-coded reports 3.8%
Cross-breed median
3.8% of 4,292 great pyrenees reports involved a death outcome.
How to read this number
Read alongside breed popularity, veterinary access, and owner awareness, these shape how many events ever reach the FDA. The comparison line marks the cross-breed median death-coded share (about 4.8%) among breeds with 50 or more reports; values above it suggest higher reporting bias toward severe outcomes, not necessarily higher true mortality.
Average weight at time of report: 39.7 kg (87.5 lbs)
Top Reported Reactions
Lack of efficacy (endoparasite) - heartworm 871
Vomiting 610
INEFFECTIVE, HEARTWORM LARVAE 316
Lethargy (see also Central nervous system depression in 'Neurological') 246
Diarrhoea 218
Lack of efficacy (endoparasite) - hookworm 212
Lack of efficacy (ectoparasite) - flea 196
Emesis 196
Lack of efficacy - NOS 180
Lack of efficacy (ectoparasite) - tick NOS 160
Lack of efficacy (bacteria) - Borrelia 134
Seizure NOS 132
Underdose 109
Cardiac disorder NOS 101
Panting 97
Most Referenced Drugs
Ivermectin + Pyrantel As Pamoate Salt 821
Milbemycin Oxime + Spinosad 670
Pyrantel Pamoate;Sarolaner 422
Milbemycin Oxime + Praziquantel 383
Moxidectin 376
Afoxolaner 333
Fluralaner 13.64% 12-Week Chew 160
Fluralaner Chew Tablets 140
Spinosad 132
Melarsomine Dihydrochloride 126
Bedinvetmab 118
Carprofen 92
Oclacitinib Maleate 79
Sarolaner 79
Lotilaner 75
Outcome Breakdown
Outcome Unknown
1,424 (34.5%)
Ongoing
1,403 (34.0%)
Recovered/Normal
908 (22.0%)
Recovered with Sequela
231 (5.6%)
Died
90 (2.2%)
Euthanized
74 (1.8%)
Gender Distribution
Male 2,200 (51.3%)
Female 2,000 (46.6%)
Unknown 71 (1.7%)
Mixed 21 (0.5%)
Reports by Year
| Year | Reports | Trend |
|---|---|---|
| 2010 | 85 | |
| 2011 | 120 | |
| 2012 | 149 | |
| 2013 | 180 | |
| 2014 | 173 | |
| 2015 | 174 | |
| 2016 | 238 | |
| 2017 | 238 | |
| 2018 | 261 | |
| 2019 | 322 | |
| 2020 | 363 | |
| 2021 | 365 | |
| 2022 | 403 | |
| 2023 | 436 | |
| 2024 | 484 | |
| 2025 | 301 | |
Great Pyrenees Pet Health Insights
Great Pyrenees accounts for 4,292 FDA adverse event reports, ranking #45 by volume among dog breeds, with 164 reports (3.8%) coded as a death outcome. Mean age at report: 3.8 years, average weight 39.7 kg (87.5 lbs).
Top reported signs: Lack of efficacy (endoparasite) - heartworm (871), Vomiting (610), INEFFECTIVE, HEARTWORM LARVAE (316). Most-referenced drug: Ivermectin + Pyrantel As Pamoate Salt (821 reports), followed by Milbemycin Oxime + Spinosad (670) and Pyrantel Pamoate;Sarolaner (422).
Outcome coding on 4,130 status-recorded reports is dominated by Outcome Unknown (34.5%). Annual submissions ranged 2,010-2,025 across 16 years on file.
Dog Breeds With a Similar Report Volume
Terrier - West Highland White
4,266 reports · 4.9% death rate
Deutsche Dogge, Great Dane
4,227 reports · 6.0% death rate
Poodle - Standard
4,455 reports · 3.1% death rate
Dachshund - Miniature
4,095 reports · 4.6% death rate
Doberman Pinscher
4,495 reports · 5.7% death rate
Poodle - Toy
4,084 reports · 4.0% death rate
Frequently Asked Questions
How many FDA adverse event reports involve Great Pyrenees? ▼
There are 4,292 adverse event reports involving Great Pyrenees in the FDA database, with 164 reports involving death (3.8% death rate). Great Pyrenees ranks #45 by report volume.
What are the most common adverse reactions reported for Great Pyrenees? ▼
The most commonly reported adverse reactions for Great Pyrenees are Lack of efficacy (endoparasite) - heartworm (871 reports), Vomiting (610 reports), INEFFECTIVE, HEARTWORM LARVAE (316 reports), Lethargy (see also Central nervous system depression in 'Neurological') (246 reports), Diarrhoea (218 reports).
What drugs are most frequently associated with Great Pyrenees adverse events? ▼
The drugs most frequently referenced in Great Pyrenees adverse event reports are Ivermectin + Pyrantel As Pamoate Salt (821 reports), Milbemycin Oxime + Spinosad (670 reports), Pyrantel Pamoate;Sarolaner (422 reports), Milbemycin Oxime + Praziquantel (383 reports), Moxidectin (376 reports).
What is the average age of Great Pyrenees in adverse event reports? ▼
The average age of Great Pyrenees at the time of adverse event reports is 3.8 years, with an average weight of 39.7 kg (87.5 lbs).
Does a high number of adverse event reports mean Great Pyrenees 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 Great Pyrenees 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.
Compare a breed's report volume against how common the breed is before drawing conclusions. See our methodology for how death rate and rankings are computed.
Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. Breed figures are computed directly from FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.