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2026 FDA CVM data 1,253 reports on file official source

Saint Bernard Dog — FDA Adverse Event Profile

Adverse-event records and label data for Saint Bernard 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. 105 78.75 52.5 26.25 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Saint Bernard Dog drawn from FDA CVM filings.

Saint Bernard Dog (Dog) has 1,253 FDA adverse event reports on record, with 98 deaths reported (780.0% death rate) — ranking #98 by report volume. The most frequently reported reaction is Vomiting (218 cases). The top associated drug is Milbemycin Oxime + Spinosad. Average age at report: 4.4 years.

Total Reports

1,253

FDA CVM filings

Deaths Reported

98

of 1,253 reports

Death Rate

780.0%

death-coded share

Avg Age at Report

4.4 yr

50.6 kg avg weight

Death-Coded Outcome Share

Saint Bernard Dog death-coded reports 100.0%
Database median

780.0% of 1,253 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: 50.6 kg (111.6 lbs)

Top Reported Reactions

Vomiting 218
INEFFECTIVE, HEARTWORM LARVAE 94
Diarrhoea 89
Emesis 85
Lethargy (see also Central nervous system depression in 'Neurological') 84
Seizure NOS 84
Lack of efficacy - NOS 74
Lack of efficacy (endoparasite) - heartworm 67
Anorexia 58
Lack of efficacy (ectoparasite) - flea 53
Underdose 47
Death by euthanasia 46
Death 43
Weight loss 41
Lack of efficacy (endoparasite) - hookworm 40

Most Referenced Drugs

Milbemycin Oxime + Spinosad 211
Ivermectin + Pyrantel As Pamoate Salt 157
Carprofen 91
Pyrantel Pamoate;Sarolaner 88
Afoxolaner 79
Milbemycin Oxime + Praziquantel 78
Spinosad 69
Fluralaner Chew Tablets 63
Bedinvetmab 62
Moxidectin 58
Fluralaner 13.64% 12-Week Chew 52
Oclacitinib Maleate 35
Sarolaner 33
Gabapentin 29
Prednisone 28

Outcome Breakdown

Outcome Unknown
394 (34.0%)
Ongoing
314 (27.1%)
Recovered/Normal
313 (27.0%)
Died
52 (4.5%)
Euthanized
46 (4.0%)
Recovered with Sequela
39 (3.4%)

Gender Distribution

Male 692 (55.2%)
Female 523 (41.7%)
Unknown 33 (2.6%)
Mixed 5 (0.4%)

Reports by Year

Year Reports Trend
2010 52
2011 75
2012 81
2013 88
2014 60
2015 77
2016 82
2017 96
2018 100
2019 81
2020 76
2021 59
2022 63
2023 84
2024 105
2025 74
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 Saint Bernard Dog sits in the registered size-class taxonomy. Average reported weight: 50.6 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.

Saint Bernard Dog Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Saint Bernard Dog accounts for 1,253 submitted reports and currently ranks #98 by report volume within the dog population. Of those reports, 98 involved a death outcome — a 780.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 4.4 years, with an average recorded body weight of 50.6 kg (111.6 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 Saint Bernard Dog are Vomiting (218 reports), INEFFECTIVE, HEARTWORM LARVAE (94 reports), Diarrhoea (89 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 211 reports and is the single most-referenced drug, followed by Ivermectin + Pyrantel As Pamoate Salt (157) and Carprofen (91). 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 1,158 reports with a recorded status is dominated by Outcome Unknown (34.0% 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 Saint Bernard Dog Adverse Event Data

Saint Bernard Dog has a moderate volume of adverse event reports (1,253). Report counts are influenced by breed popularity, owner awareness, and veterinary reporting practices.

The 780.0% 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 Milbemycin Oxime + Spinosad, appearing in 211 reports. This may indicate widespread use of the medication rather than a specific safety concern for Saint Bernard Dog.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Saint Bernard Dog?
There are 1,253 adverse event reports involving Saint Bernard Dog in the FDA database, with 98 reports involving death (780.0% death rate). Saint Bernard Dog ranks #98 by report volume.
What are the most common adverse reactions reported for Saint Bernard Dog?
The most commonly reported adverse reactions for Saint Bernard Dog are Vomiting (218 reports), INEFFECTIVE, HEARTWORM LARVAE (94 reports), Diarrhoea (89 reports), Emesis (85 reports), Lethargy (see also Central nervous system depression in 'Neurological') (84 reports).
What drugs are most frequently associated with Saint Bernard Dog adverse events?
The drugs most frequently referenced in Saint Bernard Dog adverse event reports are Milbemycin Oxime + Spinosad (211 reports), Ivermectin + Pyrantel As Pamoate Salt (157 reports), Carprofen (91 reports), Pyrantel Pamoate;Sarolaner (88 reports), Afoxolaner (79 reports).
What is the average age of Saint Bernard Dog in adverse event reports?
The average age of Saint Bernard Dog at the time of adverse event reports is 4.4 years, with an average weight of 50.6 kg (111.6 lbs).
Does a high number of adverse event reports mean Saint Bernard 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 Saint Bernard 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.

Saint Bernard Dog ranks #98 by total report volume. Death rate (780.0%) 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