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2026 FDA CVM data 2,817 reports on file official source

Mountain Dog - Bernese — FDA Adverse Event Profile

Adverse-event records and label data for Mountain Dog - Bernese (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. 461 345.75 230.5 115.25 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Mountain Dog - Bernese drawn from FDA CVM filings.

Mountain Dog - Bernese (Dog) has 2,817 FDA adverse event reports on record, with 126 deaths reported (450.0% death rate) — ranking #65 by report volume. The most frequently reported reaction is Vomiting (539 cases). The top associated drug is Pyrantel Pamoate;Sarolaner. Average age at report: 2.8 years.

Total Reports

2,817

FDA CVM filings

Deaths Reported

126

of 2,817 reports

Death Rate

450.0%

death-coded share

Avg Age at Report

2.8 yr

31.4 kg avg weight

Death-Coded Outcome Share

Mountain Dog - Bernese death-coded reports 100.0%
Database median

450.0% of 2,817 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: 31.4 kg (69.2 lbs)

Top Reported Reactions

Vomiting 539
Diarrhoea 331
Lack of efficacy (bacteria) - Borrelia 303
Lack of efficacy (endoparasite) - hookworm 231
Lack of efficacy (ectoparasite) - tick NOS 184
Lethargy (see also Central nervous system depression in 'Neurological') 169
Lack of efficacy (endoparasite) - roundworm NOS 135
Anorexia 110
Other abnormal test result NOS 106
Seizure NOS 104
Lack of efficacy - NOS 102
Lethargy (see also Central nervous system depression in Neurological) 84
Lack of efficacy (bacteria) - NOS 76
Death by euthanasia 75
Panting 74

Most Referenced Drugs

Pyrantel Pamoate;Sarolaner 632
Ivermectin + Pyrantel As Pamoate Salt 355
Afoxolaner 340
Milbemycin Oxime + Praziquantel 209
Milbemycin Oxime + Spinosad 169
Lotilaner 135
Carprofen 111
Moxidectin 98
Oclacitinib Maleate 88
Fluralaner 13.64% 12-Week Chew 84
Sarolaner 76
Bedinvetmab 72
Recombitek Lyme - 2126.R0 70
Fluralaner Chew Tablets 63
Recombinant E. Coli Bl21;Recombinant E. Coli Ecl19 60

Outcome Breakdown

Ongoing
972 (35.6%)
Outcome Unknown
878 (32.1%)
Recovered/Normal
724 (26.5%)
Euthanized
64 (2.3%)
Died
62 (2.3%)
Recovered with Sequela
31 (1.1%)

Gender Distribution

Male 1,510 (53.6%)
Female 1,227 (43.6%)
Unknown 67 (2.4%)
Mixed 13 (0.5%)

Reports by Year

Year Reports Trend
2010 51
2011 56
2012 59
2013 60
2014 103
2015 100
2016 105
2017 132
2018 117
2019 147
2020 207
2021 245
2022 299
2023 342
2024 461
2025 333
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 Mountain Dog - Bernese sits in the registered size-class taxonomy. Average reported weight: 31.4 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.

Mountain Dog - Bernese Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Mountain Dog - Bernese accounts for 2,817 submitted reports and currently ranks #65 by report volume within the dog population. Of those reports, 126 involved a death outcome — a 450.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 2.8 years, with an average recorded body weight of 31.4 kg (69.2 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 Mountain Dog - Bernese are Vomiting (539 reports), Diarrhoea (331 reports), Lack of efficacy (bacteria) - Borrelia (303 reports), together capturing a substantial share of the top-reaction traffic seen in this breed's record. On the product side, Pyrantel Pamoate;Sarolaner appears in 632 reports and is the single most-referenced drug, followed by Ivermectin + Pyrantel As Pamoate Salt (355) and Afoxolaner (340). 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 2,731 reports with a recorded status is dominated by Ongoing (35.6% 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 Mountain Dog - Bernese Adverse Event Data

Mountain Dog - Bernese has a moderate volume of adverse event reports (2,817). Report counts are influenced by breed popularity, owner awareness, and veterinary reporting practices.

The 450.0% 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 Pyrantel Pamoate;Sarolaner, appearing in 632 reports. This may indicate widespread use of the medication rather than a specific safety concern for Mountain Dog - Bernese.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Mountain Dog - Bernese?
There are 2,817 adverse event reports involving Mountain Dog - Bernese in the FDA database, with 126 reports involving death (450.0% death rate). Mountain Dog - Bernese ranks #65 by report volume.
What are the most common adverse reactions reported for Mountain Dog - Bernese?
The most commonly reported adverse reactions for Mountain Dog - Bernese are Vomiting (539 reports), Diarrhoea (331 reports), Lack of efficacy (bacteria) - Borrelia (303 reports), Lack of efficacy (endoparasite) - hookworm (231 reports), Lack of efficacy (ectoparasite) - tick NOS (184 reports).
What drugs are most frequently associated with Mountain Dog - Bernese adverse events?
The drugs most frequently referenced in Mountain Dog - Bernese adverse event reports are Pyrantel Pamoate;Sarolaner (632 reports), Ivermectin + Pyrantel As Pamoate Salt (355 reports), Afoxolaner (340 reports), Milbemycin Oxime + Praziquantel (209 reports), Milbemycin Oxime + Spinosad (169 reports).
What is the average age of Mountain Dog - Bernese in adverse event reports?
The average age of Mountain Dog - Bernese at the time of adverse event reports is 2.8 years, with an average weight of 31.4 kg (69.2 lbs).
Does a high number of adverse event reports mean Mountain Dog - Bernese 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 Mountain Dog - Bernese 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.

Mountain Dog - Bernese ranks #65 by total report volume. Death rate (450.0%) 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