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2026 FDA CVM data 5 reports on file official source

Mastiff - Pyrenean — FDA Adverse Event Profile

Adverse-event records and label data for Mastiff - Pyrenean (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. 1 0.75 0.5 0.25 0 2014 2015 2016 2019 2025 Reports filed Death-coded reports
Annual report volume for Mastiff - Pyrenean drawn from FDA CVM filings.

Mastiff - Pyrenean (Dog) has 5 FDA adverse event reports on record, with 0 deaths reported (0.0% death rate) — ranking #495 by report volume. The most frequently reported reaction is Vomiting (2 cases). The top associated drug is Milbemycin Oxime + Spinosad. Average age at report: 4.7 years.

Total Reports

5

FDA CVM filings

Deaths Reported

0

of 5 reports

Death Rate

0.0%

death-coded share

Avg Age at Report

4.7 yr

55.6 kg avg weight

Death-Coded Outcome Share

Mastiff - Pyrenean death-coded reports 0.0%
Database median

0.0% of 5 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: 55.6 kg (122.6 lbs)

Top Reported Reactions

Vomiting 2
Lethargy (see also Central nervous system depression in 'Neurological') 2
Emesis 1
INEFFECTIVE, WORMS NOS 1
Overdose 1
Skin disorders NOS 1
Pododermatitis 1
Hypothyroidism 1
Tooth disorder 1
Drooling 1
Anorexia 1
Neutrophilia 1
Cough 1
Abnormal radiograph finding 1
Intestinal perforation 1

Most Referenced Drugs

Milbemycin Oxime + Spinosad 2
Deracoxib 2
Fenbendazol Granules 1
Marbofloxacin 1
Doxycycline 1
Metronidazole 1
Ilunocitinib 1
Antibiotic (Unknown) 1
Itching Medication (Unknown) 1
Shampoo 1

Outcome Breakdown

Ongoing
3 (60.0%)
Recovered/Normal
1 (20.0%)
Outcome Unknown
1 (20.0%)

Gender Distribution

Male 4 (80.0%)
Female 1 (20.0%)

Reports by Year

Year Reports Trend
2014 1
2015 1
2016 1
2019 1
2025 1
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 Mastiff - Pyrenean sits in the registered size-class taxonomy. Average reported weight: 55.6 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.

Mastiff - Pyrenean Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Mastiff - Pyrenean accounts for 5 submitted reports and currently ranks #495 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 4.7 years, with an average recorded body weight of 55.6 kg (122.6 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 Mastiff - Pyrenean are Vomiting (2 reports), Lethargy (see also Central nervous system depression in 'Neurological') (2 reports), Emesis (1 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 2 reports and is the single most-referenced drug, followed by Deracoxib (2) and Fenbendazol Granules (1). 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 5 reports with a recorded status is dominated by Ongoing (60.0% of coded outcomes). Annual submission volume ranges from 2,014 to 2,025 reports across the 5 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 Mastiff - Pyrenean Adverse Event Data

Mastiff - Pyrenean has 5 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 2 reports. This may indicate widespread use of the medication rather than a specific safety concern for Mastiff - Pyrenean.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Mastiff - Pyrenean?
There are 5 adverse event reports involving Mastiff - Pyrenean in the FDA database, with 0 reports involving death (0.0% death rate). Mastiff - Pyrenean ranks #495 by report volume.
What are the most common adverse reactions reported for Mastiff - Pyrenean?
The most commonly reported adverse reactions for Mastiff - Pyrenean are Vomiting (2 reports), Lethargy (see also Central nervous system depression in 'Neurological') (2 reports), Emesis (1 reports), INEFFECTIVE, WORMS NOS (1 reports), Overdose (1 reports).
What drugs are most frequently associated with Mastiff - Pyrenean adverse events?
The drugs most frequently referenced in Mastiff - Pyrenean adverse event reports are Milbemycin Oxime + Spinosad (2 reports), Deracoxib (2 reports), Fenbendazol Granules (1 reports), Marbofloxacin (1 reports), Doxycycline (1 reports).
What is the average age of Mastiff - Pyrenean in adverse event reports?
The average age of Mastiff - Pyrenean at the time of adverse event reports is 4.7 years, with an average weight of 55.6 kg (122.6 lbs).
Does a high number of adverse event reports mean Mastiff - Pyrenean 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 Mastiff - Pyrenean 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.

Mastiff - Pyrenean ranks #495 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